ISRCTN32652461已完成未知
Cervical Ripening at Home or In-Hospital - prospective cohort study and process evaluation (CHOICE study)
niversity of Edinburgh0 个研究点目标入组 25,677 人开始时间: 2020年7月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 25,677
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33947741/ (added 06/05/2021)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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