Prostaglandin E2 vaginal gel or tablets for induction of labour at term
Completed
- Conditions
- Induction of labourPregnancy and Childbirth
- Registration Number
- ISRCTN78483537
- Lead Sponsor
- Queen Charlotte's and Chelsea Hospital (QCCH) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 220
Inclusion Criteria
Women undergoing induction of labour with a cephalic presentation (singleton) or first twin cephalic at term (greater than or equal to 36+6 to 42 weeks gestation)
Exclusion Criteria
1. Favourable cervix (defined as a modified Bishop score of greater than or equal to 8)
2. Any contraindication to vaginal birth
3. Previous uterine surgery (including caesarean section)
4. Unwillingness to participate in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time interval between induction of labour to delivery in minutes, irrespective of the mode of delivery, and the rate of failed induction of labour leading to caesarean section. Assessed in every patient during the process of labour induction at gestation (greater than or equal to 36+6 to 42 weeks gestation).
- Secondary Outcome Measures
Name Time Method 1. Requirement for oxytocin augmentation<br>2. Incidence of uterine hyperstimulation, defined as uterine tachysystole (with five or more contractions in a 10 minute period for two consecutive 10 minute periods) or uterine hypertonus (a uterine contraction lasting for more than two minutes) resulting in pathological cardiotocography trace that necessitated intervention by administering of a tocolytic or delivery<br>3. Incidence of intrapartum foetal blood sampling<br>4. Epidural requirement<br>5. Mode of delivery<br>6. Blood loss at delivery<br>7. Incidence of maternal pyrexia<br>8. Perineal lacerations require suturing<br>9. 1 and 5-minute Apgar score<br>10. Need for admission to NIC