Regulated Expiratory Breathing Method During Childbirth

Study Overview
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Brief Summary
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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 .

Detailed Description
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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. 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, we 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 .

Official Title
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Results of Regulated Expiratory Breathing Method During Childbirth Process

Conditions
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Childbirth

Intervention / Treatment
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* Device: expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WINNER- FLOW-URO-MG GROUP<br>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. | Device: expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.<br>* women enrolled in WINNER-FLOW-URO-MG group will freely use the expiratory mouthpiece device during all their childbirth process.<br>|
| No Intervention: NO WINNER-FLOW-URO-MG GROUP<br>Women enrolled in WF- group will be managed classically during their child birth process regardless to the study participation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cesarean delivery rate | percentage of cesarean delivery in each group | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of first stage of labor | For each recruited patient this outcome will be measured in minutes between onset of labor and achievement of complete cervical dilation | 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 the second stage of labor | For each included patient investigators will measure in minutes the time elapsed from complete cervical dilation and newborn delivery | up to one hour . In deed, investigators will measure for each included patient the time ( minutes ) elapsed from complete cervical dilation and newborn delivery | 
| duration of placental delivery | Investigators will measure for each included patient the time in minutes elapsed between newborn delivery and placental expulsion. | up to 20 minutes .Investigators will measure for each included patient the time in minutes elapsed between newborn delivery and placental expulsion. | 
| Rate of Spontaneous vaginal birth | percentage of natural vaginal birth in each group | through study completion, an average of 1 year | 
| Rate of Instrumental vaginal birth | percentage of use of forceps in case of vaginal birth | through study completion, an average of 1 year | 
| Episiotomy rate | percentage of episiotomy in case of vaginal delivery in each group | through study completion, an average of 1 year | 
| rate of Intra-partum Fetal compromise | percentage of fetal heart rate observed during labor and delivery in each group | through study completion, an average of 1 year | 
| Pain scores during labor and delivery | pain assessment will use Visual Analogue Scale for Pain (VAS Pain) intensity ( The pain VAS is a single-item scale.For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale] ) During childbirth process, pain assessment will be repeated four times: First assessment during early first stage of labor with a cervix dilation less than 3 cm Second assessment during advanced first stage of labor with a cervix dilation Over 3 cm and less than 10 cm Third assessment during second stage of labor at complete cervix dilation Fourth assessment during the pushing process | four times: up yo one hour, up to four hours, up to 8 hours , up to 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delivery, cesarean, expiration, exercise, labor