Skip to main content
OpenTrials
Completed

NCT Number: NCT00141687

Early External Cephalic Version (ECV) 2 Trial

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)?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breech Presentation Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with any breech presentation
  • A live singleton fetus
  • Gestational age of 33 weeks 0 days to 35 weeks 6 days

Exclusion criteria

  • Contraindications to ECV (e.g. fetal heart rate abnormalities, abruptio placenta, major life-threatening fetal anomalies, uterine anomalies, hyper-extended fetal head, rupture of membranes, severe oligohydramnios, severe polyhydramnios)
  • Contraindications to early ECV (e.g. increased risk of preterm labour [such as past history of preterm labour in this or previous pregnancies], increased risk of abruptio placenta [such as maternal hypertension])
  • Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS)
  • Women planning delivery by CS if the fetus turns to cephalic
  • Women planning a vaginal delivery if the fetus remains breech
  • Women at increased risk of unstable lie (eg. grand multiparity)
  • Previous participation in EECV2 Trial

Treatment and study plan

Early ECV between 34 0/7 and 35 6/7 weeks

Procedure

Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation

Other names: Early External Cephalic Version (ECV)

Delayed ECV at or after 37 0/7 weeks

Procedure

Delayed external cephalic version at or after 37 0/7 weeks of gestation

Other names: Delayed External Cephalic Version (ECV)

Primary outcomes

  1. Rate of cesarean section

    Time frame: Information not available

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • University of British Columbia

Registry information

Official study title

Early External Cephalic Version 2 Trial

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 1, 2005
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.