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
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

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

Phone +60 (0)3 7949 2059
Email pctan@um.edu.my

Study information

Study designDouble blind randomised placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleConcurrent 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 acronymPROXY trial
Study objectivesConcurrent 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) studiedPrelabour rupture of membranes
InterventionVaginal 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dinoprostone, oxytocin
Primary outcome measurePrimary 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 measuresSecondary 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 date10/11/2007
Completion date30/09/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsAt least 106 women
Total final enrolment114
Key inclusion criteria1. 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 criteria1. Previous uterine incision
2. Meconium stained liquor at trial entry
3. Gross foetal anomaly
4. Asthma
5. Allergy to prostaglandin
Date of first enrolment10/11/2007
Date of final enrolment30/09/2008

Locations

Countries of recruitment

  • Malaysia

Study participating centre

Department of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia

Sponsor information

University of Malaya Medical Centre (Malaysia)
Hospital/treatment centre

University of Malaya
Jalan Universiti
Kuala Lumpur
59100
Malaysia

Website http://www.ummc.edu.my/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
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.