Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 258
- 试验地点
- 3
- 主要终点
- compare the duration of induction and labor between outpatient and inpatient care.
研究概览
简要总结
The aim goal of this study is to compare the duration of induction and labor between outpatient and inpatient care in low-risk pregnant women.
The secondary objectives are to compare between the two groups the maternal satisfaction from induction to delivery, the maternal and neonatal morbidity and mortality, impact on service organization and a medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month For women who do not agree to take part in the randomized study, an observational study will be proposed to them in order to collect the reason for their refusal and their maternal satisfaction.
Researchers will compare the return home with conventional hospitalization
Patients presenting with a singleton pregnancy and with an indication for induction of labor will be proposed to participate in the study.
If the pregnant woman refuses to participate in the randomized study, she will be invited to take part in the observational study.
For women who accept, a fetal heart rate recording (FHRR) is made prior to balloon insertion. If there is no fetal heart rhythm abnormality (FHR), the double balloon catheter is inserted by a midwife. A further ERCF is performed to ensure that the procedure is well tolerated.
In the absence of metrorrhagia, fetal heart rate abnormalities, rupture of the water sac or uterine hypertonia/hyperkinesia, the patient will then be randomized to either the in-patient or out-patient arm. The patient will either be placed in a room or go home.
In both cases, the balloon will be removed after 24 hours in hospital in the absence of spontaneous labor, and the patient will be referred to the delivery room for water breakage and/or oxytocin infusion for induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman with singleton pregnancy in cephalic presentation
- •Term ≥ 37SA+0d
- •Age ≥ 18 years
- •Affiliated or beneficiary of a social security scheme
- •No severe maternal/neonatal pathology (severe pre-eclampsia, intra-uterine growth retardation, etc.)
- •Indication for balloon induction
- •Bishop score <6
- •Home-hospital distance ≤ 30 minutes' drive
- •Presence of a family member at the woman's side to help her return home
排除标准
- •Scarred uterus
- •Fetal heart rhythm abnormalities
- •Rupture of membranes
- •Death in utero
- •Placenta previa or adherent placenta (accreta or percreta)
- •Maternal respiratory, cardiac, hepatic, renal, digestive or decompensated psychiatric pathology
- •Patient under guardianship, curatorship and/or safeguard of justice
研究组 & 干预措施
Inpatient
patients randomized to this arm will stay at hospital
干预措施: Inpatient (Other)
observationnal study
patients refusing to be randomized will be able to enter this cohort without their care affecting the site's usual clinical practice
Outpatient
patients randomized to this arm will go home until labour or 24 hours after balloon insertion
干预措施: Outpatient (Other)
结局指标
主要结局
compare the duration of induction and labor between outpatient and inpatient care.
时间窗: 72 hours
次要结局
- Compare maternal satisfaction from induction to delivery between the two groups outpatient and inpatient via EXIT questionnaire(48 hours)
- Compare maternal morbidity and mortality between the two groups outpatient and inpatient(48 hours)
- Compare neonatal morbidity and mortality between the two groups outpatient and inpatient(48 hours)
- Compare the number of hospital beds freed up and the number of concurrent induction in the department(24 hours)
- Compare medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month between the two groups outpatient and inpatient(1 month)