Condition category
Pregnancy and Childbirth
Date applied
28/03/2013
Date assigned
23/04/2013
Last edited
23/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 provider’s 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

Contact information

Type

Scientific

Primary contact

Dr Aizura Adlan

ORCID ID

Contact details

Department of Obstetrics & Gynaecology
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia

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 measures

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

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

http://www.um.edu.my/

Funders

Funder type

University/education

Funder name

University of Malaya (Malaysia) (H-20001-00-E000066)

Alternative name(s)

University of Malaya, 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes