Clinical Trial: Early External Cephalic Version (ECV) 2 Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Early External Cephalic Version 2 Trial

Brief Summary: For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (CS)?

Detailed Summary:

Primary Outcomes: Rate of Caesarean section

Secondary Outcomes: Rate of preterm birth

Other Outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious fetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs.

The Data Coordination for this study is being carried out at the Maternal, Infant Reproductive Health Research Unit at Sunnybrook and Women's College Health Sciences Centre.

Sponsor: McMaster University

Current Primary Outcome: Rate of cesarean section [ Time Frame: Information not available ]

Original Primary Outcome: Lower rates of non-cephalic presentation at birth and CS. The Early ECV 2 Trial will be adequately sized to assess the effect of early versus delayed ECV in terms of the need

Current Secondary Outcome: Rate of pre-term births. Other outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, or others. [ Time Frame: Information not available ]

Original Secondary Outcome: Preterm birth impacts on neonatal morbidity50 and health care utilisation, and is therefore an important surrogate outcome for serious perinatal or neonatal morbidity.

Information By: McMaster University

Dates:
Date Received: August 30, 2005
Date Started: December 2004
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016