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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)
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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)
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Secondary ID [1]
310380
0
Mi-Labour Trial
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Universal Trial Number (UTN)
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Trial acronym
MI-LABOUR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
vaginal birth after caesarean
331122
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labour
331123
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Condition category
Condition code
Reproductive Health and Childbirth
327904
327904
0
0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
327513
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Treatment: Drugs
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
336719
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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.
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Assessment method [1]
336719
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Timepoint [1]
336719
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From drug ingestion to 48 hours post drug ingestion
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Secondary outcome [1]
429432
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Rupture of membranes at term prior to labour,
Confirmed by physical examination by a midwife or doctor. Confirmed via electronic medical record review.
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Assessment method [1]
429432
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Timepoint [1]
429432
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From drug ingestion to 48 hours post drug ingestion
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Secondary outcome [2]
429433
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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.
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Assessment method [2]
429433
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Timepoint [2]
429433
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [3]
429434
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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.
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Assessment method [3]
429434
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Timepoint [3]
429434
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From drug ingestion until 30 days from drug ingestion
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Secondary outcome [4]
429435
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Induction of labour.
Performed in a hospital setting by either a midwife or a doctor. Confirmed via electronic medical record review.
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Assessment method [4]
429435
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Timepoint [4]
429435
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From drug ingestion until 30 days from drug ingestion
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Secondary outcome [5]
429436
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Induction of labour with an intracervical catheter as initial approach.
Confirmed via electronic medical record review.
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Assessment method [5]
429436
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Timepoint [5]
429436
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [6]
429437
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Induction of labour with amniotomy as initial approach.
Confirmed via electronic medical record review.
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Assessment method [6]
429437
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Timepoint [6]
429437
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From drug ingestion until 30 days from drug ingestion
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Secondary outcome [7]
429438
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Induction of labour with exogenous contractile agent (oxytocin, as initial approach)
Confirmed via electronic medical record review.
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Assessment method [7]
429438
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Timepoint [7]
429438
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [8]
429439
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Induction of labour with exogenous contractile agent (oxytocin, as sequential approach).
Confirmed via electronic medical record review.
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Assessment method [8]
429439
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Timepoint [8]
429439
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [9]
429440
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Performance of 'stretch and sweep' or 'membrane stripping'
Confirmed via electronic medical record review.
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Assessment method [9]
429440
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Timepoint [9]
429440
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [10]
429441
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Caesarean birth for any indication (overall rate)
Confirmed via electronic medical record review.
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Assessment method [10]
429441
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Timepoint [10]
429441
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [11]
429442
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Caesarean birth for fetal heart rate abnormalities (as identified from operative report).
Confirmed via electronic medical record review.
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Assessment method [11]
429442
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Timepoint [11]
429442
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [12]
429443
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Cesarean birth for labour dystocia (as identified from operative report).
Confirmed via electronic medical record review.
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Assessment method [12]
429443
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Timepoint [12]
429443
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [13]
429444
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Fetal heart rate abnormalities (as documented in the patient chart).
Confirmed via electronic medical record review.
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Assessment method [13]
429444
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Timepoint [13]
429444
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [14]
429445
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Fetal heart rate abnormalities resulting in fetal scalp lactate sampling (as determined from review of the patient chart)
Confirmed via electronic medical record review.
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Assessment method [14]
429445
0
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Timepoint [14]
429445
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [15]
429446
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Fetal heart rate abnormalities resulting in instrumental vaginal birth (as documented in the patient chart)
Confirmed via electronic medical record review.
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Assessment method [15]
429446
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Timepoint [15]
429446
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [16]
429447
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Infant born with a 5 minute Apgar score less than 7
Confirmed via electronic medical record review.
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Assessment method [16]
429447
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Timepoint [16]
429447
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Measure completed at 5 minutes of age.
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Secondary outcome [17]
429448
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Average time from onset of labour to vaginal birth
Confirmed via electronic medical record review.
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Assessment method [17]
429448
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Timepoint [17]
429448
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [18]
429449
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Cost effectiveness (calculated by assessing cost of induction, caesarean and delivery unit stays in days for each participant).
Confirmed via electronic medical record review.
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Assessment method [18]
429449
0
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Timepoint [18]
429449
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [19]
429450
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Time to artificial rupture of membranes
Confirmed via electronic medical record review.
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Assessment method [19]
429450
0
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Timepoint [19]
429450
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [20]
429451
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Uterine tachysystole (defined as greater than 5 contractions per 10 minute period for at least 20 minutes).
Confirmed via electronic medical record review.
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Assessment method [20]
429451
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Timepoint [20]
429451
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [21]
429452
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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.
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Assessment method [21]
429452
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Timepoint [21]
429452
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [22]
429453
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Average time from drug administration to onset of labour
Confirmed via electronic medical record review.
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Assessment method [22]
429453
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Timepoint [22]
429453
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [23]
429454
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Average time from drug administration to vaginal birth
Confirmed via electronic medical record review.
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Assessment method [23]
429454
0
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Timepoint [23]
429454
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [24]
429455
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Use of epidural anaesthesia, time placed
Confirmed via electronic medical record review.
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Assessment method [24]
429455
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Timepoint [24]
429455
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [25]
429456
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Use of intravenous narcotic analgesia
Confirmed via electronic medical record review.
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Assessment method [25]
429456
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Timepoint [25]
429456
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [26]
429457
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Antepartum haemorrhage (defined as greater than or equal to 500mL)
Confirmed via electronic medical record review.
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Assessment method [26]
429457
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Timepoint [26]
429457
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Prior to established labour (from drug ingestion to 30 days from drug ingestion).
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Secondary outcome [27]
429458
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Intrapartum haemorrhage (defined as greater than or equal to 500mL).
Confirmed via electronic medical record review.
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Assessment method [27]
429458
0
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Timepoint [27]
429458
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During established labour (from drug ingestion to 30 days from drug ingestion).
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Secondary outcome [28]
429459
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Postpartum haemorrhage (within 24 hours of birth, defined as greater than or equal to 500mL),
Confirmed via electronic medical record review.
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Assessment method [28]
429459
0
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Timepoint [28]
429459
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Within 24 hours of birth (from drug ingestion to 30 days from drug ingestion).
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Secondary outcome [29]
429460
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Uterine rupture
Confirmed via electronic medical record review.
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Assessment method [29]
429460
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Timepoint [29]
429460
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [30]
429461
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Cord prolapse
Confirmed via electronic medical record review.
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Assessment method [30]
429461
0
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Timepoint [30]
429461
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [31]
429462
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Non-cephalic presentation (breech, transverse, oblique)
Confirmed via electronic medical record review.
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Assessment method [31]
429462
0
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Timepoint [31]
429462
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [32]
429463
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Admission to ICU or equivalent
Confirmed via electronic medical record review.
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Assessment method [32]
429463
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Timepoint [32]
429463
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [33]
429464
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Maternal satisfaction, based on survey data collected after birth
Survey created for this study.
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Assessment method [33]
429464
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Timepoint [33]
429464
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The survey will be administered once, timing from one week after the birth until 180 days post birth.
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Secondary outcome [34]
429465
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Live birth
Confirmed via electronic medical record review.
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Assessment method [34]
429465
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Timepoint [34]
429465
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [35]
429467
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Apgar scores at 1, 5, 10 minutes (if applicable)
Confirmed via electronic medical record review.
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Assessment method [35]
429467
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Timepoint [35]
429467
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At 1, 5 and 10 minutes after birth
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Secondary outcome [36]
429469
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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.
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Assessment method [36]
429469
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Timepoint [36]
429469
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [37]
429470
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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.
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Assessment method [37]
429470
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Timepoint [37]
429470
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From drug ingestion to 30 days from drug ingestion
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Secondary outcome [38]
429471
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Adverse neonatal outcome, defined as admission to the neonatal intensive care unit, neonatal seizures, neonatal encephalopathy.
Confirmed via electronic medical record review.
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Assessment method [38]
429471
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Timepoint [38]
429471
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From birth to 28 days from birth
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Secondary outcome [39]
429472
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Neonatal death (early) within 28 days
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Assessment method [39]
429472
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Timepoint [39]
429472
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From birth to 28 days from birth
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Secondary outcome [40]
429473
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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.
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Assessment method [40]
429473
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Timepoint [40]
429473
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From drug ingestion to 37 days from drug ingestion
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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
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Minimum age
16
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Electronic, through the Liggins Institute
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/03/2024
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Actual
4/07/2024
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
30/09/2026
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Actual
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Sample size
Target
168
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Accrual to date
2
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Final
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Recruitment outside Australia
Country [1]
26000
0
New Zealand
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State/province [1]
26000
0
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Funding & Sponsors
Funding source category [1]
314581
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Charities/Societies/Foundations
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Name [1]
314581
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Auckland Medical Research Foundation
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Address [1]
314581
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81 Grafton Road, Grafton, Auckland 1010
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Country [1]
314581
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
85 Park Road, Grafton, Auckland 1023
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Country
New Zealand
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Secondary sponsor category [1]
317376
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None
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Name [1]
317376
0
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Address [1]
317376
0
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Country [1]
317376
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313616
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Northern A Health and Disability Ethics Committees
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Ethics committee address [1]
313616
0
Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140
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Ethics committee country [1]
313616
0
New Zealand
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Date submitted for ethics approval [1]
313616
0
09/08/2023
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Approval date [1]
313616
0
19/12/2023
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Ethics approval number [1]
313616
0
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Summary
Brief summary
We hypothesize that the administration of a single 200mg oral dose of mifepristone will increase the rate of spontaneous onset of labour within 48 hours in pregnant people with a prior caesarean compared to placebo. We are performing a randomised controlled trial to assess this. Trial participants and investigators will be blinded to allocation.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
128758
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Dr Meghan Hill
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Address
128758
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The University of Auckland, Department of Obstetrics and Gynaecology, Building 507, Level 1, Grafton, Auckland, 1023
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Country
128758
0
New Zealand
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Phone
128758
0
+64 0 9 923 9493
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Fax
128758
0
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Email
128758
0
[email protected]
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Contact person for public queries
Name
128759
0
Meghan Hill
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Address
128759
0
The University of Auckland, Department of Obstetrics and Gynaecology, Building 507, Level 1, Grafton, Auckland, 1023
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Country
128759
0
New Zealand
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Phone
128759
0
+64 0 9 923 9493
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Fax
128759
0
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Email
128759
0
[email protected]
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Contact person for scientific queries
Name
128760
0
Meghan Hill
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Address
128760
0
The University of Auckland, Department of Obstetrics and Gynaecology, Building 507, Level 1, Grafton, Auckland, 1023
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Country
128760
0
New Zealand
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Phone
128760
0
+64 0 9 923 9493
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Fax
128760
0
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Email
128760
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21084
Statistical analysis plan
This is included in the study protocol.
21085
Study protocol
386425-(Uploaded-04-01-2024-12-08-28)-Study-related document.docx
21086
Informed consent form
386425-(Uploaded-04-01-2024-12-02-15)-Study-related document.doc
21087
Ethical approval
386425-(Uploaded-04-01-2024-11-59-25)-Study-related document.pdf
23941
Study protocol
Updated study protocol after site review
386425-(Uploaded-02-07-2024-19-07-58)-MifeTrialProtocolCleanJune2024.docx
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.
Download to PDF