Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 4
- 主要终点
- Obstetrical labor and delivery experience in birthgiving women
研究概览
简要总结
Childbirth is a special event for women. Maternal satisfaction regarding childbirth is quite important, that is why this factor has to be taken into account. A bad experience related to childbirth could lead to serious psychological and organic consequences such as postpartum depression, mother-baby bond deterioration and chronic pelvic pain. Childbirth image changed over the years to the extent that an increasingly physiological process keeping analgesia and safety is more and more desired. In this perspective, this study aims to investigate an approach so-called ambulatory epidural. Indeed, only a few studies have been conducted and the ones published in 1990s did not involve the current recommended pharmacological protocols.
详细描述
This is a multi-centre prospective observational analytical before/after-type study.
Practice changes are planned in concerned departments, in particular regarding usual patient care. This observational study aims to quantify the impact of practice changes on patient experience using a Childbirth Assessment Questionnaire (QEVA). During the "before" period, patients will receive a conventional epidural while the others, during the "after" period, will receive an ambulatory epidural. The women involved into this study must fill the QEVA form 2 days after giving birth (at the maternity) then 4 weeks after giving birth in order to get a feedback related to postpartum feelings (phone call).
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
- 否
入选标准
- •Women older than 18 years old
- •with Physiological pregnancy (fetus cephalic position, normal fetal heart rate, spontaneous work between 37 and 41 SA)
- •Having benefited from epidural, usual or ambulatory depending on the study period
- •who speeks and understand French
- •who signed a free and informed consent form
排除标准
- •Hearing or comprehension impairment
- •Twin pregnancies
- •Scarred uterus
- •Fetus in non cephalic position
- •Imminent delivery
- •Women under protective supervision (guardianship, curatorship)
- •Women bereaved of a spouse or child during pregnancy
- •Hospitalization of child in neonatology after delivery
- •Women hospitalized in critical care units after childbirth
结局指标
主要结局
Obstetrical labor and delivery experience in birthgiving women
时间窗: at 2 days postpartum
The "emotional state" dimension of the Childbirth Assessment Questionnaire (QEVA) will be evaluated. This questionnaire is written and validated in French. It contains 26 questions covering 4 dimensions: emotional state, relations with nursing staff, first moments with the baby, and the young mother's feelings one month before delivery.
次要结局
- Obstetrical labor and delivery experience in birthgiving women(at 4 weeks postpartum)
- Labor and delivery safety : emergency caesarean sections(at 2 days postpartum)
- Labor and delivery safety: need for instrumental extraction(at 2 days postpartum)
- Relations with nursing staff and first moments with the child(at 2 days postpartum)
- Labor and delivery safety : time spent in the delivery room(at 2 days postpartum)
- Labor and delivery safety: ability to maintain spontaneous micturition(at 2 days postpartum)
- Safety of ambulation(at 2 days postpartum)