Regulated Expiratory Breathing Method During Childbirth

March 15, 2021 updated by: Kaouther Dimassi, University Tunis El Manar

Results of Regulated Expiratory Breathing Method During Childbirth Process

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Sidi Daoued La Marsa
      • Tunis, Sidi Daoued La Marsa, Tunisia, 2045
        • Mongi Slim University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: expiration 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cesarean delivery rate
Time Frame: through study completion, an average of 1 year
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
Time Frame: 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
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
Time Frame: up to one hour . In deed, investigators will measure for each included patient the time ( minutes ) elapsed from complete cervical dilation and newborn delivery
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
Time Frame: up to 20 minutes .Investigators will measure for each included patient the time in minutes elapsed between newborn delivery and placental expulsion.
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
Time Frame: through study completion, an average of 1 year
percentage of natural vaginal birth in each group
through study completion, an average of 1 year
Rate of Instrumental vaginal birth
Time Frame: through study completion, an average of 1 year
percentage of use of forceps in case of vaginal birth
through study completion, an average of 1 year
Episiotomy rate
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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
Time Frame: four times: up yo one hour, up to four hours, up to 8 hours , up to 10 hours

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Tunis El Manar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Winner flow-URO- MG Mongi Slim

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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