Limits...
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.

Show MeSH

Related in: MedlinePlus

Flow of twins through record linkage at ISD.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4400139&req=5

pone.0122341.g001: Flow of twins through record linkage at ISD.

Mentions: Of the 500 women in the original STOPPIT trial, 68 were excluded from attempted record linkage as they lived in England (and would therefore not have relevant health records in Scotland), leaving 432 for whom record linkage was attempted. A further six women were lost to follow-up at the end of the original trial and ten could not be identified on the CHI database. Therefore, 416 women were potentially eligible to be sent a questionnaire and had current contact details available. Linkage to the children’s CHI numbers was performed in March 2013. CHI numbers of one child (in seven women) and both children (in 22 women) could not be identified, leaving 781 children whose CHI numbers were submitted for linkage to national child health records at ISD (386 in the progesterone group and 395 in the placebo group). Record linkage was successfully performed on at least one record in 759/781 (97%) children. The numbers of children for whom records were linked in each group are shown in Fig 1.


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 twins through record linkage at ISD.
© Copyright Policy
Related In: Results  -  Collection

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

pone.0122341.g001: Flow of twins through record linkage at ISD.
Mentions: Of the 500 women in the original STOPPIT trial, 68 were excluded from attempted record linkage as they lived in England (and would therefore not have relevant health records in Scotland), leaving 432 for whom record linkage was attempted. A further six women were lost to follow-up at the end of the original trial and ten could not be identified on the CHI database. Therefore, 416 women were potentially eligible to be sent a questionnaire and had current contact details available. Linkage to the children’s CHI numbers was performed in March 2013. CHI numbers of one child (in seven women) and both children (in 22 women) could not be identified, leaving 781 children whose CHI numbers were submitted for linkage to national child health records at ISD (386 in the progesterone group and 395 in the placebo group). Record linkage was successfully performed on at least one record in 759/781 (97%) children. The numbers of children for whom records were linked in each group are shown in Fig 1.

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