Concurrent vaginal dinoprostone and oxytocin infusion versus oxytocin infusion for labour induction in term nulliparous with prelabour rupture of membranes: a randomised placebo controlled trial
ISRCTN | ISRCTN74376345 |
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DOI | https://doi.org/10.1186/ISRCTN74376345 |
Secondary identifying numbers | 607.9 |
- Submission date
- 06/11/2007
- Registration date
- 16/11/2007
- Last edited
- 31/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peng Chiong Tan
Scientific
Scientific
Department of Obstetrics & Gynaecology
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
Phone | +60 (0)3 7949 2059 |
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pctan@um.edu.my |
Study information
Study design | Double blind randomised placebo controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Concurrent vaginal dinoprostone and oxytocin infusion versus oxytocin infusion for labour induction in term nulliparous with prelabour rupture of membranes: a randomised placebo controlled trial |
Study acronym | PROXY trial |
Study objectives | Concurrent vaginal dinoprostone and oxytocin infusion compared to placebo and oxytocin infusion shortens the labour induction to delivery interval and improves the women's satisfaction with the birth process. |
Ethics approval(s) | Ethics approval received from the University of Malaya Medical Ethics Committee on the 28th August 2007. |
Health condition(s) or problem(s) studied | Prelabour rupture of membranes |
Intervention | Vaginal dinoprostone and oxytocin infusion versus vaginal placebo and oxytocin infusion to induce labour. Women randomised to concurrent oxytocin infusion and prostaglandin will receive a single dose of prostaglandin (3 mg of dinoprostone as a vaginal tablet) vaginally at commencement of the labour induction process at the same time as the standard infusion regime of oxytocin (infusion regime starting at 2 mU/min and doubling every 30 minutes to a maximum of 32 mU/min or until 4 contractions in 10 minutes if achieved sooner). Women randomised to the opposing arm will receive placebo tablet vaginally and standard oxytocin infusion regime for labour induction. Continuous Cardiotocographic (CTG) monitoring will in place throughout the induction and labour. Standard management of labour induction and labour apply throughout the trial. In the event of CTG abnormalities associated with excessive uterine activity, oxytocin infusion can be reduced or stopped, tocolysis effected with terbutaline subcutaneously or expedited operative delivery performed depending on individual circumstances and severity of CTG abnormalities. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Dinoprostone, oxytocin |
Primary outcome measure | Primary outcomes will be measured at or soon after delivery: 1. Proportion delivered vaginal delivery within 12 hours of commencement of induction of labour 2. Maternal satisfaction with the birth process using a 10 point visual analog scale |
Secondary outcome measures | Secondary outcomes are intrapartum events, peri-delivery events and the "last" secondary outcome (occurence of maternal fever) will be available by hospital discharge of the mother: 1. Induction to delivery interval 2. Mode of delivery 3. Neonatal outcome (admission, umbilical cord blood pH, Apgar score) 4. Analgesia use in labour 5. Cardiotocographic abnormalities in labour (tachysystole, hyperstimulation) 6. Meconium stained liquor 7. Blood loss during labour and delivery 8. Maternal fever (any maternal temperature greater than or equal to 38°C during labour or postpartum before discharge) |
Overall study start date | 10/11/2007 |
Completion date | 30/09/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | At least 106 women |
Total final enrolment | 114 |
Key inclusion criteria | 1. Ruptured membranes confirmed clinically by demonstration of pooling of liquor at upper vagina on speculum assessment 2. Nulliparous (no previous delivery greater than 20 weeks) 3. Term gestation (greater than 36 weeks) 4. Bishop score on recruitment less than or equal to 6 5. Less than 1 contraction in 15 minutes 6. Singleton foetus 7. Cephalic presentation 8. Reassuring cardiotocogram |
Key exclusion criteria | 1. Previous uterine incision 2. Meconium stained liquor at trial entry 3. Gross foetal anomaly 4. Asthma 5. Allergy to prostaglandin |
Date of first enrolment | 10/11/2007 |
Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Department of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia
50603
Malaysia
Sponsor information
University of Malaya Medical Centre (Malaysia)
Hospital/treatment centre
Hospital/treatment centre
University of Malaya
Jalan Universiti
Kuala Lumpur
59100
Malaysia
Website | http://www.ummc.edu.my/ |
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https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
University of Malaya (Malaysia) - internal funding
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/05/2009 | 31/12/2020 | Yes | No |
Editorial Notes
31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.