Abstract
ObjectivesTo determine the long-term effects of in utero progesterone exposure in twin children.MethodsThis study evaluated the health and developmental outcomes of all surviving children born to mothers who participated in a double-blind, placebo-controlled trial of progesterone given for the prevention of preterm birth in twin pregnancies (STOPPIT, ISRCTN35782581). Follow-up was performed via record linkage and two parent-completed validated questionnaires, the Child Development Inventory and the Health Utilities Index.ResultsRecord linkage was successfully performed on at least one record in 759/781 (97%) children eligible for follow-up. There were no differences between progesterone-exposed and placebo-exposed twins with respect to incidence of death, congenital anomalies and hospitalisation, nor on routine national child health assessments. Questionnaire responses were received for 324/738 (44%) children. The mean age at questionnaire follow-up was 55.5 months. Delay in at least one developmental domain on the Child Development Inventory was observed in 107/324 (33%) children, with no evidence of difference between progesterone-exposed and placebo-exposed twins. There was no evidence of difference between the progesterone and placebo groups in global health status assessed using the Health Utilities Index: 89% of children were rated as having ‘excellent’ health and a further 8% as having ‘very good’ health.ConclusionsIn this cohort of twin children there was no evidence of a detrimental or beneficial impact on health and developmental outcomes at three to six years of age due to in utero exposure to progesterone.
Highlights
Preterm birth, defined as birth prior to 37 weeks’ estimated gestation, is a leading cause of perinatal mortality and short-term and long-term morbidity
This study evaluated the health and developmental outcomes of all surviving children born to mothers who participated in a double-blind, placebo-controlled trial of progesterone given for the prevention of preterm birth in twin pregnancies (STOPPIT, ISRCTN35782581)
Delay in at least one developmental domain on the Child Development Inventory was observed in 107/324 (33%) children, with no evidence of difference between progesterone-exposed and placebo-exposed twins
Summary
Preterm birth, defined as birth prior to 37 weeks’ estimated gestation, is a leading cause of perinatal mortality and short-term and long-term morbidity. Progesterone, administered either as intramuscular 17 α-hydroxyprogesterone caproate or vaginal progesterone, has been demonstrated to reduce the rate of preterm birth in women with high-risk singleton pregnancies [1,2,3,4,5,6,7]. We and others have shown that neither progesterone nor 17 α-hydroxyprogesterone caproate prevents preterm birth in multiple pregnancies [8,9,10,11,12,13]. Use of progesterone for prevention of preterm birth in women with a previous preterm birth and/or with a short cervix is becoming widespread [14]. In 2011, the USA Food and Drug Administration approved use of 17 α-hydroxyprogesterone caproate for the prevention of preterm birth in women at risk because of previous spontaneous preterm birth [15]
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