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Completed

NCT Number: NCT04219631

Regulated Expiratory Breathing Method During Childbirth

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 .

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Key information

Conditions

Childbirth Behavior Death Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mongi Slim University Hospital

Tunis, Sidi Daoued La Marsa, 2045, Tunisia

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. cesarean delivery rate

    Time frame: through study completion, an average of 1 year

    percentage of cesarean delivery in each group

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. Rate of Spontaneous vaginal birth

    Time frame: through study completion, an average of 1 year

    percentage of natural vaginal birth in each group

  5. 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

  6. Episiotomy rate

    Time frame: through study completion, an average of 1 year

    percentage of episiotomy in case of vaginal delivery in each group

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Results of Regulated Expiratory Breathing Method During Childbirth Process

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2020
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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