Fetus in Posterior or Transverse Position; Manual Rotation ; Obstetrics ; Delivery Room PracticeNCT06886854
Evaluation of the Impact of Rotating Posterior and Transverse Presentations At 2 Hours of Full Dilation
An observational study of Fetus in Posterior or Transverse Position; Manual Rotation ; Obstetrics ; Delivery Room Practice, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
During labor, 20% of fetuses present in a posterior or transverse position. Among them, 90% rotate spontaneously during labor. For the remaining 10%, maintaining a posterior or transverse position leads to longer labor, increased instrumental deliveries, more cesarean sections, and more severe perineal tears. Read more about this study
- Who is it for?
- Ages 15 to 50 years, men only
- Conditions the study is for
- Fetus in Posterior or Transverse Position; Manual Rotation ; Obstetrics ; Delivery Room Practice
- What is being tested?
- Mode of delivery
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 50 years
- Men only
- Child, Adult
Study population: Woman in labor, not delivered at 2 hours of complete dilation, with a posterior or transverse fetal presentation
Who may be able to join
- - Patient delivering at Hospices Civils de Lyon (XR, HFME, LS?)
- Low-pitched voice agreement
- Mobile fetal cephalic presentation
- Transverse or posterior presentation confirmed by ultrasound
- 2 hours of complete dilation
- Agreement for 3 hours by OB-GYN
Show all 9Show fewer
- Normal fetal heart rate
- Epidural anesthesia in place
- Bladder catheterized
Who cannot join
- - Multiparous uterus with scars
- Breech presentation
- Fetus > 5000 g
- Patient refusal
- Inadequate analgesia
- Fetal hypoxia
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital de la croix rousse
France, 69001
Hopital Femme Mere Enfant
France, 69500
About this study
During labor, 20% of fetuses present in a posterior or transverse position. Among them, 90% rotate spontaneously during labor. For the remaining 10%, maintaining a posterior or transverse position leads to longer labor, increased instrumental deliveries, more cesarean sections, and more severe perineal tears. Obstetricians can intervene by manually rotating the fetus to an anterior position. Several studies have shown the benefits of this technique, but they were all conducted at full dilation or one hour after full dilation. This timing does not allow enough time for the fetus to rotate spontaneously. Additionally, manual rotation can be poorly tolerated by the patient, especially if pain management is insufficient.
Our study aims to demonstrate the benefits of manual rotation two hours after full dilation. This delay allows 90% of fetuses to rotate spontaneously, and it could help harmonize obstetrical practices.
- Conditions
- Fetus in Posterior or Transverse Position; Manual Rotation ; Obstetrics ; Delivery Room Practice
- Being tested
- Mode of delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mode of deliveryDevice
Retrieval of delivery data, typically recorded by midwives - retrieval of data per delivery and post-delivery - Consultation of medical data on labor duration, labor onset method, estimated fetal weight, etc.
Data collected for each delivery, identical in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Success of the rotation | Patients in labor with a fetus in posterior or transverse position at 2 hours of full dilation, verified by ultrasound. Manual rotation by an obstetrician after confirming effective analgesia, an empty bladder, and normal fetal heart rate. Success of the manual rotation Receives: Device: Mode of delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of eutocic deliveries
Collection of delivery data recorded by the midwife: eutocic delivery, instrumental extraction by vacuum, instrumental extraction by forceps, instrumental extraction by spatula, emergency cesarean section (green, orange, or red code).
Measured: Collected at the time of delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetus in Posterior or Transverse Position; Manual Rotation ; Obstetrics ; Delivery Room PracticeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886854
- Sponsor's protocol ID
- 24-5373
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Rotating Posterior and Transverse Presentations At 2 Hours of Full Dilation
- ClinicalTrials.gov ID
- NCT06886854
- Acronym / sponsor ID
- 24-5373
- Conditions
- Fetus in Posterior or Transverse Position; Manual Rotation ; Obstetrics ; Delivery Room Practice
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Mar 2025 (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.
During labor, 20% of fetuses present in a posterior or transverse position. Among them, 90% rotate spontaneously during labor. For the remaining 10%, maintaining a posterior or transverse position leads to longer labor, increased instrumental deliveries, more cesarean sections, and more severe perineal tears. Obstetricians can intervene by manually rotating the fetus to an anterior position. Several studies have shown the benefits of this technique, but they were all conducted at full dilation or one hour after full dilation. This timing does not allow enough time for the fetus to rotate spontaneously. Additionally, manual rotation can be poorly tolerated by the patient, especially if pain management is insufficient.
Our study aims to demonstrate the benefits of manual rotation two hours after full dilation. This delay allows 90% of fetuses to rotate spontaneously, and it could help harmonize obstetrical practices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Success of the rotation | – | Device: Mode of deliveryPatients in labor with a fetus in posterior or transverse position at 2 hours of full dilation, verified by ultrasound. Manual rotation by an obstetrician after confirming effective analgesia, an empty bladder, and normal fetal heart rate. Success of the manual rotation |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Male only
- Age groups
- Child, Adult
- Study population
- Woman in labor, not delivered at 2 hours of complete dilation, with a posterior or transverse fetal presentation
Key inclusion criteria (9 listed)
- - Patient delivering at Hospices Civils de Lyon (XR, HFME, LS?)
- Low-pitched voice agreement
- Mobile fetal cephalic presentation
- Transverse or posterior presentation confirmed by ultrasound
- 2 hours of complete dilation
Key exclusion criteria (6 listed)
- - Multiparous uterus with scars
- Breech presentation
- Fetus > 5000 g
- Patient refusal
- Inadequate analgesia
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 |
|---|---|---|
| Mode of deliveryRetrieval of delivery data, typically recorded by midwives - retrieval of data per delivery and post-delivery - Consultation of medical data on labor duration, labor onset method, estimated fetal weight, etc. Data collected for each delivery, identical in both groups. | Device | Success of the rotation |
Primary outcome
Rate of eutocic deliveries
Time frame: Collected at the time of delivery.
Collection of delivery data recorded by the midwife: eutocic delivery, instrumental extraction by vacuum, instrumental extraction by forceps, instrumental extraction by spatula, emergency cesarean section (green, orange, or red code).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetus in Posterior or Transverse Position; Manual Rotation ; Obstetrics ; Delivery Room Practice, run by Hospices Civils de Lyon at 2 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 9 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of eutocic deliveries (time frame: Collected at the time of delivery.). 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 20 Mar 2025.