Early External Cephalic Version (ECV) 2 Trial

Study Overview
=================
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 Description
-----------------
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.

Official Title
-----------------
Early External Cephalic Version 2 Trial

Conditions
-----------------
Breech Presentation

Intervention / Treatment
-----------------
* Procedure: Early ECV between 34 0/7 and 35 6/7 weeks
* Procedure: Delayed ECV at or after 37 0/7 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early External Cephalic Version Group<br>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<br>* Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation<br>* Other names: Early External Cephalic Version (ECV);|
| Active Comparator: Delayed External Cephalic Version Group<br>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<br>* Delayed external cephalic version at or after 37 0/7 weeks of gestation<br>* Other names: Delayed External Cephalic Version (ECV);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cesarean section |  | Information not available | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
External cephalic version, Cesarean section, pregnancy, labour, Breech pregnancy