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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. Predictive Value of Cervical Length Measurement and Fibronectin Testing in Threatened Preterm Labor

Author

van Baaren, Gert-Jan, 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., Bax, Caroline J., Cornette, Jérôme M. J., Duvekot, Johannes J., Nij Bijvanck, Bas W. A., van Eyck, Jim, Franssen, Maureen T. M., Sollie, Krystyna M., Vandenbussche, Frank P. H. A., Woiski, Mallory, Grobman, William A., van der Post, Joris A. M., Bossuyt, Patrick M. M., Opmeer, Brent C., and Mol, Ben W. J.

Published
2014
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32. 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

33. 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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34. 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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35. 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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36. 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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37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

43. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

Author

Freeman Liv M, Bloemenkamp Kitty WM, Franssen Maureen TM, Papatsonis Dimitri NM, Hajenius Petra J, van Huizen Marloes E, Bremer Henk A, van den Akker Eline SA, Woiski Mallory D, Porath Martina M, van Beek Erik, Schuitemaker Nico, van der Salm Paulien CM, Fong Bianca F, Radder Celine, Bax Caroline J, Sikkema Marko, van den Akker-van Marle M, van Lith Jan MM, Lopriore Enrico, Uildriks Renske J, Struys Michel MRF, Mol Ben Willem J, Dahan Albert, and Middeldorp Johanna M

Subjects
Analgesia, Labour, Remifentanil, Patient controlled analgesia, Epidural, Gynecology and obstetrics, RG1-991
Abstract

Abstract Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day. Trial registration number Dutch Trial Register NTR2551, http://www.trialregister.nl

Published
2012
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44. 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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45. 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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46. 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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48. 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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50. 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

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