Effect of Amnioinfusion on External Cephalic Version Successful Rate - Full Text View

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

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:

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.

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.

Boucher M, Bujold E, Marquette GP, Vezina Y. The relationship between amniotic fluid index and successful external cephalic version: a 14-year experience. Am J Obstet Gynecol. 2003 Sep;189(3):751-4.

Cheng M, Hannah M. Breech delivery at term: a critical review of the literature. Obstet Gynecol. 1993 Oct;82(4 Pt 1):605-18. Review.

Collaris RJ, Oei SG. External cephalic version: a safe procedure? A systematic review of version-related risks. Acta Obstet Gynecol Scand. 2004 Jun;83(6):511-8. Review.

Collea JV, Chein C, Quilligan EJ. The randomized management of term frank breech presentation: a study of 208 cases. Am J Obstet Gynecol. 1980 May 15;137(2):235-44.

Fernandez CO, Bloom SL, Smulian JC, Ananth CV, Wendel GD Jr. A randomized placebo-controlled evaluation of terbutaline for external cephalic version. Obstet Gynecol. 1997 Nov;90(5):775-9.

Fisk NM. Diagnostic and therapeutic amnioinfusion in oligoamnios. Obstet Gynecol 1991;78:270-278.

Flamm BL, Fried MW, Lonky NM, Giles WS. External cephalic version after previous cesarean section. Am J Obstet Gynecol. 1991 Aug;165(2):370-2.

Gembruch U, Hansmann M. Artificial instillation of amniotic fluid as a new technique for the diagnostic evaluation of cases of oligohydramnios. Prenat Diagn. 1988 Jan;8(1):33-45.

Gimovsky ML, Wallace RL, Schifrin BS, Paul RH. Randomized management of the nonfrank breech presentation at term: a preliminary report. Am J Obstet Gynecol. 1983 May 1;146(1):34-40.

Gramellini D, Fieni S, Kaihura C, Faiola S, Vadora E. Transabdominal antepartum amnioinfusion. Int J Gynaecol Obstet. 2003 Nov;83(2):171-8.

Gramellini D, Fieni S, Kaihura C, Piantelli G, Verrotti C. Antepartum amnioinfusion: a review. J Matern Fetal Neonatal Med. 2003 Nov;14(5):291-6. Review.

Gramellini D, Fieni S, Piantelli G, Faiola S, Kaihura C, Verrotti C, Cavallotti D, Viola P, Bacchini G, Vadora E. [Amnioinfusion: techniques, indications, and controlled retrospective study of 55 cases] Acta Biomed Ateneo Parmense. 2000;71 Suppl 1:325-9. Italian.

Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet. 2000 Oct 21;356(9239):1375-83.

Hellstrom AC, Nilsson B, Stange L, Nylund L. When does external cephalic version succeed? Acta Obstet Gynecol Scand. 1990;69(4):281-5.

Hofmeyr GJ. Interventions to help external cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2004;(1):CD000184. Review.

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.

Hofmeyr GJ. External cephalic version facilitation for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000184. Review. Update in: Cochrane Database Syst Rev. 2001;(4):CD000184.

Hutton EK, Kaufman K, Hodnett E, Amankwah K, Hewson SA, McKay D, Szalai JP, Hannah ME. External cephalic version beginning at 34 weeks' gestation versus 37 weeks' gestation: a randomized multicenter trial. Am J Obstet Gynecol. 2003 Jul;189(1):245-54.

Kotaska A. Inappropriate use of randomised trials to evaluate complex phenomena: case study of vaginal breech delivery. BMJ. 2004 Oct 30;329(7473):1039-42. Review. No abstract available. Erratum in: BMJ. 2004 Dec 11;329(7479):1385.

Le Bret T, Grange G, Goffinet F, Cabrol D. [External cephalic version: experience about 237 versions at Port-Royal maternity] J Gynecol Obstet Biol Reprod (Paris). 2004 Jun;33(4):297-303. French.

Lilford RJ, van Coeverden de Groot HA, Moore PJ, Bingham P. The relative risks of caesarean section (intrapartum and elective) and vaginal delivery: a detailed analysis to exclude the effects of medical disorders and other acute pre-existing physiological disturbances. Br J Obstet Gynaecol. 1990 Oct;97(10):883-92.

Newman RB, Peacock BS, VanDorsten JP, Hunt HH. Predicting success of external cephalic version. Am J Obstet Gynecol. 1993 Aug;169(2 Pt 1):245-9; discussion 249-50.

Novakov-Mikic A, Stojic S, Bogavac M, Mandic A. [Amnionic infusion therapy in conditions with low amnionic fluid levels] Med Pregl. 2003 Jan-Feb;56(1-2):33-7. Croatian.

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.

Rietberg CC, Elferink-Stinkens PM, Brand R, van Loon AJ, Van Hemel OJ, Visser GH. Term breech presentation in The Netherlands from 1995 to 1999: mortality and morbidity in relation to the mode of delivery of 33824 infants. BJOG. 2003 Jun;110(6):604-9.

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

Shalev E, Battino S, Giladi Y, Edelstein S. External cephalic version at term--using tocolysis. Acta Obstet Gynecol Scand. 1993 Aug;72(6):455-7.

Stuart IP. Term breech trial. Lancet. 2001 Jan 20;357(9251):228. No abstract available.

Mousa HA. Re: Ledee et al. Management in intractable obstetric haemorrhage: an audit study on 61 cases. Eur J Obstet Gynecol Reprod Biol 2001;94:189-96. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 10;100(1):116-7. No abstract available.

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

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 June 18, 2013

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