Regulated Expiratory Breathing Method During Childbirth

University Tunis El Manar

Status: Completed

Conditions: Childbirth

Treatments: Device: expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.

Study type: Interventional

Funder types: Other

Identifiers

NCT04219631

Winner flow-URO- MG Mongi Slim

Details and patient eligibility

About

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 .

Full description

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 .

Enrollment: 120 patients

Sex: Female

Ages: 18 to 46 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

WINNER- FLOW-URO-MG GROUP

Experimental group

Description:

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.

Treatment:

Device: expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.

NO WINNER-FLOW-URO-MG GROUP

No Intervention group

Description:

Women enrolled in WF- group will be managed classically during their child birth process regardless to the study participation.