Clinical Trials Directory

Trials / Completed

CompletedNCT04219631

Regulated Expiratory Breathing Method During Childbirth

Results of Regulated Expiratory Breathing Method During Childbirth Process

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
University Tunis El Manar · Academic / Other
Sex
Female
Age
18 Years – 46 Years
Healthy volunteers
Not accepted

Summary

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

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 .

Conditions

Interventions

TypeNameDescription
DEVICEexpiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.women enrolled in WINNER-FLOW-URO-MG group will freely use the expiratory mouthpiece device during all their childbirth process.

Timeline

Start date
2020-02-01
Primary completion
2021-03-15
Completion
2021-03-15
First posted
2020-01-07
Last updated
2021-03-16

Locations

1 site across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT04219631. Inclusion in this directory is not an endorsement.