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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00116246




Registration number
NCT00116246
Ethics application status
Date submitted
27/06/2005
Date registered
28/06/2005
Date last updated
8/09/2006

Titles & IDs
Public title
McRoberts Manoeuvre Or Pushing Study (McMOPS)
Scientific title
Secondary ID [1] 0 0
02151B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childbirth 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - McRobert's manoeuvre

Treatment: Surgery: McRobert's manoeuvre
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Operative delivery rate
Timepoint [1] 0 0
Primary outcome [2] 0 0
Patient satisfaction with treatment
Timepoint [2] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Mercy Hospital for Women - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00116246
Trial related presentations / 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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Sheila F Mulvey, PhD,MB
Address 0 0
University of Melbourne,Dept of Obstetrics & Gynaecology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sheila F Mulvey, PhD,MB
Address 0 0
Country 0 0
Phone 0 0
61-3 84584381
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00116246