STOPPIT Baby Follow-Up Study: The Effect of Prophylactic Progesterone in Twin Pregnancy on Childhood Outcome

Helen Christine McNamara, Rachael Wood, James Chalmers, Neil Marlow, John Norrie, Graeme MacLennan, Gladys McPherson, Charles Boachie, Jane Elizabeth Norman

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Abstract

OBJECTIVES: To determine the long-term effects of in utero progesterone exposure in twin children.

METHODS: 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). Follow-up was performed via record linkage and two parent-completed validated questionnaires, the Child Development Inventory and the Health Utilities Index.

RESULTS: Record 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.

CONCLUSIONS: In 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.

Original languageEnglish
Article numbere0122341
Number of pages13
JournalPloS ONE
Volume10
Issue number4
Early online date16 Apr 2015
DOIs
Publication statusPublished - 16 Apr 2015

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  • Datasets

    STOPPIT clinical trial data

    Norrie, J. D. T. (Data Manager), Norman, J. (Data Manager) & Ramsay, C. (Data Manager), University of Aberdeen, 2008

    Dataset

    Cite this

    McNamara, H. C., Wood, R., Chalmers, J., Marlow, N., Norrie, J., MacLennan, G., McPherson, G., Boachie, C., & Norman, J. E. (2015). STOPPIT Baby Follow-Up Study: The Effect of Prophylactic Progesterone in Twin Pregnancy on Childhood Outcome. PloS ONE, 10(4), [e0122341]. https://doi.org/10.1371/journal.pone.0122341