Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000156583
Ethics application status
Approved
Date submitted
3/06/2001
Date registered
3/06/2001
Date last updated
2/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oral misoprostal for the induction of labour at term
Scientific title
Oral misoprostol versus vaginal prostaglandin E2 for the induction of labour at term (beyond 37 weeks gestation).
Secondary ID [1] 28 0
Perinatal Trials Registry: PTR361
Universal Trial Number (UTN)
Trial acronym
MILO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy at a gestational age of 37 weeks or more. 29 0
Condition category
Condition code
Reproductive Health and Childbirth 33 33 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Misoprostol group: oral misoprostol in solution (1mg/ml) 20 mls repeated two hourly to a maxmimum of 12 doses plus placebo vaginal gel treatment. Vaginal prostaglandin group: oral placebo (25mg pyradoxive) following dosing regimen described above plus prostaglandin vaginal gel
Intervention code [1] 1013 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 60 0
Caesarean section
Timepoint [1] 60 0
Assessed during induction and labour
Primary outcome [2] 61 0
Women undelivered after 24 hours
Timepoint [2] 61 0
Assessed during induction and labour
Primary outcome [3] 62 0
Uterine hyperstimulation with fetal heart rate abnormality
Timepoint [3] 62 0
Assessed during induction and labour
Secondary outcome [1] 102 0
Admission to Neonatal Intensive Care Unit (NICU).
Timepoint [1] 102 0
Secondary outcome [2] 103 0
Length of stay (neonatal).
Timepoint [2] 103 0
Secondary outcome [3] 104 0
Maternal and neonatal morbidity
Timepoint [3] 104 0
Measured up to six weeks postpartum.

Eligibility
Key inclusion criteria
Singleton pregnancy, at a gestational age of 37 weeks or more, planned induction of labour for defined obstetric and medical conditions - prolonged pregnancy, pre-eclampsia, hypertensive disoreders, antepartum haemorrhage (ecluding placenta praevia), oligohydramnios, IUGR, or abnormal glucose tolerance.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Induction planned for non-defined conditions, active labour o, or a favourable cervix, contraindication to vaginal birth, previous uterine surgery, ruptured membranes, parity 5 or more, history of asthma, glaucoma or heart disease, suspected cephalo-pelvic disproportion, abnormal lie, breech presentation, fetal distress/non-reassuring fetal heart trace, multiple pregnancy, intrauterine infection, vasa praevia, placenta praevia, active herpes infection, maternal illness precluding induction of labour, and maternal renal or hepatic failure.

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)
Identical appearing treatment packs
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
738
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 43 0
Hospital
Name [1] 43 0
Women's and Children's Hospital Research Foundation Project Grant
Country [1] 43 0
Australia
Primary sponsor type
University
Name
The Department of Obstetrics & Gynaecology, The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 37 0
None
Name [1] 37 0
Nil
Address [1] 37 0
Country [1] 37 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 327 0
Women's and Children's Hospital
Ethics committee address [1] 327 0
Ethics committee country [1] 327 0
Australia
Date submitted for ethics approval [1] 327 0
Approval date [1] 327 0
Ethics approval number [1] 327 0

Summary
Brief summary
This is a prospective randomised, double blind, placebo controlled trial comparing vaginal prostaglandins E2 gel with an oral synthetic prostaglandin E2 analogue (misoprostol) in the induction of labour at term. Both agents are thought to be equally effective in inducing labour. The main outcomes assessed in this study will be the rate of caesarean section, the number of women who remain undelivered after 24 hours, and uterine hyperstimulation with associated changes in the fetal heart rate. Women, caregivers and outcome assessors (MILO trial) are blinded. For the timing of induction component, it is not possible for women or caregivers to be blinded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36341 0
Address 36341 0
Country 36341 0
Phone 36341 0
Fax 36341 0
Email 36341 0
Contact person for public queries
Name 10202 0
Jacki Smith
Address 10202 0
The Discipline of Obstetrics and Gynaecology
The University of Adelaide
Women's and Children's Hospital (WCH)
72 King William Road
North Adelaide SA 5019
Country 10202 0
Australia
Phone 10202 0
+61 8 81617619
Fax 10202 0
+61 8 81617652
Email 10202 0
jacki.smith@adelaide.edu.au
Contact person for scientific queries
Name 1130 0
Dr Jodie Dodd
Address 1130 0
Discipline of Obstetrics & Gynaecology, The University of Adelaide
Women's & Children's Hospital
72 King William Road, North Adelaide
SA 5019
Country 1130 0
Australia
Phone 1130 0
+61 8 81617619
Fax 1130 0
+61 8 81617652
Email 1130 0
jodie.dodd@adelaide.edu.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
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Documents added automatically
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