McRoberts Manoeuvre Or Pushing Study (McMOPS)

NCT00116246 | Unknown Phase 1

• 1 other identifier: 02151B
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Childbirth

Keywords

Labour; vaginal delivery; primigravida; McRobert's Manoeuvre; operative delivery

Outcome Measures

Primary Outcomes (2)

• Operative delivery rate

• Patient satisfaction with treatment

Interventions

McRobert's manoeuvre PROCEDURE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (1)

Mercy Hospital for Women

Melbourne, Victoria, 3084, Australia

RECRUITING

Related Publications (4)

• 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. doi: 10.1016/S0140-6736(01)05632-X.

  PMID: 11513914 BACKGROUND

• Murphy DJ. Failure to progress in the second stage of labour. Curr Opin Obstet Gynecol. 2001 Dec;13(6):557-61. doi: 10.1097/00001703-200112000-00002.

  PMID: 11707657 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2001.00034.x.

  PMID: 11281466 BACKGROUND

• 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. doi: 10.1016/s0002-9378(99)70104-3.

  PMID: 10561641 BACKGROUND

Study Officials

• Sheila F Mulvey, PhD,MB

  University of Melbourne,Dept of Obstetrics & Gynaecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila F Mulvey, PhD,MB

CONTACT

61-3 84584381; smulvey@unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2005
• First Posted: June 28, 2005
• Study Start: August 1, 2005
• Study Completion: December 1, 2006
• Last Updated: September 8, 2006

Record last verified: 2005-08

Locations

AU (1)