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


CONCLUSIONS
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.


BACKGROUND
This trial was registered with the Australian New Zealand Clinical Trials Registry (identifier: ACTRN12613000005752 ) on 4 January 2013.
RPA Women & Babies, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, Sydney, NSW, 2050, Australia. bradley.devries@sswahs.nsw.gov.au.|Discipline of Obstetrics, Gynaecology and Neonatology, University of Sydney, Sydney, NSW, 2006, Australia. bradley.devries@sswahs.nsw.gov.au.
Bradley
B
de Vries
RPA Women & Babies, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, Sydney, NSW, 2050, Australia. hala.phipps@sswahs.cs.nsw.gov.au.|Discipline of Obstetrics, Gynaecology and Neonatology, University of Sydney, Sydney, NSW, 2006, Australia. hala.phipps@sswahs.cs.nsw.gov.au.
Hala
H
Phipps
Women's and Children's Hospital, Department of Perinatal Medicine, 72 King William Road, North Adelaide, SA, 5006, Australia. sabriba.Kuah@health.sa.gov.au.
Sabrina
S
Kuah
Nepean Hospital, Department of Obstetrics and Gynaecology, Derby St., Penrith, NSW, 2750, Australia. john@pardey.com.au.
John
J
Pardey
RPA Women & Babies, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, Sydney, NSW, 2050, Australia. Joanne.ludlow@sswahs.nsw.gov.au.
Joanne
J
Ludlow
Royal Hospital for Women, Maternity Division, Barker Rd, Randwick, Sydney, NSW, 2031, Australia. Andrew.Bisits@SESIAHS.HEALTH.NSW.GOV.AU.
Andrew
A
Bisits
The John Hunter Hospital, Department of Obstetrics and Gynaecology, Lookout Rd, New Lambton, Newcastle, NSW, 2035, Australia. felicit@med.usyd.edu.au.
Felicity
F
Park
RPA Women & Babies, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, Sydney, NSW, 2050, Australia. dkowalski@optusnet.com.au.|Canterbury Hospital, 575 Canterbury Rd, Campsie, Sydney, NSW, 2194, Australia. dkowalski@optusnet.com.au.
David
D
Kowalski
RPA Women & Babies, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, Sydney, NSW, 2050, Australia. Jon.hyett@sswahs.nsw.gov.au.|Discipline of Obstetrics, Gynaecology and Neonatology, University of Sydney, Sydney, NSW, 2006, Australia. Jon.hyett@sswahs.nsw.gov.au.
Jon A
JA
Hyett
D000293:Adolescent; D000328:Adult; D002585:Cesarean Section; D016009:Chi-Square Distribution; D002985:Clinical Protocols; D004311:Double-Blind Method; D005113:Extraction, Obstetrical / Q000295:instrumentation; D005260:Female; D005865:Gestational Age; D017052:Hospital Mortality; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D057194:Intention to Treat Analysis; D007748:Labor Stage, Second; D016015:Logistic Models; D008428:Maternal Mortality; D009517:New South Wales; D007744:Obstetric Labor Complications / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011247:Pregnancy; D012107:Research Design; D012307:Risk Factors; D012399:Rotation; D013021:South Australia; D016896:Treatment Outcome; D016216:Ultrasonography, Prenatal; D014710:Version, Fetal / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D055815:Young Adult