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Long-term effects of prenatal progesterone exposure: Neurophysiological development and hospital admissions in twins up to 8 years of age

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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OBJECTIVES: To perform a neurophysiological follow-up at 48 or 60 months in children exposed prenatally to progesterone compared to placebo and evaluate their medical histories up to 8 years of age.

METHODS: This follow-up of the Danish participants in the PREDICT study included 989 surviving children from 498 pregnancies. PREDICT is a placebo-controlled randomized trial examining progesterone for prevention of preterm delivery in unselected twin pregnancies. Medical histories of the children were reviewed, and neurophysiological development was evaluated by the parent-completed Ages and Stages Questionnaire (ASQ) at either 48 or 60 months after the estimated date of delivery. We used the method of generalized estimating equation to account for the correlation within twins.

RESULTS: A total of 492 children had been exposed to progesterone prenatally and 497 to placebo. There were no differences between the groups in number or length of admissions, and we found no overall differences in rates of diagnoses. However, the odds ratio for a diagnosis related to the heart was 1.66 (95%CI 0.80;3.37) in favor of placebo among all children, 2.29 (1.02;5.12) in dichorionic twins, and 8.19 (1.02;65.6) in all children when outpatient diagnoses were excluded. ASQ scores were available for 437 children (progesterone, n = 225; placebo, n = 212). Mean ASQ score was slightly higher in the progesterone group compared to placebo (P=0.03). In dichorionic twins, the risk of having a low ASQ score (<10(th) centile) was decreased in the progesterone group (OR 0.34 (0.14;0.86)).

CONCLUSIONS: Second and third trimester exposure to progesterone does not seem to have long-term harmful effects on children, but future studies should focus on cardiac disease in the offspring.

CLINICAL TRIAL REGISTRATION: EudraCT, https://eudract.ema.europa.eu, 2006-000503-41, and ClinicalTrials. gov, www.clinicaltrials.gov, NCT00329914.

OriginalsprogEngelsk
TidsskriftUltrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology
Vol/bind48
Udgave nummer3
Sider (fra-til)382-9
ISSN0960-7692
DOI
StatusUdgivet - 2016

ID: 46400186