Birth; ProlongedNCT04056793
Acceptability Assessment of an Optimized Birthing Position
A study testing Optimized birthing position in people with Birth; Prolonged, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
This qualitative study evaluates the acceptability of positioning pregnant women in labour in an optimized position, which consists in the hyperflexion of the legs and the loss of the lumbar lordosis. Twenty patients in situation of dystocia will adopt the described position for a limited amount of time. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth; Prolonged
- What is being tested?
- Optimized birthing position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Aug 2019to 1 Jan 2020
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Informed consent as documented by signature
- Parturient in situation of mechanical dystocia (non engagement at full dilation)
Who cannot join
- Inability or medical contraindications to undergo the investigated intervention (e.g. orthopaedic injury or disease preventing the parturient from adopting the optimised position)
- Clinically significant concomitant diseases
- Incapacity of judgment
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, etc.
- Foetus cardiac rhythm disorder
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: A Qualitative Study to Assess the Feasibility and Acceptability of an Optimized Birthing Position
This qualitative study evaluates the acceptability of positioning pregnant women in labour in an optimized position, which consists in the hyperflexion of the legs and the loss of the lumbar lordosis. Twenty patients in situation of dystocia will adopt the described position for a limited amount of time.
Read the detailed description
Recent data brings out that the Caesarian Section rate in Switzerland is quite high, reaching 33.4 %. Though, the reasons to this increasing amount of CS are not fully known. Therefore, it is absolutely necessary to expand the existing knowledge in different fields, including the biomechanics of childbirth. Numerous CS are performed in response to an obstructed labour, especially when the foetus does not engage in the pelvis near full dilatation. In order to manage such situations, midwifes currently position parturients in pragmatic postures. Although not verified by data, this care management suggests that it is possible to impact the position of the bone segments at stake for vaginal birth including pelvis and lumbar spine and to promote the descent of the foetus through the pelvic inlet plane. In his PhD thesis about vaginal birth biomechanics, Desseauve et al investigated this area and found out that an optimized position similar to the squatting position (hyperflexion of the thighs and loss of the lumbar lordosis) could be close to the perfect delivery position in terms of ability for the foetus to go through the pelvic inlet plane. Although these findings are encouraging, it is yet to be confirmed in clinical practice, particularly when a dystocia occurs. Prior to doing that, it is though necessary to validate the optimized posture in terms of acceptability in a qualitative clinical study. In this study, fifteen to twenty parturients who respond to the inclusion criteria and whose foetus does not engage in the pelvis near full dilation will be asked to adopt the optimized position for a twenty minutes period. The investigator will then consign information reflecting the progress of the labour on a data sheet.
- Conditions
- Birth; Prolonged
- Being tested
- Optimized birthing position
- Keywords
- Birthing position, Dystocia
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized birthing positionOther
The parturients will be asked to adopt a supine position with a hyperflexion of the thighs and a flat back, and to maintain the position for a duration of twenty minutes.
| Study group | Role | What they receive |
|---|---|---|
| Parturients in situation of dystocia | Experimental | Positioning of the parturients in an optimized birthing position Receives: Other: Optimized birthing position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the optimized birthing position assessed by calculating the average score obtained through the VAS
The Visual Analogue Scale will allow to obtain a score from 0 to 10, 0 standing for complete dissatisfaction and 10 for complete satisfaction of the participants
Measured: 20 minutes
Secondary outcomes (6)
Number of refusals
Number of parturients who will refuse to participate to the study
Measured: 20 minutes
Number of risk factors of non-engagement of the foetus at full dilation
The risk factors are constituted of macrosomy, medical induction of labour, artificial rupture of membranes, hypokinesia (<5 uterine contractions/min), use of oxytocin and presence of a peridural anaesthesia
Measured: 20 minutes
Neonatal adaptation assessed by the Apgar score
The Apgar score will be evaluated at 1, 5 and 10 minutes
Measured: 20 minutes
Birth outcome assessed by the percentage of vaginal delivery, Caesarian Section, delivery hemorrhage and perineal tear
Measured: 20 minutes
Weight of the foetus measured in kilograms
Measured: 20 minutes
Height and head circumference of the foetus measured in centimeters
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start6 Aug 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth; ProlongedStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAVID DESSEAUVE, Centre Hospitalier Universitaire Vaudois
- Investigators
- Pr David Baud - Médecin chef de service - MD, PHD, Study chair, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056793
- Sponsor's protocol ID
- 2019-00872
- Other IDs
- 2019
- Status last verified
- Feb 2021
- First submitted
- 9 Aug 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study to Assess the Feasibility and Acceptability of an Optimized Birthing Position
- ClinicalTrials.gov ID
- NCT04056793
- Acronym / sponsor ID
- 2019-00872
- Conditions
- Birth; Prolonged
- Keywords
- Birthing position, Dystocia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 14 Aug 2019 (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.
This qualitative study evaluates the acceptability of positioning pregnant women in labour in an optimized position, which consists in the hyperflexion of the legs and the loss of the lumbar lordosis. Twenty patients in situation of dystocia will adopt the described position for a limited amount of time.
Detailed description
Recent data brings out that the Caesarian Section rate in Switzerland is quite high, reaching 33.4 %. Though, the reasons to this increasing amount of CS are not fully known. Therefore, it is absolutely necessary to expand the existing knowledge in different fields, including the biomechanics of childbirth. Numerous CS are performed in response to an obstructed labour, especially when the foetus does not engage in the pelvis near full dilatation. In order to manage such situations, midwifes currently position parturients in pragmatic postures. Although not verified by data, this care management suggests that it is possible to impact the position of the bone segments at stake for vaginal birth including pelvis and lumbar spine and to promote the descent of the foetus through the pelvic inlet plane. In his PhD thesis about vaginal birth biomechanics, Desseauve et al investigated this area and found out that an optimized position similar to the squatting position (hyperflexion of the thighs and loss of the lumbar lordosis) could be close to the perfect delivery position in terms of ability for the foetus to go through the pelvic inlet plane. Although these findings are encouraging, it is yet to be confirmed in clinical practice, particularly when a dystocia occurs. Prior to doing that, it is though necessary to validate the optimized posture in terms of acceptability in a qualitative clinical study. In this study, fifteen to twenty parturients who respond to the inclusion criteria and whose foetus does not engage in the pelvis near full dilation will be asked to adopt the optimized position for a twenty minutes period. The investigator will then consign information reflecting the progress of the labour on a data sheet.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients in situation of dystocia | Experimental | Other: Optimized birthing positionPositioning of the parturients in an optimized birthing position |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent as documented by signature
- Parturient in situation of mechanical dystocia (non engagement at full dilation)
Key exclusion criteria (5 listed)
- Inability or medical contraindications to undergo the investigated intervention (e.g. orthopaedic injury or disease preventing the parturient from adopting the optimised position)
- Clinically significant concomitant diseases
- Incapacity of judgment
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, etc.
- Foetus cardiac rhythm disorder
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 |
|---|---|---|
| Optimized birthing positionThe parturients will be asked to adopt a supine position with a hyperflexion of the thighs and a flat back, and to maintain the position for a duration of twenty minutes. | Other | Parturients in situation of dystocia |
Primary outcome
Acceptability of the optimized birthing position assessed by calculating the average score obtained through the VAS
Time frame: 20 minutes
The Visual Analogue Scale will allow to obtain a score from 0 to 10, 0 standing for complete dissatisfaction and 10 for complete satisfaction of the participants
6 secondary outcomes
Number of refusals
Time frame: 20 minutes
Number of risk factors of non-engagement of the foetus at full dilation
Time frame: 20 minutes
Neonatal adaptation assessed by the Apgar score
Time frame: 20 minutes
Birth outcome assessed by the percentage of vaginal delivery, Caesarian Section, delivery hemorrhage and perineal tear
Time frame: 20 minutes
Weight of the foetus measured in kilograms
Time frame: 20 minutes
Height and head circumference of the foetus measured in centimeters
Time frame: 20 minutes
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 Feb 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.
Pr David Baud - Médecin chef de service - MD, PHD study chair
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized birthing position in people with Birth; Prolonged, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 2 inclusion and 5 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 Feb 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 Switzerland. 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?
Acceptability of the optimized birthing position assessed by calculating the average score obtained through the VAS (time frame: 20 minutes). 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 Feb 2021.