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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00465712
Recruitment Status : Terminated
First Posted : April 25, 2007
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
University Hospital, Tours

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Breech Presentation Procedure: transabdominal amnioinfusion Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study
Study Start Date : July 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. cephalic presentation at birth [ Time Frame: at birth ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465712


Locations
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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
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Principal Investigator: Franck Perrotin, MD-PhD Tours University Hospital
More Information
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Publications:
Fischer R. Breech Presentation. 2004. http://www.emedicine.com/med/topic3272.htm
Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term (Cochrane Review). In: The Cochrane Library, Issue 3, 2004d. Chichester, UK: John Wiley & Sons, Ltd
Hofmeyr GJ. External cephalic version for breech presentation before term (Cochrane Review). In: The Cochrane Library, Issue 3, 2004e. Chichester, UK: John Wiley & Sons, Ltd.
Lansac J, Body G, Perrotin F, Marret H. Pratique de l'accouchement. Paris: Masson ; 2001, p. 365-369.
Perrotin F, Sauget S, Laffont M, Lansac J, Body G. Version par manœuvre externe: nouveaux apports techniques. In: Collège National des Gynécologues Obstétriciens Français. Mises à jour en Gynécologie Obstétrique - VIGOT Ed. - Paris, 2003;25:5-23
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 The management of breech presentation. 2001
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).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pr Franck Perrotin, CHRU de Tours
ClinicalTrials.gov Identifier: NCT00465712    
Other Study ID Numbers: PHRN05-FP/AMNIO2006
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011
Keywords provided by University Hospital, Tours:
transabdominal amnioinfusion
external cephalic version
breech presentation
Additional relevant MeSH terms:
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Breech Presentation
Obstetric Labor Complications
Pregnancy Complications