Effect of Amnioinfusion on External Cephalic Version Successful Rate

Breech Presentation Clinical Trial

— AMNIO  

Official title:

Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00465712
• Other study ID #: PHRN05-FP/AMNIO2006
• Status: Terminated
• Phase: N/A
• First received: April 24, 2007
• Last updated: May 31, 2011
• Start date: July 2006
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breech Presentation

Intervention

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

Locations

Country	Name	City	State
France	Mother Child University Hospital	Nantes
France	Olympe de Gouges Women Health Centre, Bretonneau University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (41)

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Wagner A, Potin J, Himily V, Arbeille P, Perrotin F. The "Loss Of Resistance" Syringe: a useful tool for difficult amnioinfusion. Fetal Diagn Ther (submitted).

Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12. Review. — View Citation

* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cephalic presentation at birth		at birth	No