ChildbirthNCT04219631
Regulated Expiratory Breathing Method During Childbirth
A study testing expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate. in people with Childbirth, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Childbirth
- What is being tested?
- expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Feb 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 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Parity of at least 2
- Multiple pregnancy
- Intra uterine fetal demise
- Previous uterine scar
- Fetus in Breach presentation
- Non Vertex cephalic presentation
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Mongi Slim University Hospital
Tunis, Sidi Daoued La Marsa, 2045
About this study
Official title: Results of Regulated Expiratory Breathing Method During Childbirth Process
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.
Read more
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 .
Read the 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 .
- Conditions
- Childbirth
- Being tested
- expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.
- Keywords
- delivery, cesarean, expiration, exercise, labor
- Medical subject headings
- Death, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.Device
women enrolled in WINNER-FLOW-URO-MG group will freely use the expiratory mouthpiece device during all their childbirth process.
| Study group | Role | What they receive |
|---|---|---|
| WINNER- FLOW-URO-MG GROUP | Experimental | After admission to the delivery room, all women assigned to WF + group will have an interview with one of the midwifes responsible for the study. The latter will explain the use of the WINNER FLOW®-URO MG® device which is the expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate. Then, WF+ patients will use the expiratory mouthpiece device during all their childbirth process. Receives: Device: expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate. |
| NO WINNER-FLOW-URO-MG GROUP | No intervention | Women enrolled in WF- group will be managed classically during their child birth process regardless to the study participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cesarean delivery rate
percentage of cesarean delivery in each group
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: through study completion, an average of 1 year
Rate of Instrumental vaginal birth
percentage of use of forceps in case of vaginal birth
Measured: through study completion, an average of 1 year
Episiotomy rate
percentage of episiotomy in case of vaginal delivery in each group
Measured: 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
Measured: 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
Measured: four times: up yo one hour, up to four hours, up to 8 hours , up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Feb 2020
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildbirthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219631
- Sponsor's protocol ID
- Winner flow-URO- MG Mongi Slim
- Status last verified
- Mar 2021
- First submitted
- 19 Dec 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dimassi K, Halouani A, Ben Zina F, Khemessi N, Triki A. Regulated Expiratory Methods During Childbirth Process: A Randomized Controlled Trial. J Obstet Gynaecol Can. 2024 Mar;46(3):102265. doi: 10.1016/j.jogc.2023.102265. Epub 2023 Nov 7.
PubMed 37940044
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
- Results of Regulated Expiratory Breathing Method During Childbirth Process
- ClinicalTrials.gov ID
- NCT04219631
- Acronym / sponsor ID
- Winner flow-URO- MG Mongi Slim
- Conditions
- Childbirth
- Keywords
- delivery, cesarean, expiration, exercise, labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 7 Jan 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.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WINNER- FLOW-URO-MG GROUP | Experimental | Device: expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.After admission to the delivery room, all women assigned to WF + group will have an interview with one of the midwifes responsible for the study. The latter will explain the use of the WINNER FLOW®-URO MG® device which is the expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate. Then, WF+ patients will use the expiratory mouthpiece device during all their childbirth process. |
| NO WINNER-FLOW-URO-MG GROUP | No intervention | –Women enrolled in WF- group will be managed classically during their child birth process regardless to the study participation. |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Primiparae
- Singleton pregnancy
- Gestational age ≥ 37 SA
- Fetus in cephalic presentation
- Fetus with a normal weight for a the gestational age
Key exclusion criteria (12 listed)
- Parity of at least 2
- Multiple pregnancy
- Intra uterine fetal demise
- Previous uterine scar
- Fetus in Breach presentation
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 |
|---|---|---|
| expiration 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. | Device | WINNER- FLOW-URO-MG GROUP |
Primary outcome
cesarean delivery rate
Time frame: through study completion, an average of 1 year
percentage of cesarean delivery in each group
8 secondary outcomes
Duration of first stage of labor
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
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
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
Time frame: through study completion, an average of 1 year
Rate of Instrumental vaginal birth
Time frame: through study completion, an average of 1 year
Episiotomy rate
Time frame: through study completion, an average of 1 year
rate of Intra-partum Fetal compromise
Time frame: through study completion, an average of 1 year
Pain scores during labor and delivery
Time frame: four times: up yo one hour, up to four hours, up to 8 hours , up to 10 hours
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.
- Derived from this study: PubMed 37940044Dimassi K, Halouani A, Ben Zina F, Khemessi N, Triki A. Regulated Expiratory Methods During Childbirth Process: A Randomized Controlled Trial. J Obstet Gynaecol Can. 2024 Mar;46(3):102265. doi: 10.1016/j.jogc.2023.102265. Epub 2023 Nov 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate. in people with Childbirth, 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 8 inclusion and 12 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?
cesarean delivery rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04219631, which also lists 1 linked publication.
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.