Contact information
Type
Scientific
Primary contact
Dr Peng Chiong Tan
ORCID ID
Contact details
Department of Obstetrics & Gynaecology
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
+60 (0)3 7949 2059
pctan@um.edu.my
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
607.9
Study information
Scientific title
Acronym
PROXY trial
Study hypothesis
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
Ethics approval received from the University of Malaya Medical Ethics Committee on the 28th August 2007.
Study design
Double blind randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Dinoprostone, oxytocin
Primary outcome measures
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 trial start date
10/11/2007
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
At least 106 women
Participant exclusion criteria
1. Previous uterine incision
2. Meconium stained liquor at trial entry
3. Gross foetal anomaly
4. Asthma
5. Allergy to prostaglandin
Recruitment start date
10/11/2007
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Malaysia
Trial participating centre
Department of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya Medical Centre (Malaysia)
Sponsor details
University of Malaya
Jalan Universiti
Kuala Lumpur
59100
Malaysia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University of Malaya (Malaysia) - internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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