Home or in-hospital cervical ripening for induction of labour
- Conditions
- Women with singleton pregnancies having induction of labour at or beyond 39 weeks gestationPregnancy and Childbirth
- Registration Number
- ISRCTN32652461
- Lead Sponsor
- niversity of Edinburgh
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33947741/ (added 06/05/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 25677
Current inclusion criteria as of 17/11/2022:
Observational study:
For data collection:
1. Gestation 37+0 weeks or more
2. Undergoing IOL
For primary analysis:
1. Gestation of 39+0 weeks or more
Qualitative study:
For questionnaire-based survey:
1. Gestation 37+0 weeks or more
2. Undergoing IOL
For case studies:
1. Gestation of 37+0 weeks or more
Previous inclusion criteria:
Observational study:
For data collection:
1. Gestation 37+0 weeks or more
2. Undergoing IOL
For primary analysis:
1. Gestation of 39+0 weeks or more
Qualitative study:
For questionnaire-based survey:
1. Gestation 39+0 weeks or more
2. Undergoing IOL
For case studies:
1. Gestation of 39+0 weeks or more
Current exclusion criteria as of 17/11/2022:
Observational study:
For data collection:
1. Opted out of data provision (checkbox)
Applied for primary analysis:
1. Grand multiparity (6 or more previous pregnancies)
2. Previous caesarean section
3. Antepartum stillbirth (before cervical ripening initiated)
4. Class III obesity at booking (BMI 40 kg/m2 or more)
5. Prelabour rupture of membranes documented as primary or other indication for IOL (prolonged ROM; SROM; ?SROM)
6. Maternal, fetal or medical condition that would/could preclude home cervical ripening documented as primary or other indication for IOL
7. Maternal conditions: proteinuria; hypertension; antepartum haemorrhage; diabetes; obstetric cholestasis; past obstetric history; pre-eclampsia; PIH/PET (not defined); PIH; PET; thrombophilia
8. Fetal conditions: oligohydramnios; reduced liquor volume; macrosomia; intrauterine growth restriction (IUGR); static growth; congenital fetal anomaly; polyhydramnios; abnormal CTG/Doppler; breech; reduced fetal movements; termination of pregnancy for fetal anomaly
Qualitative study:
For case studies:
1. Women who did not have IOL at 37+0 weeks of gestation
2. Women who had IOL for medical reasons
3. Women who had an elective cesarean section
4. Women who have experienced intrauterine death, stillbirth or neonatal death
Previous exclusion criteria:
Observational study:
For data collection:
1. Opted out of data provision (checkbox)
Applied for primary analysis:
1. Grand multiparity (6 or more previous pregnancies)
2. Previous caesarean section
3. Antepartum stillbirth (before cervical ripening initiated)
4. Class III obesity at booking (BMI 40 kg/m2 or more)
5. Prelabour rupture of membranes documented as primary or other indication for IOL (prolonged ROM; SROM; ?SROM)
6. Maternal, fetal or medical condition that would/could preclude home cervical ripening documented as primary or other indication for IOL
7. Maternal conditions: proteinuria; hypertension; antepartum haemorrhage; diabetes; obstetric cholestasis; past obstetric history; pre-eclampsia; PIH/PET (not defined); PIH; PET; thrombophilia
8. Fetal conditions: oligohydramnios; reduced liquor volume; macrosomia; intrauterine growth restriction (IUGR); static growth; congenital fetal anomaly; polyhydramnios; abnormal CTG/Doppler; breech; reduced fetal movements; termination of pregnancy for fetal anomaly
Qualitative study:
For case studies:
1. Women who did not have IOL at 39+0 weeks of gestation
2. Women who had IOL for medical reasons
3. Women who had an elective cesarean section
4. Women who have experienced intrauterine death, stillbirth or neonatal death
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method