Childbirth Clinical Trial
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).
Status | Recruiting |
Enrollment | 222 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Mercy Hospital for Women | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
University of Melbourne |
Australia,
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. — View Citation
Murphy DJ. Failure to progress in the second stage of labour. Curr Opin Obstet Gynecol. 2001 Dec;13(6):557-61. Review. — View Citation
Nordström 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative delivery rate | |||
Primary | Patient satisfaction with treatment |
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