Childbirth ProcessNCT04302090
Changes in Pain Level With the Use of the Regulated Expiratory Method.
A study testing Regulated expiratory method in people with Childbirth Process, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth Process
- What is being tested?
- Regulated expiratory method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Apr 2020to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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
Show all 9Show fewer
- Women without regular uterine contraction .
- Gestational term <30 weeks
- fetal heart rate abnormalities
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Mongi Slim University Hospital
La Marsa, Tunis Governorate, 2045
About this study
Official title: Changes in Pain Level With the Use of the 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.
Read more
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.
Read the 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.
- Conditions
- Childbirth Process
- Being tested
- Regulated expiratory method
- Keywords
- pain, childbirth, delivery, expiration, exercise, mothers
- Medical subject headings
- Pain, Death, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulated expiratory methodOther
Also called Winner flow Pro
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.
| Study group | Role | What they receive |
|---|---|---|
| pain level changes according to the use of the Winner flow | Experimental | 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 Receives: Other: Regulated expiratory method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes for each participant
Secondary outcomes (1)
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
Measured: up to 12 hours In deed , For each recruited patient this outcome will be measured in minutes between onset of labor and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Apr 2020
- Primary completion28 Feb 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth ProcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will experience successives periods A period of 4 consecutive contractions without using the expiration mouthpiece and a second period of 4 consecutive contractions using the the expiration mouthpiece . pain levels measured in each period will be compared for the same participant
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaouther Dimassi, University Tunis El Manar
- Investigators
- kaouther dimassi, MD, Principal investigator, university tunis el manar , faculty of medicine Tunis, TUNISIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302090
- Sponsor's protocol ID
- Doloris-Winner-flow-URO-MG
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pain Level With the Use of the Regulated Expiratory Method During Childbirth Process .
- ClinicalTrials.gov ID
- NCT04302090
- Acronym / sponsor ID
- Doloris-Winner-flow-URO-MG
- Conditions
- Childbirth Process
- Keywords
- pain, childbirth, delivery, expiration, exercise, mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will experience successives periods A period of 4 consecutive contractions without using the expiration mouthpiece and a second period of 4 consecutive contractions using the the expiration mouthpiece . pain levels measured in each period will be compared for the same participant
| Arm | Type | Receives |
|---|---|---|
| pain level changes according to the use of the Winner flow | Experimental | Other: Regulated expiratory methodeach 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 |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regulated expiratory methodAlso: Winner flow ProThis 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. | Other | pain level changes according to the use of the Winner flow |
Primary outcome
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.
1 secondary outcome
Patient's pain management experience
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kaouther dimassi, MD principal investigator
university tunis el manar , faculty of medicine Tunis, TUNISIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulated expiratory method in people with Childbirth Process, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesia nociception index (time frame: 60 minutes for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.