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Trial registered on ANZCTR


Registration number
ACTRN12613000005752
Ethics application status
Approved
Date submitted
18/12/2012
Date registered
4/01/2013
Date last updated
12/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The TURN-OUT Trial: Transverse position. Using Rotation to aid Normal birth: OUTcomes following manual rotation.
Scientific title
Among women who are at least 37 weeks gestation, whose baby is in the occiput transverse position early in the second stage of labour, does manual rotation compared with a "sham" rotation, reduce the incidence of operative delivery?

(Operative delivery is defined as forceps, ventouse or caesarean section).
Secondary ID [1] 281696 0
The TURN-OUT Trial
Universal Trial Number (UTN)
Trial acronym
POT-OUT: Persistent Occiput Transverse-OUTcomes following manual rotation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Occiput transverse position in the second stage of labour 287984 0
Condition category
Condition code
Reproductive Health and Childbirth 288367 288367 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manual rotation is a procedure that is most commonly performed at full dilatation if the fetal position is occiput posterior (OP) or occiput transverse (OT). It entails the use of the accoucheur's hand or fingers to rotate the fetal head from the OP and OT position to the usual OA position.
The procedure takes 4-5 contractions to perform (about 6-10 mins).
Intervention code [1] 286233 0
Treatment: Other
Comparator / control treatment
Women randomised to the “sham rotation” will have a vaginal examination as for the intervention BUT no rotational force will be applied
Control group
Placebo

Outcomes
Primary outcome [1] 288539 0
Operative delivery

(defined as caesarean section, forceps or ventouse delivery)
Timepoint [1] 288539 0
At the birth of the baby
Secondary outcome [1] 300409 0
Serious maternal morbidity or mortality (combined outcome):- This will include one or more of the following: Serious maternal morbidity defined as: post-partum haemorrhage requiring blood transfusion, third or fourth degree perineal trauma; dilatation and curettage for bleeding or retained placental tissue; cervical laceration; vertical uterine incision; vulvar or perineal haematoma; pneumonia; venous thromboembolism requiring anticoagulation; wound infection requiring prolonged hospital stay; readmission to hospital for obstetric related causes; wound dehiscence; maternal fever of at least 38.5 degrees C on two occasions at least 24 hours apart, not including the first 24hours; bladder, ureter or bowel injury requiring repair; genital-tract fistula; bowel obstruction; admission to intensive care unit
Timepoint [1] 300409 0
Up to 6 weeks after delivery. This outcome will be assessed by review of the medical records
Secondary outcome [2] 300410 0
Serious perinatal/neonatal morbidity, or mortality within 6 weeks of birth (combined outcome):- This will include one or more of the following: shoulder dystocia, 5 minute Apgars < 4; Cord pH < 7.0 or lactate > 10 or base excess < -15; serious birth trauma, seizures < 24 hours of age, intubation/ventilation > 24hours, tube feeding > 4 days, admission to neonatal intensive care > 4 days, neonatal jaundice requiring phototherapy
Timepoint [2] 300410 0
Up to 6 weeks after delivery. This outcome will be assessed by review of the medical records
Secondary outcome [3] 300411 0
Caesarean section
Timepoint [3] 300411 0
At delivery. This outcome will be assessed by review of the medical records
Secondary outcome [4] 300412 0
Estimated blood loss.
Timepoint [4] 300412 0
At delivery. This outcome will be assessed by review of the medical records
Secondary outcome [5] 300413 0
Degree of perineal/vaginal trauma.
Timepoint [5] 300413 0
At delivery.This outcome will be assessed by review of the medical records
Secondary outcome [6] 300414 0
Time from intervention or "sham" to delivery
Timepoint [6] 300414 0
At delivery. This outcome will be assessed by review of the documented data forms of the study and review of the medical records
Secondary outcome [7] 300415 0
Length of hospital stay.
Timepoint [7] 300415 0
From delivery until discharge. This outcome will be assessed by review of the medical records
Secondary outcome [8] 300416 0
Quality of life (SF-12 Health Survey)
Timepoint [8] 300416 0
6 weeks, 6 months and 1 year
Secondary outcome [9] 300417 0
Pelvic floor function (Australian pelivic floor questionnaire)
(this integrates bladder, bowel and sexual function, pelvic organ prolapse, severity, bothersomeness and condition-specific quality of life)
Timepoint [9] 300417 0
At 1 year
Secondary outcome [10] 300419 0
Length of second stage
Timepoint [10] 300419 0
At the birth of the baby. This outcome will be assessed by review of the medical records

Eligibility
Key inclusion criteria
At least 37 completed weeks of gestation;
Singleton pregnancy;
Planning a vaginal delivery;
Cephalic presentation;
Full cervical dilatation;
Fetus in the OP position confirmed by ultrasound.
(OP position is defined as fetal occiput posterior with respect to the mother and within 45 degrees of the midline
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinical suspicion of cephalopelvic disproportion; previous caesarean section; brow or face presentation; “Pathologic” CTG according to RCOG classification plus either baseline >160 beats per minute or reduced variability for > 90 minutes; Fetal scalp pH < 7.25 or lactate > 4; Known major anatomical fetal abnormality (could influence safety or efficacy of manual rotation); Known or suspected chorioamnionitis; Intrapartum haemorrhage > 50mL; Temperature > 37.9 degrees C in the first stage of labour; Suspected fetal bleeding disorder; Pre-existing maternal diabetes

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consent obtained antenatally or in labour.
Ultrasound performed in the second stage of labour
If occiput transverse position one hour into in the second stage of labour or at first urge to push, randomised to either manual rotation or sham procedure. Centralised telephone-based randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Chi squared analysis of primary outcome (operative delivery) and secondary outcomes (maternal morbidity/mortality, fetal/neonatal morbidity/mortality and caesarean section).
Logistic regression analysis for these outcomes to account for any confounders that are not evenly distributed between the two groups (despite randomisation).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
2/05/2012
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
416
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 331 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 332 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [3] 334 0
Canterbury Hospital - Campsie
Recruitment hospital [4] 335 0
Nepean Private Hospital - Kingswood
Recruitment hospital [5] 336 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [6] 337 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 6130 0
2050 - Missenden Road
Recruitment postcode(s) [2] 6131 0
5006 - North Adelaide
Recruitment postcode(s) [3] 6133 0
2194 - Campsie
Recruitment postcode(s) [4] 6134 0
2031 - Randwick
Recruitment postcode(s) [5] 6135 0
2305 - New Lambton
Recruitment postcode(s) [6] 6136 0
2751 - Penrith

Funding & Sponsors
Funding source category [1] 286484 0
Hospital
Name [1] 286484 0
Royal Prince Alfred
Country [1] 286484 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Rd, Camperdown
camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 285275 0
None
Name [1] 285275 0
N/A
Address [1] 285275 0
N/A
Country [1] 285275 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288562 0
Ethics Review Committee (RPA Zone), Sydney Local Health District
Ethics committee address [1] 288562 0
Ethics committee country [1] 288562 0
Australia
Date submitted for ethics approval [1] 288562 0
30/11/2011
Approval date [1] 288562 0
25/02/2012
Ethics approval number [1] 288562 0
X11-0410

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36690 0
Dr Bradley de Vries
Address 36690 0
C/O Women & Babies
Building 89, Level 5 East,
Royal Prince Alfred Hospital
Missenden Road CAMPERDOWN
NSW AUSTRALIA 2050
Country 36690 0
Australia
Phone 36690 0
+61, 421, 087388
Fax 36690 0
+61, 02, 95651595
Email 36690 0
bradley.devries@sswahs.nsw.gov.au
Contact person for public queries
Name 36691 0
Hala Phipps
Address 36691 0
C/O Women & Babies Executive Unit
Building 89, Level 5 East,
Royal Prince Alfred Hospital
Missenden Road CAMPERDOWN
NSW AUSTRALIA 2050
Country 36691 0
Australia
Phone 36691 0
+61, 02, 95156079
Fax 36691 0
+61, 02, 95651595
Email 36691 0
hala.phipps@email.cs.nsw.gov.au
Contact person for scientific queries
Name 36692 0
Brad de Vries
Address 36692 0
C/O Women & Babies Executive Unit
Building 89, Level 5 East,
Royal Prince Alfred Hospital
Missenden Road CAMPERDOWN
NSW AUSTRALIA 2050
Country 36692 0
Australia
Phone 36692 0
+61, 421, 087388
Fax 36692 0
+61, 02, 95651595
Email 36692 0
bradley.devries@sswahs.nsw.gov.au

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

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