Early External Cephalic Version (ECV) 2 Trial

NCT00141687 | Completed

• 2 other identifiers: C04-0348ISRCTN56498577
• Study Type: interventional
• Target: 1,543
• Locations: 1 country
• Sites: 1

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)?

Conditions

Breech Presentation

Keywords

External cephalic version; Cesarean section; pregnancy; labour; Breech pregnancy

Outcome Measures

Primary Outcomes (1)

• Rate of cesarean section

  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.

  Information not available

Study Arms (2)

Early External Cephalic Version Group

EXPERIMENTAL

Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation

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

Delayed External Cephalic Version Group

ACTIVE COMPARATOR

Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation

Procedure: Delayed ECV at or after 37 0/7 weeks

Interventions

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

Also known as: Early External Cephalic Version (ECV)

Early External Cephalic Version Group

Delayed ECV at or after 37 0/7 weeks PROCEDURE

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

Also known as: Delayed External Cephalic Version (ECV)

Delayed External Cephalic Version Group

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of British Columbia: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Links

• Main results: Hutton EK et al. The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies. BJOG. 2011 Apr;118(5):564-77.
• Reitsma A et al. Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes. Trials. 2014 Sep 26;15:377.
• Murray-Davis B. et al. Women's experiences of participating in the early external cephalic version 2 trial. Birth. 2012 Mar;39(1):30-8
• Cost analysis: Ahmed RJ, Gafni A, Hutton EK. The Cost Implications in Ontario, Alberta, and British Columbia of Early Versus Delayed External Cephalic Version in the EECV2 Trial. J Obstet Gynaecol Can. 2016 Mar;38(3):235-245.

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dr. Eileen Hutton, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: December 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

CA (1)