Clinical trial NCT04219631: Regulated Expiratory Breathing Method During Childbirth
Official title: Results of Regulated Expiratory Breathing Method During Childbirth Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth
Keywords: delivery
cesarean
expiration
exercise
labor
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 .

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 .

Eligibility criteria: 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

Primary outcomes:
measure: cesarean delivery rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Duration of first stage of labor
timeFrame: 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
measure: Duration of the second stage of labor
timeFrame: up to one hour . In deed, investigators will measure for each included patient the time ( minutes ) elapsed from complete cervical dilation and newborn delivery
measure: duration of placental delivery
timeFrame: up to 20 minutes .Investigators will measure for each included patient the time in minutes elapsed between newborn delivery and placental expulsion.
measure: Rate of Spontaneous vaginal birth
timeFrame: through study completion, an average of 1 year
measure: Rate of Instrumental vaginal birth
timeFrame: through study completion, an average of 1 year
measure: Episiotomy rate
timeFrame: through study completion, an average of 1 year
measure: rate of Intra-partum Fetal compromise
timeFrame: through study completion, an average of 1 year
measure: Pain scores during labor and delivery
timeFrame: four times: up yo one hour, up to four hours, up to 8 hours , up to 10 hours
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim University Hospital
state: Sidi Daoued La Marsa
Study officials:
References: