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Trial registered on ANZCTR


Registration number
ACTRN12609000833268
Ethics application status
Approved
Date submitted
16/09/2009
Date registered
23/09/2009
Date last updated
15/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Persistent Occipito-Posterior: Outcomes following digital rotation. The “POPOUT” Pilot Study
Scientific title
In singleton pregnancies of at least 37 weeks gestational age with an occipito-posterior position early in the second stage of labour, does manual rotation reduce the incidence of operative operative delivery rate (forceps/ vontouse/ caesarean section).
Secondary ID [1] 279815 0
The POPOUT Pilot study
Universal Trial Number (UTN)
Trial acronym
The “POPOUT” Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Occipito-posterior position in the second stage of labour 243675 0
Condition category
Condition code
Reproductive Health and Childbirth 239945 239945 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
With an empty bladder, a vaginal examination is performed. If intact, the obstetric membranes are ruptured. The patient is asked to bear down. For the left occipito-posterior (OP) position, the right index finger is applied to the right lambdoid suture, exerting constant pressure with the aim of rotating the fetus in an anti-clockwise direction. For the right OP position, the left index finger is used and the fetus rotated in a clockwise direction (28). On the basis of our clinical experience we would aim to rotate the fetus into the occipito-anterior (OA) position over 2 to 3 contractions, then hold the presenting part in this position over another 2 contractions while the woman bears down, to reduce the chances of reversion back to the OP position.
The overall expected duration of study is 3 years.
Intervention code [1] 241224 0
Other interventions
Comparator / control treatment
In patients in active labour, persistent OP position of the fetal head has long been recognised as an important problem.The reported operative delivery rate varies from 54% to 82% when OP position is present at delivery, compared with 6 to 22% among OA controls, a difference which was invariably statistically significant in cohort studies.Persistent OP position is also reportedly associated with many abnormalities of labor and delivery including more frequent induction of labour, greater use of oxytocin augmentation, prolonged labour, abnormal second stage cardiotocograph (CTG), a longer second stage of labor, chorioamnionitis, third or fourth degree perineal lacerations, and post-partum haemorrhage.OP position is also associated with post-partum and neonatal adverse outcomes, including, postpartum wound infection, endometritis, lower 5-minute Apgar scores, meconium stained liquor, acidaemic cord blood gases, birth trauma, and admission to the neonatal intensive care unit.
Control group
Active

Outcomes
Primary outcome [1] 240751 0
Operative delivery (defined as C/S, forceps or ventouse delivery).
Timepoint [1] 240751 0
once the participants have delivered or at end of trial
Secondary outcome [1] 257407 0
Third or fourth degree perineal trauma. This outcome will be assessed by completing a data questionnaire from medical records data.
Timepoint [1] 257407 0
once the participants have delivered or at end of trial
Secondary outcome [2] 297440 0
wound infection requiring prolonged hospital stay. This outcome will be assessed by completing a data questionnaire from medical records data.
Timepoint [2] 297440 0
once the participants have delivered or at end of trial
Secondary outcome [3] 297441 0
Complications directly related to caesarean section (eg:wound dehiscence,bladder, ureter or bowel injury requiring repair or bowel obstruction). This outcome will be assessed by completing a data questionnaire from medical records data.
Timepoint [3] 297441 0
once the participants have delivered or at end of trial
Secondary outcome [4] 297442 0
Fetal distress (eg:5 minute Apgars < 4; Cord pH < 7.0 or lactate > 10 or base excess < -15). This outcome will be assessed by completing a data questionnaire from medical records data.
Timepoint [4] 297442 0
once the participants have delivered or at end of trial
Secondary outcome [5] 297443 0
Serious birth trauma (eg:seizures < 24 hours of age, intubation/ventilation > 24hours, tube feeding > 4 days, admission to neonatal intensive care > 4 days). This outcome will be assessed by completing a data questionnaire from medical records data.
Timepoint [5] 297443 0
once the participants have delivered or at end of trial

Eligibility
Key inclusion criteria
.At least 37 completed weeks of gestation
· Planned vaginal delivery Cephalic presentation
· Full cervical dilatation
·Fetal position confidently assessed as occipito-posterior on vaginal examination, and confirmed by ultrasound in labour ward
Minimum age
18 Years
Maximum age
45 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 Royal College of Obstetrics and Gynecology (RCOG) classification plus either baseline >160 beats per minute or reduced variability
·Fetal scalp pH < 7.25 (if taken)
·Suspected fetal compromise
·Known anatomical fetal abnormality
·Known or suspected chorioamnionitis
·Any condition requiring immediate delivery
·Any condition requiring elective caesarean section
·Intrapartum haemorrhage
·Temperature > 38oC in the first stage of labour
·Suspected fetal bleeding diaphesis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be provided with an information sheet on the study at 36-37 weeks through the antenatal clinics of the hospital. Women then will be consented antenatally or in early labour and randomised after vaginal examination confirming full dilatation and an ultrasound confirming baby was in the posterior position. Randomisation will be performed by computer generated random number sequences in random sized blocks of four to eight determined by an independent person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by computer generated random number sequences in random sized blocks of four to eight determined by an independent person (a neonatologist). This will ensure numerical balance between treatment groups’ participants and prevent staff guessing sequences associated with constant sized blocks. Stratification for parity will be undertaken and randomisation will be blinded. Once consented women will be randomly allocated to intervention or control (routine care) group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243606 0
Hospital
Name [1] 243606 0
Royal Prince Alfred Hospital
Country [1] 243606 0
Australia
Funding source category [2] 243751 0
Self funded/Unfunded
Name [2] 243751 0
Country [2] 243751 0
Primary sponsor type
Hospital
Name
Royal Prince Alfred Women and Babies
Address
C/O RPA Women and Babies Building 89, Level 5 East Royal Prince Alfred HospitalMissenden RdCamperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 237055 0
None
Name [1] 237055 0
Address [1] 237055 0
Country [1] 237055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243731 0
Ethics review Committee (RPAH Zone)
Ethics committee address [1] 243731 0
Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 243731 0
Australia
Date submitted for ethics approval [1] 243731 0
24/09/2009
Approval date [1] 243731 0
20/08/2010
Ethics approval number [1] 243731 0
HREC/10/RPAH/170

Summary
Brief summary
In most labours, the baby is delivered head first, face downwards. When the baby is facing upwards, 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
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 30152 0
Address 30152 0
Country 30152 0
Phone 30152 0
Fax 30152 0
Email 30152 0
Contact person for public queries
Name 13399 0
Hala Phipps
Address 13399 0
Building 89, Level 5 east
C/O RPA Women and Babies
Royal Prince Alfred HospitalMissenden RdCamperdown, NSW, 2050
Country 13399 0
Australia
Phone 13399 0
+61 2 9515 6079
Fax 13399 0
+61 2 9565 1595
Email 13399 0
[email protected]
Contact person for scientific queries
Name 4327 0
Hala Phipps
Address 4327 0
Building 89, Level 5 east
C/O RPA Women and Babies
Royal Prince Alfred HospitalMissenden RdCamperdown, NSW, 2050
Country 4327 0
Australia
Phone 4327 0
+61 2 9515 6079
Fax 4327 0
+61 2 9565 1595
Email 4327 0
[email protected]

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
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