Progesterone for preterm birth prevention in women with short cervical length: outcomes in children at 2 years
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Date
2021
Authors
Cuijpers, C.J.J.
van 't Hooft, J.
Schneeberger, C.
van der Lee, J.H.
Simons, N.E.
van Os, M.A.
van der Ven, J.
de Groot, C.J.M.
Mol, B.W.J.
van Wassenaer-Leemhuis, A.G.
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Ultrasound in Obstetrics and Gynecology, 2021; 57(3):431-439
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C.J.J. Cuijpers, J. Van’t Hooft, C. Schneeberger, J.H. Van Der Lee, N.E. Simons, M.A. Van Os, J. Van Der Ven, C.J.M. De Groot, B.W.J. Mol, and A.G. Van Wassenaer-Leemhuis
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Abstract
Objective: To evaluate, in children born to women with a short cervix, and otherwise low-risk , the long-term outcomes after antenatal vaginal progesterone versus placebo (follow-up of the Triple P trial). Methods: The Triple P trial randomized low risk women (n=80) with a short cervix at screening (≤30mm), to progesterone (n=41) or placebo (n=39). At 2'years corrected age children were invited for a neurodevelopmental assessment using the Bayley Scales of Infant and Toddler Development-third edition (BSID-III) and a neurological and physical examination by a blinded assessor. Parents filled out the Ages and Stages Questionnaire, the Child Behaviour Checklist (CBCL) and a general health questionnaire. The main outcome of interest was the mean BSID-III cognitive and motor score. Additionally, a composite score of abnormal developmental outcome included BSID-III <-1SD, CBCL in clinical range, parental reported physical problems (i.e. >'1 surgery or >'1 hospital admittance) or mortality. Our sample size, dictated by the original sample of the Triple P trial, gave us 80% power to detect a mean difference (MD) of 15 points (1SD) between groups for the BSID-III tests. Results: Of the 80 children born to the randomised women, 1 child in the progesterone group and 2 children in the placebo group died in the neonatal period. Follow-up data were obtained from 59/77 children (77%) and BSID-III outcomes in 57 children (n=28 progesterone vs n=29 placebo) born at a median gestational age (GA) of 38+6'weeks (IQR 37+3; 40+1'weeks) with a median birthweight of 3240 grams (IQR 2785; 3620grams), Mean BSID-III cognitive developmental scores were 101.6 and 105.0 , mean difference (MD) [95% Confidence Interval (CI)] -3.4 [ 95% -9.3 to 2.6], p=0.29 ) while mean motor scores were 102.4 and 107.3 , MD -4.9 [95% CI -11.2 to 1.4], p='0.13) for progesterone and placebo, respectively. No differences in physical outcomes (including genital and neurological examination) were seen between groups. Conclusion: In this sample of children born to low risk women with a short cervix at screening no relevant differences in neurodevelopmental, behavioural, health care related and physical outcomes were found in the offspring between those exposed to vaginal progesterone or placebo.
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© 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.