Abstract
ABSTRACTObjectiveTo evaluate the long‐term outcomes of children born to women with a short cervix and otherwise low risk for preterm birth, after antenatal exposure to vaginal progesterone vs placebo.MethodsThis was a follow‐up study of the Triple P trial, which randomized 80 low‐risk women with a short cervix (≤ 30 mm) at 18–22 weeks' gestation to progesterone (n = 41) or placebo (n = 39). At 2 years of 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 an assessor blinded to the allocated treatment. Parents filled out the Ages and Stages Questionnaire, the Child Behavior Checklist (CBCL) and a general‐health questionnaire. The main outcome of interest was mean BSID‐III cognitive and motor scores. Additionally, a composite score of mortality and abnormal developmental outcome, including BSID‐III ≤–1 SD, CBCL score in the clinical range and/or parental reported physical problems (at least two operations or at least two hospital admissions in the previous 2 years), was evaluated. Our sample size, dictated by the original sample of the Triple P trial, provided 80% power to detect a mean difference (MD) of 15 points (1 SD) between groups for the BSID‐III tests.ResultsOf the 80 children born to the randomized women, one in the progesterone group and two in the placebo group died in the neonatal period. Follow‐up data were obtained for 59/77 (77%) children and BSID‐III outcomes in 57 children (n = 28 in the progesterone group and n = 29 in the placebo group) born at a median gestational age of 38 + 6 weeks (interquartile range (IQR), 37 + 3 to 40 + 1 weeks) with a median birth weight of 3240 g (IQR, 2785–3620 g). In the progesterone vs placebo groups, mean BSID‐III cognitive development scores were 101.6 vs 105.0 (MD, –3.4 (95% CI, –9.3 to 2.6); P = 0.29) while mean motor scores were 102.4 vs 107.3 (MD, –4.9 (95% CI, –11.2 to 1.4); P = 0.13). No differences were seen between the two groups in physical (including genital and neurological examination), behavioral and health‐related outcomes.ConclusionIn this sample of children born to low‐risk women with a short cervix at screening, no relevant differences in neurodevelopmental, behavioral, health‐related and physical outcomes were found between offspring exposed to vaginal progesterone and those exposed to placebo. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Highlights
Preterm birth (PTB) is associated with increased rates of neonatal mortality and long-term morbidity[1]
Of the 80 children born to the randomized women, one in the progesterone group and two in the placebo group died in the neonatal period
In the progesterone vs placebo groups, mean BSID-III cognitive development scores were 101.6 vs 105.0 (MD, –3.4; P = 0.29) while mean motor scores were 102.4 vs 107.3 (MD, –4.9; P = 0.13)
Summary
Preterm birth (PTB) is associated with increased rates of neonatal mortality and long-term morbidity[1]. An individual-patient data (IPD) meta-analysis evaluating the effect of vaginal progesterone vs placebo in 974 women with a singleton pregnancy with a cervical length ≤ 25 mm, showed a reduction in the rate of PTB before 33 weeks’ gestation from 22% to 14% (relative risk (RR), 0.62 (95% CI, 0.47–0.81))[3]. This IPD meta-analysis concluded that there is no evidence that vaginal progesterone has adverse effects on childhood neurodevelopmental outcomes[3]. To increase confidence in the absence of harm of progesterone, more sensitive in-person developmental examination data are needed
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