Fetal Occipitoposterior Position During the LaborEVADELANCT01854450
Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position
A study testing Asymmetrical Lateral Decubitus in people with Fetal Occipitoposterior Position During the Labor, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal position in anterior. Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the fetal head. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Occipitoposterior Position During the Labor
- What is being tested?
- Asymmetrical Lateral Decubitus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 4 sitesFrance
- Study dates
- May 2013to May 2015
- 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
- women older than 18 years
- Gestational age ≥ 37SA,
- Ruptured membranes,
- single living fetus in cephalic presentation with an occipitoposterior position clinically diagnosed between 2 and 9 cm dilated and confirmed by ultrasound.
- Affiliation to a social security scheme (beneficiary or assignee)
- Signing the consent
Who cannot join
- Fetal presentation other than posterior
- Multiple pregnancy,
- Breech presentation
- History of previous cesarean section
- Fetal death in utero, termination of pregnancy
- Fetal intrauterine fetal growth restriction <5e percentile,
Show all 10Show fewer
- Fetal malformation,
- Women younger than 18 years old,
- Women do not understand French,
- Women with psychiatric condition
Trial locations and contacts
4 sites in 1 country.
France4 sites
Maternité du CH d'Avranches-Granville
Avranches-Granville
CHU côte de nacre
Caen
Port-Royal Maternity Hospital
Paris, 75005
bluets maternity Hospital
Paris
About this study
Official title: Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial
Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal position in anterior.
Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the fetal head.
Read the detailed description
The prevalence of fetal occipitoposterior position during labor is 20%. Compared to anterior positions, they are known to be at higher risk of complications (cesarean section, instrumental delivery, severe perineal laceration).
Maternal posturing is used during labor to facilitate the rotation of the fetal head in anterior position. Asymmetrical lateral decubitus is used frequently, without having ever been evaluated.
Our study aims to evaluate the efficacy of this maternal posturing, through a randomized open trial.
We hypothesized that posturing women in asymmetrical lateral decubitus allows increasing frequency of anterior fetal position after 1 hour.
- Being tested
- Asymmetrical Lateral Decubitus, control
- Keywords
- Occipitoposterior position, Maternal posturing, Labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asymmetrical Lateral DecubitusOther
Also called maternal posturing
After randomization, women are postured in pronounced lateral decubitus (side opposite to the back of the fetus), with the inferior leg in extension, and the superior leg in hyperflexion, during 1 hour (minimum 30 minutes).
Then, women are encouraged to take this posture during labor as frequently as possible if the fetus remains in occipitoposterior position
controlOther
usual obstetrical care
| Study group | Role | What they receive |
|---|---|---|
| Asymmetrical Lateral Decubitus | Experimental | Women in labor are postured in pronounced lateral decubitus (side opposite to the back of the fetus), with the inferior leg in extension, and the superior leg in hyperflexion Receives: Other: Asymmetrical Lateral Decubitus |
| control | Other | usual obstetrical care Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal head position
fetal head position one hour after randomization
Measured: 1 hour
Secondary outcomes (4)
fetal head position
Clinical evaluation of the fetal head position at diagnosis of full cervical dilatation confirmed with ultrasound
Measured: at diagnosis of full dilatation
Speed of cervical dilatation
Duration of labor between randomization and full dilatation
Measured: during the first stage of labour
Mode of delivery and perineal complications
Mode of delivery (spontaneous vaginal, instrumental vaginal delivery, cesarean section) and perineal complications (episiotomy, severe perineal tears).
Measured: at delivery
feasibility and acceptability of asymmetrical lateral decubitus
quality of fetal heart rate monitoring during maternal posturing Evaluation of maternal satisfaction using self-administered questionnaire
Measured: during and after labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMay 2015
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 Fetal Occipitoposterior Position During the LaborStudies 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
- 326 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
- Camille Le Ray, MD, PhD, Principal investigator, Port-Royal Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854450
- Sponsor's protocol ID
- P120902
- Other IDs
- 2012-A01578-35
- Acronym
- EVADELA
- Status last verified
- Aug 2025
- First submitted
- 13 May 2013
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Ray C, Lepleux F, De La Calle A, Guerin J, Sellam N, Dreyfus M, Chantry AA. Lateral asymmetric decubitus position for the rotation of occipito-posterior positions: multicenter randomized controlled trial EVADELA. Am J Obstet Gynecol. 2016 Oct;215(4):511.e1-7. doi: 10.1016/j.ajog.2016.05.033. Epub 2016 May 27.
PubMed 27242201
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial
- ClinicalTrials.gov ID
- NCT01854450
- Acronym / sponsor ID
- EVADELA / P120902
- Keywords
- Occipitoposterior position, Maternal posturing, Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 May 2013 (estimated)
- 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.
Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal position in anterior.
Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the fetal head.
Detailed description
The prevalence of fetal occipitoposterior position during labor is 20%. Compared to anterior positions, they are known to be at higher risk of complications (cesarean section, instrumental delivery, severe perineal laceration).
Maternal posturing is used during labor to facilitate the rotation of the fetal head in anterior position. Asymmetrical lateral decubitus is used frequently, without having ever been evaluated.
Our study aims to evaluate the efficacy of this maternal posturing, through a randomized open trial.
We hypothesized that posturing women in asymmetrical lateral decubitus allows increasing frequency of anterior fetal position after 1 hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymmetrical Lateral Decubitus | Experimental | Other: Asymmetrical Lateral DecubitusWomen in labor are postured in pronounced lateral decubitus (side opposite to the back of the fetus), with the inferior leg in extension, and the superior leg in hyperflexion |
| control | Other | Other: controlusual obstetrical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- women older than 18 years
- Gestational age ≥ 37SA,
- Ruptured membranes,
- single living fetus in cephalic presentation with an occipitoposterior position clinically diagnosed between 2 and 9 cm dilated and confirmed by ultrasound.
- Affiliation to a social security scheme (beneficiary or assignee)
Key exclusion criteria (10 listed)
- Fetal presentation other than posterior
- Multiple pregnancy,
- Breech presentation
- History of previous cesarean section
- Fetal death in utero, termination of pregnancy
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 |
|---|---|---|
| Asymmetrical Lateral DecubitusAlso: maternal posturingAfter randomization, women are postured in pronounced lateral decubitus (side opposite to the back of the fetus), with the inferior leg in extension, and the superior leg in hyperflexion, during 1 hour (minimum 30 minutes). Then, women are encouraged to take this posture during labor as frequently as possible if the fetus remains in occipitoposterior position | Other | Asymmetrical Lateral Decubitus |
| controlusual obstetrical care | Other | control |
Primary outcome
Fetal head position
Time frame: 1 hour
fetal head position one hour after randomization
4 secondary outcomes
fetal head position
Time frame: at diagnosis of full dilatation
Speed of cervical dilatation
Time frame: during the first stage of labour
Mode of delivery and perineal complications
Time frame: at delivery
feasibility and acceptability of asymmetrical lateral decubitus
Time frame: during and after labour
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 5 Sep 2025.
- Results publication: PubMed 27242201Le Ray C, Lepleux F, De La Calle A, Guerin J, Sellam N, Dreyfus M, Chantry AA. Lateral asymmetric decubitus position for the rotation of occipito-posterior positions: multicenter randomized controlled trial EVADELA. Am J Obstet Gynecol. 2016 Oct;215(4):511.e1-7. doi: 10.1016/j.ajog.2016.05.033. Epub 2016 May 27.
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.
Camille Le Ray, MD, PhD principal investigator
Port-Royal Maternity Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asymmetrical Lateral Decubitus in people with Fetal Occipitoposterior Position During the Labor, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 6 inclusion and 10 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Fetal head position (time frame: 1 hour). 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 NCT01854450, 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 5 Sep 2025.