Women with singleton pregnancies having induction of labour at or beyond 39 weeks gestation Pregnancy and Childbirth
Conditions
Interventions
Observational cohort:
The researchers will include at least 14 maternity units offering only in-hospital cervical ripening and at least 12 offering dinoprostone home cervical ripening. They will concu
Sponsors
University of Edinburgh
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observational study: Admission to neonatal unit (NNU) within 48 hours, for a period of 48 hours or more, measured using patient records at a single timepoint qCHOICE: Sense of control (agentry) in labour, based on the use of the labour agentry scale which will form part of the patient questionnaire at a single timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records at a single timepoint: 1. Neonatal morbidities 2. Maternal morbidities 3. Mode of birth 4. Time of birth 5. Duration of hospital stay 5. Breastfeeding Health economic outcomes will form part of the patient questionnaire, and will be measured by patient-related resource use and expenditures of cervical ripening for women | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed