Regulated Expiratory Breathing Method During Childbirth
NCT ID: NCT04219631
Last Updated: 2021-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
120 participants
INTERVENTIONAL
2020-02-01
2021-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 .
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Synthetic Oxytocin Administered During Labor on Breastfeedings
NCT01951040
Optimized Oxygen Delivery During General Anesthesia in Newborn Infants
NCT02698020
Immediate Skin-To-Skin Contact and Early Breastfeeding During Caesarean Section
NCT06543160
Effects of Relaxation and Guided Imagery Training on Pain at Childbirth
NCT00917332
Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
NCT03567031
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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 WINNER-FLOW-URO-MG GROUP
Women enrolled in WF- group will be managed classically during their child birth process regardless to the study participation.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
46 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Tunis El Manar
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kaouther Dimassi
associate professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mongi Slim University Hospital
Tunis, Sidi Daoued La Marsa, Tunisia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Winner flow-URO- MG Mongi Slim
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.