Epidural Analgesia for Labour and DeliveryIP3NCT04754282
Cross-legged Versus Traditional Sitting Position for the Success of Epidural Analgesia During Labor
A study testing Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP) and Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP) in people with Epidural Analgesia for Labour and Delivery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epidural Analgesia for Labour and Delivery
- What is being tested?
- Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP) and Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2021to 26 Mar 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women admitted to the delivery room and requesting an epidural analgesia during labour
- Written informed consent
- French speaking patient
Who cannot join
- Patient with a contraindication to neuraxial analgesia
- Impossibility for the patient to seat in a cross-legged position
- No health insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Cross-legged Versus Traditional Sitting Position for the Success of an Epidural Analgesia Catheter Placement During Labor
The success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. In most cases, insertion of the epidural analgesia catheter is performed in sitting position or in lateral decubitus, the choice being generally guided by the preference of the anesthetist.
According to anesthetists' experience in the obstetrical anesthesia unit at Necker-Enfants Malades hospital, a cross-legged sitting position is comfortable for parturients, restricts interfering movements during the procedure, and provides adequate widening of interspinous spaces. This position results in knees and hips flexion, tilting the pelvis backward and opening the interspinous spaces, while limiting muscular strain to maintain the position. However, literature on this matter is scarce.
The aim of this study is to prove the superiority of the cross-legged position for successful placement of the epidural analgesia catheter at the first puncture without needle reorientation compared to a traditional sitting position on the edge of the bed.
Read the detailed description
Labour pain is one of the most intense pain known. To relieve this pain, epidural analgesia is both the most effective and the safest technique. An epidural analgesia catheter also allows for anesthesia in the event of the need for instrumental extraction or emergency caesarean section; it is thus recommended by learned societies.
The 2016 national perinatal survey conducted by the National Institute of Health and Medical Research (INSERM) and the Directorate of Research, Studies, Evaluation and Statistics (DREES) in France revealed that more than 80% of women had chosen to benefit from an epidural analgesia during labour. The first puncture failure rate ranges from 3% to almost 40% depending on the study. Identified factors for difficult epidural analgesia catheter placement were: non-palpable spinous processes, obesity, spine deformity, inability for the patient to maintain an adequate position and poor experience of the operator.
The success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. Different positions have been described: the lateral decubitus, the traditional sitting position, and its variants such as the squatting position, the "hamstring stretch" position, the "pendant position" (with a bilateral axillary support) and more recently the cross-legged position. In most cases, insertion of the epidural analgesia catheter is performed in sitting position or in lateral decubitus, the choice being generally guided by the preference of the anesthetist.
According to anesthetists' experience in the obstetrical anesthesia unit at Necker-Enfants Malades hospital, a cross-legged sitting position is comfortable for parturients, restricts interfering movements during the procedure, and provides adequate widening of interspinous spaces. This position results in knees and hips flexion, tilting the pelvis backward and opening the interspinous spaces, while limiting muscular strain to maintain the position. However, literature on this matter is scarce.
The aim of this study is to prove the superiority of the cross-legged position for successful placement of the epidural analgesia catheter at the first puncture without needle reorientation compared to a traditional sitting position on the edge of the bed.
- Being tested
- Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP), Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)
- Keywords
- Epidural anesthesia, Sitting position, Cross-legged position, Labour, Pain, Obstetric
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP)Other
Also called Traditional Sitting Position (TSP)
Labouring women admitted to the delivery room of Necker Enfants Malades hospital, requesting an epidural analgesia for labour, and willing to participate in our study will be randomized in the Traditional Sitting Position (TSP) group on odd days or in the Cross-legged Sitting Position (CSP) group on even days.
Patients in the TSP group seat on the edge of the bed, their feet laid on a support set next to the bed. Patients in the CSP group also seat on the edge the bed, but in a so-called "tailor" position, their knees bent, their hips flexed and in abduction, their feet under each contralateral thigh.
The epidural catheter will be placed according to standard local practice in either of the groups.
Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)Other
Also called Cross-legged Sitting Position (CSP)
Labouring women admitted to the delivery room of Necker Enfants Malades hospital, requesting an epidural analgesia for labour, and willing to participate in our study will be randomized in the Traditional Sitting Position (TSP) group on odd days or in the Cross-legged Sitting Position (CSP) group on even days.
Patients in the TSP group seat on the edge of the bed, their feet laid on a support set next to the bed. Patients in the CSP group also seat on the edge the bed, but in a so-called "tailor" position, their knees bent, their hips flexed and in abduction, their feet under each contralateral thigh.
The epidural catheter will be placed according to standard local practice in either of the groups.
| Study group | Role | What they receive |
|---|---|---|
| Traditional sitting position | Active comparator | Expecting women are positioned in a traditional sitting position for epidural analgesia catheter placement during labour. Receives: Other: Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP) |
| Cross-legged sitting position | Experimental | Expecting women are positioned in a crosse-legged sitting position for epidural analgesia catheter placement during labour. Receives: Other: Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural analgesia success rate
Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation
Measured: 20 minutes
Secondary outcomes (6)
Patient's comfort
Visual Analog Scale (VAS) comfort score (0 (maximum discomfort) to 10 (maximum comfort)) of parturients during the epidural analgesia catheter placement
Measured: 20 minutes
Patient's pain
VAS pain score (0 (no pain) to 10 (worst imaginable pain)) of parturients during the epidural analgesia catheter placement
Measured: 20 minutes
Epidural analgesia success rate in obese patients
Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation in the subpopulation of obese patients
Measured: 20 minutes
Successful rate of epidural analgesia catheter placement by residents
Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation for epidurals placed by anaesthetist residents
Measured: 20 minutes
Operator satisfaction
VAS satisfaction score (0 (maximum dissatisfaction) to 10 (maximum satisfaction)) of the operator in relation to the parturient's position during the procedure
Measured: 20 minutes
Adverse event occurrence rate
Percentage of intra-vascular catheter position, dura-mater puncture, paraesthesia, hypotension after epidural analgesia initiation
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 posted15 Feb 2021
- Study start24 Feb 2021
- Primary completion26 Mar 2022
- Study completion26 Mar 2022
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 Epidural Analgesia for Labour and DeliveryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Hawa KEITA-MEYER, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisKevin SEREY, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754282
- Sponsor's protocol ID
- APHP201193
- Other IDs
- 2020-A02267-32
- Acronym
- IP3
- Status last verified
- Sep 2025
- First submitted
- 10 Feb 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serey K, Osse L, Repesse X, Babou J, Banna L, Ayoub M, Elseblani R, Brebion M, Keita H. Cross-legged position versus traditional sitting position for epidural catheter insertion for labor analgesia: a non-randomized prospective study. Int J Obstet Anesth. 2024 Feb;57:103938. doi: 10.1016/j.ijoa.2023.103938. Epub 2023 Oct 11. No abstract available.
PubMed 37891125
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Cross-legged Versus Traditional Sitting Position for the Success of an Epidural Analgesia Catheter Placement During Labor
- ClinicalTrials.gov ID
- NCT04754282
- Acronym / sponsor ID
- IP3 / APHP201193
- Keywords
- Epidural anesthesia, Sitting position, Cross-legged position, Labour, Pain, Obstetric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 15 Feb 2021 (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 success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. In most cases, insertion of the epidural analgesia catheter is performed in sitting position or in lateral decubitus, the choice being generally guided by the preference of the anesthetist.
According to anesthetists' experience in the obstetrical anesthesia unit at Necker-Enfants Malades hospital, a cross-legged sitting position is comfortable for parturients, restricts interfering movements during the procedure, and provides adequate widening of interspinous spaces. This position results in knees and hips flexion, tilting the pelvis backward and opening the interspinous spaces, while limiting muscular strain to maintain the position. However, literature on this matter is scarce.
The aim of this study is to prove the superiority of the cross-legged position for successful placement of the epidural analgesia catheter at the first puncture without needle reorientation compared to a traditional sitting position on the edge of the bed.
Detailed description
Labour pain is one of the most intense pain known. To relieve this pain, epidural analgesia is both the most effective and the safest technique. An epidural analgesia catheter also allows for anesthesia in the event of the need for instrumental extraction or emergency caesarean section; it is thus recommended by learned societies.
The 2016 national perinatal survey conducted by the National Institute of Health and Medical Research (INSERM) and the Directorate of Research, Studies, Evaluation and Statistics (DREES) in France revealed that more than 80% of women had chosen to benefit from an epidural analgesia during labour. The first puncture failure rate ranges from 3% to almost 40% depending on the study. Identified factors for difficult epidural analgesia catheter placement were: non-palpable spinous processes, obesity, spine deformity, inability for the patient to maintain an adequate position and poor experience of the operator.
The success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. Different positions have been described: the lateral decubitus, the traditional sitting position, and its variants such as the squatting position, the "hamstring stretch" position, the "pendant position" (with a bilateral axillary support) and more recently the cross-legged position. In most cases, insertion of the epidural analgesia catheter is performed in sitting position or in lateral decubitus, the choice being generally guided by the preference of the anesthetist.
According to anesthetists' experience in the obstetrical anesthesia unit at Necker-Enfants Malades hospital, a cross-legged sitting position is comfortable for parturients, restricts interfering movements during the procedure, and provides adequate widening of interspinous spaces. This position results in knees and hips flexion, tilting the pelvis backward and opening the interspinous spaces, while limiting muscular strain to maintain the position. However, literature on this matter is scarce.
The aim of this study is to prove the superiority of the cross-legged position for successful placement of the epidural analgesia catheter at the first puncture without needle reorientation compared to a traditional sitting position on the edge of the bed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional sitting position | Active comparator | Other: Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP)Expecting women are positioned in a traditional sitting position for epidural analgesia catheter placement during labour. |
| Cross-legged sitting position | Experimental | Other: Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)Expecting women are positioned in a crosse-legged sitting position for epidural analgesia catheter placement during labour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult women admitted to the delivery room and requesting an epidural analgesia during labour
- Written informed consent
- French speaking patient
Key exclusion criteria (3 listed)
- Patient with a contraindication to neuraxial analgesia
- Impossibility for the patient to seat in a cross-legged position
- No health insurance
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 |
|---|---|---|
| Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP)Also: Traditional Sitting Position (TSP)Labouring women admitted to the delivery room of Necker Enfants Malades hospital, requesting an epidural analgesia for labour, and willing to participate in our study will be randomized in the Traditional Sitting Position (TSP) group on odd days or in the Cross-legged Sitting Position (CSP) group on even days. Patients in the TSP group seat on the edge of the bed, their feet laid on a support set next to the bed. Patients in the CSP group also seat on the edge the bed, but in a so-called "tailor" position, their knees bent, their hips flexed and in abduction, their feet under each contralateral thigh. The epidural catheter will be placed according to standard local practice in either of the groups. | Other | Traditional sitting position |
| Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)Also: Cross-legged Sitting Position (CSP)Labouring women admitted to the delivery room of Necker Enfants Malades hospital, requesting an epidural analgesia for labour, and willing to participate in our study will be randomized in the Traditional Sitting Position (TSP) group on odd days or in the Cross-legged Sitting Position (CSP) group on even days. Patients in the TSP group seat on the edge of the bed, their feet laid on a support set next to the bed. Patients in the CSP group also seat on the edge the bed, but in a so-called "tailor" position, their knees bent, their hips flexed and in abduction, their feet under each contralateral thigh. The epidural catheter will be placed according to standard local practice in either of the groups. | Other | Cross-legged sitting position |
Primary outcome
Epidural analgesia success rate
Time frame: 20 minutes
Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation
6 secondary outcomes
Patient's comfort
Time frame: 20 minutes
Patient's pain
Time frame: 20 minutes
Epidural analgesia success rate in obese patients
Time frame: 20 minutes
Successful rate of epidural analgesia catheter placement by residents
Time frame: 20 minutes
Operator satisfaction
Time frame: 20 minutes
Adverse event occurrence rate
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 6 Mar 2026.
- Results publication: PubMed 37891125Serey K, Osse L, Repesse X, Babou J, Banna L, Ayoub M, Elseblani R, Brebion M, Keita H. Cross-legged position versus traditional sitting position for epidural catheter insertion for labor analgesia: a non-randomized prospective study. Int J Obstet Anesth. 2024 Feb;57:103938. doi: 10.1016/j.ijoa.2023.103938. Epub 2023 Oct 11. No abstract available.
- 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.
Hawa KEITA-MEYER, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Kevin SEREY, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP) and Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP) in people with Epidural Analgesia for Labour and Delivery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 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 6 Mar 2026. 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 France. 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?
Epidural analgesia success rate (time frame: 20 minutes). 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 NCT04754282, 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 6 Mar 2026.