Regulated Expiratory Breathing Method During Childbirth

NCT04219631 | Completed

• 1 other identifier: Winner flow-URO- MG Mongi Slim
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Childbirth

Keywords

delivery; cesarean; expiration; exercise; labor

Outcome Measures

Primary Outcomes (1)

• cesarean delivery rate

  percentage of cesarean delivery in each group

  through study completion, an average of 1 year

Secondary Outcomes (8)

• 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 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

• 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.

• Rate of Spontaneous vaginal birth

  through study completion, an average of 1 year

• Rate of Instrumental vaginal birth

  through study completion, an average of 1 year

Study Arms (2)

WINNER- FLOW-URO-MG GROUP

EXPERIMENTAL

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.

NO WINNER-FLOW-URO-MG GROUP

NO INTERVENTION

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

Interventions

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

women enrolled in WINNER-FLOW-URO-MG group will freely use the expiratory mouthpiece device during all their childbirth process.

WINNER- FLOW-URO-MG GROUP

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Mongi Slim University Hospital

Tunis, Sidi Daoued La Marsa, 2045, Tunisia

Location

Related Publications (1)

• Dimassi K, Halouani A, Ben Zina F, Khemessi N, Triki A. Regulated Expiratory Methods During Childbirth Process: A Randomized Controlled Trial. J Obstet Gynaecol Can. 2024 Mar;46(3):102265. doi: 10.1016/j.jogc.2023.102265. Epub 2023 Nov 7.

  PMID: 37940044 DERIVED

MeSH Terms

Conditions

Death; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 7, 2020
• Study Start: February 1, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

TU (1)