Prelabour rupture of membranes Pregnancy and Childbirth Prelabour rupture of membranes
Conditions
Interventions
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
Sponsors
University of Malaya Medical Centre (Malaysia)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria: 1. Previous uterine incision 2. Meconium stained liquor at trial entry 3. Gross foetal anomaly 4. Asthma 5. Allergy to prostaglandin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Malaysia
Outcome results
None listed