Effect of Amnioinfusion on External Cephalic Version Successful Rate (AMNIO)

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00465712
First received: April 24, 2007
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Breech Presentation
Procedure: transabdominal amnioinfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • cephalic presentation at birth [ Time Frame: at birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: July 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Transabdominal amnioinfusion performed before external cephalic version
Procedure: transabdominal amnioinfusion
transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version
No Intervention: V
Without transabdominal amnioinfusion

Detailed Description:

The purpose of the study is to evaluate the effect of transabdominal amnioinfusion before a second external cephalic version after initial failure. In case of success it could be an alternative to cesarian section. Without any other technique the foetus is in cephalic presentation after a first external cephalic version in 50%.

Patients with a single fetus, at term, in breech presentation are proposed to participate. The randomization is done at the inclusion and determines whether the patient is included in the group with amnioinfusion before second cephalic version or usual second cephalic version only. The only difference between the two groups is the realisation of an amnioinfusion, the cephalic version's technique is the same.

Efficacy's evaluation is based on rate of cephalic presentation at birth. Success rate of cephalic version, rates of cesarian section, maternal and fetal morbidity in the two groups, time between second cephalic version and birth will be studied.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • single fetal pregnancy
  • breech presentation
  • at term
  • initial failure of external cephalic version
  • structurally normal foetus

Exclusion Criteria:

  • polyhydramnios
  • anhydramnios
  • abnormality of the fetal heart rhythm
  • uterine congenital malformation
  • cesarian section for a previous birth
  • unability to understand study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465712

Locations
France
Mother Child University Hospital
Nantes, France, 44000
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Franck Perrotin, MD-PhD Tours University Hospital
  More Information

Publications:
Fisk NM. Diagnostic and therapeutic amnioinfusion in oligoamnios. Obstet Gynecol 1991;78:270-278.
Hofmeyr GJ, Kulier R. Cephalic version by postural management for breech presentation (Cochrane Review). In: The Cochrane Library, Issue 3, 2004c. Chichester, UK: John Wiley & Sons, Ltd.
Pritchard JA, MacDonald PC. Dystocia caused by abnormalities in presentation, position, or development of the fetus. Williams Obstetrics. Norwalk, CT: Appleton-Century-Crofts; 1980, p. 787-796.
Royal College of Obstetricians and Gynaecologists Clinical Audit Unit. Effective procedures in maternity care suitable for audit. London: RCOG Press; 1997;4(7). Breech presentation at term, p. 32.
Royal College of Obstetricians and Gynaecologists. Use of anti-D immunoglobulin for Rh Prophylaxis. London: RCOG Press; 1999. Guideline n° 22

Responsible Party: Pr Franck Perrotin, CHRU de Tours
ClinicalTrials.gov Identifier: NCT00465712     History of Changes
Other Study ID Numbers: PHRN05-FP/AMNIO2006
Study First Received: April 24, 2007
Last Updated: May 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
transabdominal amnioinfusion
external cephalic version
breech presentation

Additional relevant MeSH terms:
Breech Presentation
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 23, 2014