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

Research output: Contribution to journalArticle

16 Citations (Scopus)
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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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Twin Pregnancy
infants
childhood
Progesterone
progesterone
Health
pregnancy
placebos
Placebos
child development
questionnaires
Child Development
linkage (genetics)
Equipment and Supplies
premature birth
Premature Birth
Health Status
health status
Hospitalization
long term effects

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STOPPIT Baby Follow-Up Study : The Effect of Prophylactic Progesterone in Twin Pregnancy on Childhood Outcome. / McNamara, Helen Christine; Wood, Rachael; Chalmers, James; Marlow, Neil; Norrie, John; MacLennan, Graeme; McPherson, Gladys; Boachie, Charles; Norman, Jane Elizabeth.

In: PloS ONE, Vol. 10, No. 4, e0122341, 16.04.2015.

Research output: Contribution to journalArticle

McNamara, HC, Wood, R, Chalmers, J, Marlow, N, Norrie, J, MacLennan, G, McPherson, G, Boachie, C & Norman, JE 2015, 'STOPPIT Baby Follow-Up Study: The Effect of Prophylactic Progesterone in Twin Pregnancy on Childhood Outcome', PloS ONE, vol. 10, no. 4, e0122341. https://doi.org/10.1371/journal.pone.0122341
McNamara, Helen Christine ; Wood, Rachael ; Chalmers, James ; Marlow, Neil ; Norrie, John ; MacLennan, Graeme ; McPherson, Gladys ; Boachie, Charles ; Norman, Jane Elizabeth. / STOPPIT Baby Follow-Up Study : The Effect of Prophylactic Progesterone in Twin Pregnancy on Childhood Outcome. In: PloS ONE. 2015 ; Vol. 10, No. 4.
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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.",
author = "McNamara, {Helen Christine} and Rachael Wood and James Chalmers and Neil Marlow and John Norrie and Graeme MacLennan and Gladys McPherson and Charles Boachie and Norman, {Jane Elizabeth}",
note = "Funding: This study was funded by the Chief Scientist Office, Scotland (grant number CZH/2/575) and the charity, Tommy’s. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Data Availability: The STOPPIT Baby Follow-up Study uses two linked datasets, the STOPPIT clinical trial data and routine NHS data collected by Information Services Division (ISD), NHS Scotland. The governance and ethics approvals for this project around anonymity for the participants do not permit us to deposit the linked dataset on a publicly available website. Individuals wishing to access the STOPPIT clinical trial data should contact Professor Jane E Norman jane.norman@ed.ac.uk or Professor John Norrie john.norrie@abdn.ac.uk for access. General information on how to access data held by ISD for research purposes is available from ISD’s research coordination team – see http://www.isdscotland.org/Products-and-​Services/eDRIS. Please contact Rachael Wood rachaelwood@nhs.net for queries about the specific ISD data used in this study.",
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AU - McNamara, Helen Christine

AU - Wood, Rachael

AU - Chalmers, James

AU - Marlow, Neil

AU - Norrie, John

AU - MacLennan, Graeme

AU - McPherson, Gladys

AU - Boachie, Charles

AU - Norman, Jane Elizabeth

N1 - Funding: This study was funded by the Chief Scientist Office, Scotland (grant number CZH/2/575) and the charity, Tommy’s. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Data Availability: The STOPPIT Baby Follow-up Study uses two linked datasets, the STOPPIT clinical trial data and routine NHS data collected by Information Services Division (ISD), NHS Scotland. The governance and ethics approvals for this project around anonymity for the participants do not permit us to deposit the linked dataset on a publicly available website. Individuals wishing to access the STOPPIT clinical trial data should contact Professor Jane E Norman jane.norman@ed.ac.uk or Professor John Norrie john.norrie@abdn.ac.uk for access. General information on how to access data held by ISD for research purposes is available from ISD’s research coordination team – see http://www.isdscotland.org/Products-and-​Services/eDRIS. Please contact Rachael Wood rachaelwood@nhs.net for queries about the specific ISD data used in this study.

PY - 2015/4/16

Y1 - 2015/4/16

N2 - 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.

AB - 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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DO - 10.1371/journal.pone.0122341

M3 - Article

VL - 10

JO - PloS ONE

JF - PloS ONE

SN - 1932-6203

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