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 .
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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
120
women enrolled in WINNER-FLOW-URO-MG group will freely use the expiratory mouthpiece device during all their childbirth process.
Mongi Slim University Hospital
Tunis, Sidi Daoued La Marsa, Tunisia
cesarean delivery rate
percentage of cesarean delivery in each group
Time frame: through study completion, an average of 1 year
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
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
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
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
duration of placental delivery
Investigators will measure for each included patient the time in minutes elapsed between newborn delivery and placental expulsion.
Time frame: up to 20 minutes .Investigators will measure for each included patient the time in minutes elapsed between newborn delivery and placental expulsion.
Rate of Spontaneous vaginal birth
percentage of natural vaginal birth in each group
Time frame: through study completion, an average of 1 year
Rate of Instrumental vaginal birth
percentage of use of forceps in case of vaginal birth
Time frame: through study completion, an average of 1 year
Episiotomy rate
percentage of episiotomy in case of vaginal delivery in each group
Time frame: through study completion, an average of 1 year
rate of Intra-partum Fetal compromise
percentage of fetal heart rate observed during labor and delivery in each group
Time frame: through study completion, an average of 1 year
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
Time frame: four times: up yo one hour, up to four hours, up to 8 hours , up to 10 hours
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