Condition category
Pregnancy and Childbirth
Date applied
06/11/2007
Date assigned
16/11/2007
Last edited
16/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ummc.edu.my/

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

Publication citations

Additional files

Editorial Notes