Progesterone for preterm birth prevention in women with short cervical length: outcomes in children at 2 years.

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 '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. This article is protected by copyright. All rights reserved.