Regulated Expiratory Breathing Method During Childbirth

Childbirth Clinical Trial

Official title:

Results of Regulated Expiratory Breathing Method During Childbirth Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219631
• Other study ID #: Winner flow-URO- MG Mongi Slim
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2021
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Childbirth
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Mongi Slim University Hospital	Tunis	Sidi Daoued La Marsa

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cesarean delivery rate	percentage of cesarean delivery in each group	through study completion, an average of 1 year
Secondary	Duration of first stage of labor	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
Secondary	Duration of the second stage of labor	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
Secondary	duration of placental delivery	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.
Secondary	Rate of Spontaneous vaginal birth	percentage of natural vaginal birth in each group	through study completion, an average of 1 year
Secondary	Rate of Instrumental vaginal birth	percentage of use of forceps in case of vaginal birth	through study completion, an average of 1 year
Secondary	Episiotomy rate	percentage of episiotomy in case of vaginal delivery in each group	through study completion, an average of 1 year
Secondary	rate of Intra-partum Fetal compromise	percentage of fetal heart rate observed during labor and delivery in each group	through study completion, an average of 1 year
Secondary	Pain scores during labor and delivery	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