35 results on '"Boers, KE"'
Search Results
2. Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial
- Author
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Prick, BW, primary, Jansen, AJG, additional, Steegers, EAP, additional, Hop, WCJ, additional, Essink-Bot, ML, additional, Uyl-de Groot, CA, additional, Akerboom, BMC, additional, van Alphen, M, additional, Bloemenkamp, KWM, additional, Boers, KE, additional, Bremer, HA, additional, Kwee, A, additional, van Loon, AJ, additional, Metz, GCH, additional, Papatsonis, DNM, additional, van der Post, JAM, additional, Porath, MM, additional, Rijnders, RJP, additional, Roumen, FJME, additional, Scheepers, HCJ, additional, Schippers, DH, additional, Schuitemaker, NWE, additional, Stigter, RH, additional, Woiski, MD, additional, Mol, BWJ, additional, van Rhenen, DJ, additional, and Duvekot, JJ, additional
- Published
- 2014
- Full Text
- View/download PDF
3. Neonatal morbidity after induction vs expectant monitoring in intrauterine growth restriction at term: a subanalysis of the DIGITAT RCT
- Author
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Boers, KE, van Wyk, L, van der Post, JAM, Kwee, A, van Pampus, MG, Spaanderdam, MEA, Duvekot, J.J., Bremer, HA, Delemarre, FMC, Bloemenkamp, KWM, de Groot, CJM, Willekes, C, Rijken, Mikel, Roumen, FJME, Thornton, JG, van Lith, JMM, Mol, BWJ (Ben), le Cessie, S, Scherjon, SA, Boers, KE, van Wyk, L, van der Post, JAM, Kwee, A, van Pampus, MG, Spaanderdam, MEA, Duvekot, J.J., Bremer, HA, Delemarre, FMC, Bloemenkamp, KWM, de Groot, CJM, Willekes, C, Rijken, Mikel, Roumen, FJME, Thornton, JG, van Lith, JMM, Mol, BWJ (Ben), le Cessie, S, and Scherjon, SA
- Abstract
OBJECTIVE: The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) compared induction of labor and expectant management in suspected intrauterine growth restriction (IUGR) at term. In this subanalysis, we report neonatal morbidity between the policies based on the Morbidity Assessment Index for Newborns (MAIN). STUDY DESIGN: We used data from the DIGITAT. For each neonate, we calculated the MAIN score, a validated outcome scale. RESULTS: There were no differences in mean MAIN scores or in MAIN morbidity categories. We found that neonatal admissions are lower after 38 weeks' gestational age compared with 36 and 37 weeks in both groups. CONCLUSION: The incidence of neonatal morbidity in IUGR at term is comparable and relatively mild either after induction or after an expectant policy. However, neonatal admissions are lower after 38 weeks of pregnancy, so if induction to preempt possible stillbirth is considered, it is reasonable to delay until 38 weeks, provided watchful monitoring.
- Published
- 2012
4. Maternal health-related quality of life after induction of labor or expectant monitoring in pregnancy complicated by intrauterine growth retardation beyond 36 weeks
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Bijlenga, D, Boers, KE, Birnie, Erwin, Mol, BWJ (Ben), Vijgen, SCM, van der Post, JAM, de Groot, CJM, Rijnders, RJP, Pernet, PJ, Roumen, FJ, Stigter, RH, Delemarre, FMC, Bremer, HA, Porath, MM, Scherjon, SA, Bonsel, Gouke, Bijlenga, D, Boers, KE, Birnie, Erwin, Mol, BWJ (Ben), Vijgen, SCM, van der Post, JAM, de Groot, CJM, Rijnders, RJP, Pernet, PJ, Roumen, FJ, Stigter, RH, Delemarre, FMC, Bremer, HA, Porath, MM, Scherjon, SA, and Bonsel, Gouke
- Published
- 2011
5. Disproportionate intrauterine growth intervention trial at term: DIGITAT
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Boers, KE, Bijlenga, D, Mol, BWJ (Ben), le Cessie, S, Birnie, Erwin, van Pampus, MG, Stigter, RH, Bloemenkamp, KWM, van Meir, CA, Van der Post, JAM, Bekedam, DJ, Ribbert, LSM, Drogtrop, AP, van der Salm, PCM, Huisjes, AJM, Willekes, C, Roumen, FJME, Scheepers, HCJ, de Boer, K, Duvekot, JJ, Thornton, JG, Scherjon, SA, Boers, KE, Bijlenga, D, Mol, BWJ (Ben), le Cessie, S, Birnie, Erwin, van Pampus, MG, Stigter, RH, Bloemenkamp, KWM, van Meir, CA, Van der Post, JAM, Bekedam, DJ, Ribbert, LSM, Drogtrop, AP, van der Salm, PCM, Huisjes, AJM, Willekes, C, Roumen, FJME, Scheepers, HCJ, de Boer, K, Duvekot, JJ, Thornton, JG, and Scherjon, SA
- Published
- 2007
6. Comparison of participants and non-participants in a trial of induction versus expectant monitoring for intrauterine growth restriction at term (the digitat trial)
- Author
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Boers, KE, primary, Thornton, JG, additional, and Scherjon, S, additional
- Published
- 2012
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- View/download PDF
7. Neonatal morbidity after induction versus expectant monitoring in intrauterine growth restriction at term
- Author
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Boers, KE, primary, Thornton, JG, additional, and Scherjon, SA, additional
- Published
- 2012
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- View/download PDF
8. Maternal health-related quality of life after induction of labor or expectant monitoring in pregnancy complicated by intrauterine growth retardation beyond 36 weeks.
- Author
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Bijlenga D, Boers KE, Birnie E, Mol BW, Vijgen SC, Van der Post JA, De Groot CJ, Rijnders RJ, Pernet PJ, Roumen FJ, Stigter RH, Delemarre FM, Bremer HA, Porath M, Scherjon SA, Bonsel GJ, Bijlenga, Denise, Boers, Kim E, Birnie, Erwin, and Mol, Ben-Willem J
- Abstract
Objective: Pregnancies complicated by intrauterine growth retardation (IUGR) beyond 36 weeks of gestation are at increased risk of neonatal morbidity and mortality. Optimal treatment in IUGR at term is highly debated. Results from the multicenter DIGITAT (Disproportionate Intrauterine Growth Intervention Trial At Term) trial show that induction of labor and expectant monitoring result in equal neonatal and maternal outcomes for comparable cesarean section rates. We report the maternal health-related quality of life (HR-QoL) that was measured alongside the trial at several points in time.Methods: Both randomized and non-randomized women were asked to participate in the HR-QoL study. Women were asked to fill out written validated questionnaires, covering background characteristics, condition-specific issues and the Short Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression scale (HADS), and Symptom Check List (SCL-90) at baseline, 6 weeks postpartum and 6 months postpartum. We compared the difference scores of all summary measures between the two management strategies by ANOVA. A repeated measures multivariate mixed model was defined to assess the effect of the management strategies on the physical (PCS) and mental (MCS) components of the SF-36. Analysis was by intention to treat.Results: We analyzed data of 361 randomized and 198 non-randomized patients. There were no clinically relevant differences between the treatments at 6 weeks or 6 months postpartum on any summary measures; e.g., on the SF-36 (PCS: P = .09; MCS: P = .48). The PCS and the MCS were below norm values at inclusion. The PCS improved over time but stayed below norm values at 6 months, while the MCS did not improve.Conclusion: In pregnancies complicated by IUGR beyond 36 weeks, induction of labor does not affect the long-term maternal quality of life. [ABSTRACT FROM AUTHOR]- Published
- 2011
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9. Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial.
- Author
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Prick, Bw, Jansen, Ajg, Steegers, Eap, Hop, Wcj, Essink-Bot, Ml, Uyl-de Groot, Ca, Akerboom, Bmc, van Alphen, M, Bloemenkamp, Kwm, Boers, Ke, Bremer, Ha, Kwee, A, van Loon, Aj, Metz, Gch, Papatsonis, Dnm, van der Post, Jam, Porath, Mm, Rijnders, Rjp, Roumen, Fjme, and Scheepers, Hcj
- Published
- 2007
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- View/download PDF
10. Effects on (neuro)developmental and behavioral outcome at 2 years of age of induced labor compared with expectant management in intrauterine growth-restricted infants: long-term outcomes of the DIGITAT trial.
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van Wyk L, Boers KE, van der Post JA, van Pampus MG, van Wassenaer AG, van Baar AL, Spaanderdam ME, Becker JH, Kwee A, Duvekot JJ, Bremer HA, Delemarre FM, Bloemenkamp KW, de Groot CJ, Willekes C, Roumen FJ, van Lith JM, Mol BW, le Cessie S, and Scherjon SA
- Abstract
OBJECTIVE: We sought to study long-term (neuro)developmental and behavioral outcome of pregnancies complicated by intrauterine growth restriction at term in relation to induction of labor or an expectant management. STUDY DESIGN: Parents of 2-year-old children included in the Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) answered the Ages and Stages Questionnaire (ASQ) and Child Behavior Checklist (CBCL). RESULTS: We approached 582 (89.5%) of 650 parents. The response rate was 50%. Of these children, 27% had an abnormal score on the ASQ and 13% on the CBCL. Results of the ASQ and the CBCL for the 2 policies were comparable. Low birthweight, positive Morbidity Assessment Index score, and admission to intermediate care increased the risk of an abnormal outcome of the ASQ. This effect was not seen for the CBCL. CONCLUSION: In women with intrauterine growth restriction at term, neither a policy of induction of labor nor expectant management affect developmental and behavioral outcome when compared to expectant management. [ABSTRACT FROM AUTHOR]
- Published
- 2012
11. Neonatal morbidity after induction vs expectant monitoring in intrauterine growth restriction at term: a subanalysis of the DIGITAT RCT.
- Author
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Boers KE, van Wyk L, van der Post JA, Kwee A, van Pampus MG, Spaanderdam ME, Duvekot JJ, Bremer HA, Delemarre FM, Bloemenkamp KW, de Groot CJ, Willekes C, Rijken M, Roumen FJ, Thornton JG, van Lith JM, Mol BW, le Cessie S, Scherjon SA, and DIGITAT Study Group
- Abstract
OBJECTIVE: The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) compared induction of labor and expectant management in suspected intrauterine growth restriction (IUGR) at term. In this subanalysis, we report neonatal morbidity between the policies based on the Morbidity Assessment Index for Newborns (MAIN). STUDY DESIGN: We used data from the DIGITAT. For each neonate, we calculated the MAIN score, a validated outcome scale. RESULTS: There were no differences in mean MAIN scores or in MAIN morbidity categories. We found that neonatal admissions are lower after 38 weeks' gestational age compared with 36 and 37 weeks in both groups. CONCLUSION: The incidence of neonatal morbidity in IUGR at term is comparable and relatively mild either after induction or after an expectant policy. However, neonatal admissions are lower after 38 weeks of pregnancy, so if induction to preempt possible stillbirth is considered, it is reasonable to delay until 38 weeks, provided watchful monitoring. [ABSTRACT FROM AUTHOR]
- Published
- 2012
12. The impact of caesarean scar niche on fertility - a systematic review.
- Author
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van den Tweel MM, van der Struijs S, Le Cessie S, and Boers KE
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- Humans, Female, Pregnancy, Reproductive Techniques, Assisted adverse effects, Vagina microbiology, Microbiota, Infertility, Female etiology, Infertility, Female microbiology, Live Birth, Fertility, Adult, Birth Rate, Cicatrix etiology, Cesarean Section adverse effects, Cesarean Section statistics & numerical data
- Abstract
Background: The trend of increasing caesarean section (CS) rates brings up questions related to subfertility. Research regarding the influence of CS on assisted reproduction techniques (ART) is conflicting. A potential mechanism behind CS-induced subfertility is intra uterine fluid resulting from a caesarean scar defect or niche. The vaginal microbiome has been repeatedly connected to negative ART outcomes, but it is unknown if the microbiome is changed in relation to a niche., Methods: This systematic review describes literature investigating the effect of a niche on live birth rates after assisted reproduction. Furthermore, studies investigating a difference in microbial composition in subfertile persons with a niche compared to no niche are evaluated. Pubmed, Embase and Web of Science were searched on March 2023 for comparative studies on both study questions. Inclusion criteria were i.e., English language, human-only studies, availability of the full article and presence of comparative pregnancy data on a niche. The quality of the included studies and their risk of bias were assessed using the Newcastle-Ottawa scale for cohort studies. The results were graphically displayed in a forest plot., Results: Six retrospective cohort studies could be included on fertility outcomes, with a total of 1083 persons with a niche and 3987 without a niche. The overall direction of effect shows a negative impact of a niche on the live birth rate (pooled aOR 0.58, 95% CI 0.48-0.69) with low-grade evidence. Three studies comparing the microbiome between persons with and without a CS could be identified., Conclusion: There is low-grade evidence to conclude that the presence of a niche reduces live birth rates when compared to persons without a niche. The theory that a caesarean has a negative impact on pregnancy outcomes because of dysbiosis promoted by the niche is interesting, but there is no sufficient literature about this.
- Published
- 2024
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13. The Vaginal Microbiome Changes During Various Fertility Treatments.
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van den Tweel MM, van den Munckhof EHA, van der Zanden M, Molijn A, van Lith JMM, and Boers KE
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- Humans, Female, Adult, Prospective Studies, Pregnancy, Vaginosis, Bacterial microbiology, Fertilization in Vitro methods, Ovulation Induction methods, Fertility, Lactobacillus isolation & purification, Infertility therapy, Infertility microbiology, Vagina microbiology, Microbiota drug effects
- Abstract
This study aimed to investigate the influence of hormonal treatment on the vaginal microbiome during fertility treatments. Bacterial vaginosis (BV) could affect fecundity, particularly in the in vitro fertilization (IVF) population, where negative effects on pregnancy outcomes have been reported. It is hypothesized that the hormone treatment during fertility treatments could influence the abundance of Lactobacilli, with negative effects on the pregnancy results. A total of 53 couples attending a fertility clinic in the Netherlands between July 2019 and August 2022 were included in this prospective cohort study. Vaginal samples were collected at start of treatment, oocyte retrieval or insemination from subjects undergoing intra uterine insemination (IUI) with mild ovarian stimulation, and IVF or intra cytoplasmatic sperm injection (ICSI) with controlled ovarian hyperstimulation. AmpliSens® Florocenosis/Bacterial vaginosis-FRT qPCR and 16S rRNA gene-based amplicon sequencing were performed on all samples. In total, 140 swabs were analyzed, with a median of two swabs per person. 33 (24%) tested qPCR BV positive. Lactobacilli percentage decreased during fertility treatments, leading to changes in the vaginal microbiome. Shannon diversity index was not significantly different. Of the total of 53 persons, nine switched from qPCR BV negative to positive during treatment. The persons switching to qPCR BV positive had already a (not significant) higher Shannon diversity index at start of treatment. If the vaginal microbiome of persons deteriorates during fertility treatments, timing of following treatments, lifestyle modifications, or a freeze all strategy could be of possible benefit., (© 2024. The Author(s).)
- Published
- 2024
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14. Bacterial vaginosis in a subfertile population undergoing fertility treatments: a prospective cohort study.
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van den Tweel MM, van den Munckhof EHA, van der Zanden M, Molijn AC, van Lith JMM, Le Cessie S, and Boers KE
- Subjects
- Pregnancy, Infant, Newborn, Male, Humans, Female, Prospective Studies, RNA, Ribosomal, 16S genetics, Semen, Fertilization in Vitro, Pregnancy Rate, Fertility, Vaginosis, Bacterial complications, Vaginosis, Bacterial epidemiology, Infertility, Abortion, Spontaneous epidemiology
- Abstract
Purpose: This study investigates the role of bacterial vaginosis (BV) on pregnancy rates during various fertility treatments. BV is known to influence several obstetric outcomes, such as preterm delivery and endometritis. Only few studies investigated the effect of BV in subfertile women, and studies found a negative effect on fecundity especially in the in vitro fertilisation population., Methods: Observational prospective study, 76 couples attending a fertility clinic in the Netherlands between July 2019 and June 2022, undergoing a total of 133 attempts of intra uterine insemination, in vitro fertilization or intra cytoplasmatic sperm injection. Vaginal samples taken at oocyte retrieval or insemination were analysed on qPCR BV and 16S rRNA gene microbiota analysis of V1-V2 region. Logistic regression with a Generalized Estimated Equations analysis was used to account for multiple observations per couples., Results: A total of 26% of the 133 samples tested positive for BV. No significant differences were observed in ongoing pregnancy or live birth rates based on BV status (OR 0.50 (0.16-1.59), aOR 0.32 (0.09-1.23)) or microbiome community state type. There was a tendency of more miscarriages based on positive BV status (OR 4.22 (1.10-16.21), aOR 4.28 (0.65-28.11)) or community state type group III and IV. On baseline qPCR positive participants had significantly higher body mass index and smoked more often. Odds ratios were adjusted for smoking status, body mass index, and socioeconomic status., Conclusion: Bacterial vaginosis does not significantly impact ongoing pregnancy rates but could affect miscarriage rates., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2024
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15. The relationship between vaginal pH and bacterial vaginosis as diagnosed using qPCR in an asymptomatic subfertile population.
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van den Tweel MM, van der Struijs S, van den Munckhof EHA, and Boers KE
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- Female, Humans, Hydrogen-Ion Concentration, Prospective Studies, Vagina microbiology, Infertility, Vaginosis, Bacterial microbiology
- Abstract
Purpose: Bacterial vaginosis (BV) is a dysbiosis of the vaginal microbiome and a condition found in 20-30% of all women. Literature describing the possible link between BV and subfertility is increasing. Newer techniques such as quantitative polymerase chain reactions (qPCR) detect BV more accurately than traditional methods but come with high costs. The association between pH and BV as diagnosed using traditional methods is well-established in a symptomatic population. This study is the first to investigate the association between pH and BV diagnosed by qPCR in an asymptomatic subfertile population and to examine the usefulness of pH as a means of cost reduction., Methods: Data of 170 pH-qPCR combinations were used from a prospective cohort study examining bacterial vaginosis in a subfertile population. 102 women received a vaginal swab and pH measurement at baseline and subsequent advanced reproductive technology (ART) treatments. The swabs are analysed using the AmpliSens
® Florocenosis/Bacterial vaginosis-FRT qPCR kit., Results: pH is strongly associated with BV as diagnosed by qPCR (OR 3.06, p = 0.000, CI 1.65-5.68). The cut-off point for pH ≥ 4.7 maximised diagnostic performance [AUC 0.74 (CI 0.66-0.83), sensitivity 76%] and reduced costs by 60%., Conclusion: This study shows that the vaginal pH for a multi-ethnic, asymptomatic population of women attending fertility clinics is strongly associated with BV qPCR outcome. Using the cut-off of pH of 4.7 has a high sensitivity for diagnosis of BV by qPCR and can be achieved at a cost reduction of 60%., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)- Published
- 2022
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16. Developing an algorithm for the diagnosis of abnormal vaginal discharge in a dutch clinical setting: a pilot study.
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van den Munckhof EHA, van Sitter RL, Lamont RF, le Cessie S, Kuijper EJ, Knetsch CW, Molijn A, Quint WGV, Boers KE, and Leverstein-van Hall MA
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- Adolescent, Adult, Clinical Laboratory Techniques, Female, Humans, Hydrogen-Ion Concentration, Middle Aged, Netherlands, Odorants, Pilot Projects, Vaginal Discharge microbiology, Vaginal Discharge parasitology, Vaginosis, Bacterial diagnosis, Young Adult, Algorithms, Vaginal Discharge diagnosis
- Abstract
Abnormal vaginal discharge may be caused by bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis and/or aerobic vaginitis. For the development of a diagnostic algorithm, tree-based classification analysis was performed on symptoms, signs and bedside test results of 56 patients, and laboratory tests (culture, Nugent score, qPCRs) were compared. Amplicon sequencing of the 16S rRNA gene was used as reference test for bacterial vaginosis and aerobic vaginitis, culture for vulvovaginal candidiasis and qPCR for trichomoniasis. For bacterial vaginosis, the best diagnostic algorithm was to screen at the bedside with a pH and odour test and if positive, to confirm by qPCR (sensitivity 94%; specificity 97%) rather than Nugent score (sensitivity of 59%; specificity 97%; P = 0.031). The analysis for the other infections was less conclusive due to the low number of patients with these infections. For bacterial vaginosis, the developed algorithm is sensitive, specific, and reduces the need for laboratory tests in 50% of the patients., Competing Interests: Declaration of competing interest WQ is a shareholder of DDL Diagnostic Laboratory. The other authors declare that they have no competing interests., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
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17. Perinatal death in a term fetal growth restriction randomized controlled trial: the paradox of prior risk and consent.
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van Wyk L, Boers KE, Gordijn SJ, Ganzevoort W, Bremer HA, Kwee A, Delemarre FMC, van Pampus MG, Bloemenkamp KWM, Roumen FJME, van Lith JMM, Mol BWJ, Thornton JG, Scherjon SA, and le Cessie S
- Subjects
- Child, Female, Humans, Infant, Newborn, Informed Consent, Labor, Induced, Pregnancy, Watchful Waiting, Fetal Growth Retardation, Perinatal Death
- Abstract
Background: The disproportionate intrauterine growth intervention trial at term was an intention to treat analysis and compared labor induction with expectant monitoring in pregnancies complicated by fetal growth restriction at term and showed equivalence for neonatal outcomes., Objective: To evaluate trial participation bias and to examine the generalizability of the results of an obstetrical randomized trial., Study Design: We used data from participants and nonparticipants of a randomized controlled trial-the disproportionate intrauterine growth intervention trial at term (n=1116) -to perform a secondary analysis. This study compared induction of labor and expectant management in women with term growth restriction. Data were collected in the same manner for both groups. Baseline characteristics and neonatal and maternal outcomes were compared. The primary outcome was a composite measure of adverse neonatal outcome. Secondary outcomes were delivery by cesarean delivery and instrumental vaginal delivery; length of stay in the neonatal intensive care, neonatal ward, and the maternal hospital; and maternal morbidity., Results: Nonparticipants were older, had a lower body mass index, had a higher level of education, smoked less, and preferred expectant management. The time between study inclusion and labor onset was shorter in participants than in nonparticipants. Notably, 4 perinatal deaths occurred among nonparticipants and none among participants. Among nonparticipants, there were more children born with a birthweight below the third centile. The nonparticipants who had expectant management were monitored less frequently than the participants in both the intervention and the expectant arm., Conclusion: We found less favorable outcomes and more perinatal deaths in nonparticipants. Protocol-driven management, differences between participants and nonparticipants, or the fact that nonparticipants had a preference for expectant management might explain the findings., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2020
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18. Repeated oral glucose tolerance tests in women at risk for gestational diabetes mellitus.
- Author
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de Wit L, Bos DM, van Rossum AP, van Rijn BB, and Boers KE
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- Adult, Female, Glucose Tolerance Test, Humans, Pregnancy, Retrospective Studies, Diabetes, Gestational diagnosis
- Abstract
Objective: Pregnant women with a negative oral glucose tolerance test (OGTT) between 24-28 weeks as part of risk-based screening for gestational diabetes mellitus (GDM) may develop clinical signs or symptoms suggestive for GDM in the third trimester. We aimed to determine the additional yield of repeating an OGTT to detect missed GDM in this group and assess patient characteristics and indications associated with a positive second OGTT., Study Design: We conducted a retrospective cohort study of women with a negative OGTT between 24-28 weeks of pregnancy in two hospitals in the Netherlands. Patient characteristics, pregnancy outcomes, OGTT results and indications were compared between women with normal (non-GDM) and abnormal (GDM) results of the second OGTT, using the WHO 1999 criteria (fasting glucose ≥7.0 mmol/L or 2 -h post load ≥7.8 mmol/L). We used receiver operating characteristic (ROC) curve analysis to determine cut-offs for fasting and 2 -h glucose values of the index OGTT that were associated with a positive OGTT in the third trimester., Results: Of 3147 women at risk for GDM, 183 underwent a second OGTT in the third trimester following their regular OGTT at 24-28 weeks. In 43 women (23.5%) GDM was diagnosed based on the second OGTT. A history of GDM was associated with subsequent GDM diagnosis, with an odds ratio of 2.6 (95% CI 1.0-6.3). Both fasting and 2 -h post load glucose values of the index OGTT were significantly higher in women with abnormal OGTT results later in pregnancy. Index OGTT glucose value cut-offs of 4.8 mmol/L (fasting) and 6.5 mmol/L (2 -h) had positive predictive values of 0.32 and 0.47 for a positive OGTT in the third trimester, and negative predictive values of 0.83 and 0.90, respectively. Fetal growth as a clinical symptom for GDM was the most frequent indication for repeating the OGTT, resulting in the diagnosis of GDM in 22.7% of women tested for this indication., Conclusion: Repeating an OGTT after initial negative screening results in additional GDM diagnoses. In case of clinical signs, especially in women with additional risk factors such as a history of GDM or higher index OGTT glucose values, repeating an OGTT could be considered., (Copyright © 2019 Elsevier B.V. All rights reserved.)
- Published
- 2019
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19. Short report: Post-operative wound infections after the gentle caesarean section.
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Bronsgeest K, Wolters VERA, Freeman LM, Te Pas AB, Kreijen-Meinesz JH, and Boers KE
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- Adult, Cesarean Section adverse effects, Cesarean Section methods, Female, Humans, Netherlands epidemiology, Pregnancy, Prospective Studies, Surgical Wound Infection etiology, Cesarean Section statistics & numerical data, Surgical Wound Infection epidemiology
- Abstract
Objectives: Worldwide, the caesarean section (CS) is the most performed type of surgery and numbers are still rising. The gentle CS has become a more common procedure as it allows the parents to experience birth. Early and continuous skin-to-skin contact between the mother and her newborn is pursued. Parents are not separated from their newborns and stay with their child in the operation theatre and recovery room. However, data are limited on the incidence of surgical site infections (SSI) after gentle CS. The aim of our study was to examine the risk of postoperative wound infections after gentle CS. Secondary outcomes included other maternal complications and neonatal outcomes., Study Design: In this multicenter prospective cohort study, all women who underwent an elective gentle CS between January 2015 and January 2017 were eligible. Demographics, per procedural data, maternal complications and neonatal outcomes were collected. The follow-up lasted until six weeks post partum., Results: Of the 243 performed CSs, two (0.8%) SSIs occurred; one superficial and one deep wound infection. One patient (0.4%) was readmitted for treatment of endometritis. In total, 20 (8.2%) maternal complications were identified. Median time to skin-to-skin contact was 3 minutes (IQR 2-4.25) with a median neonatal oxygen saturation 10 minutes after birth of 95% (IQR 92-98). Mean gestational age was 274 ± 4.1 days (39 + 1 weeks) and mean neonatal pH was 7.28 (±SD 0.07). All children had Apgar scores >7 at 5 minutes after birth. Neonatal admission occurred in 19 cases (7.8%) and neonatal readmission in 10 cases (4.1%)., Conclusion: The gentle CS seems to be a safe procedure for both mother and child and is not associated with an increased risk of surgical site infections or direct suboptimal neonatal outcomes. Therefore, more intensive mother-child interaction during CS is allowed., (Copyright © 2019 Elsevier B.V. All rights reserved.)
- Published
- 2019
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20. Postnatal Catch-Up Growth After Suspected Fetal Growth Restriction at Term.
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van Wyk L, Boers KE, van Wassenaer-Leemhuis AG, van der Post JAM, Bremer HA, Delemarre FMC, Gordijn SJ, Bloemenkamp KWM, Roumen FJME, Porath M, van Lith JMM, Mol BWJ, le Cessie S, and Scherjon SA
- Abstract
Objective: The aim of this study was to study growth patterns of children born after suspected fetal growth restriction (FGR) at term and to compare the effect of induction of labor (IoL) and expectant management (EM), also in relation to neurodevelopmental and behavioral outcome at age 2. Methods: We performed a 2 years' follow-up of growth of children included in the Disproportionate Intrauterine Growth Restriction Trial at Term (DIGITAT) study, a Randomized Controlled Trial (RCT) comparing IoL with EM in pregnancies with suspected FGR at term. We collected data on child growth until the age of 2 years. Standard deviation scores (SDSs) for height and weight were calculated at different ages. We assessed the effects of IoL compared with EM and the effects of a birth weight below or above the 3rd or 10th centile on catch-up growth. Target height SDSs were calculated using the height of both parents. Results: We found a significant increase in SDS in the first 2 years. Children born after EM showed more catch-up growth in the first month [height: mean difference -0.7 (95% CI: 0.2; 1.3)] and weight [mean difference -0.5 (95% CI: 0.3; 0.7)]. Children born with a birth weight below the 3rd and 10th centiles showed more catch-up growth after 1 year [mean difference -0.8 SDS (95% CI: -1.1; -0.5)] and after 2 years [mean difference -0.7 SDS (95% CI: -1.2; -0.2)] as compared to children with a birth weight above the 3rd and 10th centiles. SDS at birth had the strongest effect on adverse neurodevelopmental outcome at 2 years of age. Conclusion: After FGR at term, postnatal catch-up growth is generally present and associated with the degree of FGR. Obstetric management in FGR influences postnatal growth. Longer-term follow-up is therefore needed and should be directed at growth and physical health. Clinical Trial Registration: www.ClinicalTrials.gov, identifier SRCTN10363217.
- Published
- 2019
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21. Comparison of Amsel criteria, Nugent score, culture and two CE-IVD marked quantitative real-time PCRs with microbiota analysis for the diagnosis of bacterial vaginosis.
- Author
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van den Munckhof EHA, van Sitter RL, Boers KE, Lamont RF, Te Witt R, le Cessie S, Knetsch CW, van Doorn LJ, Quint WGV, Molijn A, and Leverstein-van Hall MA
- Subjects
- Adolescent, Adult, Bacteria genetics, DNA, Bacterial genetics, Diagnostic Tests, Routine, Female, Humans, Middle Aged, RNA, Ribosomal, 16S genetics, Real-Time Polymerase Chain Reaction standards, Sensitivity and Specificity, Sequence Analysis, DNA, Vagina microbiology, Vaginosis, Bacterial microbiology, Young Adult, Bacteria isolation & purification, Microbiological Techniques standards, Microbiota, Vaginosis, Bacterial diagnosis
- Abstract
Bacterial vaginosis (BV) is a common gynaecological condition. Diagnosis of BV is typically based on Amsel criteria, Nugent score and/or bacterial culture. In this study, these conventional methods and two CE-IVD marked quantitative real-time (q)PCR assays were compared with microbiota analysis for the diagnosis of BV. Eighty women were evaluated for BV during two sequential hospital visits by Amsel criteria, Nugent score, culture, the AmpliSens® Florocenosis/Bacterial vaginosis-FRT PCR kit (InterLabService, Moscow, Russia), and the BD MAX™ Vaginal Panel (BD Diagnostics, MD, USA). Microbiota analysis based on amplicon sequencing of the 16S ribosomal RNA gene was used as reference test. The microbiota profile of 36/115 (31%) included cases was associated with BV. Based on microbiota analysis, the sensitivity of detecting BV was 38.9% for culture, 61.15% for Amsel criteria, 63.9% for Nugent score and the BD MAX assay, and 80.6% for the AmpliSens assay, while the specificity of all methods was ≥ 92.4%. Microbiota profiles of the cases with discrepant results between microbiota analysis and the diagnostic methods were variable. All five diagnostic methods missed BV positive cases with a relatively high abundance of the genus Alloscardovia, Bifidobacterium, or Dialister, which were categorised as unspecified dysbiosis by the AmpliSens assay. Compared to Amsel criteria, Nugent score, culture, and the BD MAX assay, the AmpliSens assay was most in agreement with microbiota analysis, indicating that currently, the AmpliSens assay may be the best diagnostic method available to diagnose BV in a routine clinical setting.
- Published
- 2019
- Full Text
- View/download PDF
22. Re: Small-for-gestational-age babies after 37 weeks: impact study of risk-stratification protocol. M. Veglia, A. Cavallaro, A. Papageorghiou, R. Black and L. Impey. Ultrasound Obstet Gynecol 2018; 52: 66-71.
- Author
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Boers KE
- Subjects
- Humans, Infant, Newborn, Risk, Gestational Age, Infant, Small for Gestational Age
- Published
- 2018
- Full Text
- View/download PDF
23. Neonatal Safety of Elective Family-Centered Caesarean Sections: A Cohort Study.
- Author
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Narayen IC, Mulder EEM, Boers KE, van Vonderen JJ, Wolters VERA, Freeman LM, and Te Pas AB
- Abstract
Background: Although little data are available concerning safety for newborns, family-centered caesarean sections (FCS) are increasingly implemented. With FCS mothers can see the delivery of their baby, followed by direct skin-to-skin contact. We evaluated the safety for newborns born with FCS in the Leiden University Medical Center (LUMC), where FCS was implemented in June 2014 for singleton pregnancies with a gestational age (GA) ≥38 weeks and without increased risks for respiratory morbidity., Methods: The incidence of respiratory pathology, unplanned admission, and hypothermia in infants born after FCS in LUMC were retrospectively reviewed and compared with a historical cohort of standard elective cesarean sections (CS)., Results: From June 2014 to November 2015, 92 FCS were performed and compared to 71 standard CS in 2013. Incidence of respiratory morbidity, hypothermia, temperatures at arrival at the department, GA, and birth weight were comparable (ns). Unplanned admission occurred more often after FCS when compared to standard CS (21 vs 7%; p = 0.03), probably due to peripheral oxygen saturation (SpO
2 ) monitoring. There was no increase in respiratory pathology (8 vs 6%, ns). One-third of the babies were separated from their mother during or after FCS., Conclusion: Unplanned neonatal admissions after elective CS increased after implementing FCS, without an increase in respiratory morbidity or hypothermia. SpO2 monitoring might have a contribution. Separation from the mother occurred often.- Published
- 2018
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24. Caesarean section rates and adverse neonatal outcomes after induction of labour versus expectant management in women with an unripe cervix: a secondary analysis of the HYPITAT and DIGITAT trials.
- Author
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Bernardes TP, Broekhuijsen K, Koopmans CM, Boers KE, van Wyk L, Tajik P, van Pampus MG, Scherjon SA, Mol BW, Franssen MT, van den Berg PP, and Groen H
- Subjects
- Adult, Apgar Score, Female, Fetal Blood chemistry, Hospitalization statistics & numerical data, Humans, Hydrogen-Ion Concentration, Hypertension, Pregnancy-Induced therapy, Infant, Infant, Newborn, Pregnancy, Randomized Controlled Trials as Topic, Young Adult, Cervical Ripening, Cesarean Section statistics & numerical data, Fetal Growth Retardation therapy, Infant, Newborn, Diseases epidemiology, Intensive Care Units, Neonatal statistics & numerical data, Labor, Induced methods, Perinatal Death, Pre-Eclampsia therapy, Seizures epidemiology, Watchful Waiting
- Abstract
Objective: To evaluate caesarean section and adverse neonatal outcome rates after induction of labour or expectant management in women with an unripe cervix at or near term., Design: Secondary analysis of data from two randomised clinical trials., Setting: Data were collected in two nationwide Dutch trials., Population: Women with hypertensive disease (HYPITAT trial) or suspected fetal growth restriction (DIGITAT trial) and a Bishop score ≤6., Methods: Comparison of outcomes after induction of labour and expectant management., Main Outcome Measures: Rates of caesarean section and adverse neonatal outcome, defined as 5-minute Apgar score ≤6 and/or arterial umbilical cord pH <7.05 and/or neonatal intensive care unit admission and/or seizures and/or perinatal death., Results: Of 1172 included women with an unripe cervix, 572 had induction of labour and 600 had expectant management. We found no significant difference in the overall caesarean rate (difference -1.1%, 95% CI -5.4 to 3.2). Induction of labour did not increase caesarean rates in women with Bishop scores from 3 to 6 (difference -2.7%, 95% CI -7.6 to 2.2) or adverse neonatal outcome rates (difference -1.5%, 95% CI -4.3 to 1.3). However, there was a significant difference in the rates of arterial umbilical cord pH <7.05 favouring induction (difference -3.2%, 95% CI -5.6 to -0.9). The number needed to treat to prevent one case of umbilical arterial pH <7.05 was 32., Conclusions: We found no evidence that induction of labour increases the caesarean rate or compromises neonatal outcome as compared with expectant management. Concerns over increased risk of failed induction in women with a Bishop score from 3 to 6 seem unwarranted., Tweetable Abstract: Induction of labour at low Bishop scores does not increase caesarean section rate or poor neonatal outcome., (© 2016 Royal College of Obstetricians and Gynaecologists.)
- Published
- 2016
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25. Determinants of health-related quality of life in the postpartum period after obstetric complications.
- Author
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Prick BW, Bijlenga D, Jansen AJ, Boers KE, Scherjon SA, Koopmans CM, van Pampus MG, Essink-Bot ML, van Rhenen DJ, Mol BW, and Duvekot JJ
- Subjects
- Adult, Female, Humans, Pregnancy, Regression Analysis, Socioeconomic Factors, Young Adult, Cesarean Section adverse effects, Postpartum Period, Pregnancy Complications, Quality of Life
- Abstract
Objective: To determine the influence of socio-demographic, clinical parameters and obstetric complications on postpartum health-related quality of life (HRQoL)., Study Design: We used data of three randomized controlled trials to investigate HRQoL determinants in women after an obstetric complication. The DIGITAT and HYPITAT trials compared induction of labor and expectant management in women with intra-uterine growth restriction (IUGR) and hypertensive disorders. The WOMB trial randomized anemic women after postpartum hemorrhage to red blood cell transfusion or expectant management. The HRQoL-measure Short-Form36 was completed at six weeks postpartum. Multivariable analyses were used to identify which parameters affected the Short-Form36 physical component score (PCS) and mental component score (MCS)., Results: HRQoL analyses included 1391 women (60%) of the 2310 trial participants. HYPITAT and DIGITAT participants had significantly lower MCS than WOMB participants. In multivariable analysis, PCS after elective and emergency cesarean section was 5-6 points lower than after vaginal delivery. Gestational hypertension, neonatal admission and delivery in an academic hospital had a small negative effect on PCS. No effect was found for randomization status, maternal age, BMI, country of birth, education, parity, induction of labor, analgesics, birth weight, perineal laceration, delivery of placenta, postpartum hemorrhage, congenital anomaly, urinary tract infection, thromboembolic event or endometritis. MCS was influenced only mildly by these parameters., Conclusions: IUGR and hypertensive disorders lead to lower HRQoL scores postpartum than PPH. In a heterogeneous obstetric population, only mode of delivery by cesarean section has a profound, negative impact, on physical HRQoL (PCS). No profound impacts on MCS were detected., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2015
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26. Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial.
- Author
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Prick BW, Jansen AJ, Steegers EA, Hop WC, Essink-Bot ML, Uyl-de Groot CA, Akerboom BM, van Alphen M, Bloemenkamp KW, Boers KE, Bremer HA, Kwee A, van Loon AJ, Metz GC, Papatsonis DN, van der Post JA, Porath MM, Rijnders RJ, Roumen FJ, Scheepers HC, Schippers DH, Schuitemaker NW, Stigter RH, Woiski MD, Mol BW, van Rhenen DJ, and Duvekot JJ
- Subjects
- Adult, Anemia etiology, Fatigue etiology, Female, Follow-Up Studies, Hospitals, General, Hospitals, University, Humans, Netherlands, Practice Guidelines as Topic, Quality of Life, Risk Assessment, Severity of Illness Index, Treatment Outcome, Anemia therapy, Erythrocyte Transfusion standards, Fatigue therapy, Maternal Welfare, Postpartum Hemorrhage therapy
- Abstract
Objective: To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage., Design: Randomised non-inferiority trial., Setting: Thirty-seven Dutch university and general hospitals., Population: Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities., Methods: Women were allocated to RBC transfusion or non-intervention., Main Outcome Measures: Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum., Results: In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable., Conclusions: Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified., (© 2014 Royal College of Obstetricians and Gynaecologists.)
- Published
- 2014
- Full Text
- View/download PDF
27. Which intrauterine growth restricted fetuses at term benefit from early labour induction? A secondary analysis of the DIGITAT randomised trial.
- Author
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Tajik P, van Wyk L, Boers KE, le Cessie S, Zafarmand MH, Roumen F, van der Post JA, Porath M, van Pampus MG, Spaanderdam ME, Kwee A, Duvekot JJ, Bremer HA, Delemarre FM, Bloemenkamp KW, de Groot CJ, Willekes C, van Lith JM, Bossuyt PM, Mol BW, and Scherjon SA
- Subjects
- Acid-Base Imbalance blood, Adolescent, Adult, Body Mass Index, Female, Humans, Infant, Newborn, Labor Onset, Laser-Doppler Flowmetry, Male, Pregnancy, Treatment Outcome, Ultrasonography, Prenatal, Umbilical Arteries, Watchful Waiting, Young Adult, Apgar Score, Fetal Growth Retardation therapy, Infant Mortality, Labor, Induced methods
- Abstract
Objective: The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT trial) showed that in women with suspected intrauterine growth restriction (IUGR) at term, there were no substantial outcome differences between induction of labour and expectant monitoring. The objective of the present analysis is to evaluate whether maternal or fetal markers could identify IUGR fetuses who would benefit from early labour induction., Study Design: The DIGITAT trial was a multicenter, parallel and open-label randomised controlled trial in women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected IUGR (n=650). Women had been randomly allocated to either labour induction or expectant monitoring. The primary outcome was a composite measure of adverse neonatal outcome, defined as neonatal death before hospital discharge, Apgar score <7, umbilical artery pH <7.05, or admission to neonatal intensive care. Using logistic regression modelling, we investigated associations between outcome and 17 markers, maternal characteristics and fetal sonographic and Doppler velocimetry measurements, all collected at study entry., Results: 17 (5.3%) infants in the induction group had an adverse neonatal outcome compared to 20 (6.1%) in the expectant monitoring group. The only potentially informative marker for inducing labour was maternal pre-pregnancy body mass index (BMI). Otherwise, we observed at best weak associations between a benefit from labour induction and maternal age, ethnicity, smoking, parity, pregnancy-induced hypertension or preeclampsia, Bishop score and gestational age, or fetal sonographic markers (gender, estimated fetal weight, body measurements, oligohydramnios, or umbilical artery pulsatility index and end diastolic flow)., Conclusion: In late preterm and term pregnancies complicated by suspected intrauterine growth restriction, most of the known prognostic markers seem unlikely to be helpful in identifying women who could benefit from labour induction, except for maternal pre-pregnancy BMI., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2014
- Full Text
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28. Economic analysis comparing induction of labour and expectant management for intrauterine growth restriction at term (DIGITAT trial).
- Author
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Vijgen SM, Boers KE, Opmeer BC, Bijlenga D, Bekedam DJ, Bloemenkamp KW, de Boer K, Bremer HA, le Cessie S, Delemarre FM, Duvekot JJ, Hasaart TH, Kwee A, van Lith JM, van Meir CA, van Pampus MG, van der Post JA, Rijken M, Roumen FJ, van der Salm PC, Spaanderman ME, Willekes C, Wijnen EJ, Mol BW, and Scherjon SA
- Subjects
- Female, Humans, Pregnancy, Fetal Growth Retardation economics, Labor, Induced economics, Randomized Controlled Trials as Topic economics, Watchful Waiting economics
- Abstract
Objective: Pregnancies complicated by intrauterine growth restriction (IUGR) are at increased risk for neonatal morbidity and mortality. The Dutch nationwide disproportionate intrauterine growth intervention trial at term (DIGITAT trial) showed that induction of labour and expectant monitoring were comparable with respect to composite adverse neonatal outcome and operative delivery. In this study we compare the costs of both strategies., Study Design: A cost analysis was performed alongside the DIGITAT trial, which was a randomized controlled trial in which 650 women with a singleton pregnancy with suspected IUGR beyond 36 weeks of pregnancy were allocated to induction or expectant management. Resource utilization was documented by specific items in the case report forms. Unit costs for clinical resources were calculated from the financial reports of participating hospitals. For primary care costs Dutch standardized prices were used. All costs are presented in Euros converted to the year 2009., Results: Antepartum expectant monitoring generated more costs, mainly due to longer antepartum maternal stays in hospital. During delivery and the postpartum stage, induction generated more direct medical costs, due to longer stay in the labour room and longer duration of neonatal high care/medium care admissions. From a health care perspective, both strategies generated comparable costs: on average €7106 per patient for the induction group (N=321) and €6995 for the expectant management group (N=329) with a cost difference of €111 (95%CI: €-1296 to 1641)., Conclusion: Induction of labour and expectant monitoring in IUGR at term have comparable outcomes immediately after birth in terms of obstetrical outcomes, maternal quality of life and costs. Costs are lower, however, in the expectant monitoring group before 38 weeks of gestation and costs are lower in the induction of labour group after 38 weeks of gestation. So if induction of labour is considered to pre-empt possible stillbirth in suspected IUGR, it is reasonable to delay until 38 weeks, with watchful monitoring., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2013
- Full Text
- View/download PDF
29. Labour and neonatal outcome in small for gestational age babies delivered beyond 36+0 weeks: a retrospective cohort study.
- Author
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Boers KE, van der Post JA, Mol BW, van Lith JM, and Scherjon SA
- Subjects
- Cesarean Section statistics & numerical data, Emergencies, Extraction, Obstetrical statistics & numerical data, Female, Fetal Growth Retardation epidemiology, Humans, Infant, Newborn, Netherlands epidemiology, Pregnancy, Pregnancy Outcome, Retrospective Studies, Birth Weight, Gestational Age, Hypertension, Pregnancy-Induced epidemiology, Infant, Small for Gestational Age, Labor, Induced statistics & numerical data
- Abstract
Objective: Small for gestational age (SGA) is associated with increased neonatal morbidity and mortality. At present, evidence on whether these pregnancies should be managed expectantly or by induction is lacking. To get insight in current policy we analysed data of the National Dutch Perinatal Registry (PRN)., Methods: We used data of all nulliparae between 2000 and 2005 with a singleton in cephalic presentation beyond 36+0 weeks, with a birth weight below the 10th percentile. We analysed two groups of pregnancies: (I) with isolated SGA and (II) with both SGA and hypertensive disorders. Onset of labour was related to route of delivery and neonatal outcome., Results: Induction was associated with a higher risk of emergency caesarean section (CS), without improvement in neonatal outcome. For women with isolated SGA the relative risk of emergency CS after induction was 2.3 (95% Confidence Interval [CI] 2.1 to 2.5) and for women with both SGA and hypertensive disorders the relative risk was 2.7 (95% CI 2.3 to 3.1)., Conclusion: Induction in pregnancies complicated by SGA at term is associated with a higher risk of instrumental deliveries without improvement of neonatal outcome. Prospective studies are needed to determine the best strategy in suspected IUGR at term.
- Published
- 2011
- Full Text
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30. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT).
- Author
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Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, and Scherjon SA
- Subjects
- Adult, Female, Gestational Age, Humans, Labor Onset, Length of Stay, Pregnancy, Pregnancy Outcome, Young Adult, Fetal Growth Retardation therapy, Labor, Induced, Watchful Waiting
- Abstract
Objective: To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term., Design: Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT))., Setting: Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008., Participants: Pregnant women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected intrauterine growth restriction., Interventions: Induction of labour or expectant monitoring., Main Outcome Measures: The primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means., Results: 321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference -9.9 days, 95% CI -11.3 to -8.6) and weighed 130 g less (mean difference -130 g, 95% CI -188 g to -71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (6.1%) in the expectant monitoring group (difference -0.8%, 95% CI -4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI -5.0% to 5.6%)., Conclusions: In women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth., Trial Registration: International Standard Randomised Controlled Trial number ISRCTN10363217.
- Published
- 2010
- Full Text
- View/download PDF
31. Well being of obstetric patients on minimal blood transfusions (WOMB trial).
- Author
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Prick BW, Steegers EA, Jansen AJ, Hop WC, Essink-Bot ML, Peters NC, Uyl-de Groot CA, Papatsonis DN, Akerboom BM, Metz GC, Bremer HA, van Loon AJ, Stigter RH, van der Post JA, van Alphen M, Porath M, Rijnders RJ, Spaanderman ME, Schippers DH, Bloemenkamp KW, Boers KE, Scheepers HC, Roumen FJ, Kwee A, Schuitemaker NW, Mol BW, van Rhenen DJ, and Duvekot JJ
- Subjects
- Anemia etiology, Female, Humans, Netherlands, Postpartum Hemorrhage, Practice Guidelines as Topic, Pregnancy, Anemia therapy, Clinical Protocols, Erythrocyte Transfusion, Quality of Life psychology, Research Design
- Abstract
Background: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands., Methods/design: The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs. The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%)., Discussion: This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs.
- Published
- 2010
- Full Text
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32. Spontaneous rupture of broad ligament and uterine vessels during pregnancy.
- Author
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Huisman CM and Boers KE
- Subjects
- Adult, Cesarean Section, Female, Humans, Infant, Newborn, Male, Pregnancy, Pregnancy Outcome, Rupture, Spontaneous, Broad Ligament, Pregnancy Complications surgery, Uterine Artery, Uterine Diseases surgery, Uterus blood supply
- Published
- 2010
- Full Text
- View/download PDF
33. Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT.
- Author
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Boers KE, Bijlenga D, Mol BW, LeCessie S, Birnie E, van Pampus MG, Stigter RH, Bloemenkamp KW, van Meir CA, van der Post JA, Bekedam DJ, Ribbert LS, Drogtrop AP, van der Salm PC, Huisjes AJ, Willekes C, Roumen FJ, Scheepers HC, de Boer K, Duvekot JJ, Thornton JG, and Scherjon SA
- Subjects
- Adult, Confidence Intervals, Costs and Cost Analysis, Female, Fetal Growth Retardation epidemiology, Humans, Infant Welfare statistics & numerical data, Infant, Newborn, Labor, Induced methods, Maternal Welfare statistics & numerical data, Pregnancy, Pregnancy Outcome epidemiology, Prospective Studies, Quality of Life, Fetal Growth Retardation economics, Infant Welfare economics, Labor, Induced economics, Maternal Welfare economics, Pregnancy Outcome economics, Term Birth
- Abstract
Background: Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term., Methods/design: The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm., Discussion: This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term., Trial Registration: Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.
- Published
- 2007
- Full Text
- View/download PDF
34. Schistosomiasis of the uterus in a patient with dysmenorrhoea and menorrhagia.
- Author
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Boers KE, Sastrowijoto PH, Elzakker van EP, and Hermans MP
- Subjects
- Adult, Dysmenorrhea surgery, Female, Humans, Hysterectomy, Menorrhagia surgery, Netherlands, Praziquantel therapeutic use, Schistosomiasis mansoni drug therapy, Uterine Diseases surgery, Uterus parasitology, Dysmenorrhea parasitology, Menorrhagia parasitology, Schistosomiasis mansoni diagnosis, Uterine Diseases parasitology
- Abstract
Abdominal hysterectomy was performed in a patient because of complaints of dysmenorrhoea and menorrhagia and the uterus was sent for histopathological analysis. Besides adenomyosis an extensive granulomatous infection with Schistosoma mansoni eggs was found.
- Published
- 2003
- Full Text
- View/download PDF
35. [Diagnostic image (98). A woman with a vanished intra-uterine device].
- Author
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Boers KE, Dekker JW, and Yedema CA
- Subjects
- Abdominal Pain etiology, Adult, Female, Humans, Peritoneal Cavity, Radiography, Abdominal, Uterus, Intrauterine Devices adverse effects, Uterine Perforation etiology
- Abstract
A 36-year-old woman suffered from abdominal pain immediately after placement of an intra-uterine device (IUD). Abdominal X-ray revealed that the IUD had perforated the uterus and lay in the peritoneal cavity.
- Published
- 2002
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