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STOPPIT Baby Follow-up Study: the effect of prophylactic progesterone in twin pregnancy on childhood outcome.

McNamara HC, Wood R, Chalmers J, Marlow N, Norrie J, MacLennan G, McPherson G, Boachie C, Norman JE - PLoS ONE (2015)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Monash University, Melbourne, Australia.

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.

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Related in: MedlinePlus

Flow of participants through questionnaire arm of study.
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pone.0122341.g002: Flow of participants through questionnaire arm of study.

Mentions: The flow of participants through the questionnaire arm of the study is shown in Fig 2. After relevant exclusions, 369 families were sent a questionnaire. A positive response was received from 167 mothers. Data for the primary outcome (CDI and HUI scores) were obtained from 162 mothers (44% of those mailed questionnaires).


STOPPIT Baby Follow-up Study: the effect of prophylactic progesterone in twin pregnancy on childhood outcome.

McNamara HC, Wood R, Chalmers J, Marlow N, Norrie J, MacLennan G, McPherson G, Boachie C, Norman JE - PLoS ONE (2015)

Flow of participants through questionnaire arm of study.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4400139&req=5

pone.0122341.g002: Flow of participants through questionnaire arm of study.
Mentions: The flow of participants through the questionnaire arm of the study is shown in Fig 2. After relevant exclusions, 369 families were sent a questionnaire. A positive response was received from 167 mothers. Data for the primary outcome (CDI and HUI scores) were obtained from 162 mothers (44% of those mailed questionnaires).

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Monash University, Melbourne, Australia.

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.

Show MeSH
Related in: MedlinePlus