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

Completed

Conditions: Prelabour rupture of membranes
Pregnancy and Childbirth

Registration Number: ISRCTN74376345

Lead Sponsor: niversity of Malaya Medical Centre (Malaysia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 106

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

Exclusion Criteria

1. Previous uterine incision
2. Meconium stained liquor at trial entry
3. Gross foetal anomaly
4. Asthma
5. Allergy to prostaglandin

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcomes will be measured at or soon after delivery:<br>1. Proportion delivered vaginal delivery within 12 hours of commencement of induction of labour<br>2. Maternal satisfaction with the birth process using a 10 point visual analog scale

Secondary Outcome Measures

Name	Time	Method
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:<br>1. Induction to delivery interval<br>2. Mode of delivery<br>3. Neonatal outcome (admission, umbilical cord blood pH, Apgar score)<br>4. Analgesia use in labour<br>5. Cardiotocographic abnormalities in labour (tachysystole, hyperstimulation)<br>6. Meconium stained liquor<br>7. Blood loss during labour and delivery<br>8. Maternal fever (any maternal temperature greater than or equal to 38°C during labour or postpartum before discharge)