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Clinical Trials/NCT04302090
NCT04302090
Completed
Not Applicable

Changes in Pain Level With the Use of the Regulated Expiratory Method During Childbirth Process .

University Tunis El Manar1 site in 1 country30 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childbirth Process
Sponsor
University Tunis El Manar
Enrollment
30
Locations
1
Primary Endpoint
analgesia nociception index
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
March 15, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
University Tunis El Manar
Responsible Party
Principal Investigator
Principal Investigator

Kaouther Dimassi

associate professor obstetrics and gynecology faculty of medicine Tunis

University Tunis El Manar

Eligibility Criteria

Inclusion Criteria

  • women with a Gestational age of at least 30 weeks of amenorrhea
  • women with a Normal fetal heart rate before inclusion.
  • women having regular uterine contraction before inclusion .

Exclusion Criteria

  • Refusal of participation
  • Women requiring epidural anesthesia
  • Women in an advanced stage of labor with a cervical dilation upon admission over 3 cm
  • A medical contraindication to vaginal delivery .
  • Intra uterine fetal demise.
  • Previous participation to childbirth training workshops
  • Women without regular uterine contraction .
  • Gestational term \<30 weeks
  • fetal heart rate abnormalities

Outcomes

Primary Outcomes

analgesia nociception index

Time Frame: 60 minutes for each participant

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.

Secondary Outcomes

  • Patient's pain management experience(up to 12 hours In deed , For each recruited patient this outcome will be measured in minutes between onset of labor and delivery)

Study Sites (1)

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