Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Transverse occiput position: Using manual Rotation to aid Normal birth and improve delivery OUTcomes (TURN-OUT): A study protocol for a randomised controlled trial

Authors: Bradley de Vries, Hala Phipps, Sabrina Kuah, John Pardey, Joanne Ludlow, Andrew Bisits, Felicity Park, David Kowalski, Jon A. Hyett

Published in: Trials | Issue 1/2015

Login to get access

Abstract

Background

Fetal occiput transverse position in the form of deep transverse arrest has long been associated with caesarean section and instrumental vaginal delivery. Occiput transverse position incidentally found in the second stage of labour is also associated with operative delivery in high risk cohorts. There is evidence from cohort studies that prophylactic manual rotation reduces the caesarean section rate. This is a protocol for a double blind, multicentre, randomised, controlled clinical trial to define whether this intervention decreases the operative delivery (caesarean section, forceps or vacuum delivery) rate.

Methods/Design

Eligible participants will be ≥37 weeks pregnant, with a singleton pregnancy, and a cephalic presentation in the occiput transverse position on transabdominal ultrasound early in the second stage of labour. Based on a background risk of operative delivery of 49%, for a reduction to 35%, an alpha value of 0.05 and a beta value of 0.2, 416 participants will need to be enrolled. Participants will be randomised to either prophylactic manual rotation or a sham procedure. The primary outcome will be operative delivery. Secondary outcomes will be caesarean section, significant maternal mortality and morbidity, and significant perinatal mortality and morbidity.
Analysis will be on an intention-to-treat basis. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, Sydney, Australia, (protocol number: X110410).

Discussion

This trial addresses an important clinical question concerning a commonly used procedure which has the potential to reduce operative delivery and its associated complications. Some issues discussed in the protocol include methods of assessing risk of bias due to inadequate masking of a procedural interventions, variations in intervention efficacy due to operator experience and the recruitment difficulties associated with intrapartum studies.

Trial registration

This trial was registered with the Australian New Zealand Clinical Trials Registry (identifier: ACTRN12613000005​752) on 4 January 2013.
Literature
1.
Jones EP. Deep transverse arrest: what does it mean? BJOG. 1952;59:377–9.CrossRef
2.
Senecal J, Xiong X, Fraser WE. Effect of fetal position on second-stage duration and labor outcome. Obstet Gynecol. 2005;105:763–72.CrossRefPubMed
3.
Phipps H, Hyett J, Graham K, Carseldine W, Tooher J, de Vries B. What is the operative delivery rate of fetal occiput transverse position in the second stage of labour? Acta Obstet Gynecol Scand. 2014;93:1018–24.CrossRefPubMed
4.
5.
Barros FC, Victoria CG, Barros AJ, Santos IS, Albernaz E, Matijasevich A, et al. The challenge of reducing neonatal mortality in middle-income countries: findings from three Brazilian birth cohorts in 1982, 1993, and 2004. Lancet. 2005;365:847–54.CrossRefPubMed
6.
Bahl R, Strachan B, Murphy DJ. Outcome of subsequent pregnancy three years after previous operative delivery in the second stage of labour: cohort study. BMJ. 2004;328:311.CrossRefPubMedPubMedCentral
7.
Islam A, Hanif Khan A, Murtaza NJ. Vacuum extraction and forceps deliveries; comparison of maternal and neonatal complications. Professional Med J. 2008;15:87–90.
8.
Murphy DJ, Macleod M, Bahl R, Strachan B. A cohort study of maternal and neonatal morbidity in relation to use of sequential instruments at operative vaginal delivery. Eur J Obst Gynacol Rep Biol. 2011;156:41–5.CrossRef
9.
The Society of Obstetricians and Gynaecologists for Canada. Guidelines for operative vaginal birth. Number 148, May 2004. Int J Gynaecol Obstet. 2004;88:229–36.
10.
Phipps H, de Vries B, Lee PN, Hyett JA. Management of occiput posterior position in the second stage of labour: a survey of obstetric practice in Australia and New Zealand. Aus NZ J Obst Gynacol. 2012;52:450–4.CrossRef
11.
Phipps H, de Vries B, Jagadish U, Hyett J. Management of occiput posterior position in the second stage of labour: A survey of midwifery practice in Australia. Birth. 2014;41(1):64–9.CrossRefPubMed
12.
Shaffer BL, Cheng YW, Vargas E. Manual rotation to reduce caesarean delivery in persistent occiput posterior or transverse position. J Matern Fetal Neonatal Med. 2011;24(1):65–72.CrossRefPubMed
13.
Lieberman E, Davidson K, Lee-Parritz A, Shearer E. Changes in fetal position during labor and their association with epidural analgesia. Obstet Gynecol. 2005;105:974–82.CrossRefPubMed
14.
Souka AP, Haritos T, Basayiannis K, Noikokyri N, Antsaklis A. Intrapartum ultrasound for the examination of the fetal head position in normal and obstructed labor. J Matern Fetal Neonatal Med. 2003;13:59–63.CrossRefPubMed
15.
Akmal S, Tsoi E, Howard R. Investigation of occiput posterior delivery by intrapartum sonography. J Matern Fetal Neonatal Med. 2004;24:425–8.
16.
Sherer DM, Miodovnik M, Bradley KS, Langer O. Intrapartum fetal head position II: comparison between transvaginal digital examination and transabdominal ultrasound assessment during the second stage of labor. Ultrasound Obst Gynacol. 2002;19:264–8.CrossRef
17.
Ponkey SE, Cohen AP, Heffner LJ, Lieberman E. Persistent fetal occiput posterior position: obstetric outcomes. Obstet Gynecol. 2003;101:915–20.PubMed
18.
19.
Usta IM, Mercer BM, Sibai BM. Current obstetrical practice and umbilical cord prolapse. Am J Epidemiology. 1999;16:479–84.
20.
Le Ray C. Manual rotation in occiput posterior or transverse positions: risk factors and consequences on the cesarean delivery rate. Obstet Gynecol. 2007;110:873–9.CrossRefPubMed
21.
Jackson N, Paterson-Brown S. Physical sequelae of caesarean section. Best Pract Res Clin Obstet Gynacol. 2001;15:49–61.CrossRef
22.
Zelop C, Heffner LJ. The downside of cesarean delivery: short-and long-term complications. Clin Obstet Gynaecol. 2004;47:386.CrossRef
23.
Guise JM, McDonagh MS, Osterweil P, Nygren P, Chan BK, Helfand M. Systematic review of the incidence and consequences of uterine rupture in women with previous caesarean section. BMJ. 2004;329:19–25.CrossRefPubMedPubMedCentral
24.
Sarsam SE, Elliott JP, Lam GK. Management of wound complications from cesarean delivery. Obstet Gynacol Survey. 2005;60:462–73.CrossRef
25.
Lumbiganon P, Laopaiboon M, Gulmezoglu AM, Souza JP, Taneepanichskul S, Ruyan P, et al. Method of delivery and pregnancy outcomes in Asia: the WHO global survey on maternal and perinatal health 2007-08. Lancet. 2010;375:490–9.CrossRefPubMed
26.
Baessler K, O’Neill SM, Maher CF, Battistutta D. A validated self-administered female pelvic floor questionnaire. J Int Urogynecol. 2010;21(2):163–72.CrossRef
Metadata
Title
Transverse occiput position: Using manual Rotation to aid Normal birth and improve delivery OUTcomes (TURN-OUT): A study protocol for a randomised controlled trial
Authors
Bradley de Vries
Hala Phipps
Sabrina Kuah
John Pardey
Joanne Ludlow
Andrew Bisits
Felicity Park
David Kowalski
Jon A. Hyett
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0854-3

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Research

A randomized pilot study on the effect of niacin on pulmonary arterial pressure

STUDY PROTOCOL

Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults?: study protocol for a randomized controlled trial

Study protocol

Would transcranial direct current stimulation (tDCS) enhance the effects of working memory training in older adults with mild neurocognitive disorder due to Alzheimer’s disease: study protocol for a randomized controlled trial

Study protocol

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

Study protocol

An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial

Study protocol

Continuous wound infusion of local anesthetic and steroid after major abdominal surgery: study protocol for a randomized controlled trial