197 results on '"de Boer, Marjon A"'
Search Results
152. Maternal Sildenafil vs Placebo in Pregnant Women With Severe Early-Onset Fetal Growth Restriction: A Randomized Clinical Trial.
- Author
-
Pels, Anouk, Derks, Jan, Elvan-Taspinar, Ayten, van Drongelen, Joris, de Boer, Marjon, Duvekot, Hans, van Laar, Judith, van Eyck, Jim, Al-Nasiry, Salwan, Sueters, Marieke, Post, Marinka, Onland, Wes, van Wassenaer-Leemhuis, Aleid, Naaktgeboren, Christiana, Jakobsen, Janus C., Gluud, Christian, Duijnhoven, Ruben G., Lely, Titia, Gordijn, Sanne, and Ganzevoort, Wessel
- Published
- 2020
- Full Text
- View/download PDF
153. The role of middle cerebral and umbilical artery Doppler ultrasound in monitoring the small fetus
- Author
-
Schreurs, C.A., de Groot, Christianne, Bax, Caroline, de Boer, Marjon, Obstetrics and gynaecology, de Groot, C.J.M., Bax, C.J., and de Boer, M.A.
- Subjects
fetal growth restriction ,prenatal diagnosis ,obstetrics ,Doppler ultrasound - Published
- 2019
154. Hypertensive disorders of pregnancy: Aspects of prevention and follow-up
- Author
-
Abheiden, CNH, de Vries, Hanneke, Thijs, Abel, de Boer, Marjon, Obstetrics and gynaecology, and ACS - Atherosclerosis & ischemic syndromes
- Published
- 2017
155. Systemic lupus erythematosus is associated with an increased frequency of spontaneous preterm births: systematic review and meta-analysis.
- Author
-
Abheiden CNH, Blomjous BS, Slaager C, Landman AJEMC, Ket JCF, Salmon JE, Buyon JP, Heymans MW, de Vries JIP, Bultink IEM, and de Boer MA
- Subjects
- Female, Humans, Pregnancy, Lupus Erythematosus, Systemic complications, Lupus Erythematosus, Systemic epidemiology, Lupus Erythematosus, Systemic therapy, Pregnancy Complications epidemiology, Pregnancy Complications therapy, Premature Birth epidemiology, Premature Birth etiology, Premature Birth prevention & control
- Abstract
Objective: Preterm birth is one of the most frequent complications of pregnancy in women with systemic lupus erythematosus. The high indicated preterm birth proportion due to hypertensive disorders of pregnancy and/or fetal growth restriction is well known, and preventive measures and screening for early detection are performed. The risk of spontaneous preterm birth is less well recognized. This study aimed to determine the proportions of spontaneous and indicated preterm birth in pregnancies of women with systemic lupus erythematosus., Data Sources: A systematic literature search using Pubmed, Embase, Web of Science, and Google Scholar was performed in June 2021., Study Eligibility Criteria: Studies in pregnant women with systemic lupus erythematosus reporting spontaneous and indicated preterm birth rates were selected. Original research articles published from 1995 to June 2021 were included., Methods: Quality and risk of bias of the included studies were assessed using the Newcastle-Ottawa quality assessment scale. To estimate the pooled event rates and 95% confidence intervals, meta-analysis of single proportions with a random-effects model was performed., Results: We included 21 articles, containing data of 8157 pregnancies in women with systemic lupus erythematosus. On average, 31% (95% prediction interval, 0.14-0.50) of the pregnancies resulted in preterm birth, including 14% (95% prediction interval, 0.04-0.27) spontaneous and 16% (95% prediction interval, 0.03-0.35) indicated preterm birth., Conclusion: In pregnant women with systemic lupus erythematosus, spontaneous and indicated preterm birth proportions are high. This information should be applied in (prepregnancy) counseling and management in pregnancy. The knowledge obtained by this meta-analysis paves the way for further research of associated risk factors and development of interventions to reduce spontaneous preterm birth in systemic lupus erythematosus pregnancies., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
156. Optimal treatment for women with acute hypertension in pregnancy; a randomized trial comparing intravenous labetalol versus nicardipine.
- Author
-
Bij de Weg JM, de Boer MA, Gravesteijn BY, Hermes W, Ganzevoort W, van Bel F, Willem Mol B, and de Groot CJM
- Abstract
Objectives: Blood pressure control in severe hypertension of pregnancy is crucial for mother and neonate. In absence of evidence, guidelines recommend either intravenous labetalol or nicardipine. We compared the effectiveness and safety of these two drugs in women with severe hypertension in pregnancy., Study Design: We performed an open label randomized controlled trial. Women with a singleton pregnancy complicated by severe hypertension (systolic ≥ 160 mmHg and/or diastolic ≥ 110 mmHg) requiring intravenous antihypertensive treatment were randomized to intravenous labetalol or intravenous nicardipine. The primary outcome was a composite adverse neonatal outcome defined as severe Respiratory Distress Syndrome (RDS), Broncho Pulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH) IIB or worse, Necrotizing Enterocolitis (NEC), or perinatal death defined as fetal death or neonatal death before discharge from the neonatal intensive care unit (NICU). Based on a power analysis, we estimated that 472 women (236 per group) needed to be included to detect a difference of 15% in the primary outcome with 90% power. The study was halted prematurely at 30 inclusions because of slow recruitment and trial fatigue., Results: Between August 2018 and April 2022, we randomized 30 women of which 16 were allocated to intravenous nicardipine and 14 to intravenous labetalol. The composite adverse neonatal outcome was not significantly different between the two groups (25 % versus 43 % OR 0.28 (95 % CI 0.05-1.43), p = 0.12)). Respiratory distress syndrome occurred more often in the labetalol group than in the nicardipine group (42.9 % versus 12.5 %). Neonatal hypoglycemia occurred more often in the nicardipine group than in the labetalol group (31 % versus 7 %). Time until blood pressure control was faster in women treated with nicardipine than in women treated with labetalol (45 (15-150 min vs. 120 (60-127,5) min)., Conclusion: In our prematurely halted small RCT, we were unable to provide evidence for the optimal choice of treatment for severe hypertension to improve neonatal outcome and/or to obtain faster blood pressure control. Differences in Respiratory distress syndrome and neonatal hypoglycemia between the groups might be the result of coincidental finding due to the small groups included in the study. A larger randomized trial would be needed to determine the safest and most efficacious (intravenous) therapy for severe hypertension in pregnancy. This study emphasizes the challenges of conducting a RCT for the optimal treatment for these women., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
157. Implementation of aspirin use during pregnancy in community midwifery-led care in the Netherlands: A pilot survey.
- Author
-
Bij de Weg JM, van Doornik R, van den Auweele KLHE, de Groot CJM, de Boer MA, and de Vries JIP
- Abstract
Introduction: Aspirin nowadays is widely used in pregnancy, but implementation among gynecologists took nearly four decades. For a complete insight in the implementation of aspirin, community midwives are to be involved. Community midwives do not have authority to prescribe aspirin and have to refer to a general practitioner or consultant obstetrician for a prescription., Methods: The study was an online, national pilot survey about the implementation of aspirin use during pregnancy among independently practicing community midwives consisting of 29 items with five categories: background, advising, prescribing, possible indications, and clinical practice., Results: Forty-seven community midwives completed the survey between April and May 2021. All respondents had experience on advising aspirin use in pregnancy. History of preterm pre-eclampsia or HELLP syndrome was identified as a risk factor for developing utero-placental complications by 97.9% of the community midwives. Moderate risk factors in women with otherwise low-risk pregnancy were identified by >75% of the participants. Practical issues in prescribing aspirin were experienced by one-third of the respondents. Suggestions were made to obtain authority for community midwives to prescribe aspirin and improve collaboration with consultant obstetricians and general practitioners., Conclusions: Community midwives seem to be adequate in identifying risk factors for developing utero-placental complications in women with otherwise low-risk pregnancy. Practical issues for prescribing aspirin occur often. Obtaining authority for community midwives to prescribe aspirin after education should be considered and consulting a consultant obstetrician should become more accessible to overcome the practical issues. Further educating community midwives and general practitioners might improve implementation rates and perinatal outcomes., Competing Interests: The authors have completed and submitted the ICMJE Form for disclosure of Potential Conflicts of Interest and none was reported., (© 2024 bij de Weg J.M. et al.)
- Published
- 2024
- Full Text
- View/download PDF
158. Multicentre study and systematic review: Allopurinol exposure during pregnancy.
- Author
-
Crouwel F, Simsek M, de Boer MA, van Asseldonk DP, Bhalla A, Weusthuis ALM, Gilissen LPL, Verburg RJ, Mares WGN, Jharap B, Kuijvenhoven JP, Oldenburg B, Buiter HJC, Julsgaard M, and de Boer NK
- Subjects
- Humans, Pregnancy, Female, Infant, Newborn, Adult, Allopurinol adverse effects, Pregnancy Complications drug therapy, Inflammatory Bowel Diseases drug therapy, Pregnancy Outcome, Abnormalities, Drug-Induced etiology
- Abstract
Background: Data about the safety of allopurinol in pregnant women are sparsely reported., Aims: To investigate the risk of adverse pregnancy outcome and congenital abnormalities after in utero exposure to allopurinol in inflammatory bowel disease (IBD) pregnancies and in general., Methods: We collected safety data of patients with IBD who were treated with allopurinol during pregnancy between January 2013 and March 2022. Additionally, we performed a systematic review about the teratogenic potential of allopurinol., Results: We collected data from 42 allopurinol-exposed pregnancies, including one twin pregnancy; in all women, allopurinol was combined with a thiopurine. Six pregnancies (14.3%) resulted in miscarriage and one in stillbirth at 32 weeks. A congenital anomaly was observed in one newborn (coarctation of the aorta discovered postpartum). Three pregnancies, including the twin pregnancy, ended in moderate preterm delivery and one in very preterm delivery. Five neonates (15.2%) were small for gestational age. From our literature search, we identified an additional 102 allopurinol-exposed pregnancies resulting in 129 live births, including 36 infants from our cohort. Ten infants (7.8%) were born with a congenital anomaly. Two (1.6%) had a comparable pattern of multiple anomalies. The systematic review sub-analysis including only infants born to mothers with IBD (n = 76) revealed that 2.6% of infants had congenital anomalies after in utero exposure to a low dose of allopurinol., Conclusions: Overall, the teratogenicity of allopurinol remains inconclusive. Children conceived by mothers treated for IBD with allopurinol/thiopurine co-therapy do not seem to have an increased risk of congenital anomalies., (© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)
- Published
- 2024
- Full Text
- View/download PDF
159. Preterm birth and uterine fibroid necrosis: The clinical presentation illustrated in a case series.
- Author
-
Don EE, Vissers G, Landman AJEMC, de Groot CJM, Mijatovic V, de Boer MA, and Huirne JAF
- Subjects
- Humans, Female, Adult, Pregnancy, Retrospective Studies, Young Adult, Middle Aged, Leiomyoma pathology, Leiomyoma complications, Leiomyoma diagnostic imaging, Premature Birth, Uterine Neoplasms pathology, Uterine Neoplasms complications, Necrosis
- Abstract
Objective: Uterine fibroids increase the risk of preterm birth. The current study highlights uterine fibroid necrosis as a possible cause of (extreme) preterm birth., Study Design: Retrospective cohort study in one Dutch academic hospital. Cases were selected from the 526 participants of the MyoFert study (Netherlands Trial Register, NL7990), which included patients who presented between 2004 and 2018 and were between the age of 18 and 45 years at the time of diagnosis of uterine fibroids. Of these participants, 414 women became pregnant. A retrospective chart review of the first pregnancies was performed. The main outcomes were (imminent) preterm birth and signs of fibroid necrosis on ultrasound. In women with signs of fibroid necrosis, the following data were collected systematically: fibroid characteristics, clinical presentation, pregnancy outcome, and postpartum period., Results: In total, 66 women had a preterm birth (16 %, 66/414), of which 25 pregnancies ended between 16 and <24 weeks (38 %, 25/66) and 41 pregnancies ended between 24 and <37 weeks of gestation (62 %, 41/66). Of all women with preterm birth and available ultrasound images, 15 % (7/48) had fibroid necrosis at the time of labour. These seven patients, supplemented with three patients with fibroid necrosis during their first pregnancy and at least one episode of imminent preterm birth, are described in more detail. In these ten patients, the fibroids increased substantially in size during the first and second trimester, leading to severe abdominal pain in all patients and hospital admission in seven patients. Ultrasound examination of the fibroids showed heterogenic changes and focal transonic areas in the fibroid, which are characteristics that indicate fibroid necrosis. In four patients, myomectomy was performed and necrosis was confirmed histologically., Conclusion: Fibroid necrosis during pregnancy is likely associated with (imminent) preterm birth. Clinicians are advised to structurally evaluate the myometrium in pregnancy, specifically in women presenting with abdominal pain in the second trimester., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
160. Patient perspectives and preferences on cerclage and preterm birth: a focus group study.
- Author
-
Abdulrahman N, Burger NB, van den Broek S, Kaaijk EM, Oudijk MA, de Boer MA, and Huirne JAF
- Subjects
- Humans, Female, Pregnancy, Adult, Netherlands, Patient Preference psychology, Young Adult, Focus Groups, Cerclage, Cervical, Premature Birth psychology, Qualitative Research, Quality of Life psychology
- Abstract
Aim: This qualitative focus group study aims to asses cerclage-related symptoms, the impact of a cerclage on daily functioning and patient perspectives of their healthcare experience. This study extends beyond the current focus on surgical and obstetric outcomes of a cerclage, thereby contributing to a more comprehensive understanding of the challenges faced by individuals in the context of extreme preterm birth and fetal loss and the impact of a cerclage on multiple facets in life., Methods: Participants were recruited from the Amsterdam University Medical Center, Amsterdam, the Netherlands or via the website of a Dutch patient organization for (extreme) preterm birth. Eligible participants were ≥ 18 years old with a previous vaginal and/or abdominal cerclage with a subsequent delivery at ≥ 34 weeks of gestation with neonatal survival. Two focus group discussions (FGD) were performed. A predefined format was used, which was identical for both the vaginal and abdominal cerclage group. The International Classification of Functioning, Disability and Health (ICF-DH) was used to provide structure. Outcomes were a broad range of participants reported perspectives on physical, emotional, and social-related quality of life., Results: In the Vaginal Cerclage Group (VCG) and Abdominal Cerclage Group (ACG), respectively, 11 and 8 participants were included. Fear for a subsequent pregnancy loss was the most limiting factor to perform daily activities during pregnancy in all participants with a cerclage. Fear to conceive again because of prior second-trimester fetal loss was experienced by 27% in the VCG and 13% in the ACG. The majority of participants experienced a reduction in anxiety after placement of their cerclage (VCG = 64%, ACG = 75%). Decreased mobility/bedrest (VCG = 100%, ACG = 75%) and blood loss (VCG = 55%, ACG = 13%) were frequently mentioned complaints during pregnancy with cerclage. Other aspects mentioned in both groups were social isolation, the lack of societal participation, and the perceived need to quit work and sports. All participants in the abdominal cerclage group reported a lack of comprehensible and unambiguous information about obstetric management and expectations during pregnancy in secondary care hospitals. Clear communication between secondary and tertiary care hospitals about obstetric management following an abdominal cerclage, for example, about the need for cervical length measurements by ultrasound, the need for bedrest or advice concerning sexual activity was missing (63%). Psychologic support was desired in half of all participants, but was not offered to them., Conclusions: The fear of a subsequent pregnancy loss was reported as the most limiting factor in daily life by all participants. Cerclage placement resulted in the reduction of anxiety. Participants mentioned a significant impact of bedrest and activity restriction during pregnancy with cerclage on social participation and daily activities. Unfortunately, no high level evidence is available on this matter. Patients might even benefit from appropriate levels of physical activity throughout their pregnancy to promote their overall well-being. More evidence is needed to determine the optimal level of physical activity. There is a need for clear and unambiguous patient information about obstetric management., (© 2024. The Author(s).)
- Published
- 2024
- Full Text
- View/download PDF
161. Vaginal microbiota and spontaneous preterm birth in pregnant women at high risk of recurrence.
- Author
-
Schuster HJ, Bos AM, Himschoot L, van Eekelen R, Matamoros SPF, de Boer MA, Oudijk MA, Ris-Stalpers C, Cools P, Savelkoul PHM, Painter RC, and van Houdt R
- Abstract
We describe vaginal microbiota, including Gardnerella species and sexually transmitted infections (STIs), during pregnancy and their associations with recurrent spontaneous preterm birth (sPTB). We performed a prospective cohort study in a tertiary referral centre in the Netherlands, among pregnant women with previous sPTB <34 weeks' gestation. Participants collected three vaginal swabs in the first and second trimester. Vaginal microbiota was profiled with 16S rDNA sequencing. Gardnerella species and STI's were tested with qPCR. Standard care was provided according to local protocol, including screening and treatment for bacterial vaginosis (BV), routine progesterone administration and screening for cervical length shortening. Of 154 participants, 26 (16.9 %) experienced recurrent sPTB <37 weeks' gestation. Microbiota composition was not associated with sPTB. During pregnancy, the share of Lactobacillus iners- dominated microbiota increased at the expense of diverse microbiota between the first and second trimester. This change coincided with treatment for BV, demonstrating a similar change in microbiota composition after treatment. In this cohort of high-risk women, we did not find an association between vaginal microbiota composition and recurrent sPTB. This should be interpreted with care, as these women were offered additional preventive therapies to reduce sPTB according to national guidelines including progesterone and BV treatment. The increase observed in L. iners dominated microbiota and the decrease in diverse microbiota mid-gestation was most likely mediated by BV treatment. Our findings suggest that in recurrent sPTB occurring despite several preventive therapies, the microbe-related etiologic contribution might be limited., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:R.C. Painter, P.H.M. Savelkoul reports financial support was provided by Amsterdam Reproduction and Development. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)
- Published
- 2024
- Full Text
- View/download PDF
162. Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies.
- Author
-
van Gils L, de Boer MA, Bosmans J, Duijnhoven R, Schoenmakers S, Derks JB, Prins JR, Al-Nasiry S, Lutke Holzik M, Lopriore E, van Drongelen J, Knol MH, van Laar JOEH, Jacquemyn Y, van Holsbeke C, Dehaene I, Lewi L, van der Merwe H, Gyselaers W, Obermann-Borst SA, Holthuis M, Mol BW, Pajkrt E, and Oudijk MA
- Subjects
- Humans, Female, Pregnancy, Netherlands, Infant, Newborn, Multicenter Studies as Topic, Cervix Uteri surgery, Adult, Cerclage, Cervical methods, Pregnancy, Twin, Premature Birth prevention & control, Randomized Controlled Trials as Topic, Perinatal Mortality
- Abstract
Introduction: Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage., Methods and Analysis: We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at <24 weeks of gestation and an asymptomatic short cervix of ≤25 mm or cervical dilatation will be randomly allocated (1:1) to both trials on vaginal cerclage and standard treatment according to the current Dutch Society of Obstetrics and Gynaecology guideline (no cerclage). Permuted blocks sized 2 and 4 will be used to minimise the risk of disbalance. The primary outcome measure is PTB of <28 weeks. Analyses will be by intention to treat. The first trial is to demonstrate a risk reduction from 25% to 10% in the short cervix group, for which 194 patients need to be recruited. The second trial is to demonstrate a risk reduction from 80% to 35% in the dilatation group and will recruit 44 women. A cost-effectiveness analysis will be performed from a societal perspective., Ethics and Dissemination: This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results., Trial Registration Number: ClinicalTrials.gov, NCT05968794., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2024
- Full Text
- View/download PDF
163. Long-Term Maternal Mental Health after Spontaneous Preterm Birth.
- Author
-
Janssen LE, Laarman ARC, van Dijk-Lokkart EM, Bröring-Starre T, Oudijk MA, de Groot CJM, and de Boer MA
- Subjects
- Humans, Female, Prospective Studies, Adult, Pregnancy, Mental Health, Middle Aged, Social Support, Premature Birth psychology, Anxiety epidemiology, Depression epidemiology
- Abstract
Objective: The aim of this study is to investigate whether a history of spontaneous preterm birth (SPTB) is associated with maternal depressive and anxiety symptoms, or psychosocial distress in the fifth decade of life., Study Design: This is a secondary analysis of the PreCaris-study, a prospective observational study in which we included 350 women with a history of SPTB between 22
0/7 and 366/7 weeks of gestation and compared them to 115 women who had a term birth. Primary outcomes were the Depression and Anxiety scores measured using the Hospital Anxiety Depression Scale and Psychosocial distress assessed with the Distress Thermometer for Parents. Secondary outcomes were self-reported impact of the birth in daily life and psychosocial support after delivery., Results: After a median of 13 years after delivery, no significant differences were found in primary outcomes. Significantly more women with a history of SPTB reported that the birth still had impact in daily life; adjusted odds ratio: 2.46 (95% confidence interval: 1.35-4.48). A total of 57 (16.3%) women after SPTB reported to have needed professional psychosocial support after delivery but did not receive it. These women more often had a high Anxiety score ( p = 0.030), psychosocial distress ( p = 0.001), and influence of birth in daily life ( p = 0.000)., Conclusion: There are no long-term effects on depressive and anxiety symptoms and psychosocial distress in women who experienced SPTB compared with women who had a full-term pregnancy. A significant part of the women who delivered preterm needed psychosocial support but did not receive it and were at higher risk of anxiety, psychosocial distress, and impact in daily life. We therefore recommend offering all women after SPTB psychosocial support after delivery., Key Points: · No long-term effects on depressive and anxiety symptoms and psychosocial distress after SPTB.. · A total of 16.3% of the cases needed professional psychosocial support after delivery but did not receive it.. · This subgroup was at higher risk of anxiety symptoms, psychosocial distress, and impact on daily life.., Competing Interests: None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)- Published
- 2024
- Full Text
- View/download PDF
164. Concentrations of subcutaneously administered belimumab in human breast milk of a woman with systemic lupus erythematosus: a case report.
- Author
-
Blomjous BS, de Boer MA, van Weissenbruch MM, Laan KCJ, Rispens T, Voskuyl AE, and Bultink IEM
- Subjects
- Female, Humans, Antibodies, Monoclonal, Humanized therapeutic use, Milk, Human, Lupus Erythematosus, Systemic complications, Lupus Erythematosus, Systemic drug therapy
- Abstract
Competing Interests: Competing interests: None declared.
- Published
- 2024
- Full Text
- View/download PDF
165. Cervical pessary versus vaginal progesterone in women with a singleton pregnancy, a short cervix, and no history of spontaneous preterm birth at less than 34 weeks' gestation: open label, multicentre, randomised, controlled trial.
- Author
-
van Dijk CE, van Gils AL, van Zijl MD, Koullali B, van der Weide MC, van den Akker ES, Hermsen BJ, van Baal WM, Visser H, van Drongelen J, Vollebregt KC, Muller M, van der Made FW, Gordijn SJ, de Mooij YM, Oudijk MA, de Boer MA, Mol BW, Kazemier BM, and Pajkrt E
- Subjects
- Adult, Female, Humans, Infant, Newborn, Pregnancy, Administration, Intravaginal, Cervix Uteri, Pessaries, Vagina, Premature Birth prevention & control, Progesterone
- Abstract
Objective: To compare the effectiveness of cervical pessary and vaginal progesterone in the prevention of adverse perinatal outcomes and preterm birth in pregnant women of singletons with no prior spontaneous preterm birth at less than 34 weeks' gestation and who have a short cervix of 35 mm or less., Design: Open label, multicentre, randomised, controlled trial., Setting: 20 hospitals and five obstetric ultrasound practices in the Netherlands., Participants: Women with a healthy singleton pregnancy and an asymptomatic short cervix of 35 mm or less between 18 and 22 weeks' gestation were eligible. Exclusion criteria were prior spontaneous preterm birth at less than 34 weeks, a cerclage in situ, maternal age of younger than 18 years, major congenital abnormalities, prior participation in this trial, vaginal blood loss, contractions, cervical length of less than 2 mm or cervical dilatation of 3 cm or more. Sample size was set at 628 participants., Interventions: 1:1 randomisation to an Arabin cervical pessary or vaginal progesterone 200 mg daily up to 36 weeks' of gestation or earlier in case of ruptured membranes, signs of infection, or preterm labour besides routine obstetric care., Main Outcome Measures: Primary outcome was a composite adverse perinatal outcome. Secondary outcomes were rates of (spontaneous) preterm birth at less than 28, 32, 34, and 37 weeks. A predefined subgroup analysis was planned for cervical length of 25 mm or less., Results: From 1 July 2014 to 31 March 2022, 635 participants were randomly assigned to pessary (n=315) or to progesterone (n=320). 612 were included in the intention to treat analysis. The composite adverse perinatal outcome occurred in 19 (6%) of 303 participants with a pessary versus 17 (6%) of 309 in the progesterone group (crude relative risk 1.1 (95% confidence interval (CI) 0.60 to 2.2)). The rates of spontaneous preterm birth were not significantly different between groups. In the subgroup of cervical length of 25 mm or less, spontaneous preterm birth at less than 28 weeks occurred more often after pessary than after progesterone (10/62 (16%) v 3/69 (4%), relative risk 3.7 (95% CI 1.1 to 12.9)) and adverse perinatal outcomes seemed more frequent in the pessary group (15/62 (24%) v 8/69 (12%), relative risk 2.1 (0.95 to 4.6))., Conclusions: In women with a singleton pregnancy with no prior spontaneous preterm birth at less than 34 weeks' gestation and with a midtrimester short cervix of 35 mm or less, pessary is not better than vaginal progesterone. In the subgroup of a cervical length of 25 mm or less, a pessary seemed less effective in preventing adverse outcomes. Overall, for women with single baby pregnancies, a short cervix, and no prior spontaneous preterm birth less than 34 weeks' gestation, superiority of a cervical pessary compared with vaginal progesterone to prevent preterm birth and consecutive adverse outcomes could not be proven., Trial Registration: International Clinical Trial Registry Platform (ICTRP, EUCTR2013-002884-24-NL)., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest and declare: BWJM declared support by a NHMRC Investigator grant (GNT1176437). BWM reports consultancy, research funding and travel support from Merck. EP and MAO declared participation on the board of the Research foundation ‘Stichting Stoptevroegbevallen’ that supported this study. EP, MAO and SJG received several grants with the purpose of scientific research in the field op preterm birth and fetal growth restriction. All other authors declare no support from any organisation for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)
- Published
- 2024
- Full Text
- View/download PDF
166. Methods of induction of labor in women with obesity: A secondary analysis of two multicenter randomized controlled trials.
- Author
-
Croll DMR, De Vaan MDT, Moes SL, Bloemenkamp KWM, Ten Eikelder MLG, De Heus R, Jozwiak M, Kooiman J, Mol BW, Verhoeven CJM, and De Boer MA
- Subjects
- Pregnancy, Female, Humans, Dinoprostone, Cesarean Section adverse effects, Labor, Induced methods, Randomized Controlled Trials as Topic, Cervical Ripening, Misoprostol, Oxytocics, Postpartum Hemorrhage epidemiology, Postpartum Hemorrhage etiology
- Abstract
Introduction: Obesity is an increasing public health concern worldwide and can lead to more complications in pregnancy and childbirth. Women with obesity more often require induction of labor for various indications. The aim of this study is to assess which method of induction of labor is safest and most effective in women with obesity., Material and Methods: This is a secondary analysis of two randomized controlled trials about induction of labor. Women with a term singleton pregnancy in cephalic presentation, an unfavorable cervix, intact membranes and without a previous cesarean section were randomly allocated to cervical priming with a Foley catheter or vaginal prostaglandin-E2-gel (PROBAAT-I) or a Foley catheter or oral misoprostol (PROBAAT-II). The inclusion and exclusion criteria for the studies were identical. Induction methods were compared in women with obesity (body mass index ≥30.0). Main outcomes were cesarean section and postpartum hemorrhage (blood loss >1000 mL)., Results: A total of 2664 women, were included in the trials, 517 of whom were obese: 254 women with obesity received a Foley catheter, 176 oral misoprostol and 87 prostaglandin E2 (PGE2). A cesarean section was performed in 29.1% of women allocated to Foley vs 22.2% in the misoprostol and 23.0% in the PGE2 groups. Comparisons between groups revealed no statistically significant differences: the relative risk [RR] was 1.31 (95% confidence interval [CI] 0.94-1.84) in the Foley vs misoprostol group and 1.27 (95% CI 0.83-1.95) in the Foley vs PGE2 group. The rates of postpartum hemorrhage were comparable (10.6%, 11.4% and 6.9%, respectively; P = 0.512). In women with obesity, more often a switch to another method occurred in the Foley group, (20.1% vs 6.3% in misoprostol vs 1.1% in the PGE2 group; P < 0.001). The risk of a failed Foley placement was higher in women with obesity than in women without obesity (8.3% vs 3.2%; adjusted odds ratio 3.12, 95% CI 1.65-5.90)., Conclusions: In women with obesity we found a nonsignificant trend towards an increased rate of cesarean sections in the group induced with a Foley catheter compared to oral misoprostol; however, the study lacked power for this subgroup analysis. The finding of a higher risk of failed placement of a Foley catheter in women with obesity can be used in shared decision making., (© 2024 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)
- Published
- 2024
- Full Text
- View/download PDF
167. The value of a mobile educative Application additional to Standard counselling on aspirin Adherence in Pregnancy: the ASAP study, a randomised controlled trial.
- Author
-
Bij de Weg JM, de Boer MA, Meijer C, Lugtenburg N, Melles M, de Vries JIP, and de Groot CJM
- Abstract
Objective: To assess the added value of a novel, mobile educative application to standard counselling on aspirin adherence during pregnancy versus standard counselling alone., Methods: Participants were randomly assigned for additional use of a mobile educative application or standard counselling alone. Main outcome measures were adherence to aspirin measured by two validated questionnaires: Simplified Medication Adherence Questionnaire (SMAQ), Believes and Behaviour Questionnaire (BBQ), and patients reported tablet intake >90%., Results: A total of 174 women with an indication for aspirin during pregnancy were included. The questionnaires were filled in by 126 out of the 174 participants (72.4%). Similar results were found in the app group and the standard counselling groups for both validated questionnaires. Tablet intake >90% was seen in 88.7% and 87.5% ( p = 0.834) of the app group and standard counselling group respectively. Subgroup analyses demonstrated a negative effect of BMI and a positive effect of educational level on adherence., Conclusions: Our study revealed no added effect of a novel, mobile educative application to standard counselling on aspirin adherence during pregnancy. Tablet intake was equally high in both groups probably explained by our high educated population., Innovation: Future studies should focus on tailored counselling on medication to pregnant women's needs including medication reminders, addressing concerns, adequate health literacy and side effects, offering rewards to further stimulate aspirin adherence in pregnancy with optimal outcome for mother and their neonate., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)
- Published
- 2024
- Full Text
- View/download PDF
168. Corrigendum to "Left ventricular diastolic function in the fifth decade of life in women with a history of spontaneous preterm birth" [Eur. J. Obstet. Gynecol. Reprod. Biol. 286 (2023) 40-46].
- Author
-
Janssen LE, de Boer MA, von Königslöw ECE, Dal Canto E, Oudijk MA, Robbers-Visser D, and de Groot CJM
- Published
- 2024
- Full Text
- View/download PDF
169. Spontaneous haemoperitoneum in pregnancy: Nationwide surveillance and Delphi audit system.
- Author
-
Schreurs AMF, Overtoom EM, de Boer MA, van der Houwen LEE, Lier MCI, van den Akker T, Cornette J, Vogelvang TE, Beenakkers ICM, Rosman AN, Maas JWM, Heineman DJ, Finken MJJ, de Vries JJJ, Burger NB, Schaap TP, Bloemenkamp KWM, and Mijatovic V
- Subjects
- Female, Humans, Pregnancy, Cohort Studies, Parturition, Perinatal Mortality, Infant, Newborn, Hemoperitoneum diagnosis, Hemoperitoneum epidemiology, Hemoperitoneum etiology, Perinatal Death, Pregnancy Complications diagnosis, Pregnancy Complications epidemiology, Pregnancy Complications etiology
- Abstract
Objective: To evaluate the incidence, diagnostic management strategies and clinical outcomes of women with spontaneous haemoperitoneum in pregnancy (SHiP) and reassess the definition of SHiP., Design: A population-based cohort study using the Netherlands Obstetric Surveillance System (NethOSS)., Setting: Nationwide, the Netherlands., Population: All pregnant women between April 2016 and April 2018., Methods: This is a case study of SHiP using the monthly registry reports of NethOSS. Complete anonymised case files were obtained. A newly introduced online Delphi audit system (DAS) was used to evaluate each case, to make recommendations on improving the management of SHiP and to propose a new definition of SHiP., Main Outcome Measures: Incidence and outcomes, lessons learned about clinical management and the critical appraisal of the current definition of SHiP., Results: In total, 24 cases were reported. After a Delphi procedure, 14 cases were classified as SHiP. The nationwide incidence was 4.9 per 100 000 births. Endometriosis and conceiving after artificial reproductive techniques were identified as risk factors. No maternal and three perinatal deaths occurred. Based on the DAS, adequate imaging of free intra-abdominal fluid, and identifying and treating women with signs of hypovolemic shock could improve the early detection and management of SHiP. A revised definition of SHiP was proposed, excluding the need for surgical or radiological intervention., Conclusions: SHiP is a rare and easily misdiagnosed condition that is associated with high perinatal mortality. To improve care, better awareness among healthcare workers is needed. The DAS is a sufficient tool to audit maternal morbidity and mortality., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)
- Published
- 2023
- Full Text
- View/download PDF
170. Hypertensive disorders of pregnancy after multifetal pregnancy reduction: a systematic review and meta-analysis.
- Author
-
van Baar PM, Bij de Weg JM, Ten Hove EA, Schoonmade LJ, van de Mheen L, Pajkrt E, de Groot CJM, and de Boer MA
- Subjects
- Pregnancy, Female, Humans, Pregnancy Reduction, Multifetal adverse effects, Retrospective Studies, Prospective Studies, Pregnancy Outcome, Pregnancy, Twin, Hypertension, Pregnancy-Induced epidemiology, Hypertension, Pregnancy-Induced etiology, Pre-Eclampsia etiology
- Abstract
Objective: To systematically review the literature on hypertensive disorders of pregnancy (HDP) after multifetal pregnancy reduction (MFPR)., Methods: A comprehensive search in PubMed, Embase, Web of Science, and Scopus was performed. Prospective or retrospective studies reporting on MFPR from triplet or higher-order to twin compared to ongoing (i.e., non-reduced) triplets and/or twins were included. A meta-analysis of the primary outcome HDP was carried out using a random-effects model. Subgroup analyses of gestational hypertension (GH) and preeclampsia (PE) were performed. Risk of bias was assessed using the Newcastle-Ottawa Quality Assessment Scale., Results: Thirty studies with a total of 9,811 women were included. MFPR from triplet to twin was associated with a lower risk for HDP compared to ongoing triplets (OR 0.55, 95% CI, 0.37-0.83; p = 0.004). In a subgroup analysis, the decreased risk of HDP was driven by GH, and PE was no longer significant (OR 0.34, 95% CI, 0.17-0.70; p = 0.004 and OR 0.64, 95% CI, 0.38-1.09; p = 0.10, respectively). HDP was also significantly lower after MFPR from all higher-order (including triplets) to twin compared to ongoing triplets (OR 0.55, 95% CI, 0.38-0.79; p = 0.001). In a subgroup analysis, the decreased risk of HDP was driven by PE, and GH was no longer significant (OR 0.55, 95% CI 0.32-0.92; p = 0.02 and OR 0.55, 95% CI 0.28-1.06; p = 0.08, respectively). No significant differences in HDP were found in MFPR from triplet or higher-order to twin versus ongoing twins., Conclusions: MFPR in women with triplet and higher-order multifetal pregnancies decreases the risk of HDP. Twelve women should undergo MFPR to prevent one event of HDP. These data can be used in the decision-making process of MFPR, in which the individual risk factors of HDP can be taken into account.
- Published
- 2023
- Full Text
- View/download PDF
171. Stress-reducing interventions in pregnancy for the prevention of preterm birth: a systematic review and meta-analysis.
- Author
-
Janssen LE, Gieskes AA, Kok M, de Groot CJM, Oudijk MA, and de Boer MA
- Subjects
- Pregnancy, Infant, Newborn, Female, Humans, Risk Factors, Gestational Age, Premature Birth prevention & control, Premature Birth epidemiology
- Abstract
Preterm birth (PTB) is the leading cause of neonatal morbidity and mortality. Maternal stress during pregnancy is an established risk factor for PTB. We aimed to review the effects of stress-reducing interventions during pregnancy on PTB. Studies reporting on stress-reducing interventions during pregnancy and PTB rates in general low-risk obstetric populations were included. PTB rates, low birth weight (LBW) rates, mean gestational age and birth weight, maternal anxiety and stress, and adverse perinatal outcomes were investigated. Data were extracted using a standardized extraction form, pooled effect sizes were calculated with the random effects model. Ten studies with a total of 4.816 women were included. The interventions included Pilates, yoga, a multidisciplinary stress reduction program, combination therapy (combining mindfulness, yoga, music, baby bonding, and education), and hypnosis. The incidence of PTB was significantly lower in the intervention group (RR 0.50, 95% CI 0.35 - 0.71). The overall quality of the included studies was low, and the risk of bias was high. In conclusion, this study provides evidence supporting the potential efficacy of stress-reducing interventions in reducing the incidence of PTB in low-risk women. We propose a RCT of high quality to determine the effectiveness of stress-reducing interventions in reducing PTB risk.
- Published
- 2023
- Full Text
- View/download PDF
172. Assessment of cervical softening and the prediction of preterm birth (STIPP): protocol for a prospective cohort study.
- Author
-
Breuking S, Oudijk MA, van Eekelen R, de Boer MA, Pajkrt E, and Hermans F
- Subjects
- Child, Female, Humans, Infant, Newborn, Pregnancy, Cervix Uteri diagnostic imaging, Netherlands, Parturition, Prospective Studies, Premature Birth diagnosis
- Abstract
Introduction: Preterm birth (PTB) is among the leading causes of perinatal and childhood morbidity and mortality. Therefore, accurate identification of pregnant women at high risk of PTB is key to enable obstetric healthcare professionals to apply interventions that improve perinatal and childhood outcomes. Serial transvaginal cervical length measurement is used to screen asymptomatic pregnant women with a history of PTB and identify those at high risk for a recurrent PTB. Cervical length measurement, fetal fibronectin test or a combination of both can be used to identify women at high risk of PTB presenting with symptoms of threatened PTB. The predictive capacity of these methods can be improved. Cervical softening is a precursor of cervical shortening, effacement and dilatation and could be a new marker to identify women a high risk of PTB. However, the predictive value of cervical softening to predict spontaneous PTB still needs to be determined., Methods and Analysis: This is a single-centre, prospective cohort study, conducted at the Amsterdam University Medical Centers in the Netherlands. Cervical softening will be investigated with a non-invasive CE-marked device called the Pregnolia System. This device has been developed to evaluate consistency of the cervix based on tissue elasticity. Two different cohorts will be investigated. The first cohort includes women with a history of spontaneous PTB <34 weeks. These women undergo biweekly measurements between 14 and 24 weeks of gestation. The second cohort includes women with symptoms of threatened PTB. These women will receive the measurement once at presentation between 24 and 34 weeks of gestation. The primary outcome is spontaneous PTB before 34 weeks for women with a history of PTB and delivery within 7 days for women with threatened PTB. The minimum sample size required to analyse the primary outcome is 227 women in the cohort of women with a history of PTB and 163 women in the cohort of women with symptoms of threatened PTB. Once this number is achieved, the study will be continued to investigate secondary objectives., Ethics and Dissemination: The study is approved by the Medical Ethics Committee of Amsterdam UMC (METC2022.0226). All patients will give oral and written informed consent prior to study entry. Results will be disseminated via a peer-reviewed journal., Trial Registration Number: NCT05477381., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
- Full Text
- View/download PDF
173. Spontaneous preterm birth with placental maternal vascular malperfusion is associated with cardiovascular risk in the fifth decade of life.
- Author
-
Janssen LE, de Boer MA, van Amesfoort JE, van der Voorn PJ, Oudijk MA, and de Groot CJM
- Subjects
- Pregnancy, Female, Infant, Newborn, Humans, Male, Placenta pathology, Cohort Studies, Glycated Hemoglobin, Retrospective Studies, Risk Factors, Heart Disease Risk Factors, Premature Birth pathology, Pre-Eclampsia pathology, Cardiovascular Diseases epidemiology, Cardiovascular Diseases complications, Cardiovascular Diseases pathology, Hypertension
- Abstract
Women with a history of spontaneous preterm birth (SPTB) have a mildly elevated cardiovascular risk (CVR) later in life and women with a history of preeclampsia have a highly elevated CVR. In placentas of women with preeclampsia pathological signs of maternal vascular malperfusion (MVM) are often seen. These signs of MVM are also seen in a substantial part of the placentas of women with SPTB. We therefore hypothesize that in women with a history of SPTB, the subgroup with placental MVM has an elevated CVR. This study is a secondary analysis of a cohort study including women 9-16 years after a SPTB. Women with pregnancy complications known to be associated with CVR were excluded. The primary outcome was hypertension defined as blood pressure ≥ 130/80 mmHg and/or treatment with antihypertensive medication. Secondary outcomes were mean blood pressure, anthropometrics, blood measurements including cholesterol and HbA1c, and creatinine in urine. Placental histology was available in 210 (60.0%) women. MVM was found in 91 (43.3%) of the placentas, most often diagnosed by the presence of accelerated villous maturation. Hypertension was diagnosed in 44 (48.4%) women with MVM and in 42 (35.3%) women without MVM (aOR 1.76, 95% CI 0.98 - 3.16). Women with a SPTB and placental MVM showed significantly higher mean diastolic blood pressure, mean arterial pressure and HbA1c approximately 13 years after delivery, compared to women with a SPTB without placental MVM. We therefore conclude that placental malperfusion in women with a SPTB might differentiate in CVR later in life., Competing Interests: Declaration of Competing Interest I have the following conflicts of interest: none., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
174. Left ventricular diastolic function in the fifth decade of life in women with a history of spontaneous preterm birth.
- Author
-
Janssen LE, de Boer MA, von Königslöw ECE, Dal Canto E, Oudijk MA, Robbers-Visser D, and de Groot CJM
- Subjects
- Infant, Newborn, Pregnancy, Humans, Female, Ventricular Function, Left, Pre-Eclampsia, Premature Birth epidemiology, Premature Birth etiology, Premature Birth prevention & control, Hypertension complications, Hypertension epidemiology, Cardiovascular Diseases
- Abstract
Objective: Cardiovascular disease (CVD) is the number one cause of death in women and defining its risk factors is necessary to reduce its prevalence. A history of preeclampsia is shown to be associated with hypertension and alterations in left ventricular (LV) diastolic function parameters. Because of overlapping mechanisms between preeclampsia and spontaneous preterm birth (SPTB), our most recent study investigated the association between SPTB and hypertension, and found an almost 2 times higher prevalence of hypertension after SPTB. No previous studies have focused on the association between SPTB and LV diastolic function. The aim of this study is to investigate LV diastolic function as potential early parameter of CVD in women with a history of SPTB., Study Design: We included cases with a history of SPTB between 22 and 37 weeks and controls who had a term birth. Women with hypertensive disorders or gestational diabetes in any of their pregnancies, were excluded. Both groups underwent cardiovascular risk assessment and transthoracic echocardiography 9 to 16 years after pregnancy. Echocardiographic measures were adjusted using a linear regression analysis accounting for hypertension and other risk factors known to be associated with CVD. A subgroup analysis was performed based on hypertension at follow-up., Results: A total of 94 cases and 94 controls were included, on average 13 years after pregnancy. There were no significant differences in LV diastolic function parameters. Women with a history of SPTB and diagnosed hypertension at follow-up, showed significant higher late diastolic mitral flow velocity, lower e'septal velocity and higher E/e'ratio, compared to women with a history of SPTB without hypertension, although within normal ranges., Conclusions: When a history of SPTB is accompanied by hypertension at follow-up, significant changes in LV diastolic function were seen. Therefore, hypertension is the central factor in preventive screening methods, and transthoracic echocardiography has no additional value at this follow-up duration., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
175. Sexual intercourse during pregnancy and its association with spontaneous preterm birth.
- Author
-
Janssen LE, Verduin RJT, de Groot CJM, Oudijk MA, and de Boer MA
- Subjects
- Pregnancy, Female, Infant, Newborn, Humans, Male, Coitus, Term Birth, Premature Birth
- Abstract
This study investigated whether sexual intercourse during pregnancy is associated with spontaneous preterm birth (SPTB). We included 77 women with SPTB and 145 women with a term birth. A total of 195 (87.8%) women had sexual intercourse during pregnancy, which was comparable between the groups. Primiparas with SPTB tended to report more often having sexual intercourse 3 - 4 times a week compared to primiparas with a term birth (8.8% vs. 0%, p =.082). We advise not to completely discourage sexual intercourse among pregnant women. Yet, high sexual intercourse frequency could be associated with SPTB., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
176. Exposure to Thioguanine During 117 Pregnancies in Women With Inflammatory Bowel Disease.
- Author
-
Crouwel F, Simsek M, de Boer MA, Mulder CJJ, van Andel EM, Creemers RH, van Asseldonk DP, van Bodegraven AA, Horjus CS, Visschedijk MC, Weusthuis ALM, Seinen ML, Jharap B, van Schaik FDM, Ahmad I, Boekema PJ, Tack GJ, Wormmeester L, Lutgens MWMD, van Boeckel PGA, Gilissen LPL, Kerkhof M, Russel MGVM, Hoentjen F, Bartelink ME, Kuijvenhoven JP, Maljaars JWJ, van Dop WA, Wonders J, van der Voorn MMPJA, Buiter HJC, and de Boer NK
- Subjects
- Pregnancy, Infant, Newborn, Child, Humans, Female, Adult, Thioguanine adverse effects, Pregnancy Outcome epidemiology, Stillbirth epidemiology, Inflammatory Bowel Diseases drug therapy, Abortion, Spontaneous chemically induced, Abortion, Spontaneous epidemiology, Pregnancy Complications drug therapy, Pregnancy Complications epidemiology
- Abstract
Background: Safety of thioguanine in pregnant patients with inflammatory bowel disease [IBD] is sparsely recorded. This study was aimed to document the safety of thioguanine during pregnancy and birth., Methods: In this multicentre case series, IBD patients treated with thioguanine during pregnancy were included. Data regarding disease and medication history, pregnancy course, obstetric complications, and neonatal outcomes were collected., Results: Data on 117 thioguanine-exposed pregnancies in 99 women were collected. Most [78%] had Crohn's disease and the mean age at delivery was 31 years. In 18 pregnancies [15%], IBD flared. Obstetric and infectious complications were seen in 15% [n = 17] and 7% [n = 8] of pregnancies, respectively. Ten pregnancies [8.5%] resulted in a first trimester miscarriage, one in a stillbirth at 22 weeks of gestational age and one in an induced abortion due to trisomy 21. In total, 109 neonates were born from 101 singleton pregnancies and four twin pregnancies. One child was born with a congenital abnormality [cleft palate]. In the singleton pregnancies, 10 children were born prematurely and 10 were born small for gestational age. Screening for myelosuppresion was performed in 16 neonates [14.7%]; two had anaemia in umbilical cord blood. All outcomes were comparable to either the general Dutch population or to data from three Dutch cohort studies on the use of conventional thiopurines in pregnant IBD patients., Conclusion: In this large case series, the use of thioguanine during pregnancy is not associated in excess with adverse maternal or neonatal outcomes., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.)
- Published
- 2023
- Full Text
- View/download PDF
177. The influence of various induction methods on adverse outcomes in small for gestational age neonates: A secondary analysis of the PROBAAT 1 and 2 trials.
- Author
-
de Vaan MDT, Croll DMR, Verhoeven CJM, de Boer MA, Jozwiak M, Ten Eikelder MLG, Mol BW, Bloemenkamp KWM, and de Heus R
- Subjects
- Infant, Newborn, Pregnancy, Humans, Female, Dinoprostone, Gestational Age, Labor, Induced adverse effects, Labor, Induced methods, Cervical Ripening, Randomized Controlled Trials as Topic, Misoprostol adverse effects, Oxytocics adverse effects
- Abstract
Objective: To evaluate the safety aspects of different induction methods in pregnancies with small-for-gestational-age neonates., Study Design: This was a secondary analysis of two previously reported multicenter, randomized controlled trials conducted in the Netherlands. In the original trials, women were randomized to either a 30 cc Foley catheter, vaginal prostaglandin E2 (PROBAAT-1) or oral misoprostol (PROBAAT-2). A total of 425 patients with a term, singleton pregnancy in cephalic presentation with an indication for labor induction and a small-for-gestational-age neonate were included in this secondary analysis. Our primary outcome was a composed adverse neonatal outcome of Apgar score < 7 after 5 min and/or a pH in the umbilical artery < 7.05 and/or NICU admission. Secondary outcomes were mode of birth, operative birth for fetal distress and pH < 7.10 in the umbilical artery. For these outcome measures, multivariate as well as bivariate analyses were performed., Results: An adverse neonatal outcome occurred in 4.7 % (10/214) induction with a Foley catheter, versus 12.8 % (19/149) after misoprostol (RR 0.36; 95 % CI 0.17-0.76) and 4.7 % (3/64) after Prostaglandin E2 (RR 0.98; 95 %CI 0.28-3.51). For individual components of the composed outcome of adverse events, a difference was found between a Foley catheter and misoprostol for Apgar score < 7 at 5 min (0.5 % versus 3.4; RR 0.14; 95 %CI 0.02-1.16) and NICU admission (1.9 % versus 6.1 %; RR 0.31; 0.10-0.97). No differences were found for mode of birth., Conclusions: For women who gave birth to a small-for-gestational-age neonate, a Foley catheter is probably a safer induction method compared to oral misoprostol., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
178. Authors' response to Letter to the Editor on The effect of low-dose aspirin on platelet function during pregnancy compared to placebo: An explorative study.
- Author
-
Bij de Weg JM, Landman AJEMC, de Vries JIP, Thijs A, Harmsze AM, Oudijk MA, and de Boer MA
- Subjects
- Pregnancy, Female, Humans, Aspirin pharmacology, Platelet Aggregation Inhibitors pharmacology, Platelet Aggregation Inhibitors therapeutic use
- Abstract
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
- Published
- 2023
- Full Text
- View/download PDF
179. The effect of low-dose aspirin on platelet function during pregnancy compared to placebo: An explorative study.
- Author
-
Bij de Weg JM, Landman AJEMC, de Vries JIP, Thijs A, Harmsze AM, Oudijk MA, and de Boer MA
- Subjects
- Pregnancy, Humans, Infant, Newborn, Female, Aspirin, Platelet Function Tests methods, Thromboxane B2, Double-Blind Method, Premature Birth drug therapy
- Abstract
Objectives: To evaluate the effect of aspirin 80 mg compared to placebo on platelet function tests in the second and third trimester of pregnancy., Study Design: An explorative study was performed to assess laboratory platelet function in a subpopulation of the APRIL trial: a randomized double-blind trial comparing aspirin 80 mg once daily to placebo for the prevention of recurrent preterm birth. Platelet function was measured between 18 and 22, and between 28 and 32 weeks gestational age with three platelet function tests: VerifyNow®, Chronolog light transmission aggregometry (Chronolog LTA) and serum thromboxane B
2 (TxB2 ). Medication adherence was evaluated by pill counts, self-reported diaries and structured interviews., Results: We included 11 women, six in the aspirin and five in the placebo group. In women receiving aspirin, platelet function was significantly lower compared to women receiving placebo for all three tests: VerifyNow® Aspirin Reaction Units (450.5 vs 648.0, p = 0.017); Chronolog LTA (9.5% vs 94.5%, p = 0.009); serum TxB2 levels (11.9 ng/mL versus 175.9 ng/mL, p = 0.030). For all three tests, platelet function did not differ between the second and third trimester of pregnancy in the aspirin group. In the placebo group, serum TxB2 levels were significantly higher in the third trimester. One non-adherent participant in the aspirin group showed results similar to the placebo group., Conclusion: Aspirin 80 mg has a clear inhibitory effect on laboratory platelet function during pregnancy compared to placebo. This effect is similar in the second and third trimester of pregnancy., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)- Published
- 2022
- Full Text
- View/download PDF
180. Long-term outcomes following antenatal exposure to low-dose aspirin: study protocol for the 4-year follow-up of the APRIL randomised controlled trial.
- Author
-
Landman AJEMC, van Limburg Stirum EVJ, van 't Hooft J, Leemhuis AG, Finken MJJ, van Baar AL, Roseboom TJ, Ravelli ACJ, van Wely M, Oosterlaan J, Painter RC, Pajkrt E, Oudijk MA, and de Boer MA
- Subjects
- Aspirin adverse effects, Child, Child, Preschool, Female, Follow-Up Studies, Humans, Infant, Newborn, Pregnancy, Randomized Controlled Trials as Topic, Tumor Necrosis Factor Ligand Superfamily Member 13, Premature Birth prevention & control
- Abstract
Introduction: The use of low-dose aspirin by pregnant women to prevent preterm pre-eclampsia is gradually increasing. The administration of aspirin during pregnancy improves perinatal outcome, which could translate into improved child outcome in the long term. However, antenatal exposure to aspirin could have adverse effects on child development that may manifest later in life. The aim of this follow-up study is to assess the long-term effects of antenatal exposure to low-dose aspirin compared with placebo on survival, (neuro)development, behaviour and general health at 4 years corrected age., Methods and Analysis: This is a follow-up study of the Dutch double-blind randomised controlled APRIL trial which assessed the effectiveness of treatment with aspirin (80 mg daily) compared with placebo for the prevention of preterm birth in women with a previous spontaneous preterm birth. Treatment was initiated before 16 weeks of gestation and continued until 36 weeks or birth. We aim to follow-up all 379 children born to women who participated in the APRIL trial and survived the neonatal period, at the corrected age of 4 years. The main outcomes are (neuro)development as assessed by the Ages and Stages Questionnaire, and behaviour as assessed by the Strength and Difficulties Questionnaire. Additional outcomes include mortality, growth and general health from birth up to 4 years, and a composite outcome including mortality, abnormal (neuro)development and problem behaviour. Analyses will be performed by intention-to-treat using a superiority design., Ethics and Dissemination: Institutional Review Board approval was obtained from the Medical Research Ethics Committee from Amsterdam Medical Center (no. W20 289#20.325). The results will be published in a peer-reviewed journal and presented at conferences., Trial Registration Number: The APRIL trial (NTR5675, NL5553; EudraCT number 2015-003220-31) and the APRIL follow-up study (NL8950) are registered in the Dutch trial register. The study is funded by the Amsterdam Reproduction & Development research institute., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2022
- Full Text
- View/download PDF
181. Pregnant women's willingness to participate in a randomized trial comparing induction of labor at 39 weeks versus expectant management: A survey in the Netherlands.
- Author
-
Croll DMR, Meuleman T, de Heus R, de Boer MA, Verhoeven CJM, Bloemenkamp KWM, and van Dillen J
- Subjects
- Adolescent, Cesarean Section, Female, Gestational Age, Humans, Infant, Netherlands, Pregnancy, Surveys and Questionnaires, Labor, Induced methods, Pregnant Women
- Abstract
Introduction: A randomized controlled trial (RCT) in the United States, the ARRIVE trial, has indicated that induction of labor (IOL) in low-risk nulliparous women with a gestational age (GA) of 39 weeks compared to expectant management (EM) resulted in a significant lower rate of cesarean deliveries. The Dutch maternity care system is different compared to the United States with, among other factors, an overall significantly lower percentage of caesarean sections (CS). To investigate whether IOL has a favorable outcome in the Dutch maternity care system, a new trial is advised. In this questionnaire-based study we aim to evaluate whether Dutch low-risk pregnant women would be willing to participate in an RCT comparing IOL at 39 weeks to EM., Materials and Methods: We conducted an online survey in 2020 in the Netherlands. Respondent recruitment took place both in outpatient clinics at hospitals and midwife practices and via social media. Inclusion criteria were pregnant women with singleton gestation, GA ≤ 39 weeks, age 18 years or older and residency in the Netherlands. Exclusion criteria were multiple gestation, a history of a CS, planned IOL or CS in current pregnancy and GA > 39 weeks. A subgroup was formed of low risk (receiving primary care) nulliparous women with a gestational age between 34 and 39 weeks, comparable with the ARRIVE trial., Results: Three hundred eighty respondents participated. Of all respondents (nulli- and multiparous), 47 (12.4%) would be willing to participate in the hypothetical RCT and 70 (18.4%) might be willing to participate. Amongst the 70 women in the subgroup 11 women (15.7%) would be willing to participate and 17 (24.3%) might be willing to participate., Discussion and Conclusion: Calculating sample size in a country with a low CS rate, in relation to 69.2% of women are not willing to participate in an RCT comparing IOL at 39 weeks with EM, would require >18.000 women to be counselled for participation. We believe such a study is a challenge in the Netherlands., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
182. Cardiovascular mortality risk a decade after twin and singleton pregnancies complicated by hypertensive disorders of pregnancy.
- Author
-
van Baar PM, Welters SM, Ravelli ACJ, de Boer MA, and de Groot CJM
- Subjects
- Cohort Studies, Female, Humans, Pregnancy, Pregnancy, Twin, Retrospective Studies, Hypertension, Pregnancy-Induced, Pre-Eclampsia epidemiology
- Abstract
Objectives: To describe the cardiovascular mortality (CVM) risk in women after twin versus singleton pregnancies complicated by hypertensive disorders of pregnancy (HDP)., Study Design: Retrospective cohort study of nulliparous women with a twin or singleton pregnancy who delivered in the Netherlands between 1995 and 2015. We used data of the Perinatal Registry of the Netherlands and data of the National Death Registry to determine baseline data, the occurrence of HDP and CVM. In the two main analyses we compared twin pregnancies complicated by HDP to 1) singleton pregnancies complicated by HDP and 2) uncomplicated twin pregnancies (i.e. without HDP) of women who delivered within a hospital setting., Main Outcome Measures: CVM risk using cox-proportional hazard models, adjusted for maternal age (aHR)., Results: 1,243,231 nulliparous women were included, of which 30,623 (2.5%) had a twin and 1,212,608 (97.5%) had a singleton pregnancy. A total of 9,853 (32.2%) twin pregnancies were complicated by HDP, versus 249,141 (20.6%) singleton pregnancies (p < 0.0001). Within the HDP twin cohort, 14/73 (19.2%) maternal deaths were due to cardiovascular causes, versus 335/1,788 (18.7%) in the HDP singleton cohort and 10/117 (8.6%) in the uncomplicated twin cohort. The corresponding aHR was 2.85 (95% CI 1.26-6.41; p = 0.01) for the HDP twin versus the uncomplicated twin cohort, and 1.05 (95% CI 0.62-1.80; p = 0.85) for the HDP twin versus the HDP singleton cohort., Conclusions: Women after both twin and singleton pregnancies complicated by HDP are at a similarly increased risk of CVM later in life., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
183. Evaluation of low-dose aspirin in the prevention of recurrent spontaneous preterm labour (the APRIL study): A multicentre, randomised, double-blinded, placebo-controlled trial.
- Author
-
Landman AJEMC, de Boer MA, Visser L, Nijman TAJ, Hemels MAC, Naaktgeboren CN, van der Weide MC, Mol BW, van Laar JOEH, Papatsonis DNM, Bekker MN, van Drongelen J, van Pampus MG, Sueters M, van der Ham DP, Sikkema JM, Zwart JJ, Huisjes AJM, van Huizen ME, Kleiverda G, Boon J, Franssen MTM, Hermes W, Visser H, de Groot CJM, and Oudijk MA
- Subjects
- Adult, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Netherlands, Pregnancy, Premature Birth prevention & control, Aspirin administration & dosage, Obstetric Labor, Premature prevention & control
- Abstract
Background: Preterm birth is the leading cause of neonatal morbidity and mortality. The recurrence rate of spontaneous preterm birth is high, and additional preventive measures are required. Our objective was to assess the effectiveness of low-dose aspirin compared to placebo in the prevention of preterm birth in women with a previous spontaneous preterm birth., Methods and Findings: We performed a parallel multicentre, randomised, double-blinded, placebo-controlled trial (the APRIL study). The study was performed in 8 tertiary and 26 secondary care hospitals in the Netherlands. We included women with a singleton pregnancy and a history of spontaneous preterm birth of a singleton between 22 and 37 weeks. Participants were randomly assigned to aspirin 80 mg daily or placebo initiated between 8 and 16 weeks of gestation and continued until 36 weeks or delivery. Randomisation was computer generated, with allocation concealment by using sequentially numbered medication containers. Participants, their healthcare providers, and researchers were blinded for treatment allocation. The primary outcome was preterm birth <37 weeks of gestation. Secondary outcomes included a composite of poor neonatal outcome (bronchopulmonary dysplasia, periventricular leukomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotising enterocolitis > stage 1, retinopathy of prematurity, culture proven sepsis, or perinatal death). Analyses were performed by intention to treat. From May 31, 2016 to June 13, 2019, 406 women were randomised to aspirin (n = 204) or placebo (n = 202). A total of 387 women (81.1% of white ethnic origin, mean age 32.5 ± SD 3.8) were included in the final analysis: 194 women were allocated to aspirin and 193 to placebo. Preterm birth <37 weeks occurred in 41 (21.2%) women in the aspirin group and 49 (25.4%) in the placebo group (relative risk (RR) 0.83, 95% confidence interval (CI) 0.58 to 1.20, p = 0.32). In women with ≥80% medication adherence, preterm birth occurred in 24 (19.2%) versus 30 (24.8%) women (RR 0.77, 95% CI 0.48 to 1.25, p = 0.29). The rate of the composite of poor neonatal outcome was 4.6% (n = 9) versus 2.6% (n = 5) (RR 1.79, 95% CI 0.61 to 5.25, p = 0.29). Among all randomised women, serious adverse events occurred in 11 out of 204 (5.4%) women allocated to aspirin and 11 out of 202 (5.4%) women allocated to placebo. None of these serious adverse events was considered to be associated with treatment allocation. The main study limitation is the underpowered sample size due to the lower than expected preterm birth rates., Conclusions: In this study, we observed that low-dose aspirin did not significantly reduce the preterm birth rate in women with a previous spontaneous preterm birth. However, a modest reduction of preterm birth with aspirin cannot be ruled out. Further research is required to determine a possible beneficial effect of low-dose aspirin for women with a previous spontaneous preterm birth., Trial Registration: Dutch Trial Register (NL5553, NTR5675) https://www.trialregister.nl/trial/5553., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: BM reported an Investigator grant from the National Health and Medical Research Council (NHMRC; grant no. GNT1176437); receipt of research funding from Guerbet; and is a former advisory board member at ObsEva. All other authors do not report any relevant financial activities outside the submitted work.
- Published
- 2022
- Full Text
- View/download PDF
184. Long-term health and neurodevelopment in children after antenatal exposure to low-dose aspirin for the prevention of preeclampsia and fetal growth restriction: A systematic review of randomized controlled trials.
- Author
-
Landman AJEMC, van Limburg Stirum EVJ, de Boer MA, van 't Hooft J, Ket JCF, Leemhuis AG, Finken MJJ, Oudijk MA, and Painter RC
- Subjects
- Aspirin adverse effects, Child, Female, Fetal Growth Retardation chemically induced, Fetal Growth Retardation prevention & control, Humans, Infant, Infant, Newborn, Parturition, Pregnancy, Randomized Controlled Trials as Topic, Pre-Eclampsia chemically induced, Pre-Eclampsia prevention & control
- Abstract
Objective: To evaluate the long-term effects of antenatal aspirin exposure on child health and neurodevelopmental outcome beyond the perinatal period., Study Design: PubMed, Embase.com, the Cochrane Library and Web of Science were systematically searched from inception through 5 November 2020. We performed a cited-reference search and ClinicalTrials.gov was searched on 20 October 2020 to identify trial results that were not reported elsewhere. We included randomized controlled trials reporting on health-related outcomes in children (aged > 28 days) exposed to aspirin versus placebo or no treatment during pregnancy. Studies with any dose or duration of aspirin use were included. We excluded studies evaluating other antiplatelet agents or non-steroidal inflammatory drugs. Two authors independently performed study selection, data extraction and quality assessment. Quality assessment was performed using the Cochrane RoB2 tool for the original randomized controlled trials and the QUIPS for the follow-up studies. Results are presented as relative risks (RR) with 95% confidence intervals (95%CI)., Results: The search yielded 6,907 unique records. Two studies were included, containing 4,168 children at age 12 months and 5,153 children at 18 months. Children were exposed to aspirin 50-60 mg versus placebo or no treatment. At 12 months, post-neonatal mortality was lower after allocation to aspirin (0.2% versus 0.5%; RR 0.28, 95%CI 0.08-0.99) in a single study. At 18 months, fewer children were found to have (gross and fine) motor problems (RR 0.49, 95%CI 0.26-0.91) after antenatal aspirin exposure in one study. No differences were found in mortality rate; the proportion of children with a short stature or low weight; or respiratory, hearing or visual problems at 18 months. Both included studies had a high risk of bias., Conclusion: The two included studies showed evidence of potential benefit of antenatal low-dose aspirin on mortality and neurodevelopment up to the age of 18 months. Our findings support the current application of low-dose aspirin in pregnant women at risk for preeclampsia and fetal growth restriction. However, further follow-up research of children who were exposed to low-dose aspirin during pregnancy is of utmost importance to exclude potential long-term harm., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
185. Changes in local protocols on inpatient cervical priming and introduction of outpatient priming: A nationwide survey in the Netherlands.
- Author
-
Croll DMR, Hoge PC, Verhoeven CJM, de Boer MA, Bloemenkamp KWM, and de Heus R
- Subjects
- Female, Humans, Inpatients, Labor, Induced, Netherlands, Pregnancy, Surveys and Questionnaires, Cervical Ripening, Outpatients
- Abstract
Objective: The aims of this study are to assess (changes in) local procedures for inpatient cervical priming as part of induction of labor and to identify the implementation of outpatient cervical priming in the Netherlands., Methods: This survey study was conducted from October 2019 until January 2020; obstetricians of all 72 hospitals with a maternity unit in the Netherlands received a questionnaire. The questionnaire consisted of three parts: basic hospital data, local protocol on methods of inpatient induction of labor (IPI), local protocol for outpatient induction of labor (OPI)., Results: A response was received from 66/72 hospitals, giving a response rate of 92%. For IPI the most preferred method was a Foley catheter (87.9%), 27.6% protocols switched to prostaglandins after day 1 if the cervix was not ripe yet. A prostaglandin gel or pessary was not the preferred method on day 1 but only used after 24 h in 5 hospitals (7.6%). OPI was offered in 53% (35/66 hospitals), all using a Foley catheter., Conclusion: In the Netherlands, local protocols for IPI have shifted towards the use of a Foley catheter. More than half of the hospitals offer OPI. As safety and efficacy data of OPI are lacking, research on this topic is urgently warranted., Competing Interests: Conflict of interest The authors have no conflicts of interest to declare. DC, CV, MdB, KB and RdH are members of the PROBAAT-trial study group., (Copyright © 2021. Published by Elsevier B.V.)
- Published
- 2021
- Full Text
- View/download PDF
186. Increased incidence of hypertensive disorders of pregnancy in women with a history of spontaneous preterm birth: A longitudinal linked national cohort study.
- Author
-
Visser L, de Boer MA, Ravelli ACJ, Groen H, Mol BW, and de Groot CJM
- Subjects
- Adult, Causality, Female, Humans, Incidence, Longitudinal Studies, Pregnancy, Registries, Risk Assessment, Hypertension, Pregnancy-Induced epidemiology, Placentation, Premature Birth epidemiology
- Abstract
Objective: Determine the risk of hypertensive disorders of pregnancy (HD) in women with a history of spontaneous preterm birth (SPTB)., Study Design: Longitudinal linked national cohort study within the Dutch Perinatal Registry (1999-2009) on linked data among 349,291 women with a first and second singleton pregnancy in the Netherlands., Main Outcome Measures: The incidence of HD, small for gestational age (SGA) and placental abruption in the second pregnancy., Results: Out of 349,291 women with a singleton first pregnancy, 19,991 (5.7%) had a SPTB. The incidence of HD in the second pregnancy was 8.1% in women with a previous SPTB, as compared to 5.6% in women with a previous term birth (aOR 1.49 (CI 1.41-1.57)). Also after excluding HD, SGA and/or placental abruption in the first pregnancy, women with a history of SPTB had a higher risk of HD in their second pregnancy compared to women with a previous term birth (4.6% versus 2.7%, aOR 1.77 (CI 1.64-191)). Similarly, the incidence of SGA and placental abruption was higher in the second pregnancy in women with a history of SPTB compared to term birth in the first pregnancy., Conclusions: Women with a history of SPTB are at elevated risk of HD in the subsequent pregnancy. These results support shared pathophysiology between SPTB and HD., (Copyright © 2020. Published by Elsevier B.V.)
- Published
- 2020
- Full Text
- View/download PDF
187. Authors' reply re: Cerebroplacental ratio in predicting adverse perinatal outcome: a meta-analysis of individual participant data.
- Author
-
Vollgraff Heidweiller-Schreurs CA, van Osch IR, Heymans MW, Ganzevoort W, Schoonmade LJ, Bax CJ, Mol BWJ, de Groot CJM, Bossuyt PMM, and de Boer MA
- Subjects
- Female, Humans, Pregnancy, Ultrasonography, Prenatal, Umbilical Arteries
- Published
- 2020
- Full Text
- View/download PDF
188. Resistance of aspirin during and after pregnancy: A longitudinal cohort study.
- Author
-
Bij de Weg JM, Abheiden CNH, Fuijkschot WW, Harmsze AM, de Boer MA, Thijs A, and de Vries JIP
- Subjects
- Adult, Cohort Studies, Female, Humans, Hypertension, Pregnancy-Induced prevention & control, Longitudinal Studies, Platelet Function Tests methods, Pregnancy, Pregnancy Trimesters, Aspirin pharmacology, Drug Resistance, Platelet Aggregation Inhibitors pharmacology
- Abstract
Objectives: The objective of this study is to investigate possible changes in aspirin resistance during and after pregnancy over time., Study Design: A longitudinal cohort study in obstetric high risk women with an indication for aspirin usage during pregnancy to prevent placenta mediated pregnancy complications., Main Outcome Measures: Aspirin resistance measured in the first, second and third trimester of pregnancy and at least three months postpartum by four complementary test: PFA-200, VerifyNow®, Chronolog light transmission aggregometry (Chronolog LTA) and serum thromboxane B
2 (TxB2 ) level measurements. Correlation between the devices was investigated., Results: In total, 23 pregnant women participated in the present study. Aspirin resistance according to the PFA-200, VerifyNow®, Chronolog LTA and serum TxB2 , was 30.4%, 17.4%, 26.1% and 23.8% respectively. Resistance by any device was 69.6%. Aspirin resistance measured by the VerifyNow®, Chronolog LTA, serum TxB2 and aspirin resistance by any device during pregnancy was demonstrated more frequently than aspirin resistance after pregnancy. Correlation between the different devices was weak., Conclusion: Aspirin resistance was found in a considerable part of the participants. Considerable variation between participants, within participants over time and between the different devices was found. Prevalence of aspirin resistance during pregnancy differs from after pregnancy. More research on aspirin resistance and clinical obstetric outcome is needed., (Copyright © 2019 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.)- Published
- 2020
- Full Text
- View/download PDF
189. Peptide hormone ELABELA enhances extravillous trophoblast differentiation, but placenta is not the major source of circulating ELABELA in pregnancy.
- Author
-
Georgiadou D, Boussata S, Ranzijn WHM, Root LEA, Hillenius S, Bij de Weg JM, Abheiden CNH, de Boer MA, de Vries JIP, Vrijkotte TGM, Lambalk CB, Kuijper EAM, Afink GB, and van Dijk M
- Subjects
- Adult, Apelin blood, Body Mass Index, Cell Line, Cell Proliferation, Cohort Studies, Female, Humans, Pre-Eclampsia blood, Pregnancy, Pregnancy Trimester, First blood, Twins, Cell Differentiation, Peptide Hormones blood, Placenta metabolism, Trophoblasts cytology
- Abstract
Preeclampsia is a frequent gestational hypertensive disorder with equivocal pathophysiology. Knockout of peptide hormone ELABELA (ELA) has been shown to cause preeclampsia-like symptoms in mice. However, the role of ELA in human placentation and whether ELA is involved in the development of preeclampsia in humans is not yet known. In this study, we show that exogenous administration of ELA peptide is able to increase invasiveness of extravillous trophoblasts in vitro, is able to change outgrowth morphology and reduce trophoblast proliferation ex vivo, and that these effects are, at least in part, independent of signaling through the Apelin Receptor (APLNR). Moreover, we show that circulating levels of ELA are highly variable between women, correlate with BMI, but are significantly reduced in first trimester plasma of women with a healthy BMI later developing preeclampsia. We conclude that the large variability and BMI dependence of ELA levels in circulation make this peptide an unlikely candidate to function as a first trimester preeclampsia screening biomarker, while in the future administering ELA or a derivative might be considered as a potential preeclampsia treatment option as ELA is able to drive extravillous trophoblast differentiation.
- Published
- 2019
- Full Text
- View/download PDF
190. Publication bias may exist among prognostic accuracy studies of middle cerebral artery Doppler ultrasound.
- Author
-
Vollgraff Heidweiller-Schreurs CA, Korevaar DA, Mol BWJ, Bax CJ, de Groot CJM, de Boer MA, and Bossuyt PMM
- Subjects
- Female, Humans, Pregnancy, Prognosis, Prospective Studies, Reproducibility of Results, Research Design, Middle Cerebral Artery diagnostic imaging, Pregnancy Outcome epidemiology, Publication Bias statistics & numerical data, Ultrasonography, Doppler methods
- Abstract
Objectives: The objective of this study was to assess if there is evidence of publication bias in prognostic accuracy studies of middle cerebral artery (MCA) or cerebroplacental ratio (CPR) for adverse perinatal outcome., Study Design and Setting: We queried PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov and searched abstract books of five perinatal conferences (1989-2017). We included prognostic accuracy studies on MCA and/or CPR. Highest reported accuracy estimates, sample size, study design, and conclusion positivity were extracted and compared., Results: We included 127 full-text articles and 51 conference abstracts, 29 of which had not been reported as full-text article. In conference abstracts not reported in full, median negative predictive value was significantly lower compared to full-text articles (0.79 [interquartile range 0.67-0.97] vs. 0.95 [0.89-0.99]; P < 0.001). No significant difference was identified for positive predictive value (0.62 vs. 0.59; P = 0.827), sensitivity (0.67 vs. 0.71; P = 0.159), and specificity (0.86 vs. 0.86; P = 0.632). Study design differed significantly as well (P = 0.030), with fewer prospective studies in conference abstracts not reported in full compared to full-text articles (28% vs. 54%). We found no significant differences in sample size or conclusion positivity., Conclusion: Possibly, a publication bias in previously published meta-analyses of MCA and CPR has led to overly generous estimates of prognostic performance., (Copyright © 2019 Elsevier Inc. All rights reserved.)
- Published
- 2019
- Full Text
- View/download PDF
191. Analysis of Publication Interest on Preterm Birth Over Two Decades.
- Author
-
Visser L, de Boer MA, and de Groot CJM
- Subjects
- Adult, Bibliometrics, Female, Humans, Infant, Newborn, Male, Pregnancy, Premature Birth psychology, Obstetrics statistics & numerical data, Premature Birth therapy, Research statistics & numerical data
- Abstract
Introduction: Preterm birth (PTB) is one of the greatest challenges in obstetric and children's healthcare. PTB remains the most important cause of perinatal morbidity and mortality worldwide. We studied the number of publications concerning PTB over the last two decades using advanced bibliometric visualization methodology. We put the number of publications in perspective of growing awareness of PTB as a major health problem., Methods: We analyzed publications over time and performed bibliometric analysis of publications on PTB in the Web of Science from 1997 to 2016. The subjects of publications were visualized using a term map showing the relevant terms occurring in titles and abstracts., Results: We identified 47,811 publications. The annual number of publications on PTB increased significantly by 443% in 2016 (n = 5027) compared to 1997 (n = 1135). Obstetrics & Gynecology is the leading research field (with 10.4% on the subject PTB in 2016) followed closely by Pediatrics (7.6% on the subject PTB in 2016), within the field Public, Environmental & Occupational Health minimal increase was observed (only 1% was published on the subject PTB in 2016). The publications on PTB have increased at higher rates than the overall increase of publications. In recent years we found more publications on PTB describing epidemiology and clinical characteristics/outcomes whereas in earlier years publications focused more on translational, basic research., Conclusion: A significant increase in research concerning PTB was observed over the last two decades. This increase of publications is in line with the growing global awareness of the need to reduce PTB by clinical research.
- Published
- 2019
- Full Text
- View/download PDF
192. Doppler measurements of both umbilical arteries do not improve predictive value for adverse perinatal outcomes in small-for-gestational age fetuses.
- Author
-
Vollgraff Heidweiller-Schreurs CA, van Maasakker NE, van de Ven PM, de Groot CJM, Bax CJ, and de Boer MA
- Subjects
- Adult, Female, Gestational Age, Humans, Infant, Newborn, Predictive Value of Tests, Pregnancy, Pregnancy Outcome, Ultrasonography, Doppler, Ultrasonography, Prenatal, Fetal Development physiology, Fetal Growth Retardation diagnostic imaging, Umbilical Arteries diagnostic imaging
- Abstract
Objective: To assess agreement of Doppler ultrasound measurements of the two umbilical arteries in small-for gestational age (SGA) fetuses, and to compare discriminative ability between the two arteries for adverse perinatal outcome., Study Design: We analysed a prospective cohort of singleton SGA pregnancies, in which the pulsatility index (PI) of both umbilical arteries was standardly measured by Doppler ultrasound in the free-floating umbilical cord. The outcome of interest was a composite adverse outcome, defined as perinatal death, Apgar score <7 at 5 min, cesarean section for fetal distress, and neonatal intensive care unit admission., Results: A total of 531 measurements were performed in 124 patients. Mean absolute difference between PI measured in the two umbilical arteries was 0.14 (95% CI: 0.12 to 0.15), showing good agreement with an ICC of 0.830 (95% CI: 0.801 to 0.854). Perinatal outcomes were available for 101 patients, of which 48 patients (48%) had a composite adverse perinatal outcome. We found no significant differences between AUCs for prediction of an adverse outcome based on lowest, highest and mean PI values in the two umbilical arteries (AUCs = 0.75, 0.74, 0.75 with p = 0.91). As a comparison, the AUC of a PI value obtained in a single, randomly selected umbilical artery was 0.74., Conclusion: The two umbilical arteries show good agreement in terms of their PI values in the free-floating umbilical cord, and do not differ in terms of their discriminative ability for adverse perinatal outcome in SGA fetuses. We found no evidence of an added value of standard Doppler measurement of both umbilical arteries., (Copyright © 2018 Elsevier B.V. All rights reserved.)
- Published
- 2018
- Full Text
- View/download PDF
193. Introduction of non-invasive prenatal testing as a first-tier aneuploidy screening test: A survey among Dutch midwives about their role as counsellors.
- Author
-
Martin L, Gitsels-van der Wal JT, de Boer MA, Vanstone M, and Henneman L
- Subjects
- Adult, Counselors psychology, Female, Genetic Testing methods, Genetic Testing standards, Humans, Male, Middle Aged, Netherlands, Prenatal Care methods, Prenatal Care standards, Prenatal Diagnosis methods, Surveys and Questionnaires, Workforce, Aneuploidy, Counseling standards, Nurse Midwives psychology, Prenatal Diagnosis standards
- Abstract
In 2014, non-invasive prenatal testing (NIPT) for trisomies 21, 18 and 13 was added to the Dutch prenatal screening program as part of the TRIDENT study. Most (85%) pregnant Dutch women are counselled for prenatal aneuploidy screening by primary care midwives. This will remain when NIPT is implemented as a first-tier screening test. We therefore investigated midwife counsellors': 1) Knowledge about NIPT; 2) Attitudes towards NIPT as first-tier screening test; and 3) Experiences with informing clients about NIPT. Between April-June 2015, an online questionnaire to assess knowledge about NIPT, attitudes towards NIPT, and experiences with NIPT was completed by 436 Dutch primary care midwives. We found that 59% midwives answered ≥7 of 8 knowledge questions correctly. Continuing professional education attendance and more positive attitudes towards prenatal screening for Down syndrome were positively associated with the total knowledge score (β = 0.261; p = 0.007 and β = 0.204; p = 0.015, respectively). The majority (67%) were in favor of replacing First trimester Combined Test with NIPT, although 41% preferred to maintain a nuchal translucency measurement alongside NIPT. We conclude that midwives demonstrated solid knowledge about NIPT that may still be improved in some areas. Dutch midwives overwhelmingly support the integration of NIPT as a first-tier screening test., (Copyright © 2017 Elsevier Ltd. All rights reserved.)
- Published
- 2018
- Full Text
- View/download PDF
194. Caesarean section increases risk of preterm birth in subsequent pregnancy.
- Author
-
Visser L, de Boer MA, and Mol BW
- Subjects
- Delivery, Obstetric, Female, Humans, Infant, Newborn, Pregnancy, Risk, Cesarean Section, Premature Birth
- Published
- 2017
- Full Text
- View/download PDF
195. What do people want to know about NIPT? Content analysis of questions emailed to national NIPT information websites.
- Author
-
Tamminga S, van Dussen L, Verweij EJ, de Boer MA, Cornel MC, and Henneman L
- Subjects
- Female, Humans, Internet, National Health Programs, Pregnancy, Consumer Health Information, Maternal Serum Screening Tests psychology
- Published
- 2017
- Full Text
- View/download PDF
196. Post-pregnancy aspirin resistance appears not to be related with recurrent hypertensive disorders of pregnancy.
- Author
-
Abheiden CNH, Fuijkschot WW, Arduç A, van Diemen JJK, Harmsze AM, de Boer MA, Thijs A, and de Vries JIP
- Subjects
- Adult, Female, Follow-Up Studies, Humans, Middle Aged, Pregnancy, Aspirin, Drug Resistance, Fibrinolytic Agents, Hypertension, Pregnancy-Induced etiology
- Abstract
Objective: The FRUIT-RCT concluded that low-molecular-weight heparin added to aspirin compared to treatment with aspirin alone is beneficial in the prevention of early-onset hypertensive disorders of pregnancy (HD) in women with inheritable thrombophilia and prior HD and/or a small-for-gestational age (SGA) infant leading to delivery before 34 weeks gestation. The aim of this study is to answer the question whether aspirin resistance is associated with recurrent HD., Study Design: Women with and without recurrent HD matched for age, study arm, and chronic hypertension were invited for this follow-up study 6-16 years after they participated in the FRUIT-RCT. Aspirin resistance was tested after 10days of aspirin intake using three complementary tests: PFA-200, VerifyNow
® and serum thromboxane B2 (TXB2 ). An independent t-test, Mann-Whitney U test, Fisher's Exact test and Chi2 test were used for the statistical analyses., Results: Thirteen of 24 women with recurrent HD and 16 of 24 women without recurrent HD participated. The prevalence of laboratory aspirin resistance was 34.5% according to the PFA-200, 3.4% according to the VerifyNow® and 24.1% according to TXB2 . The prevalence of aspirin resistance by any test was 51.7%. Aspirin resistance per individual test did not differ between women with and without recurrent HD. Aspirin resistance measured by any test occurred more frequently in women without recurrent HD (p<0.01), irrespective of low-molecular-weight heparin., Conclusions: No relation could be demonstrated between recurrent HD and aspirin resistance per test, measured up to 16 years after pregnancy. On the contrary, complementary aspirin resistance measurements were encountered more frequently in women without recurrent HD., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)- Published
- 2017
- Full Text
- View/download PDF
197. Trial by Dutch laboratories for evaluation of non-invasive prenatal testing. Part II-women's perspectives.
- Author
-
van Schendel RV, Page-Christiaens GC, Beulen L, Bilardo CM, de Boer MA, Coumans AB, Faas BH, van Langen IM, Lichtenbelt KD, van Maarle MC, Macville MV, Oepkes D, Pajkrt E, and Henneman L
- Subjects
- Adult, Chromosomes, Human, Pair 13, Chromosomes, Human, Pair 18, Down Syndrome diagnosis, Educational Status, False Positive Reactions, Female, Follow-Up Studies, Humans, Middle Aged, Netherlands, Pregnancy, Pregnancy Trimester, First, Surveys and Questionnaires, Time Factors, Trisomy diagnosis, Trisomy 13 Syndrome, Trisomy 18 Syndrome, Young Adult, Anxiety psychology, Attitude to Health, Chromosome Disorders diagnosis, Conflict, Psychological, DNA blood, Decision Making, Health Literacy, Sequence Analysis, DNA methods
- Abstract
Objective: To evaluate preferences and decision-making among high-risk pregnant women offered a choice between Non-Invasive Prenatal Testing (NIPT), invasive testing or no further testing., Methods: Nationwide implementation study (TRIDENT) offering NIPT as contingent screening test for women at increased risk for fetal aneuploidy based on first-trimester combined testing (>1:200) or medical history. A questionnaire was completed after counseling assessing knowledge, attitudes and participation following the Multidimensional Measure of Informed Choice., Results: A total of 1091/1253 (87%) women completed the questionnaire. Of these, 1053 (96.5%) underwent NIPT, 37 (3.4%) invasive testing and 1 (0.1%) declined testing. 91.7% preferred NIPT because of test safety. Overall, 77.9% made an informed choice, 89.8% had sufficient knowledge and 90.5% had positive attitudes towards NIPT. Women with intermediate (odds ratio (OR) = 3.51[1.70-7.22], p < 0.001) or high educational level (OR = 4.36[2.22-8.54], p < 0.001) and women with adequate health literacy (OR = 2.60[1.36-4.95], p = 0.004) were more likely to make an informed choice. Informed choice was associated with less decisional conflict and less anxiety (p < 0.001). Intention to terminate the pregnancy for Down syndrome was higher among women undergoing invasive testing (86.5%) compared to those undergoing NIPT (58.4%) (p < 0.001)., Conclusions: The majority of women had sufficient knowledge and made an informed choice. Continuous attention for counseling is required, especially for low-educated and less health-literate women. © 2016 The Authors. Prenatal Diagnosis published by John Wiley & Sons, Ltd., (© 2016 The Authors. Prenatal Diagnosis published by John Wiley & Sons, Ltd.)
- Published
- 2016
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.