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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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]

02151B

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Childbirth

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Operative delivery rate

Timepoint [1]

Primary outcome [2]

Patient satisfaction with treatment

Timepoint [2]

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

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]

Mercy Hospital for Women - Melbourne

Recruitment postcode(s) [1]

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/study/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

Sheila F Mulvey, PhD,MB

Address

University of Melbourne,Dept of Obstetrics & Gynaecology

Country

Phone

Fax

Contact person for public queries

Name

Sheila F Mulvey, PhD,MB

Address

Country

Phone

61-3 84584381

Fax

[email protected]

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00116246

Trial Review

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