Comparison of Patient Satisfaction With Home Induction and In-patient Induction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Questionnaire on patients' experience of induction in hospital and at home.
研究概览
简要总结
Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated.
Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction.
Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital.
详细描述
There are generally two main methods of cervical ripening, mechanical methods (Foley® catheter or Cook® double balloon catheter) and pharmacological methods (Propess® dinoprostone intravaginal tampon, Prostine® intravaginal gel, or Angusta® oral misoprostol).
Balloon induction of labour works by the dilating effect of a balloon inflated at the level of the uterine cervix, which distinguishes it from pharmacological methods acting via uterine contractions.
Balloon induction has been shown to be effective and safe. It therefore seems important to take a closer look at this method of outpatient induction, especially as the risks of uterine hyperkinesia/hypertonia and anomalies in foetal heart rate are very low with this technique.
Several foreign studies have looked at outpatient induction of labour. Meta-analyses have shown a lower caesarean section rate with outpatient induction, faster labour and less administration of oxytocin.
In terms of safety, a systematic review of the literature based on data from 26 studies, published in 2018, showed a low risk of developing adverse effects between insertion and expulsion of the balloon. A meta-analysis conducted in 2020 compared inpatient versus outpatient induction of labour, showing no significant differences between the home and inpatient groups in terms of major neonatal adverse events. In addition, several studies have suggested that allowing patients to participate actively in the decision concerning the induction method can promote better understanding and acceptance of the process, thereby strengthening their commitment to their own health.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult patient
- •Singleton pregnancy
- •Indication for induction of labour ≥ 37SA+0d
- •Unfavourable cervix (Bishop<6)
- •Living less than 30 minutes' drive from hospital
- •Having a relative at her side for a return home
排除标准
- •Scarred uterus : previous caesarean section or myomectomy
- •Premature rupture of membranes
- •Fetal death in utero
- •Placenta previa/accreta/percreta
- •Severe maternal pathology : decompensated respiratory, cardiac, hepatic, renal, digestive or psychiatric disease, severe pre-eclampsia, severe growth retardation or anamnios
- •Patient under guardianship, curatorship or safeguard of justice
结局指标
主要结局
Questionnaire on patients' experience of induction in hospital and at home.
时间窗: Day 2
To compare patients' experiences of their induction in hospital or at home, using a questionnaire handed out after the birth.
Questionnaire on patients' satisfaction of induction in hospital and at home.
时间窗: Day 2
To compare patients' satisfaction of their induction in hospital or at home, using a questionnaire handed out after the birth.
次要结局
- Maternal morbidity(Day 3)
- Neonatal mortality(Day 3)
- Maternal mortality(Day 3)
- Questionnaire on reasons for choosing home induction.(Day 0)
- Questionnaire on patients' choice of induction method(Day 0)
- Neonatal morbidity(Day 3)