ChildbirthPhase 1NCT00116246
McRoberts Manoeuvre Or Pushing Study (McMOPS)
A Phase 1 study testing McRobert's manoeuvre in people with Childbirth, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth
- What is being tested?
- McRobert's manoeuvre
- Type of treatment
- Surgery or procedure
- How many people
- 222 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2005to Dec 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Mercy Hospital for Women
Melbourne, Victoria, 3084
Sheila F Mulvey, PhD,MB, 61-3-84584381, smulvey@unimelb.edu.au
Sheila F Mulvey, PhD,MB
About this study
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).
Read the 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:
- Catalin, SB et al, "Use of McRoberts' position during delivery and increase in pushing efficiency", The Lancet (2001); 358: 470-471
- 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.
- Conditions
- Childbirth
- Being tested
- McRobert's manoeuvre
- Keywords
- Labour, vaginal delivery, primigravida, McRobert's Manoeuvre, operative delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McRobert's manoeuvreProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative delivery rate
Patient satisfaction with treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2005 (estimated)
- Study startAug 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 222 participants
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Investigators
- Sheila F Mulvey, PhD,MB, Principal investigator, University of Melbourne,Dept of Obstetrics & Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116246
- Sponsor's protocol ID
- 02151B
- Status last verified
- Aug 2005
- First submitted
- 27 Jun 2005
- Last updated
- 8 Sep 2006
- Results posted
- No
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. doi: 10.1016/S0140-6736(01)05632-X.
PubMed 11513914Murphy 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.
PubMed 11707657Nordstrom 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.
PubMed 11281466Robinson 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.
PubMed 10561641
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- McRoberts Manoeuvre Or Pushing Study (McMOPS)
- ClinicalTrials.gov ID
- NCT00116246
- Acronym / sponsor ID
- 02151B
- Conditions
- Childbirth
- Keywords
- Labour, vaginal delivery, primigravida, McRobert's Manoeuvre, operative delivery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Dec 2006
- First posted
- 28 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- Catalin, SB et al, "Use of McRoberts' position during delivery and increase in pushing efficiency", The Lancet (2001); 358: 470-471
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McRobert's manoeuvre | Procedure or surgery | – |
Primary outcome
Operative delivery rate
Patient satisfaction with treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2006.
- Background: PubMed 11513914Buhimschi 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.
- Background: PubMed 11707657Murphy 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.
- Background: PubMed 11281466Nordstrom 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.
- Background: PubMed 10561641Robinson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila F Mulvey, PhD,MB principal investigator
University of Melbourne,Dept of Obstetrics & Gynaecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing McRobert's manoeuvre in people with Childbirth, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheila F Mulvey, PhD,MB (61-3 84584381, smulvey@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative delivery rate. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00116246, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2006.