Childbirth
Conditions
Keywords
delivery, cesarean, expiration, exercise, labor
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 .
Interventions
DEVICEexpiration 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.
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 46 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cesarean delivery rate | through study completion, an average of 1 year | percentage of cesarean delivery in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | For each included patient investigators will measure in minutes the time 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. | 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 | percentage of natural vaginal birth in each group |
| 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 | For each recruited patient this outcome will be measured in minutes between onset of labor and achievement of complete cervical dilation |
| Episiotomy rate | through study completion, an average of 1 year | percentage of episiotomy in case of vaginal delivery in each group |
| rate of Intra-partum Fetal compromise | through study completion, an average of 1 year | percentage of fetal heart rate observed during labor and delivery in each group |
| Pain scores during labor and delivery | 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 |
| Rate of Instrumental vaginal birth | through study completion, an average of 1 year | percentage of use of forceps in case of vaginal birth |
Countries
Tunisia
Outcome results
None listed