McRoberts Manoeuvre Or Pushing Study (McMOPS)

September 7, 2006 updated by: University of Melbourne
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

When women are in labour, they firstly undergo the first stage of labour where the cervix (neck of the womb) progresses to full dilatation. Once this occurs, they have reached the second stage, where the mother can start pushing to deliver the baby. It is accepted practice to allow mothers to actively push for a maximum of one hour.

In most cases, the baby will deliver spontaneously. However, in about 30% of cases of those who manage to labour to the second stage (fully dilated cervix), the obstetrician will have to assist delivery by the use of forceps or vacuum extraction (instrumental delivery). There are two main situations where delivery needs assistance; 'fetal distress' where the baby is suspected to be compromised, or failure to progress where the baby has not delivered after one hour of pushing. Unfortunately, instrumental delivery is associated with increased maternal and fetal problems, particularly arising from trauma to the tissues. Therefore, the identification of any new ways to increase the spontaneous delivery rate may decrease future complications.

Shoulder dystocia is a rare but dangerous scenario where the baby's head is delivered, but the shoulders are trapped behind the pubic bones. The McRoberts' position is used in this situation to deliver the baby. The mother's legs are flexed, and pushed up and out, lateral to her abdomen. It is believed that this helps by flattening out the sacral bone (tail bone), thereby widening the bony opening and allowing the shoulders to become free.

A recent paper (1) reported the novel finding that McRoberts' position also doubled the pressure generated by contractions compared to normal pushing. The authors believed that this increase in pressure was caused by the fact that the uterus was brought closer to the diaphragm that provides the power generated with pushing.

Our group wondered whether this substantial increase in pressure could be harnessed beyond the rare setting of shoulder dystocia. We therefore 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. Studies have shown that after one hour of active pushing, the fetus shows signs of increasing distress. In our study we will allow 45 minutes of pushing before a further 45 minutes of either the same, or our intervention (McRoberts' manoeuvre).

Women in their first pregnancy will be approached at 36 weeks in the antenatal clinic and advised of our study in the form of written information. The majority of women will not be approached again since they will not be relevant to this study, most having already delivered. However, women who have been pushing for 45 minutes will be invited to participate in the study.

The second stage of labour is a demanding process where it may not be practicable to obtain written consent. Therefore, having given information about the trial at their 36 week antenatal visit, we will enrol women after obtaining informed verbal consent. They will be specifically asked whether they have read and understood the prior information given to them at clinic.

Those consenting will be randomised to either continue in their current position or be placed in McRoberts' position. The woman will be allowed to push for a further 45 minutes. After this time, women in both groups who have not yet delivered will be aided by instrumental delivery, if deemed necessary. A few days after delivery, we will provide women with a questionnaire to determine patient satisfaction and how well they tolerated the procedure they ended up having (i.e. Operative delivery or McRoberts position).

We hope to find a significant reduction in the number of instrumental deliveries in the group of women placed in McRoberts' position as compared with the other group. A positive finding may be immediately, and widely applicable.

References:

  1. Catalin, SB et al, "Use of McRoberts' position during delivery and increase in pushing efficiency", The Lancet (2001); 358: 470-471
  2. Nordstrom L et al, "Fetal and maternal lactate increase during active second stage of labour", British Journal of Obstetrics and Gynaecology, (2001); 108;263-268.

Study Type

Interventional

Enrollment

222

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3084
        • Recruiting
        • Mercy Hospital for Women
        • Contact:
        • Principal Investigator:
          • Sheila F Mulvey, PhD,MB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient satisfaction with treatment
Operative delivery rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Investigators

  • Principal Investigator: Sheila F Mulvey, PhD,MB, University of Melbourne,Dept of Obstetrics & Gynaecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

June 27, 2005

First Submitted That Met QC Criteria

June 27, 2005

First Posted (Estimate)

June 28, 2005

Study Record Updates

Last Update Posted (Estimate)

September 8, 2006

Last Update Submitted That Met QC Criteria

September 7, 2006

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02151B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Childbirth

Clinical Trials on McRobert's manoeuvre

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe