McRoberts Manoeuvre Or Pushing Study (McMOPS) - Full Text View

Sponsored by:	University of Melbourne
Information provided by:	University of Melbourne
ClinicalTrials.gov Identifier:	NCT00116246

Purpose

We propose to conduct a randomised-controlled study to investigate whether adopting McRoberts’ position, after 45 minutes of active pushing with no signs of progress, can increase the probability of vaginal delivery, preventing the need for forceps or vacuum assistance. In our study we will allow 45 minutes of pushing before a further 45 minutes of either the same, or our intervention (McRoberts’ manoeuvre).

Condition	Intervention	Phase
Childbirth	Procedure: McRobert's manoeuvre	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by University of Melbourne:

Primary Outcome Measures:

Operative delivery rate
Patient satisfaction with treatment

Estimated Enrollment:	222
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2006

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Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Nulliparous women in labour after 37 completed weeks gestation who have been pushing for 45 minutes in the second stage of labour with no progress (defined as no presenting part visible on pushing, without parting the labia)
Singleton pregnancy
Cephalic presentation
Clinical scenarios in which we propose to still include in the study: *Spontaneous or induced labour; *Regional anaesthesia; *Clinical suspicion of large baby, but was considered suitable for trial of labour

Exclusion Criteria:

Maternal weight >100kgs
Non-reassuring fetal condition
Patient being unable to tolerate McRobert’s position
Non-English speaking woman
Woman unable to give adequate consent, or suspicion that the antenatal information sheet has not been fully understood
Multiparous women
Complicated obstetric co-morbidities, including: *Preterm labour (less than 37 completed weeks gestation); *Multiple pregnancy; *Abnormal presentation; *Placenta praevia or abruption; *Non-reassuring fetal status Maternal pathology restricting maternal adoption of McRoberts’ position (e.g. back problems)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116246

Contacts

Contact: Sheila F Mulvey, PhD,MB

61-3 84584381

smulvey@unimelb.edu.au

Locations

Australia, Victoria
Mercy Hospital for Women	Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Sheila F Mulvey, PhD,MB 61-3-84584381 smulvey@unimelb.edu.au
Principal Investigator: Sheila F Mulvey, PhD,MB

Sponsors and Collaborators

University of Melbourne

Investigators

Principal Investigator:

Sheila F Mulvey, PhD,MB

University of Melbourne,Dept of Obstetrics & Gynaecology

More Information

Publications:

Buhimschi CS, Buhimschi IA, Malinow A, Weiner CP. Use of McRoberts' position during delivery and increase in pushing efficiency. Lancet. 2001 Aug 11;358(9280):470-1.

Murphy DJ. Failure to progress in the second stage of labour. Curr Opin Obstet Gynecol. 2001 Dec;13(6):557-61. Review.

Nordstrom L, Achanna S, Naka K, Arulkumaran S. Fetal and maternal lactate increase during active second stage of labour. BJOG. 2001 Mar;108(3):263-8.

Robinson JN, Norwitz ER, Cohen AP, McElrath TF, Lieberman ES. Episiotomy, operative vaginal delivery, and significant perinatal trauma in nulliparous women. Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1180-4.

Study ID Numbers:	02151B
Study First Received:	June 27, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00116246
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by University of Melbourne:

Labour
vaginal delivery
primigravida
McRobert's Manoeuvre
operative delivery

ClinicalTrials.gov processed this record on January 14, 2009