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
Protocol serial number	607.9
Sponsor	University of Malaya Medical Centre (Malaysia)
Funder	University of Malaya (Malaysia) - internal funding

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

Primary study design	Interventional
Study design	Double blind randomised placebo controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dinoprostone, oxytocin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	106
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.