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Effect of Amnioinfusion on External Cephalic Version Successful Rate

NCT00465712 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-12-30

No results posted yet for this study

Summary

The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second external cephalic version after initial failure.Patient with a single foetus, at term, in breech presentation and after a first cephalic version are included. The randomisation determines whether the patient is included in the group with amnioinfusion before second cephalic version or with usual second cephalic version only; The efficacy's evaluation is based on rate of cephalic presentation at birth.Success rate of cephalic version with or without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal and fetal morbidity, time between second cephalic version and birth will be studied.

Prospective interventional randomized sequential comparative multicentric study. A maximum of 240 patients will be included (120 in each group). As the study is sequential it will be over as soon as a significative difference is shown.

Conditions

  • Breech Presentation

Interventions

PROCEDURE

transabdominal amnioinfusion

transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Franck Perrotin, MD-PhD · Tours University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00465712 on ClinicalTrials.gov