Cervical Ripening Using Misoprostol vs Dinoprostone: A randomised, triple-blinded, interventional study comparing safety and efficacy in primiparous wome

Phase 4

• Conditions: Cervical Ripening; Induction of Labour; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12616000522415
• Lead Sponsor: John Hunter Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 208

Inclusion Criteria

1) Pregnant women between 37+0 and 41+4 weeks gestation
2) Having first baby
3) Induction of labour deemed medically indicated
4) Bishops score less than or equal to 4
5) age >=18
6) BMI <50 at booking visit

Exclusion Criteria

1) Active labour
2) Ruptured membranes
3) Non-cephalic presentation
4) Previous caesarean section or other uterine surgery
5) Unexplained vaginal bleeding >24 weeks gestation
6) Suspected or known chorioamnionitis
7) Suspected or known fetal compromise (abnormal antenatal fetal heart rate pattern, ultrasound showing fetal growth <10th centile, oligohydramnios, polyhydramnios, abnormal dopplers)
8) Unable to read or speak English without the aid of an interpreter

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of women requiring further cervical ripening with cervical ripening balloon following treatment as assessed by Bishops' Score less than or equal to 7 following removal of treatment drug[24 hours post insertion of treatment];Number of women requiring induction of labour with oxytocin as assessed by the number of women who have not achieved spontaneous labour following treatment[48 hours post treatment];Number of women requiring intervention for uterine hyperstimulation that is assessed by the number of women having 6 or more contractions in 10 minutes who require tocolysis or other intervention for fetal cardiotocography changes[within 24 hours of treatment]

Secondary Outcome Measures

Name	Time	Method
umber of women requiring delivery by caesarean section as determined by review of medical record[within 4 days of treatment];Time gap from treatment to vaginal delivery as assessed by review of medical record[within 4 days of treatment];Neonatal morbidity or mortality as assessed by presence of hypoxic ischaemic encephalopathy, 5 minute apgar score <7, Neonatal Intensive Care admission[within 24 hours of birth]