Results of Regulated Expiratory Breathing Method During Childbirth Process
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- cesarean delivery rate
研究概览
简要总结
The factors affecting the rate of primary caesarean section births are complex, and identifying interventions to reduce this rate is challenging. Effective interventions targeting at women are mainly represented by Childbirth training workshops, psychoeducation and psychosocial couple-based programs. Considering non medical interventions targeting mothers, the pattern of breathing during labor that can help for vaginal delivery is a controversial topic. There are no data to support a policy of directed maternal breathing or pushing during vaginal delivery.
The abdomino-perineal concept was originally a postpartum rehabilitation technique. Currently, applications are increasing. During labor, expiration channeled by a flow regulator device offers support to women enduring the pain of uterine contractions. During the second stage, the expiratory regulated pushing allows a long, efficient and very intuitive push.
The use of this regulated expiratory breathing method was introduced in the study unit in January 2018. Despite a positive experience both reported by women and midwives, investigators have so far only subjective feedback without objective measurable clinical impact.
As a result, investigators are conducting this scientific study whose main objective is:
- To Evaluate the impact of a regulated expiratory breathing method on childbirth process .
详细描述
Rates of cesarean delivery continue to rise worldwide, with recent (2016) reported rates of 24.5% in Western Europe, 32% in North America, and 41% in South America.
Primary cesarean deliveries account for more than half of all cesarean deliveries, and the most common indication for repeat cesarean delivery is previous cesarean delivery.
Consequently, the reduction in primary cesarean delivery rate represents a meaningful objective.
The factors affecting the rate of primary caesarean section births are complex, and identifying interventions to reduce this rate is challenging. Effective interventions targeting at women are mainly represented by Childbirth training workshops, psychoeducation and psychosocial couple-based programs. Considering non medical interventions targeting mothers, the pattern of breathing during labor that can help for vaginal delivery is a controversial topic. There are no data to support a policy of directed maternal breathing or pushing during vaginal delivery.
The abdomino-perineal concept was originally a postpartum rehabilitation technique. Currently, applications are increasing. Currently, applications are increasing. During labor, expiration channeled by a flow regulator device offers support to women enduring the pain of uterine contractions. During the second stage, the expiratory regulated pushing allows a long, efficient and very intuitive push.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparae
- •Singleton pregnancy
- •Gestational age ≥ 37 SA
- •Fetus in cephalic presentation
- •Fetus with a normal weight for a the gestational age
- •Spontaneous onset of labor
- •Early stage of labor (with cervical dilatation under 3 cm)
- •No previous Childbirth training workshops
排除标准
- •Parity of at least 2
- •Multiple pregnancy
- •Intra uterine fetal demise
- •Previous uterine scar
- •Fetus in Breach presentation
- •Non Vertex cephalic presentation
- •Narrowed pelvic bone diameters
- •A contraindication to vaginal delivery (placenta previa , fibroma previa, ...)
- •Previous participation to childbirth training workshops
- •Women in an advanced stage of labor with a cervical dilation upon admission over 3 cm
- •Women requiring epidural anesthesia
- •Refusal of participation
研究组 & 干预措施
WINNER- FLOW-URO-MG GROUP
After admission to the delivery room, all women assigned to WF + group will have an interview with one of the midwifes responsible for the study. The latter will explain the use of the WINNER FLOW®-URO MG® device which is the expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate. Then, WF+ patients will use the expiratory mouthpiece device during all their childbirth process.
干预措施: expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate. (Device)
NO WINNER-FLOW-URO-MG GROUP
Women enrolled in WF- group will be managed classically during their child birth process regardless to the study participation.
结局指标
主要结局
cesarean delivery rate
时间窗: through study completion, an average of 1 year
percentage of cesarean delivery in each group
次要结局
- Duration of first stage of labor(up to 10 hours . In deed , For each recruited patient this outcome will be measured in minutes between onset of labor and achievement of complete cervical dilation)
- duration of placental delivery(up to 20 minutes .Investigators will measure for each included patient the time in minutes elapsed between newborn delivery and placental expulsion.)
- Episiotomy rate(through study completion, an average of 1 year)
- rate of Intra-partum Fetal compromise(through study completion, an average of 1 year)
- Rate of Spontaneous vaginal birth(through study completion, an average of 1 year)
- Duration of the second stage of labor(up to one hour . In deed, investigators will measure for each included patient the time ( minutes ) elapsed from complete cervical dilation and newborn delivery)
- Rate of Instrumental vaginal birth(through study completion, an average of 1 year)
- Pain scores during labor and delivery(four times: up yo one hour, up to four hours, up to 8 hours , up to 10 hours)
研究者
Kaouther Dimassi
associate professor
University Tunis El Manar