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Trial registered on ANZCTR


Registration number
ACTRN12612001312831
Ethics application status
Approved
Date submitted
15/05/2012
Date registered
19/12/2012
Date last updated
19/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Persistent Occiput Posterior: OUTcomes following manual rotation.

Scientific title
Among women who are at least 37 weeks gestation, whose baby is in the occiput posterior 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] 279792 0
The pilot study has been registered with ID: ACTRN12609000833268
Universal Trial Number (UTN)
U1111-1127-4753
Trial acronym
POP-OUT- Persistent Occiput Posterior-OUTcomes following manual rotation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Occiput posterior position in the second stage of labour 285671 0
Condition category
Condition code
Reproductive Health and Childbirth 285853 285853 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.
Intervention code [1] 284113 0
Other interventions
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] 286357 0
Operative delivery

(defined as caesarean section, forceps or ventouse delivery)
Timepoint [1] 286357 0
At the birth of the baby
Secondary outcome [1] 295662 0
Caesarean section
Timepoint [1] 295662 0
At the birth of the baby
Secondary outcome [2] 295663 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 requiring drainage;
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;self reported depression requiring antidepressants
Timepoint [2] 295663 0
Up to 6 weeks after delivery
Secondary outcome [3] 295664 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 [3] 295664 0
Up to 6 weeks after delivery
Secondary outcome [4] 295665 0
Length of second stage.
The time the woman is first fully dilated and the time of delivery is routinely documented by the midwife in the obstetric database. These two times will be subtracted to calculate the length of the second stage of labour.
Timepoint [4] 295665 0
At delivery
Secondary outcome [5] 295666 0
Estimated blood loss.
This is estimated visually by the midwife and recorded in the obstetric database.
Timepoint [5] 295666 0
At delivery
Secondary outcome [6] 295667 0
Degree of perineal/vaginal trauma.
This is routinely assessed by a midwife or doctor for all women and recorded in the obstetric database.
Timepoint [6] 295667 0
At delivery
Secondary outcome [7] 300404 0
Quality of life (SF-12 Health Survey)
Timepoint [7] 300404 0
At 6 weeks, 6 months and 1 year
Secondary outcome [8] 300405 0
Time from intervention or "sham" to delivery.
The time the procedure is completed is recorded by the study investigator at the time on a study data collection form. The time of delivery is collected by the midwife and recorded in the obstetric database. These two times will be subtracted to calculate this time interval.
Timepoint [8] 300405 0
At delivery
Secondary outcome [9] 300406 0
Pelvic floor function (Australian pelivic floor questionnaire)

(this integrates bladder, bowel and sexual function, pelvic organ prolapse, severity and bothersomeness.
Timepoint [9] 300406 0
at 1 year
Secondary outcome [10] 300407 0
Length of hospital stay.
The date and time of maternal discharge is routinely recorded by the ward midwife in the obstetric database. The time of delivery is routinely recorded by the labour ward midwife in the database. These two times will be subtracted to calculate the length of hospital stay.
Timepoint [10] 300407 0
From delivery until discharge.

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 posterior 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
19/04/2012
Actual
19/04/2012
Date of last participant enrolment
Anticipated
31/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
254
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 325 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 326 0
Canterbury Hospital - Campsie
Recruitment hospital [3] 327 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 328 0
Royal Hospital for Women - Randwick
Recruitment hospital [5] 329 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [6] 330 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 4874 0
2031
Recruitment postcode(s) [2] 4872 0
2050
Recruitment postcode(s) [3] 4877 0
2194
Recruitment postcode(s) [4] 4876 0
2305
Recruitment postcode(s) [5] 4873 0
2751
Recruitment postcode(s) [6] 4875 0
5006

Funding & Sponsors
Funding source category [1] 284573 0
Government body
Name [1] 284573 0
National Health Medical Research Council
Country [1] 284573 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Rd, Camperdown
Sydney, NSW, 2050
Country
Australia
Secondary sponsor category [1] 283490 0
University
Name [1] 283490 0
University of Sydney
Address [1] 283490 0
The University of Sydney
NSW 2006
Country [1] 283490 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286558 0
Ethics Review Committee (RPA Zone), Sydney Local Health District
Ethics committee address [1] 286558 0
Research development Office,
Level 3, Building 92,
Royal Prince Alfred, Missenden Rd,
CAMPERDOWN nsw 2050
Ethics committee country [1] 286558 0
Australia
Date submitted for ethics approval [1] 286558 0
30/11/2011
Approval date [1] 286558 0
Ethics approval number [1] 286558 0
X11-0410

Summary
Brief summary
In most labours, the baby is delivered head first, face downwards. When the baby is facing sideways (Occiput Transverse) or upwards (Occiput Posterior), the labour may be more difficult, and assisted deliveries including suction cup, forceps, and caesarean section are more likely. When the mother is fully dilated, it is possible to perform an internal examination and to physically rotate the baby to the downwards (anterior) position, but it is unknown if this procedure reduces the chances of an assisted delivery. We plan to run a study looking at whether performing a procedure to turn the baby will reduce the risk of assisted delivery and caesarean section.
Trial website
www.popout.me
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33678 0
Mrs Hala Phipps
Address 33678 0
C/O Women & Babies
Building 89, Level 5 East,
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW AUSTRALIA 2050
Country 33678 0
Australia
Phone 33678 0
+61, 02, 95156079
Fax 33678 0
+61, 02, 95651595
Email 33678 0
hala.phipps@email.cs.nsw.gov.au
Contact person for public queries
Name 16925 0
Mrs Hala Phipps
Address 16925 0
C/O Women & Babies
Building 89, Level 5 East,
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW AUSTRALIA 2050
Country 16925 0
Australia
Phone 16925 0
+61, 02, 95156079
Fax 16925 0
+61, 02, 95651595
Email 16925 0
hala.phipps@email.cs.nsw.gov.au
Contact person for scientific queries
Name 7853 0
Mrs Hala Phipps
Address 7853 0
C/O Women & Babies
Building 89, Level 5 East,
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Country 7853 0
Australia
Phone 7853 0
+61, 02, 95156079
Fax 7853 0
+61, 02, 95651595
Email 7853 0
hala.phipps@email.cs.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePersistent Occiput Posterior position - OUTcomes following manual rotation (POP-OUT): Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0603-7
N.B. These documents automatically identified may not have been verified by the study sponsor.