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McRoberts Manoeuvre Or Pushing Study (McMOPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University of Melbourne.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00116246
First received: June 27, 2005
Last updated: September 7, 2006
Last verified: August 2005
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment

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
  Show Detailed Description

  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:

ClinicalTrials.gov Identifier: NCT00116246     History of Changes
Other Study ID Numbers: 02151B
Study First Received: June 27, 2005
Last Updated: September 7, 2006
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 May 19, 2013