Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000375550
Ethics application status
Approved
Date submitted
22/02/2024
Date registered
2/04/2024
Date last updated
2/04/2024
Date data sharing statement initially provided
2/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluate the design of a randomised trial of posture for occiput posterior position in labour (POPPIL) to reduce operative births. A feasibility study
Scientific title
Evaluate the design of a randomised trial of posture for occiput posterior position in labour to reduce operative births. A feasibility study
Secondary ID [1] 311595 0
Nil known
Universal Trial Number (UTN)
Trial acronym
POPPIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal occiput posterior malposition 332981 0
Childbirth 333167 0
Pain management 333168 0
Operative birth 333169 0
Perineal trauma 333170 0
Birth injury 333171 0
Neonatal care 333172 0
Condition category
Condition code
Reproductive Health and Childbirth 329693 329693 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 329694 329694 0 0
Complications of newborn
Reproductive Health and Childbirth 329695 329695 0 0
Other reproductive health and childbirth disorders
Surgery 329863 329863 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of semi-prone (Sims) posture, lying on the same side as the fetal spine (ipsilateral). The lower leg is straight, the upper leg is flexed at 90 degrees, the abdomen rests on the bed and the body is tilted forwards. The posture is adopted for ideally 40 minutes or more per hour every hour, from start of intervention at at least 6 cm cervical dilatation, till birth (approx 7-12 hours or less). Upright or forward leaning postures may be used for up to 20 minutes per hour every hour till birth to aid comfort and mobility. The intervention is supervised by the midwife in attendance. Strategies to monitor adherence include clinical observation using a posture tracking record completed hourly with a tick against what proportion of time the intervention was used (0-19 mins; 20-39 mins; 40-60 mins). A wrist band will be placed on the same side that the participant is to lie, to help them remember their allocated intervention.
Intervention code [1] 328049 0
Prevention
Comparator / control treatment
Use of free posture (usual care), except semi-prone (Sims) posture, every hour till birth. Participants can decide what ever posture they wish to use and for as long as they wish to use it e.g. sitting, standing, alternately lying on left and right sides, hands and knees, semi-recumbent, walking, or any other posture except semi-prone (SIMS) posture.
Control group
Active

Outcomes
Primary outcome [1] 337479 0
Spontaneous vaginal birth
Timepoint [1] 337479 0
At birth
Secondary outcome [1] 432037 0
Fetal position at birth or scanned position just prior to operative delivery or manual rotation
Timepoint [1] 432037 0
At birth
Secondary outcome [2] 432038 0
Instrumental vaginal birth (rotational or non-rotational)
Timepoint [2] 432038 0
At birth
Secondary outcome [3] 432039 0
Caesarean section
Timepoint [3] 432039 0
At birth
Secondary outcome [4] 432040 0
Pain score
Timepoint [4] 432040 0
One-two hours after randomization
Secondary outcome [5] 432042 0
Oxytocin augmentation after randomization
Timepoint [5] 432042 0
At birth
Secondary outcome [6] 432043 0
Artificial rupture of membranes
Timepoint [6] 432043 0
At birth
Secondary outcome [7] 432044 0
Epidural use after randomization
Timepoint [7] 432044 0
At birth
Secondary outcome [8] 432045 0
Composite of third or fourth degree perineal tear
Timepoint [8] 432045 0
At birth
Secondary outcome [9] 432046 0
Composite of critical events: Any one of major obstetric emergencies (placental abruption after randomization; shoulder dystocia defined as requiring internal manoeuvres; or caesarean section defined as category 1).
Timepoint [9] 432046 0
At birth
Secondary outcome [10] 432047 0
Postpartum haemorrhage defined as greater than or equal to 500 mls for vaginal birth or >1000 mls for caesarean section.
Timepoint [10] 432047 0
At birth
Secondary outcome [11] 432048 0
Duration of postnatal hospital stay in hours
Timepoint [11] 432048 0
At discharge to home
Secondary outcome [12] 432049 0
Perinatal mortality (defined as stillbirths and neonatal deaths to less than day seven).
Timepoint [12] 432049 0
At end of 7 days postnatal
Secondary outcome [13] 432050 0
Admission to neonatal care unit in first week of birth
Timepoint [13] 432050 0
At end of 7 days postnatal
Secondary outcome [14] 432052 0
Composite of stage 2 or 3 neonatal encephalopathy and/or receipt of therapeutic hypothermia.
Timepoint [14] 432052 0
Within 48 hours prior to primary hospital discharge
Secondary outcome [15] 432053 0
Apgar score <7 at 5 minutes
Timepoint [15] 432053 0
At birth
Secondary outcome [16] 432054 0
Umbilical arterial lactate >6mmol/l
Timepoint [16] 432054 0
At birth
Secondary outcome [17] 432055 0
Composite of birth trauma (defined as fracture, nerve injury or subgaleal haemorrhage).
Timepoint [17] 432055 0
Within 48 hours prior to primary hospital discharge
Secondary outcome [18] 432056 0
Resuscitation at birth (positive pressure ventilation, chest compression or adrenaline).
Timepoint [18] 432056 0
At birth
Secondary outcome [19] 432057 0
Exclusive breastfeeding defined as breastmilk only and any oral rehydration solution and/or medications.
Timepoint [19] 432057 0
At primary discharge to home
Secondary outcome [20] 432613 0
Rate of recruitment
Timepoint [20] 432613 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [21] 432614 0
Rate of scanned OP fetal position to number screened
Timepoint [21] 432614 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [22] 432615 0
Average number of people screened by ultrasound scan each week
Timepoint [22] 432615 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [23] 432616 0
Rate of people with a scanned OP position that sign consent for trial participation
Timepoint [23] 432616 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [24] 432617 0
Interquartile range of participant BMI
Timepoint [24] 432617 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [25] 432618 0
Rate of trial withdrawal
Timepoint [25] 432618 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [26] 432619 0
Summarised reasons for discontinued intervention
Timepoint [26] 432619 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [27] 432620 0
Ratio of electronic consents to hard copy consents
Timepoint [27] 432620 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [28] 432621 0
Ability to access participant information
Timepoint [28] 432621 0
Post birth up to 6 weeks postnatal
Secondary outcome [29] 432622 0
Ability to understand participant trial information
Timepoint [29] 432622 0
Post birth up to 6 weeks postnatal
Secondary outcome [30] 432623 0
Acceptability of consent/recruitment process
Timepoint [30] 432623 0
Post birth up to 6 weeks postnatal
Secondary outcome [31] 432624 0
Comfort during scan
Timepoint [31] 432624 0
Post birth up to 6 weeks postnatal
Secondary outcome [32] 432625 0
Acceptability of survey questionnaire
Timepoint [32] 432625 0
Post birth up to 6 weeks postnatal
Secondary outcome [33] 432626 0
Maternal satisfaction with labour
Timepoint [33] 432626 0
Post birth up to 6 weeks postnatal
Secondary outcome [34] 432627 0
Maternal satisfaction with posture intervention
Timepoint [34] 432627 0
Post birth up to 6 weeks postnatal
Secondary outcome [35] 432628 0
Overall satisfaction of labour
Timepoint [35] 432628 0
post birth up to 6 weeks postnatal
Secondary outcome [36] 432629 0
Composite of time in ipsilateral Sims posture in first and second stage of labour
Timepoint [36] 432629 0
At birth
Secondary outcome [37] 432630 0
Duration of first stage labour after randomized
Timepoint [37] 432630 0
At birth
Secondary outcome [38] 432631 0
Duration of second stage labour after randomized
Timepoint [38] 432631 0
At birth
Secondary outcome [39] 432632 0
Proportion of participants allocated to the intervention who use the intervention till birth
Timepoint [39] 432632 0
At birth
Secondary outcome [40] 433318 0
Maximum intrapartum temperature (axillary or oral) after randomization, greater or equal to 37.6 degrees celsius
Timepoint [40] 433318 0
At birth

Eligibility
Key inclusion criteria
Age at least 16 years, live singleton pregnancy of at least 37 weeks’ gestation, cephalic presentation, cervical dilatation of at least 6 cm, and OP malposition confirmed by portable ultrasound scan. Includes consultations for prolonged labour, oxytocin augmentation or epidural anaesthesia.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Major fetal anomalies, uterine anomalies (defined as bicornuate uterus, uterine septum defect, or large fibroid of at least 5cm), and being unable to adopt the intervention posture.

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permutated block randomization accounting for stratification factors nulliparity and in situ epidural
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
12/02/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26165 0
New Zealand
State/province [1] 26165 0

Funding & Sponsors
Funding source category [1] 315902 0
Self funded/Unfunded
Name [1] 315902 0
Country [1] 315902 0
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 318049 0
None
Name [1] 318049 0
Address [1] 318049 0
Country [1] 318049 0
Other collaborator category [1] 282964 0
Hospital
Name [1] 282964 0
Middlemore Hospital
Address [1] 282964 0
Country [1] 282964 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314749 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314749 0
Ethics committee country [1] 314749 0
New Zealand
Date submitted for ethics approval [1] 314749 0
23/11/2023
Approval date [1] 314749 0
13/02/2024
Ethics approval number [1] 314749 0
19149
Ethics committee name [2] 314751 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 314751 0
Ethics committee country [2] 314751 0
New Zealand
Date submitted for ethics approval [2] 314751 0
14/02/2024
Approval date [2] 314751 0
Ethics approval number [2] 314751 0

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

Contacts
Principal investigator
Name 132602 0
Dr Jennifer Barrowclough
Address 132602 0
Auckland University of Technology, 640 Great South Road, Manukau City, Auckland.
Country 132602 0
New Zealand
Phone 132602 0
+64 9 9219999
Fax 132602 0
Email 132602 0
[email protected]
Contact person for public queries
Name 132603 0
Jennifer Barrowclough
Address 132603 0
Auckland University of Technology, 640 Great South Road, Manukau City, Auckland.
Country 132603 0
New Zealand
Phone 132603 0
+64 9 9219999
Fax 132603 0
Email 132603 0
[email protected]
Contact person for scientific queries
Name 132604 0
Jennifer Barrowclough
Address 132604 0
Auckland University of Technology, 640 Great South Road, Manukau City, Auckland.
Country 132604 0
New Zealand
Phone 132604 0
+64 9 9219999
Fax 132604 0
Email 132604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.