Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000103561
Ethics application status
Approved
Date submitted
29/11/2023
Date registered
6/02/2024
Date last updated
11/08/2024
Date data sharing statement initially provided
6/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Mifepristone versus placebo to increase the rate of spontaneous labour in people with a prior caesarean: A double blind randomised controlled trial
(Mi-labourTrial)
Scientific title
Mifepristone versus placebo to increase the rate of spontaneous labour in people with a prior caesarean: A double blind randomised controlled trial
(Mi-labourTrial)
Secondary ID [1] 310380 0
Mi-Labour Trial
Universal Trial Number (UTN)
Trial acronym
MI-LABOUR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaginal birth after caesarean 331122 0
labour 331123 0
Condition category
Condition code
Reproductive Health and Childbirth 327904 327904 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mifepristone, 200mg, orally, given as a single dose, encapsulated in opaque capsule cover, administered to participants who are at least 36 weeks 6 days gestational age, under direct supervision by research staff.
Intervention code [1] 327513 0
Treatment: Drugs
Comparator / control treatment
Placebo, composed of filler comparable to that used in study drug, orally, given as a single dose, encapsulated in opaque capsule cover, administered to participants who are at least 36 weeks 6 days gestational age, under direct supervision by research staff.
Control group
Placebo

Outcomes
Primary outcome [1] 336719 0
Spontaneous labour onset

This is defined as regular uterine contractions causing cervical change (with a minimum cervical dilation of 3 centimetres). Confirmed with cardiotocography or uterine palpation and a cervical examination by either a midwife or doctor. Confirmed via electronic medical record review.
Timepoint [1] 336719 0
From drug ingestion to 48 hours post drug ingestion
Secondary outcome [1] 429432 0
Rupture of membranes at term prior to labour,

Confirmed by physical examination by a midwife or doctor. Confirmed via electronic medical record review.
Timepoint [1] 429432 0
From drug ingestion to 48 hours post drug ingestion
Secondary outcome [2] 429433 0
Rupture of membranes at term prior to labour where induction of labour is performed, measured until birth.

Confirmed by physical examination by a midwife or doctor. Confirmed via electronic medical record review.
Timepoint [2] 429433 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [3] 429434 0
Rupture of membranes at term prior to labour where a prelabour caesarean is performed (rather than induction with oxytocin infusion), measured until birth.

Confirmed by physical examination by a midwife or doctor. Confirmed via electronic medical record review.
Timepoint [3] 429434 0
From drug ingestion until 30 days from drug ingestion
Secondary outcome [4] 429435 0
Induction of labour.

Performed in a hospital setting by either a midwife or a doctor. Confirmed via electronic medical record review.
Timepoint [4] 429435 0
From drug ingestion until 30 days from drug ingestion
Secondary outcome [5] 429436 0
Induction of labour with an intracervical catheter as initial approach.

Confirmed via electronic medical record review.
Timepoint [5] 429436 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [6] 429437 0
Induction of labour with amniotomy as initial approach.

Confirmed via electronic medical record review.
Timepoint [6] 429437 0
From drug ingestion until 30 days from drug ingestion
Secondary outcome [7] 429438 0
Induction of labour with exogenous contractile agent (oxytocin, as initial approach)

Confirmed via electronic medical record review.
Timepoint [7] 429438 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [8] 429439 0
Induction of labour with exogenous contractile agent (oxytocin, as sequential approach).

Confirmed via electronic medical record review.
Timepoint [8] 429439 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [9] 429440 0
Performance of 'stretch and sweep' or 'membrane stripping'

Confirmed via electronic medical record review.
Timepoint [9] 429440 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [10] 429441 0
Caesarean birth for any indication (overall rate)

Confirmed via electronic medical record review.
Timepoint [10] 429441 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [11] 429442 0
Caesarean birth for fetal heart rate abnormalities (as identified from operative report).

Confirmed via electronic medical record review.
Timepoint [11] 429442 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [12] 429443 0
Cesarean birth for labour dystocia (as identified from operative report).

Confirmed via electronic medical record review.
Timepoint [12] 429443 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [13] 429444 0
Fetal heart rate abnormalities (as documented in the patient chart).

Confirmed via electronic medical record review.
Timepoint [13] 429444 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [14] 429445 0
Fetal heart rate abnormalities resulting in fetal scalp lactate sampling (as determined from review of the patient chart)

Confirmed via electronic medical record review.
Timepoint [14] 429445 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [15] 429446 0
Fetal heart rate abnormalities resulting in instrumental vaginal birth (as documented in the patient chart)

Confirmed via electronic medical record review.
Timepoint [15] 429446 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [16] 429447 0
Infant born with a 5 minute Apgar score less than 7

Confirmed via electronic medical record review.
Timepoint [16] 429447 0
Measure completed at 5 minutes of age.
Secondary outcome [17] 429448 0
Average time from onset of labour to vaginal birth

Confirmed via electronic medical record review.
Timepoint [17] 429448 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [18] 429449 0
Cost effectiveness (calculated by assessing cost of induction, caesarean and delivery unit stays in days for each participant).

Confirmed via electronic medical record review.
Timepoint [18] 429449 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [19] 429450 0
Time to artificial rupture of membranes

Confirmed via electronic medical record review.
Timepoint [19] 429450 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [20] 429451 0
Uterine tachysystole (defined as greater than 5 contractions per 10 minute period for at least 20 minutes).

Confirmed via electronic medical record review.
Timepoint [20] 429451 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [21] 429452 0
Uterine hyperstimulation (defined as greater than 5 contractions per 10 minute period for at least 20 minutes with concurrent abnormal fetal heart rate pattern). Confirmed via electronic medical record review.
Timepoint [21] 429452 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [22] 429453 0
Average time from drug administration to onset of labour

Confirmed via electronic medical record review.
Timepoint [22] 429453 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [23] 429454 0
Average time from drug administration to vaginal birth

Confirmed via electronic medical record review.
Timepoint [23] 429454 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [24] 429455 0
Use of epidural anaesthesia, time placed

Confirmed via electronic medical record review.
Timepoint [24] 429455 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [25] 429456 0
Use of intravenous narcotic analgesia

Confirmed via electronic medical record review.
Timepoint [25] 429456 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [26] 429457 0
Antepartum haemorrhage (defined as greater than or equal to 500mL)

Confirmed via electronic medical record review.
Timepoint [26] 429457 0
Prior to established labour (from drug ingestion to 30 days from drug ingestion).
Secondary outcome [27] 429458 0
Intrapartum haemorrhage (defined as greater than or equal to 500mL).

Confirmed via electronic medical record review.
Timepoint [27] 429458 0
During established labour (from drug ingestion to 30 days from drug ingestion).
Secondary outcome [28] 429459 0
Postpartum haemorrhage (within 24 hours of birth, defined as greater than or equal to 500mL),

Confirmed via electronic medical record review.
Timepoint [28] 429459 0
Within 24 hours of birth (from drug ingestion to 30 days from drug ingestion).
Secondary outcome [29] 429460 0
Uterine rupture

Confirmed via electronic medical record review.
Timepoint [29] 429460 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [30] 429461 0
Cord prolapse

Confirmed via electronic medical record review.
Timepoint [30] 429461 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [31] 429462 0
Non-cephalic presentation (breech, transverse, oblique)

Confirmed via electronic medical record review.
Timepoint [31] 429462 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [32] 429463 0
Admission to ICU or equivalent

Confirmed via electronic medical record review.
Timepoint [32] 429463 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [33] 429464 0
Maternal satisfaction, based on survey data collected after birth

Survey created for this study.
Timepoint [33] 429464 0
The survey will be administered once, timing from one week after the birth until 180 days post birth.
Secondary outcome [34] 429465 0
Live birth

Confirmed via electronic medical record review.
Timepoint [34] 429465 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [35] 429467 0
Apgar scores at 1, 5, 10 minutes (if applicable)

Confirmed via electronic medical record review.
Timepoint [35] 429467 0
At 1, 5 and 10 minutes after birth
Secondary outcome [36] 429469 0
Abnormal cord blood lactate (greater than or equal to 4.0), defined as the highest value obtained (if multiple tests performed).

Confirmed via electronic medical record review.
Timepoint [36] 429469 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [37] 429470 0
Abnormal cord blood pH (less than or equal to 7.10), defined as the lowest value obtained (if multiple tests performed)

Confirmed via electronic medical record review.
Timepoint [37] 429470 0
From drug ingestion to 30 days from drug ingestion
Secondary outcome [38] 429471 0
Adverse neonatal outcome, defined as admission to the neonatal intensive care unit, neonatal seizures, neonatal encephalopathy.

Confirmed via electronic medical record review.
Timepoint [38] 429471 0
From birth to 28 days from birth
Secondary outcome [39] 429472 0
Neonatal death (early) within 28 days
Timepoint [39] 429472 0
From birth to 28 days from birth
Secondary outcome [40] 429473 0
Cost effectiveness for mother-baby dyad (calculated by maternal length of stay during birth admission and any readmission within 7 days of birth, neonatal length of stay during birth admission, use of operating theatre).

Confirmed via electronic medical record review.
Timepoint [40] 429473 0
From drug ingestion to 37 days from drug ingestion

Eligibility
Key inclusion criteria
Pregnant people with a live singleton and cephalic presentation
History of one or two prior caesarean births
Intention to deliver vaginally
Intact membranes
Normal CTG prior to randomisation
Maternal age 16-50 years
Gestational age between 36 6/7 and 41 6/7 weeks gestation
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
History of classical caesarean birth or other major uterine surgery including transmural myomectomy
Fetal malpresentation (including breech or transverse presentation) or other contraindication to vaginal birth or induction of labour
Fetal growth restriction with Absent or Reverse End Diastolic Flow noted on umbilical artery Doppler
Rupture of amniotic membranes
Planned induction of labour or caesarean birth within the next 48 hours

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)
No study investigators will have access to the randomization sequence. The study medication will appear identical for active drug and placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Electronic, through the Liggins Institute
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
4/07/2024
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
168
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 26000 0
New Zealand
State/province [1] 26000 0

Funding & Sponsors
Funding source category [1] 314581 0
Charities/Societies/Foundations
Name [1] 314581 0
Auckland Medical Research Foundation
Country [1] 314581 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Road, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 317376 0
None
Name [1] 317376 0
Address [1] 317376 0
Country [1] 317376 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313616 0
Northern A Health and Disability Ethics Committees
Ethics committee address [1] 313616 0
Ethics committee country [1] 313616 0
New Zealand
Date submitted for ethics approval [1] 313616 0
09/08/2023
Approval date [1] 313616 0
19/12/2023
Ethics approval number [1] 313616 0

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

Contacts
Principal investigator
Name 128758 0
Dr Meghan Hill
Address 128758 0
The University of Auckland, Department of Obstetrics and Gynaecology, Building 507, Level 1, Grafton, Auckland, 1023
Country 128758 0
New Zealand
Phone 128758 0
+64 0 9 923 9493
Fax 128758 0
Email 128758 0
[email protected]
Contact person for public queries
Name 128759 0
Meghan Hill
Address 128759 0
The University of Auckland, Department of Obstetrics and Gynaecology, Building 507, Level 1, Grafton, Auckland, 1023
Country 128759 0
New Zealand
Phone 128759 0
+64 0 9 923 9493
Fax 128759 0
Email 128759 0
[email protected]
Contact person for scientific queries
Name 128760 0
Meghan Hill
Address 128760 0
The University of Auckland, Department of Obstetrics and Gynaecology, Building 507, Level 1, Grafton, Auckland, 1023
Country 128760 0
New Zealand
Phone 128760 0
+64 0 9 923 9493
Fax 128760 0
Email 128760 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?




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.