Comparing 3-hourly with 6-hourly dinoprostone vaginal tablet for labour induction in nulliparous women with an unfavourable cervix at term
| ISRCTN | ISRCTN94131405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94131405 |
| Secondary identifying numbers | 642.13 |
- Submission date
- 28/03/2013
- Registration date
- 23/04/2013
- Last edited
- 23/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Department of Obstetrics & Gynaecology
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
Study information
| Study design | Double blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | University of Malaya Medical Centre Medical Ethics Committee, 19th March 2008, ref: 642.13 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2013 |
| Completion date | 31/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | A minimum of 238 women |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2013 |
| Date of final enrolment | 31/01/2014 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
50603
Malaysia
Sponsor information
University/education
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Website | http://www.um.edu.my/ |
|---|---|
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
