Comparative Analysis of Labor Induction Using a Balloon Catheter at Home Versus in the Hospital (BALHOME)
Comparative Prospective Analysis of Labor Induction Using a Balloon Catheter at Home Versus in the Hospital: Obstetric Outcomes and Patient Satisfaction
An increasing proportion of patients undergo labor induction at the end of pregnancy. Balloon induction at home is a method validated in the literature.
Home-based balloon induction is already part of routine care at the Paule de Viguier maternity unit. However, a prospective evaluation of this home induction option has not yet been conducted at our facility or elsewhere in France.
Our study will evaluate obstetric outcomes and patient satisfaction regarding this induction method at our center.
This is an observational, non-interventional, prospective, and comparative-though non-randomized-study.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Thomas PARSY
- 电话号码：+33 05 67 77 12 31
- 邮箱：parsy.t@chu-toulouse.Fr
学习地点
-
-
Oui
-
Toulouse、Oui、法国、31000
- Service de gynécologie, Hôpital Paule de Viguier
-
接触：
- Emeline Muller
- 电话号码：+33 0561778707
- 邮箱：muller.E@chu-toulouse.Fr
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
pregnant patients with an indication for balloon induction
描述
Inclusion Criteria:
- Medical indication or request for induction
- Patients between 37 and 41+5 weeks of gestation
- Singleton pregnancy, cephalic presentation, intact membranes
- Normal amniotic fluid volume at the time of induction
- Residing within 30 minutes of the maternity unit and having access to a vehicle
- Access to a telephone, good understanding of monitoring instructions
Exclusion Criteria:
- Scarred uterus
- Multiple pregnancy
- Breech presentation
- Rupture of membranes, hydramnios
- Placenta previa or low-lying placenta, or significant unexplained bleeding
- Intrauterine growth restriction, small for gestational age, or known fetal condition requiring fetal monitoring or prompt care at birth
- Intrauterine fetal death or medical termination of pregnancy
- Preeclampsia or gestational hypertension
- Maternal condition requiring hospital monitoring.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Pregnant patients undergoing balloon induction and returning home
|
A satisfaction questionnaire is given to the patient during her stay at the maternity ward. |
|
Pregnant patients undergoing balloon induction in a standard hospital setting
|
A satisfaction questionnaire is given to the patient during her stay at the maternity ward. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of obstetric outcomes
大体时间：6 days after the inclusion
|
vaginal delivery rate |
6 days after the inclusion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of postpartum patient satisfaction
大体时间：6 days after the inclusion
|
Satisfaction survey |
6 days after the inclusion
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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