Plain English Summary
Background and study aims
Labour induction is frequently inefficient and ineffective in women who are expecting their first child and have unfavourable cervixes. Only 36% deliver vaginally within the first 24 hours and 40% eventually go on to have a Caesarean delivery. The standard treatment for labour induction for these women is a 3 mg dinoprostone tablet given vaginally, followed six hour later by a second dose if the cervix is still unripe.
The aim of the study is to see whether administering a second 3 mg dinoprostone dose at three hours, followed if needed by a third dose at six hours, induces labour better compared to the standard treatment.
Who can participate?
Women scheduled to have an induction of labour and are at term (37 weeks or more), expecting their first baby who is in cephalic presentation, with intact membranes, the cardiotocogram is reassuring and cervix is unripe.
What does the study involve?
Women will be randomly allocated to one of two grous: either 3-dose or 2-dose plus placebo dinoprostone for labour induction. All women will receive a first dose of 3 mg dinoprostone vaginally as standard. Three hours later, a vaginal examination and cardiotocography will be performed and a second dose of either 3 mg dinoprostone or identical looking placebo tablet (neither participant nor her doctor will know which is given) will be administered vaginally if the cervix is still unripe. This is followed in another three hours by another assessment and if the cervix is still unripe, a dose of 3 mg dinoprostone will be given. Following this, further management of the labour induction is up to the providers discretion.
What are the possible benefits and risks of participating?
The three-dose treatment may be more efficient compared to the standard treatment. But the three dose treatment may have more adverse events like excessive contractions which may need further treatment including the need for Caesarean delivery.
Where is the study run from?
The study is conducted in the Delivery Suite of the University of Malaya Medical Centre, a tertiary referral hospital with full-fledged operating theatres and neonatal intensive care unit (Malaysia).
When is the study starting and how long is it expected to run for?
The trial started in February 2013 and is expected to be completed within 18 months.
Who is funding the study?
University of Malaya (Malaysia)
Who is the main contact?
Dr Aizura Adlan
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
642.13
Study information
Scientific title
Comparing 3-hourly with 6-hourly dinoprostone vaginal tablet for labour induction in nulliparous women with an unfavourable cervix at term: A randomized controlled trial
Acronym
Study hypothesis
We hypothesize that a more intensive regimen for labour induction using 3-hourly (to a maximum 3 doses) compared to 6-hourly (to a maximum 2 doses) dinoprostone (3 mg) vaginal tablets can result in more vaginal deliveries within 24 hours and improve maternal satisfaction with the birth process without increasing the risk of uterine hyperstimulation.
Ethics approval
University of Malaya Medical Centre Medical Ethics Committee, 19th March 2008, ref: 642.13
Study design
Double blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Labour induction in nullliparous women with an unfavourable cervix at term
Intervention
Regimen 1
a) Dinoprostone (3 mg) vaginal tablet, followed 3 hours later by
b) Dinoprostone (3 mg) vaginal tablet if still indicated, followed 3 hours later by
c) Dinoprostone ( 3mg) vaginal tablet if still indicated
or
Regimen 2
a) Dinoprostone (3 mg) vaginal tablet, followed 3 hours later by
b) Identical placebo vaginal tablet if still indicated, followed 3 hours later by
c) Dinoprostone ( 3mg) vaginal tablet if still indicated
Intervention type
Drug
Phase
Not Applicable
Drug names
dinoprostone
Primary outcome measure
1. Vaginal delivery in 24 hours
2. Maternal satisfaction with the birth process using a 10 point numerical rating scale
Secondary outcome measures
1. Mode of delivery (and indications for operative delivery)
2. Neonatal outcome (admission, umbilical cord blood pH, Apgar score)
3. Analgesia use in during induction and labour
4. Cardiotocogram abnormalities in first 12 hours of labour induction (including tachysystole, hypertonus, hyperstimulation)
5. Meconium stained liquor
6. Blood loss during labour and delivery
7. Maternal fever (any maternal temperature ≥ 380 C during labour or before discharge)
8. Maternal pain score at 6 hours of labour induction (if undelivered)
9. Induction to delivery interval
10. Induction to hospital discharge interval
Overall trial start date
01/02/2013
Overall trial end date
31/01/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Scheduled for induction of labour
2. Nulliparous (no previous delivery > 20 weeks)
3. Term gestation (≥ 37 weeks)
4. Bishop score on recruitment ≤ 6
5. Intact membranes
6. Singleton pregnancy
7. Cephalic presentation
8. Reassuring cardiotocogram
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
A minimum of 238 women
Participant exclusion criteria
1. Previous uterine incision or injury (e.g. myomectomy, perforation)
2. Known severe fetal anomaly
3. No significant contractions (< 1 in 10 minutes)
4. Allergy to dinoprostone
Recruitment start date
01/02/2013
Recruitment end date
31/01/2014
Locations
Countries of recruitment
Malaysia
Trial participating centre
Department of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya (Malaysia)
Sponsor details
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Malaya (Malaysia) (H-20001-00-E000066)
Alternative name(s)
UM
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Malaysia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list