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2. Clinical impact of additional findings detected by genome-wide non-invasive prenatal testing: Follow-up results of the TRIDENT-2 study

Author

van Prooyen Schuurman, Lisanne, Sistermans, Erik A., Van Opstal, Diane, Henneman, Lidewij, Bekker, Mireille N., Bax, Caroline J., Pieters, Mijntje J., Bouman, Katelijne, de Munnik, Sonja, den Hollander, Nicolette S., Diderich, Karin E.M., Faas, Brigitte H.W., Feenstra, Ilse, Go, Attie T.J.I., Hoffer, Mariëtte J.V., Joosten, Marieke, Komdeur, Fenne L., Lichtenbelt, Klaske D., Lombardi, Maria P., Polak, Marike G., Jehee, Fernanda S., Schuring-Blom, Heleen, Stevens, Servi J.C., Srebniak, Malgorzata I., Suijkerbuijk, Ron F., Tan-Sindhunata, Gita M., van der Meij, Karuna R.M., van Maarle, Merel C., Vernimmen, Vivian, van Zelderen-Bhola, Shama L., van Ravesteyn, Nicolien T., Knapen, Maarten F.C.M., Macville, Merryn V.E., and Galjaard, Robert-Jan H.

Published
2022
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3. Perspectives of pregnant women on broadening the scope of noninvasive prenatal testing from screening for foetal aneuploidies to prediction of adverse pregnancy outcomes: A qualitative study.

Author

Becking, Ellis C., Henneman, Lidewij, Crombag, Neeltje M. T. H., Bertorotta, Janneke, Rijsbergen, Ylana, Bax, Caroline J., van Vliet‐Lachotzki, Elsbeth, Scheffer, Peter G., and Bekker, Mireille N.

Abstract

Objective: To explore the perspectives of pregnant women on broadening the scope of noninvasive prenatal testing (NIPT) from screening for foetal aneuploidies to prediction of adverse pregnancy outcomes. Methods: Four online focus groups (n = 23 participants) and 14 individual semi‐structured interviews were conducted. Participants included pregnant women with and without a history of adverse pregnancy outcomes. Results: Both women at low and high risk of adverse pregnancy outcomes had a positive attitude towards using NIPT to predict adverse pregnancy outcomes. Perceived benefits included the possibility to potentially improve maternal and foetal outcomes by taking risk‐reducing measures and/or intensified monitoring during pregnancy and the ability to mentally prepare for the potential adverse outcome. Perceived concerns included anxiety and stress caused by a high‐risk test result, a false sense of control over pregnancy, and potential false reassurance. Additionally, women reasoned that broadening the scope of NIPT could increase the complexity of prenatal screening and raised concerns on the combined screening aims in one test (prediction of adverse pregnancy outcomes to improve foetal and maternal health vs. screening for foetal aneuploidies to increase reproductive autonomy). On a societal level, considerations on the risk of medicalising pregnancy and overall pressure to opt for NIPT were mentioned. Conclusion: In general, pregnant women have a positive attitude towards broadening the scope of NIPT to the prediction of pregnancy outcomes, although some concerns are acknowledged. Key points: What is already known about this topic? In the future, the scope of noninvasive prenatal testing (NIPT) could expand from screening for foetal aneuploidies to increase reproductive autonomy and the prediction of adverse pregnancy outcomes to improve foetal and maternal health.The perspectives of pregnant women on using NIPT to predict adverse pregnancy outcomes have not yet been explored. What does this study add? This study shows that pregnant women have a positive attitude towards expanding the scope of NIPT to the prediction of adverse pregnancy outcomes.Possibly improving health outcomes through risk‐reducing interventions is a main perceived benefit, while potential anxiety because of a high‐risk test result is a perceived concern.If the future scope of NIPT expands, policy makers should take into account the needs and concerns of pregnant women. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Decrease in Prevalence of Cleft lip, Alveolus and Palate After Nationwide Introduction of the Second-Trimester Anomaly Scan in the Netherlands.

Author

Smit, Johannes A., Bax, Caroline J., Vermeij-Keers, Christl, Trenning, Bert A.H., de Bakker, Bernadette S., and Breugem, Corstiaan C.

Subjects
SECOND trimester of pregnancy, HEALTH policy, FETAL ultrasonic imaging, RETROSPECTIVE studies, DESCRIPTIVE statistics, TERTIARY care, DISEASE prevalence, LONGITUDINAL method, CLEFT lip, FETAL development, CLEFT palate, ALVEOLAR process, ABORTION
Abstract

Objective: Some studies have suggested that introducing a second-trimester anomaly scan (SAS) leads to increased rates of termination of pregnancy (TOP) in fetuses with orofacial clefts (OFCs). The aim of this study was to evaluate the impact of a nationwide introduction of SAS on the prevalence of live births with OFCs in the Netherlands. Design: Retrospective cohort study. Setting: Tertiary setting. Population: Included in the study were all patients diagnosed with OFCs as recorded in the "Dutch Association for Cleft Palate Anomalies" database between 1997 and 2019. Interventions: Patients were divided into three categories: cleft lip with or without alveolus (CL/A), cleft lip, alveolus and palate (CLAP) and cleft palate (CP) based on anatomical landmarks at the first consultation. Main outcome measures: Prevalence rates of OFCs before and after the nationwide introduction of the SAS on January 1, 2007 were compared. Result: Overall, 1899 patients were diagnosed with CL/A, 2586 with CLAP and 2927 with CP. The prevalence of clefts before and after introduction of the SAS did not differ (P = 0.85). The prevalence of CL/A decreased (P = 0.04), and that of CLAP decreased (P = 0.01) and that of CP increased (P = 0.02). Conclusions: This study demonstrates a significant decrease in the prevalence of CL/A and CLAP after introduction of the SAS. However, due to an increase in CP, the prevalence of all patients born with OFCs has not changed in the Netherlands between 1997 and 2019. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Fetal fraction of cell-free DNA in non-invasive prenatal testing and adverse pregnancy outcomes: a nationwide retrospective cohort study of 56,110 pregnant women

Author

BECKING, Ellis C., primary, SCHEFFER, Peter G., additional, HENRICHS, Jens, additional, BAX, Caroline J., additional, CROMBAG, Neeltje MTH., additional, WEISS, Marjan M., additional, MACVILLE, Merryn VE., additional, van OPSTAL, Diane, additional, BOON, Elles MJ., additional, SISTERMANS, Erik A., additional, HENNEMAN, Lidewij, additional, SCHUIT, Ewoud, additional, and BEKKER, Mireille N., additional

Published
2023
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9. Development of Nationwide Recommendations to Support Prenatal Counseling in Extreme Prematurity

Author

Geurtzen, Rosa, van Heijst, Arno F. J., Draaisma, Jos M. T., Kuijpers, Lindie J. M. K., Woiski, Mallory, Scheepers, Hubertina C. J., van Kaam, Anton H., Oudijk, Martijn A., Lafeber, Harrie N., Bax, Caroline J., Koper, Jan F., Duin, Leonie K., van der Hoeven, Marc A., Kornelisse, René F., Duvekot, Johannes J., Andriessen, Peter, van Runnard Heimel, Pieter J., van der Heide-Jalving, Marja, Bekker, Mireille N., Mulder-de Tollenaer, Susanne M., van Eyck, Jim, Eshuis-Peters, Ellis, Graatsma, Margo, Hermens, Rosella P. M. G., and Hogeveen, Marije

Published
2019
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10. Fetal fraction of cell-free DNA in noninvasive prenatal testing and adverse pregnancy outcomes:a nationwide retrospective cohort study of 56,110 pregnant women

Author

Becking, Ellis C., Scheffer, Peter G., Henrichs, Jens, Bax, Caroline J., Crombag, Neeltje M.T.H., Weiss, Marjan M., Macville, Merryn V.E., Van Opstal, Diane, Boon, Elles M.J., Sistermans, Erik A., Henneman, Lidewij, Schuit, Ewoud, Bekker, Mireille N., Becking, Ellis C., Scheffer, Peter G., Henrichs, Jens, Bax, Caroline J., Crombag, Neeltje M.T.H., Weiss, Marjan M., Macville, Merryn V.E., Van Opstal, Diane, Boon, Elles M.J., Sistermans, Erik A., Henneman, Lidewij, Schuit, Ewoud, and Bekker, Mireille N.

Abstract

Background: Noninvasive prenatal testing by cell-free DNA analysis is offered to pregnant women worldwide to screen for fetal aneuploidies. In noninvasive prenatal testing, the fetal fraction of cell-free DNA in the maternal circulation is measured as a quality control parameter. Given that fetal cell-free DNA originates from the placenta, the fetal fraction might also reflect placental health and maternal pregnancy adaptation. Objective: This study aimed to assess the association between the fetal fraction and adverse pregnancy outcomes. Study Design: We performed a retrospective cohort study of women with singleton pregnancies opting for noninvasive prenatal testing between June 2018 and June 2019 within the Dutch nationwide implementation study (Trial by Dutch Laboratories for Evaluation of Non-Invasive Prenatal Testing [TRIDENT]-2). Multivariable logistic regression analysis was used to assess associations between fetal fraction and adverse pregnancy outcomes. Fetal fraction was assessed as a continuous variable and as <10th percentile, corresponding to a fetal fraction <2.5%. Results: The cohort comprised 56,110 pregnancies. In the analysis of fetal fraction as a continuous variable, a decrease in fetal fraction was associated with increased risk of hypertensive disorders of pregnancy (adjusted odds ratio, 2.27 [95% confidence interval, 1.89–2.78]), small for gestational age neonates <10th percentile (adjusted odds ratio, 1.37 [1.28–1.45]) and <2.3rd percentile (adjusted odds ratio, 2.63 [1.96–3.57]), and spontaneous preterm birth from 24 to 37 weeks of gestation (adjusted odds ratio, 1.02 [1.01–1.03]). No association was found for fetal congenital anomalies (adjusted odds ratio, 1.02 [1.00–1.04]), stillbirth (adjusted odds ratio, 1.02 [0.96–1.08]), or neonatal death (adjusted odds ratio, 1.02 [0.96–1.08]). Similar associations were found for adverse pregnancy outcomes when fetal fraction was <10th percentile. Conclusion: In early pregnancy, a

Published
2023

11. Non-invasive prenatal testing (NIPT) in twin pregnancies affected by early single fetal demise:A systematic review of NIPT and vanishing twins

Author

van Eekhout, Jacintha C.A., Bekker, Mireille N., Bax, Caroline J., Galjaard, Robert Jan H., van Eekhout, Jacintha C.A., Bekker, Mireille N., Bax, Caroline J., and Galjaard, Robert Jan H.

Abstract

The screening performance of non-invasive prenatal testing (NIPT) in vanishing twin (VT) pregnancies is relatively unknown. To close this knowledge gap, we conducted a systematic review of the available literature. Studies describing the test performance of NIPT for trisomy 21, 18, 13, sex chromosomes and additional findings in pregnancies with a VT were retrieved from a literature search with a publication date until October 4, 2022. The methodological quality of the studies was assessed with the quality assessment tool for diagnostic accuracy studies-2 (QUADAS-2). The screen positive rate of the pooled data and the pooled positive predictive value (PPV) were calculated using a random effects model. Seven studies, with cohort sizes ranging from 5 to 767, were included. The screen positive rate of the pooled data for trisomy 21 was 35/1592 (2.2%), with a PPV of 20% (confirmation in 7/35 cases [95% CI 9.8%–36%]). For trisomy 18, the screen positive rate was 13/1592 (0.91%) and the pooled PPV 25% [95% CI 1.3%–90%]. The screen positive rate for trisomy 13 was 7/1592 (0.44%) and confirmed in 0/7 cases (pooled PPV 0% [95% CI 0%–100%]). The screen positive rate for additional findings was 23/767 (2.9%), of which none could be confirmed. No discordant negative results were reported. There is insufficient data to fully evaluate NIPT performance in pregnancies with a VT. However, existing studies suggest that NIPT can successfully detect common autosomal aneuploidies in pregnancies affected by a VT but with a higher false positive rate. Further studies are needed to determine the optimal timing of NIPT in VT pregnancies.

Published
2023

12. Nifedipine versus atosiban for threatened preterm birth (APOSTEL III): a multicentre, randomised controlled trial

Author

van Vliet, Elvira O G, Nijman, Tobias A J, Schuit, Ewoud, Heida, Karst Y, Opmeer, Brent C, Kok, Marjolein, Gyselaers, Wilfried, Porath, Martina M, Woiski, Mallory, Bax, Caroline J, Bloemenkamp, Kitty W M, Scheepers, Hubertina C J, Jacquemyn, Yves, Beek, Erik van, Duvekot, Johannes J, Franssen, Maureen T M, Papatsonis, Dimitri N, Kok, Joke H, van der Post, Joris A M, Franx, Arie, Mol, Ben W, and Oudijk, Martijn A

Published
2016
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13. Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes: A Randomized Controlled Trial

Author

van Kempen, Liselotte E. M., van Teeffelen, Augustinus S., de Ruigh, Annemijn A., Oepkes, Dick, Haak, Monique C., van Leeuwen, Elisabeth, Woiski, Mallory, Porath, Martina M., Bax, Caroline J., van Wassenaer-Leemhuis, Aleid G., Mulder, Antonius L., van der Ham, David P., Willekes, Christine, Franssen, Maureen T., Derks, Jan B., Schuit, Ewoud, Mol, Ben W., and Pajkrt, Eva

Published
2019
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15. Nationwide implementation of the noninvasive prenatal test:Evaluation of a blended learning program for counselors

Author

Martin, Linda, Gitsels-Van der Wal, Janneke T., Bax, Caroline J., Pieters, Mijntje J., Reijerink-Verheij, Jacqueline C.I.Y., Galjaard, Robert Jan, Henneman, Lidewij, Martin, Linda, Gitsels-Van der Wal, Janneke T., Bax, Caroline J., Pieters, Mijntje J., Reijerink-Verheij, Jacqueline C.I.Y., Galjaard, Robert Jan, and Henneman, Lidewij

Abstract

This study assesses the results of a mandatory blended learning-program for counselors (e.g. midwives, sonographers, obstetricians) guiding national implementation of the NonInvasive Prenatal Test (NIPT). We assessed counselors' 1) knowledge about prenatal aneuploidy screening, 2) factors associated with their knowledge (e.g. counselors' characteristics, attitudes towards NIPT), and 3) counselors' attitudes regarding the blended learning. A cross-sectional online pretest-posttest implementation survey was sent to all 2,813 Dutch prenatal counselors. Multivariate linear regression analyses were performed to identify associations between counselors' knowledge and e.g. their professional backgrounds, work experience and attitudes towards NIPT. At T0 and T1 1,635 and 913 counselors completed the survey, respectively. Overall results show an increased mean number of correct answered knowledge questions; 23/35 (66%) items at T0 and 28/37 (76%) items at T1. Knowledge gaps on highly specific topics remained. Work experience and secondary care work-setting were positively associated with a higher level of knowledge. Most counselors (74%) showed positive attitudes towards the blended learning program. The mandatory blended learning, along with learning by experience through implementation of NIPT, has facilitated an increase in counselors' knowledge and was well received. New implementations in healthcare may benefit from requiring blended learning for healthcare providers, especially if tailored to professionals' learning goals.

Published
2022

16. Clinical impact of additional findings detected by genome-wide non-invasive prenatal testing:Follow-up results of the TRIDENT-2 study

Author

van Prooyen Schuurman, Lisanne, Sistermans, Erik A., Van Opstal, Diane, Henneman, Lidewij, Bekker, Mireille N., Bax, Caroline J., Pieters, Mijntje J., Bouman, Katelijne, de Munnik, Sonja, den Hollander, Nicolette S., Diderich, Karin E.M., Faas, Brigitte H.W., Feenstra, Ilse, Go, Attie T.J.I., Hoffer, Mariëtte J.V., Joosten, Marieke, Komdeur, Fenne L., Lichtenbelt, Klaske D., Lombardi, Maria P., Polak, Marike G., Jehee, Fernanda S., Schuring-Blom, Heleen, Stevens, Servi J.C., Srebniak, Malgorzata I., Suijkerbuijk, Ron F., Tan-Sindhunata, Gita M., van der Meij, Karuna R.M., van Maarle, Merel C., Vernimmen, Vivian, van Zelderen-Bhola, Shama L., van Ravesteyn, Nicolien T., Knapen, Maarten F.C.M., Macville, Merryn V.E., Galjaard, Robert Jan H., van Prooyen Schuurman, Lisanne, Sistermans, Erik A., Van Opstal, Diane, Henneman, Lidewij, Bekker, Mireille N., Bax, Caroline J., Pieters, Mijntje J., Bouman, Katelijne, de Munnik, Sonja, den Hollander, Nicolette S., Diderich, Karin E.M., Faas, Brigitte H.W., Feenstra, Ilse, Go, Attie T.J.I., Hoffer, Mariëtte J.V., Joosten, Marieke, Komdeur, Fenne L., Lichtenbelt, Klaske D., Lombardi, Maria P., Polak, Marike G., Jehee, Fernanda S., Schuring-Blom, Heleen, Stevens, Servi J.C., Srebniak, Malgorzata I., Suijkerbuijk, Ron F., Tan-Sindhunata, Gita M., van der Meij, Karuna R.M., van Maarle, Merel C., Vernimmen, Vivian, van Zelderen-Bhola, Shama L., van Ravesteyn, Nicolien T., Knapen, Maarten F.C.M., Macville, Merryn V.E., and Galjaard, Robert Jan H.

Abstract

In the TRIDENT-2 study, all pregnant women in the Netherlands are offered genome-wide non-invasive prenatal testing (GW-NIPT) with a choice of receiving either full screening or screening solely for common trisomies. Previous data showed that GW-NIPT can reliably detect common trisomies in the general obstetric population and that this test can also detect other chromosomal abnormalities (additional findings). However, evidence regarding the clinical impact of screening for additional findings is lacking. Therefore, we present follow-up results of the TRIDENT-2 study to determine this clinical impact based on the laboratory and perinatal outcomes of cases with additional findings. Between April 2017 and April 2019, additional findings were detected in 402/110,739 pregnancies (0.36%). For 358 cases, the origin was proven to be either fetal (n = 79; 22.1%), (assumed) confined placental mosaicism (CPM) (n = 189; 52.8%), or maternal (n = 90; 25.1%). For the remaining 44 (10.9%), the origin of the aberration could not be determined. Most fetal chromosomal aberrations were pathogenic and associated with severe clinical phenotypes (61/79; 77.2%). For CPM cases, occurrence of pre-eclampsia (8.5% [16/189] vs 0.5% [754/159,924]; RR 18.5), and birth weight <2.3rd percentile (13.6% [24/177] vs 2.5% [3,892/155,491]; RR 5.5) were significantly increased compared to the general obstetric population. Of the 90 maternal findings, 12 (13.3%) were malignancies and 32 (35.6%) (mosaic) pathogenic copy number variants, mostly associated with mild or no clinical phenotypes. Data from this large cohort study provide crucial information for deciding if and how to implement GW-NIPT in screening programs. Additionally, these data can inform the challenging interpretation, counseling, and follow-up of additional findings.

Published
2022

17. Nifedipine Versus Atosiban for Threatened Preterm Birth (APOSTEL III): A Multicentre, Randomized Controlled Trial

Author

van Vliet, Elvira O.G., Nijman, Tobias A.J., Schuit, Ewoud, Heida, Karst Y., Opmeer, Brent C., Kok, Marjolein, Gyselaers, Wilfried, Porath, Martina M., Woiski, Mallory, Bax, Caroline J., Bloemenkamp, Kitty W.M., Scheepers, Hubertina C.J., Jacquemyn, Yves, van Beek, Erik, Duvekot, Johannes J., Franssen, Maureen T.M., Papatsonis, Dimitri N., Kok, Joke H., van der Post, Joris A.M., Franx, Arie, Mol, Ben W., and Oudijk, Martijn A.

Published
2017
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18. Which Factors Contribute to False-Positive, False-Negative, and Invalid Results in Fetal Fibronectin Testing in Women with Symptoms of Preterm Labor?

Author

Bruijn, Merel M.C., Hermans, Frederik J.R., Vis, Jolande Y., Wilms, Femke F., Oudijk, Martijn A., Kwee, Anneke, Porath, Martina M., Oei, Guid, Scheepers, Hubertina C.J., Spaanderman, Marc E.A., Bloemenkamp, Kitty W.M., Haak, Monique C., Bolte, Antoinette C., Vandenbussche, Frank P.H.A., Woiski, Mallory D., Bax, Caroline J., Cornette, Jérôme M.J., Duvekot, Johannes J., Bijvank, Bas W.A.N.I.J., van Eyck, Jim, Franssen, Maureen T.M., Sollie, Krystyna M., van der Post, Joris A.M., Bossuyt, Patrick M.M., Kok, Marjolein, Mol, Ben W.J., and van Baaren, Gert-Jan

Published
2017
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19. Nationwide implementation of the non-invasive prenatal test

Author

Martin, Linda, Gitsels-Van der Wal, Janneke T., Bax, Caroline J., Pieters, Mijntje J., Reijerink-Verheij, Jacqueline C.I.Y., Galjaard, Robert Jan, Henneman, Lidewij, Clinical Genetics, RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Obstetrics and Gynaecology, Midwifery Science, Amsterdam Reproduction & Development (AR&D), Obstetrics and gynaecology, Human genetics, and APH - Quality of Care

Subjects
Multidisciplinary, CHALLENGES, GENETICS, ANEUPLOIDY, RESOURCES, CARE, Counselors, Cross-Sectional Studies, PERSPECTIVES, Pregnancy, Prenatal Diagnosis/methods, Prenatal Diagnosis, CELL-FREE DNA, Surveys and Questionnaires, Humans, Female, DOWN-SYNDROME, NIPT
Abstract

This study assesses the results of a mandatory blended learning-program for counselors (e.g. midwives, sonographers, obstetricians) guiding national implementation of the Non-Invasive Prenatal Test (NIPT). We assessed counselors’ 1) knowledge about prenatal aneuploidy screening, 2) factors associated with their knowledge (e.g. counselors’ characteristics, attitudes towards NIPT), and 3) counselors’ attitudes regarding the blended learning. A cross-sectional online pretest-posttest implementation survey was sent to all 2,813 Dutch prenatal counselors. Multivariate linear regression analyses were performed to identify associations between counselors’ knowledge and e.g. their professional backgrounds, work experience and attitudes towards NIPT. At T0 and T1 1,635 and 913 counselors completed the survey, respectively. Overall results show an increased mean number of correct answered knowledge questions; 23/35 (66%) items at T0 and 28/37 (76%) items at T1. Knowledge gaps on highly specific topics remained. Work experience and secondary care work-setting were positively associated with a higher level of knowledge. Most counselors (74%) showed positive attitudes towards the blended learning program. The mandatory blended learning, along with learning by experience through implementation of NIPT, has facilitated an increase in counselors’ knowledge and was well received. New implementations in healthcare may benefit from requiring blended learning for healthcare providers, especially if tailored to professionals’ learning goals.

Published
2022

20. Low fetal fraction in cell-free DNA testing is associated with adverse pregnancy outcome: Analysis of a subcohort of the TRIDENT-2 study: analysis of a subcohort of the TRIDENT-2 study

Author

Becking, Ellis C., Wirjosoekarto, Soetinah A. M., Scheffer, Peter G., Huiskes, Julia V. M., Remmelink, Marinka J., Sistermans, Eril A., Bax, Caroline J., Weiss, Janneke M., Henneman, Lidewij, Bekker, Mireille N., Obstetrics and gynaecology, Human genetics, APH - Quality of Care, and Amsterdam Reproduction & Development (AR&D)

Abstract

Objectives: To assess the association between low fetal fraction (FF) in prenatal cell-free DNA (cfDNA) testing and adverse pregnancy outcomes. Methods: We conducted a retrospective cohort study of participants of the TRIDENT-2 study (Dutch nationwide government-supported study offering cfDNA screening for fetal aneuploidies) who received a failed test result due to low FF (

Published
2021

21. Association between low fetal fraction in cell-free DNA testing and adverse pregnancy outcome: A systematic review:A systematic review

Author

Scheffer, Peter G., Wirjosoekarto, Soetinah A. M., Becking, Ellis C., Weiss, Marjan M., Bax, Caroline J., Oepkes, Dick, Sistermans, Erik A., Henneman, Lidewij, and Bekker, Mireille N.

Abstract

Objective: Low fetal fraction (LFF) in prenatal cell-free DNA (cfDNA) testing is an important cause of test failure and no-call results. LFF might reflect early abnormal placentation and therefore be associated with adverse pregnancy outcome. Here, we review the available literature on the relationship between LFF in cfDNA testing and adverse pregnancy outcome. Method: A systematic literature search was conducted in MEDLINE and EMBASE up to November 1, 2020. Results: Five studies met the criteria for inclusion; all were retrospective observational cohort studies. The cohort sizes ranged from 370 to 6375 pregnancies, with all tests performed in the first trimester or early second trimester. A 4% cutoff for LFF was used in two studies, two studies used the 5th and 25th percentiles, respectively, and one study used a variety of cutoff values for LFF. LFF in prenatal cfDNA testing was observed to be associated with hypertensive disease of pregnancy, small for gestational age neonates, and preterm birth. Conflicting results were found regarding the association between LFF and gestational diabetes mellitus. Conclusions: LFF in cfDNA testing is associated with adverse pregnancy outcome,specifically pregnancy-related hypertensive disorders, preterm birth, and impaired fetal growth related to placental dysfunction. Since the available evidence is limited, a large prospective cohort study on the relationship between fetal fraction and pregnancy outcomes is needed.

Published
2021

24. Risk stratification with cervical length and fetal fibronectin in women with threatened preterm labor before 34 weeks and not delivering within 7 days

Author

Hermans, Frederik J.R., Bruijn, Merel M.C., Vis, Jolande Y., Wilms, Femke F., Oudijk, Martijn A., Porath, Martina M., Scheepers, Hubertina C.J., Bloemenkamp, Kitty W.M., Bax, Caroline J., Cornette, Jérôme M.J., Nij Bijvanck, Bas W.A., Franssen, Maureen T.M., Vandenbussche, Frank P.H.A., Kok, Marjolein, Grobman, William A., Van Der Post, Joris A.M., Bossuyt, Patrick M.M., Opmeer, Brent C., Mol, Ben Willem J., Schuit, Ewoud, and Van Baaren, Gert-Jan

Published
2015
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25. Randomized Comparison of Nifedipine and Placebo in Fibronectin-Negative Women with Symptoms of Preterm Labor and a Short Cervix (APOSTEL-I Trial)

Author

Vis, Jolande Y., van Baaren, Gert-Jan, Wilms, Femke F., Oudijk, Martijn A., Kwee, Anneke, Porath, Martina M., Scheepers, Hubertina C., Spaanderman, Marc E., Bloemenkamp, Kitty W., van Lith, Jan M., Bolte, Antoinette C., Bax, Caroline J., Cornette, Jérôme, Duvekot, Johannes J., Nij Bijvank, Sebastiaan W., van Eyck, Jim, Franssen, Maureen T., Sollie, Krystyna M., Woiski, Mallory, Vandenbussche, Frank P., van der Post, Joris A., Bossuyt, Patrick M., Opmeer, Brent C., and Mol, Ben W.

Published
2015
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26. Can Previous Associations of Single Nucleotide Polymorphisms in the , , , and Genes in the Susceptibility to and Severity of Infections Be Confirmed?

Author

Jukema, Jelmer B, Hoenderboom, Bernice M, van Benthem, Birgit H B, van der Sande, Marianne A B, de Vries, Henry J C, Hoebe, Christian J P A, Dukers-Muijrers, Nicole H T M, Bax, Caroline J, Morré, Servaas A, and Ouburg, Sander

Subjects
single nucleotide polymorphism, SNP, severity, Chlamydia trachomatis, susceptibility
Abstract

Clear inter-individual differences exist in the response to C. trachomatis (CT) infections and reproductive tract complications in women. Host genetic variation like single nucleotide polymorphisms (SNPs) have been associated with differences in response to CT infection, and SNPs might be used as a genetic component in a tubal-pathology predicting algorithm. Our aim was to confirm the role of four genes by investigating proven associated SNPs in the susceptibility and severity of a CT infection. A total of 1201 women from five cohorts were genotyped and analyzed for TLR2 + 2477 G > A, NOD1 + 32656 T -> GG, CXCR5 + 10950 T > C, and IL10 - 1082 A > G. Results confirmed that NOD1 + 32656 T ->GG was associated with an increased risk of a symptomatic CT infection (OR: 1.9, 95%CI: 1.1-3.4, p = 0.02), but we did not observe an association with late complications. IL10 - 1082 A > G appeared to increase the risk of late complications (i.e., ectopic pregnancy/tubal factor infertility) following a CT infection (OR = 2.8, 95%CI: 1.1-7.1, p = 0.02). Other associations were not found. Confirmatory studies are important, and large cohorts are warranted to further investigate SNPs' role in the susceptibility and severity of a CT infection.

Published
2021

27. Cerebroplacental ratio in predicting adverse perinatal outcome: a meta-analysis of individual participant data

Author

Charlotte A, V, Ivy R, V, Martijn W, H, Wessel, G, Linda J, S, Caroline J, B, Ben Willem J, M, Christianne Jm, D, Patrick Mm, B, Marjon A, D, Khalil, A, Thilaganathan, B, M Turan, O, Crimmins, S, Harman, C, M Shannon, A, Kumar, S, Dicker, P, Malone, F, C Tully, E, Unterscheider, J, Crippa, I, Ghidini, A, Roncaglia, N, Vergani, P, Bhide, A, D'Antonio, F, Pilu, G, Galindo, A, Herraiz, I, Vázquez-Sarandeses, A, Ebbing, C, L Johnsen, S, O Karlsen, H, Vollgraff Heidweiller-Schreurs, Charlotte A, van Osch, Ivy R, Heymans, Martijn W, Ganzevoort, Wessel, Schoonmade, Linda J, Bax, Caroline J, Mol, Ben Willem J, de Groot, Christianne Jm, Bossuyt, Patrick Mm, de Boer, Marjon A, Asma Khalil, Basky Thilaganathan, Ozhan M Turan, Sarah Crimmins, Chris Harman, Alisson M Shannon, Sailesh Kumar, Patrick Dicker, Fergal Malone, Elizabeth C Tully, Julia Unterscheider, Isabella Crippa, Alessandro Ghidini, Nadia Roncaglia, Patrizia Vergani, Amarnath Bhide, Francesco D'Antonio, Gianluigi Pilu, Alberto Galindo, Ignacio Herraiz, Alicia Vázquez-Sarandeses, Cathrine Ebbing, Synnøve L Johnsen, Henriette O Karlsen, Charlotte A, V, Ivy R, V, Martijn W, H, Wessel, G, Linda J, S, Caroline J, B, Ben Willem J, M, Christianne Jm, D, Patrick Mm, B, Marjon A, D, Khalil, A, Thilaganathan, B, M Turan, O, Crimmins, S, Harman, C, M Shannon, A, Kumar, S, Dicker, P, Malone, F, C Tully, E, Unterscheider, J, Crippa, I, Ghidini, A, Roncaglia, N, Vergani, P, Bhide, A, D'Antonio, F, Pilu, G, Galindo, A, Herraiz, I, Vázquez-Sarandeses, A, Ebbing, C, L Johnsen, S, O Karlsen, H, Vollgraff Heidweiller-Schreurs, Charlotte A, van Osch, Ivy R, Heymans, Martijn W, Ganzevoort, Wessel, Schoonmade, Linda J, Bax, Caroline J, Mol, Ben Willem J, de Groot, Christianne Jm, Bossuyt, Patrick Mm, de Boer, Marjon A, Asma Khalil, Basky Thilaganathan, Ozhan M Turan, Sarah Crimmins, Chris Harman, Alisson M Shannon, Sailesh Kumar, Patrick Dicker, Fergal Malone, Elizabeth C Tully, Julia Unterscheider, Isabella Crippa, Alessandro Ghidini, Nadia Roncaglia, Patrizia Vergani, Amarnath Bhide, Francesco D'Antonio, Gianluigi Pilu, Alberto Galindo, Ignacio Herraiz, Alicia Vázquez-Sarandeses, Cathrine Ebbing, Synnøve L Johnsen, and Henriette O Karlsen

Abstract

Objective: To investigate if cerebroplacental ratio (CPR) adds to the predictive value of umbilical artery pulsatility index (UA PI) alone – standard of practice – for adverse perinatal outcome in singleton pregnancies. Design and setting: Meta-analysis based on individual participant data (IPD). Population or sample: Ten centres provided 17 data sets for 21 661 participants, 18 731 of which could be included. Sample sizes per data set ranged from 207 to 9215 individuals. Patient populations varied from uncomplicated to complicated pregnancies. Methods: In a collaborative, pooled analysis, we compared the prognostic value of combining CPR with UA PI, versus UA PI only and CPR only, with a one-stage IPD approach. After multiple imputation of missing values, we used multilevel multivariable logistic regression to develop prediction models. We evaluated the classification performance of all models with receiver operating characteristics analysis. We performed subgroup analyses according to gestational age, birthweight centile and estimated fetal weight centile. Main outcome measures: Composite adverse perinatal outcome, defined as perinatal death, caesarean section for fetal distress or neonatal unit admission. Results: Adverse outcomes occurred in 3423 (18%) participants. The model with UA PI alone resulted in an area under the curve (AUC) of 0.775 (95% CI 0.709–0.828) and with CPR alone in an AUC of 0.778 (95% CI 0.715–0.831). Addition of CPR to the UA PI model resulted in an increase in the AUC of 0.003 points (0.778, 95% CI 0.714–0.831). These results were consistent across all subgroups. Conclusions: Cerebroplacental ratio added no predictive value for adverse perinatal outcome beyond UA PI, when assessing singleton pregnancies, irrespective of gestational age or fetal size. Tweetable abstract: Doppler measurement of cerebroplacental ratio in clinical practice has limited added predictive value to umbilical artery alone.

Published
2021

28. Association between low fetal fraction in cell-free DNA testing and adverse pregnancy outcome: A systematic review

Author

MS Verloskunde, Child Health, Circulatory Health, Scheffer, Peter G., Wirjosoekarto, Soetinah A.M., Becking, Ellis C., Weiss, Marjan M., Bax, Caroline J., Oepkes, Dick, Sistermans, Erik A., Henneman, Lidewij, Bekker, Mireille N., MS Verloskunde, Child Health, Circulatory Health, Scheffer, Peter G., Wirjosoekarto, Soetinah A.M., Becking, Ellis C., Weiss, Marjan M., Bax, Caroline J., Oepkes, Dick, Sistermans, Erik A., Henneman, Lidewij, and Bekker, Mireille N.

Published
2021

29. Low fetal fraction in cell-free DNA testing is associated with adverse pregnancy outcome: Analysis of a subcohort of the TRIDENT-2 study

Author

MS Verloskunde, Urologie Onderzoek, Child Health, Circulatory Health, Becking, Ellis C., Wirjosoekarto, Soetinah A.M., Scheffer, Peter G., Huiskes, Julia V.M., Remmelink, Marinka J., Sistermans, Erik A., Bax, Caroline J., Weiss, Janneke M., Henneman, Lidewij, Bekker, Mireille N., MS Verloskunde, Urologie Onderzoek, Child Health, Circulatory Health, Becking, Ellis C., Wirjosoekarto, Soetinah A.M., Scheffer, Peter G., Huiskes, Julia V.M., Remmelink, Marinka J., Sistermans, Erik A., Bax, Caroline J., Weiss, Janneke M., Henneman, Lidewij, and Bekker, Mireille N.

Published
2021

30. Can previous associations of single nucleotide polymorphisms in the tlr2, nod1, cxcr5, and il10 genes in the susceptibility to and severity of chlamydia trachomatis infections be confirmed?

Author

Cardiometabolic Health, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Jukema, Jelmer B., Hoenderboom, Bernice M., Van Benthem, Birgit H.B., Van Der Sande, Marianne A.B., De Vries, Henry J.C., Hoebe, Christian J.P.A., Dukers-Muijrers, Nicole H.T.M., Bax, Caroline J., Morré, Servaas A., Ouburg, Sander, Cardiometabolic Health, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Jukema, Jelmer B., Hoenderboom, Bernice M., Van Benthem, Birgit H.B., Van Der Sande, Marianne A.B., De Vries, Henry J.C., Hoebe, Christian J.P.A., Dukers-Muijrers, Nicole H.T.M., Bax, Caroline J., Morré, Servaas A., and Ouburg, Sander

Published
2021

31. Re: Cerebroplacental ratio in predicting adverse perinatal outcome: a meta-analysis of individual participant data Reply

Author

Heidweiller-Schreurs, Charlotte A. Vollgraff, van Osch, Ivy R., Heymans, Martijn W., Ganzevoort, Wessel, Schoonmade, Linda J., Bax, Caroline J., Mol, Ben Willem J., de Groot, Christianne J. M., Bossuyt, Patrick M. M., de Boer, Marjon A., General practice, Epidemiology and Data Science, APH - Methodology, APH - Personalized Medicine, Obstetrics and gynaecology, Amsterdam Reproduction & Development, and AII - Infectious diseases

Published
2020

32. Can Previous Associations of Single Nucleotide Polymorphisms in the TLR2, NOD1, CXCR5, and IL10 Genes in the Susceptibility to and Severity of Chlamydia trachomatis Infections Be Confirmed?

Author

Jukema, Jelmer B., primary, Hoenderboom, Bernice M., additional, van Benthem, Birgit H. B., additional, van der Sande, Marianne A. B., additional, de Vries, Henry J. C., additional, Hoebe, Christian J. P. A., additional, Dukers-Muijrers, Nicole H. T. M., additional, Bax, Caroline J., additional, Morré, Servaas A., additional, and Ouburg, Sander, additional

Published
2021
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33. Authors' reply re: Cerebroplacental ratio in predicting adverse perinatal outcome: a meta‐analysis of individual participant data

Author

Vollgraff Heidweiller‐Schreurs, Charlotte A., primary, Osch, Ivy R., additional, Heymans, Martijn W., additional, Ganzevoort, Wessel, additional, Schoonmade, Linda J., additional, Bax, Caroline J., additional, Mol, Ben Willem J., additional, Groot, Christianne J. M., additional, Bossuyt, Patrick M. M., additional, and Boer, Marjon A., additional

Published
2020
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34. TRIDENT-2: National Implementation of Genome-wide Non-invasive Prenatal Testing as a First-Tier Screening Test in the Netherlands

Author

van der Meij, Karuna R.M., primary, Sistermans, Erik A., additional, Macville, Merryn V.E., additional, Stevens, Servi J.C., additional, Bax, Caroline J., additional, Bekker, Mireille N., additional, Bilardo, Caterina M., additional, Boon, Elles M.J., additional, Boter, Marjan, additional, Diderich, Karin E.M., additional, de Die-Smulders, Christine E.M., additional, Duin, Leonie K., additional, Faas, Brigitte H.W., additional, Feenstra, Ilse, additional, Haak, Monique C., additional, Hoffer, Mariëtte J.V., additional, den Hollander, Nicolette S., additional, Hollink, Iris H.I.M., additional, Jehee, Fernanda S., additional, Knapen, Maarten F.C.M., additional, Kooper, Angelique J.A., additional, van Langen, Irene M., additional, Lichtenbelt, Klaske D., additional, Linskens, Ingeborg H., additional, van Maarle, Merel C., additional, Oepkes, Dick, additional, Pieters, Mijntje J., additional, Schuring-Blom, G. Heleen, additional, Sikkel, Esther, additional, Sikkema-Raddatz, Birgit, additional, Smeets, Dominique F.C.M., additional, Srebniak, Malgorzata I., additional, Suijkerbuijk, Ron F., additional, Tan-Sindhunata, Gita M., additional, van der Ven, A. Jeanine E.M., additional, van Zelderen-Bhola, Shama L., additional, Henneman, Lidewij, additional, Galjaard, Robert-Jan H., additional, Van Opstal, Diane, additional, and Weiss, Marjan M., additional

Published
2019
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35. Cover Image

Author

Palen, Roel L.F., primary, Zee, Carlijn, additional, Vink, Arja S., additional, Knobbe, Ingmar, additional, Jurgens, Sean J., additional, Leeuwen, Elizabeth, additional, Bax, Caroline J., additional, Marchie Sarvaas, Gideon J., additional, Blom, Nico A., additional, Haak, Monique C., additional, Bilardo, Caterina M., additional, and Clur, Sally‐Ann B., additional

Published
2019
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36. Antenatal Workup of Early Megacystis and Selection of Candidates for Fetal Therapy

Author

Fontanella, Federica, Duin, Leonie, Adama Van Scheltema, Phebe N., Cohen-Overbeek, Titia E., Pajkrt, Eva, Bekker, Mireille, Willekes, Christine, Bax, Caroline J., Oepkes, Dick, Bilardo, Catia M., Fontanella, Federica, Duin, Leonie, Adama Van Scheltema, Phebe N., Cohen-Overbeek, Titia E., Pajkrt, Eva, Bekker, Mireille, Willekes, Christine, Bax, Caroline J., Oepkes, Dick, and Bilardo, Catia M.

Published
2019

37. Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes : A Randomized Controlled Trial

Author

van Kempen, Liselotte E M, van Teeffelen, Augustinus S, de Ruigh, Annemijn A, Oepkes, Dick, Haak, Monique C, van Leeuwen, Elisabeth, Woiski, Mallory, Porath, Martina M, Bax, Caroline J, van Wassenaer-Leemhuis, Aleid G, Mulder, Antonius L, van der Ham, David P, Willekes, Christine, Franssen, Maureen T, Derks, Jan B, Schuit, Ewoud, Mol, Ben W, Pajkrt, Eva, van Kempen, Liselotte E M, van Teeffelen, Augustinus S, de Ruigh, Annemijn A, Oepkes, Dick, Haak, Monique C, van Leeuwen, Elisabeth, Woiski, Mallory, Porath, Martina M, Bax, Caroline J, van Wassenaer-Leemhuis, Aleid G, Mulder, Antonius L, van der Ham, David P, Willekes, Christine, Franssen, Maureen T, Derks, Jan B, Schuit, Ewoud, Mol, Ben W, and Pajkrt, Eva

Published
2019

38. Antenatal Workup of Early Megacystis and Selection of Candidates for Fetal Therapy

Author

MS Verloskunde, Child Health, Fontanella, Federica, Duin, Leonie, Adama Van Scheltema, Phebe N., Cohen-Overbeek, Titia E., Pajkrt, Eva, Bekker, Mireille, Willekes, Christine, Bax, Caroline J., Oepkes, Dick, Bilardo, Catia M., MS Verloskunde, Child Health, Fontanella, Federica, Duin, Leonie, Adama Van Scheltema, Phebe N., Cohen-Overbeek, Titia E., Pajkrt, Eva, Bekker, Mireille, Willekes, Christine, Bax, Caroline J., Oepkes, Dick, and Bilardo, Catia M.

Published
2019

39. Development of Nationwide Recommendations to Support Prenatal Counseling in Extreme Prematurity

Author

MS Verloskunde, Child Health, Geurtzen, Rosa, Van Heijst, Arno F.J., Draaisma, Jos M.T., Kuijpers, Lindie J.M.K., Woiski, Mallory, Scheepers, Hubertina C.J., Van Kaam, Anton H., Oudijk, Martijn A., Lafeber, Harrie N., Bax, Caroline J., Koper, Jan F., Duin, Leonie K., Van der Hoeven, Marc A., Kornelisse, René F., Duvekot, Johannes J., Andriessen, Peter, Van Runnard Heimel, Pieter J., Van der Heide-Jalving, Marja, Bekker, Mireille N., Mulder-De Tollenaer, Susanne M., Van Eyck, Jim, Eshuis-Peters, Ellis, Graatsma, Margo, Hermens, Rosella P.M.G., Hogeveen, Marije, MS Verloskunde, Child Health, Geurtzen, Rosa, Van Heijst, Arno F.J., Draaisma, Jos M.T., Kuijpers, Lindie J.M.K., Woiski, Mallory, Scheepers, Hubertina C.J., Van Kaam, Anton H., Oudijk, Martijn A., Lafeber, Harrie N., Bax, Caroline J., Koper, Jan F., Duin, Leonie K., Van der Hoeven, Marc A., Kornelisse, René F., Duvekot, Johannes J., Andriessen, Peter, Van Runnard Heimel, Pieter J., Van der Heide-Jalving, Marja, Bekker, Mireille N., Mulder-De Tollenaer, Susanne M., Van Eyck, Jim, Eshuis-Peters, Ellis, Graatsma, Margo, Hermens, Rosella P.M.G., and Hogeveen, Marije

Published
2019

40. Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes: A Randomized Controlled Trial

Author

MS Verloskunde, Other research (not in main researchprogram), Epi Methoden Team 4, JC onderzoeksprogramma Methodologie, van Kempen, Liselotte E M, van Teeffelen, Augustinus S, de Ruigh, Annemijn A, Oepkes, Dick, Haak, Monique C, van Leeuwen, Elisabeth, Woiski, Mallory, Porath, Martina M, Bax, Caroline J, van Wassenaer-Leemhuis, Aleid G, Mulder, Antonius L, van der Ham, David P, Willekes, Christine, Franssen, Maureen T, Derks, Jan B, Schuit, Ewoud, Mol, Ben W, Pajkrt, Eva, MS Verloskunde, Other research (not in main researchprogram), Epi Methoden Team 4, JC onderzoeksprogramma Methodologie, van Kempen, Liselotte E M, van Teeffelen, Augustinus S, de Ruigh, Annemijn A, Oepkes, Dick, Haak, Monique C, van Leeuwen, Elisabeth, Woiski, Mallory, Porath, Martina M, Bax, Caroline J, van Wassenaer-Leemhuis, Aleid G, Mulder, Antonius L, van der Ham, David P, Willekes, Christine, Franssen, Maureen T, Derks, Jan B, Schuit, Ewoud, Mol, Ben W, and Pajkrt, Eva

Published
2019

41. Prediction model of postnatal renal function in fetuses with lower urinary tract obstruction (LUTO)—Development and internal validation

Author

MS Verloskunde, Child Health, Duin, Leonie K., Fontanella, Federica, Groen, Henk, Adama van Scheltema, Phebe N., Cohen-Overbeek, Titia E., Pajkrt, Eva, Bekker, Mireille, Willekes, Christine, Bax, Caroline J., Oepkes, Dick, Bilardo, Caterina M., MS Verloskunde, Child Health, Duin, Leonie K., Fontanella, Federica, Groen, Henk, Adama van Scheltema, Phebe N., Cohen-Overbeek, Titia E., Pajkrt, Eva, Bekker, Mireille, Willekes, Christine, Bax, Caroline J., Oepkes, Dick, and Bilardo, Caterina M.

Published
2019

42. Prediction model of postnatal renal function in fetuses with lower urinary tract obstruction (LUTO)—Development and internal validation

Author

Duin, Leonie K., primary, Fontanella, Federica, additional, Groen, Henk, additional, Adama van Scheltema, Phebe N., additional, Cohen‐Overbeek, Titia E., additional, Pajkrt, Eva, additional, Bekker, Mireille, additional, Willekes, Christine, additional, Bax, Caroline J., additional, Oepkes, Dick, additional, and Bilardo, Caterina M., additional

Published
2019
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43. Transposition of the great arteries: Fetal pulmonary valve growth and postoperative neo‐aortic root dilatation

Author

Palen, Roel L.F., primary, Zee, Carlijn, additional, Vink, Arja S., additional, Knobbe, Ingmar, additional, Jurgens, Sean J., additional, Leeuwen, Elizabeth, additional, Bax, Caroline J., additional, Marchie Sarvaas, Gideon J., additional, Blom, Nico A., additional, Haak, Monique C., additional, Bilardo, Caterina M., additional, and Clur, Sally‐Ann B., additional

Published
2019
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44. Development of Nationwide Recommendations to Support Prenatal Counseling in Extreme Prematurity

Author

Geurtzen, Rosa, primary, van Heijst, Arno F.J., additional, Draaisma, Jos M.T., additional, Kuijpers, Lindie J.M.K., additional, Woiski, Mallory, additional, Scheepers, Hubertina C.J., additional, van Kaam, Anton H., additional, Oudijk, Martijn A., additional, Lafeber, Harrie N., additional, Bax, Caroline J., additional, Koper, Jan F., additional, Duin, Leonie K., additional, van der Hoeven, Marc A., additional, Kornelisse, René F., additional, Duvekot, Johannes J., additional, Andriessen, Peter, additional, van Runnard Heimel, Pieter J., additional, van der Heide-Jalving, Marja, additional, Bekker, Mireille N., additional, Mulder-de Tollenaer, Susanne M., additional, van Eyck, Jim, additional, Eshuis-Peters, Ellis, additional, Graatsma, Margo, additional, Hermens, Rosella P.M.G., additional, and Hogeveen, Marije, additional

Published
2019
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46. Temporizing management vs immediate delivery in early-onset severe preeclampsia between 28 and 34 weeks of gestation (TOTEM study): An open-label randomized controlled trial.

Author

Duvekot, Johannes J., Duijnhoven, Ruben G., Horen, Eva, Bax, Caroline J., Bloemenkamp, Kitty W., Brussé, Ingrid A., Dijk, Peter H., Franssen, Maureen T., Franx, Arie, Oudijk, Martijn A., Porath, Martina M., Scheepers, Hubertina C., Wassenaer‐Leemhuis, Aleid G., Drongelen, Joris, Mol, Ben W., Ganzevoort, Wessel, van Horen, Eva, van Wassenaer-Leemhuis, Aleid G, van Drongelen, Joris, and TOTEM study collaboration group

Subjects
ABRUPTIO placentae, RANDOMIZED controlled trials, PREECLAMPSIA, INDUCED labor (Obstetrics), PREGNANCY, NEONATAL death, CESAREAN section, RESEARCH, RESEARCH methodology, GESTATIONAL age, EVALUATION research, MEDICAL cooperation, PREGNANCY outcomes, COMPARATIVE studies, DELIVERY (Obstetrics)
Abstract

Introduction: There is little evidence to guide the timing of delivery of women with early-onset severe preeclampsia. We hypothesize that immediate delivery is not inferior for neonatal outcome but reduces maternal complications compared with temporizing management.Material and Methods: This Dutch multicenter open-label randomized clinical trial investigated non-inferiority for neonatal outcome of temporizing management as compared with immediate delivery (TOTEM NTR 2986) in women between 27+5 and 33+5 weeks of gestation admitted for early-onset severe preeclampsia with or without HELLP syndrome. In participants allocated to receive immediate delivery, either induction of labor or cesarean section was initiated at least 48 hours after admission. Primary outcomes were adverse perinatal outcome, defined as a composite of severe respiratory distress syndrome, bronchopulmonary dysplasia, culture proven sepsis, intraventricular hemorrhage grade 3 or worse, periventricular leukomalacia grade 2 or worse, necrotizing enterocolitis stage 2 or worse, and perinatal death. Major maternal complications were secondary outcomes. It was estimated 1130 women needed to be enrolled. Analysis was by intention-to-treat.Results: The trial was halted after 35 months because of slow recruitment. Between February 2011 and December 2013, a total of 56 women were randomized to immediate delivery (n = 26) or temporizing management (n = 30). Median gestational age at randomization was 30 weeks. Median prolongation of pregnancy was 2 days (interquartile range 1-3 days) in the temporizing management group. Mean birthweight was 1435 g after immediate delivery vs 1294 g after temporizing management (P = .14). The adverse perinatal outcome rate was 55% in the immediate delivery group vs 52% in the temporizing management group (relative risk 1.06; 95% confidence interval 0.67-1.70). In both groups there was one neonatal death and no maternal deaths. In the temporizing treatment group, one woman experienced pulmonary edema and one placental abruption. Analyses of only the singleton pregnancies did not result in other outcomes.Conclusions: Early termination of the trial precluded any conclusions for the main outcomes. We observed that temporizing management resulted in a modest prolongation of pregnancy without changes in perinatal and maternal outcome. Conducting a randomized study for this important research question did not prove feasible. [ABSTRACT FROM AUTHOR]

Published
2021
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48. Which Factors Contribute to False-Positive, False-Negative, and Invalid Results in Fetal Fibronectin Testing in Women with Symptoms of Preterm Labor?

Author

Bruijn, Merel M C, Hermans, Frederik J R, Vis, Jolande Y., Wilms, Femke F., Oudijk, Martijn A., Kwee, Anneke, Porath, Martina M., Oei, Guid, Scheepers, Hubertina C. J., Spaanderman, Marc E. A., Bloemenkamp, Kitty W M, Haak, Monique C., Bolte, Antoinette C., Vandenbussche, Frank P. H. A., Woiski, Mallory D, Bax, Caroline J., Cornette, Jérôme M J, Duvekot, Johannes J., Bijvank, Bas W A N I J, van Eyck, Jim, Franssen, Maureen T. M., Sollie, Krystyna M., van der Post, Joris A. M., Bossuyt, Patrick M. M., Kok, Marjolein, Mol, Ben Willem J., van Baaren, Gert-Jan, Bruijn, Merel M C, Hermans, Frederik J R, Vis, Jolande Y., Wilms, Femke F., Oudijk, Martijn A., Kwee, Anneke, Porath, Martina M., Oei, Guid, Scheepers, Hubertina C. J., Spaanderman, Marc E. A., Bloemenkamp, Kitty W M, Haak, Monique C., Bolte, Antoinette C., Vandenbussche, Frank P. H. A., Woiski, Mallory D, Bax, Caroline J., Cornette, Jérôme M J, Duvekot, Johannes J., Bijvank, Bas W A N I J, van Eyck, Jim, Franssen, Maureen T. M., Sollie, Krystyna M., van der Post, Joris A. M., Bossuyt, Patrick M. M., Kok, Marjolein, Mol, Ben Willem J., and van Baaren, Gert-Jan

Published
2017

49. Nifedipine versus placebo in the treatment of preterm prelabor rupture of membranes: a randomized controlled trial Assessment of perinatal outcome by use of tocolysis in early labor- APOSTEL IV trial

Author

Nijman, Tobias A J, van Vliet, Elvira O G, Naaktgeboren, Christiana A, Oude Rengerink, Katrien, de Lange, Thomas S, Bax, Caroline J, Bloemenkamp, Kitty W M, van Eyck, Jim, Kok, Marjolein, Scheepers, Hubertina C J, Woiski, Mallory, Franx, Arie, Mol, Ben Willem J, Oudijk, Martijn A, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, and Obstetrics and Gynaecology

Subjects
Preterm prelabor rupture of membranes, Tocolytics, Nifedipine, Neonatal outcomes, Randomized Controlled Trial, Journal Article, Preterm birth, Drug safety
Abstract

Objective: Preterm birth is the most common cause of neonatal morbidity and mortality. Around one third of preterm deliveries starts with preterm prelabor rupture of membranes (PPROM). The aim of this trial was to study the effect of prolonged tocolysis with nifedipine versus placebo in women with PPROM on perinatal outcome and prolongation of pregnancy. Study design: The Apostel IV was a nationwide multicenter randomized placebo controlled trial. We included women with PPROM without contractions between 24(+0) and 33(+6) weeks of gestation. Participants were randomly allocated to daily 80 mg nifedipine or placebo, until the start of labor, with a maximum of 18 days. The primary outcome measure was a composite of poor neonatal outcome, including perinatal death, bronchopulmonary dysplasia, periventricular leukomalacia >grade 1, intraventricular hemorrhage >grade 2, necrotizing enterocolitis > stage 1 and culture proven sepsis. Secondary outcomes were gestational age at delivery and prolongation of pregnancy. Analysis was by intention to treat. To detect a reduction of poor neonatal outcome from 30% to 10%,120 women needed to be randomized. Trial registry: NTR 3363. Results: Between October 2012 and December 2014 we randomized 25 women to nifedipine and 25 women to placebo. Due to slow recruitment the study was stopped prematurely. The median gestational age at randomization was 29.9 weeks (IQR 27.7-31.3) in the nifedipine group and 27.0 weeks (IQR 24.7-29.9) in the placebo group. Other baseline characteristics were comparable. The adverse perinatal outcome occurred in 9 neonates (33.3%) in the nifedipine group and 9 neonates (32.1%) in the placebo group (RR 1.04, 95% CI 0.49-2.2). Two perinatal deaths occurred, both in the nifedipine group. Bronchopulmonary dysplasia was seen less frequently in the nifedipine group (0% versus 17.9%; p= 0.03). Prolongation of pregnancy did not differ between the nifedipine and placebo group (median 11 versus 8 days, HR 1.02; 95% CI 0.58-1.79). Conclusion: This randomized trial did not show a beneficial effect of prolonged tocolysis on neonatal outcomes or prolongation of pregnancy in women with PPROM without contractions. However, since results are based on a small sample size, a difference in effectiveness cannot be excluded. Crown Published by

Published
2016

50. Pessary Placement in the Prevention of Preterm Birth in Multiple Pregnancies : A Propensity Score Analysis

Author

Monfrance, Maurice J M, Schuit, Ewoud, Groenwold, Rolf H., Oudijk, Martijn A., De Graaf, Irene M., Bax, Caroline J., Bekedam, Dick J., Mol, Ben Willem, and Langenveld, Josje

Subjects
Obstetrics and Gynaecology
Abstract

Preterm birth is the major contributor to perinatal mortality and serious neonatal morbidity, and approximately 30% of all patients admitted to a neonatal intensive care unit in the Netherlands are born from a multiple pregnancy. In asymptomatic women with a multiple pregnancy and short cervix, prophylactic use of a cervical pessary might reduce preterm birth. The aim of this study is to assess the possible treatment effects of pessary use in pregnancy duration and for poor perinatal outcome. This cohort study was performed between December 2012 and September 2014 in 44 hospitals in the Netherlands. Cervical length was measured between 16 and 22 weeks of gestation. When cervical length was below 38 mm, women were offered a cervical pessary. The pessaries were removed at 36 weeks of gestation or in case of premature rupture of the membranes, active vaginal bleeding, other signs of preterm labor, or severe patient discomfort. The course of pregnancy, including perinatal outcome in these women, was compared with the outcome of women from the placebo group of the AMPHIA trial (ISRCTN40512715) (historical cohort). Propensity score matching with replacement was used to create comparable baseline characteristics between both populations. The study included 63 women in the pessary group and 56 women as control subjects. Propensity score matching generated 57 women in the intervention group matched to 57 women (31 unique) in the control group. Gestational age at delivery was comparable between both groups (hazard ratio, 0.96; 95% confidence interval [CI], 0.46–1.46), as well as their delivery rates before 28, 32, and 37 weeks (RR, 0.68 [95% CI, 0.21–2.18]; RR, 0.54 [95% CI, 0.21–1.41]; and RR, 1.22 [95% CI, 0.47–3.15]), respectively. There was no difference in composite perinatal outcome (RR, 1.36 [95% CI, 0.53–3.51]) and perinatal mortality (RR, 0.89 [95% CI, 0.24–3.38]) either. Results of this cohort study with propensity score analysis could not confirm the positive effect of pessary therapy in the prevention of preterm birth in asymptomatic multiple pregnancies with a short cervix in this propensity score analysis. With ongoing studies on this subject, the definite answer whether pessaries are effective in the prevention of preterm birth will come. If effective, evaluation of implementation, similar to this study, is still necessary.

Published
2016

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