title: STOPPIT Baby Follow-up Study: the effect of prophylactic progesterone in twin pregnancy on childhood outcome.
abstract: OBJECTIVE
  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.
authors.affiliation: Monash University, Melbourne, Australia.
authors.forename: Helen Christine
authors.initials: HC
authors.lastname: McNamara
authors.affiliation: Information Services Division, NHS National Services Scotland, Edinburgh, United Kingdom.
authors.forename: Rachael
authors.initials: R
authors.lastname: Wood
authors.affiliation: Information Services Division, NHS National Services Scotland, Edinburgh, United Kingdom.
authors.forename: James
authors.initials: J
authors.lastname: Chalmers
authors.affiliation: Department of Neonatal Medicine, Institute for Women's Health, University College London, London, United Kingdom.
authors.forename: Neil
authors.initials: N
authors.lastname: Marlow
authors.affiliation: Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom.
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.affiliation: Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom.
authors.forename: Graeme
authors.initials: G
authors.lastname: MacLennan
authors.affiliation: Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom.
authors.forename: Gladys
authors.initials: G
authors.lastname: McPherson
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.
authors.forename: Charles
authors.initials: C
authors.lastname: Boachie
authors.affiliation: Tommy's Centre for Maternal and Fetal Health, University of Edinburgh MRC Centre for Reproductive Health, The Queen's Medical Research Institute, Edinburgh, United Kingdom.
authors.forename: Jane Elizabeth
authors.initials: JE
authors.lastname: Norman
mesh_terms: D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D010919:Placebos; D011247:Pregnancy; D011256:Pregnancy Outcome; D011374:Progesterone / Q000008:administration & dosage*
chemical_list: D010919:Placebos; D011374:Progesterone