An interventional study of Regulated expiratory method in Childbirth Process, sponsored by University Tunis El Manar. Completed at 1 site in Tunisia. Open to female participants aged 18 Years to 48 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by University Tunis El Manar · Not applicable, Interventional, and Supportive care
Historically, pain management during childbirth has been a primary concern in the obstetric community. In recent decades, childbirth care providers have been witnessing, especially in developed countries, a real revolution in terms of approaches around this unique moment of birth. This is how perinatal professionals are no longer concerned only with medical follow-up and the smooth running of pregnancy or the well-being of the newborn, but also with overall support for women by promoting their active participation in the childbirth process. To this end, several methods of pain management are offered to women during labor. The more documented are: locoregional (epidural) anesthesia and acupuncture. These two methods are rarely available in Tunisian public maternity hospitals where 80% of deliveries are managed. In addition, Childbirth training workshops, psychoeducation and psychosocial couple-based programs are not available in tunisian public maternities. For example, only one public structure offers a painless delivery program at Farhat Hached Sousse hospital.
In consequence, women arriving at the labor room, are largely unaware of the basic principles of childbirth process. They do not know how to manage their pain.
the application of the GUILLARME® method during labor is based on the use of a flow regulating device (Winner Flow + URO-MG®). By regulating the flow of breath during a uterine contraction, it allows better pain management. Despite a positive feedback not only from parturients but also from midwives who practiced this method, actually investigators have only subjective evaluation with no real measurable and objective impact on pain levels during childbirth process. Consequently, investigators are conducting this scientific study whose main objective is:
-To evaluate changes in pain level with the use of regulated expiratory method during childbirth process.
Historically, pain management during childbirth has been a primary concern in the obstetric community. In recent decades,childbirth care providers have been witnessing, especially in developed countries, a real revolution in terms of approaches around this unique moment of birth. This is how perinatal professionals are no longer concerned only with medical follow-up and the smooth running of pregnancy or the well-being of the newborn, but also with overall support for women by promoting their active participation in the childbirth process. To this end, several methods of pain management are offered to women during labor. The more documented are: locoregional (epidural) anesthesia and acupuncture. These two methods are rarely available in Tunisian public maternity hospitals where 80% of deliveries are managed. In addition, Childbirth training workshops, psychoeducation and psychosocial couple-based programs are not available in tunisian public maternities. For example, only one public structure offers a painless delivery program at Farhat Hached Sousse hospital.
In consequence, women arriving at the labor room, are largely unaware of the basic principles of childbirth process. They do not know how to manage their pain.
In order to overcome this situation, we introduced the GUILLARME® method to the obstetric care unit at Mongi Slim la Marsa hospital in January 2018. This method was originally a postpartum abdomino-perineal rehabilitation technique. It allows a functional abdominal rehabilitation by combining a regulated breath in a specific mouthpiece and an abdominal stimulation triggered by this same breath. The use of this method was extended to labor and childbirth. In fact, the application of the GUILLARME® method during labor is based on the use of a flow regulating device (Winner Flow + URO-MG®). By regulating the flow of breath during a uterine contraction, it allows better pain management. Despite a positive feedback not only from parturients but also from midwives who practiced this method, actually investigators have only subjective evaluation with no real measurable and objective impact on pain levels during childbirth process. Consequently, investigators are conducting this scientific study whose main objective is:
-To evaluate changes in pain level with the use of regulated expiratory method during childbirth process.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →University Tunis El Manar is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
each included patient will experience : * a period of consecutive spontaneous uterine contractions without using the regulated expiration mouthpiece * a period of consecutive uterine contractions managed by the regulated expiration method using the Winner flow
Other: Regulated expiratory method
This method was originally a postpartum abdomino-perineal rehabilitation technique. It allows a functional abdominal rehabilitation by combining a regulated breath in a specific mouthpiece and an abdominal stimulation triggered by this same breath. The use of this method was extended to labor and childbirth. In fact, the application of the method during labor is based on the use of a flow regulating device (Winner Flow + URO-MG®). By regulating the flow of breath during a uterine contraction, it allows better pain management.
Also known as: Winner flow Pro
analgesia nociception index
continuously measured by a monitor during the hole childbirth process. investigators will compare measured indexes during the two periods ( with intervention and without intervention. An index value close to 100 corresponds to a prominent parasympathetic tone (low stress level, analgesia) and a value close to 0 corresponds to a prominent sympathetic tone (high stress level, nociception). In parturients during labor or postoperative awake patients in the recovery room, a negative linear relationship between analgesia nociception index and pain scores is documented.
Time frame: 60 minutes for each participant
Patient's pain management experience
a questionnair Patient's pain management experience according to the use or no use of the expiration mouthpiece during childbirth process . estimation of Patient's pain management experience according to the use or no use of the expiration mouthpiece during childbirth process . Patient's pain management experience according to the use or no use of the expiration mouthpiece during childbirth process . estimation of patient's pain management experience according to the use or no use of the expiration mouthpiece during childbirth process using a questionnair
Time frame: up to 12 hours In deed , For each recruited patient this outcome will be measured in minutes between onset of labor and delivery
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2020 to primary completion in Feb 2021, 10 months.
Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 10 months is close to that.
Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University Tunis El Manar