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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Transabdominal amnioinfusion performed before external cephalic version |
|
| V | No Intervention | Without transabdominal amnioinfusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transabdominal amnioinfusion | Procedure | transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version |
|
| Measure | Description | Time Frame |
|---|---|---|
| cephalic presentation at birth | at birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franck Perrotin, MD-PhD | Tours University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mother Child University Hospital | Nantes | 44000 | France | |||
| Olympe de Gouges Women Health Centre, Bretonneau University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7970462 | Background | Benifla JL, Goffinet F, Darai E, Madelenat P. Antepartum transabdominal amnioinfusion to facilitate external cephalic version after initial failure. Obstet Gynecol. 1994 Dec;84(6):1041-2. | |
| 7622781 | Background | Benifla JL, Goffinet F, Bascou V, Darai E, Proust A, Madelenat P. [Transabdominal amnio-infusion facilitates external version maneuver after initial failure. Six successful attempts]. J Gynecol Obstet Biol Reprod (Paris). 1995;24(3):319-22. French. |
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| ID | Term |
|---|---|
| D001946 | Breech Presentation |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Tours |
| 37000 |
| France |
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| Background | Royal College of Obstetricians and Gynaecologists. Use of anti-D immunoglobulin for Rh Prophylaxis. London: RCOG Press; 1999. Guideline n° 22 |
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| 28279119 | Result | Diguisto C, Winer N, Descriaud C, Tavernier E, Weymuller V, Giraudeau B, Perrotin F. Amnioinfusion for women with a singleton breech presentation and a previous failed external cephalic version: a randomized controlled trial. J Matern Fetal Neonatal Med. 2018 Apr;31(8):993-999. doi: 10.1080/14767058.2017.1304909. Epub 2017 Mar 28. |