- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06886854
Evaluation of the Impact of Rotating Posterior and Transverse Presentations At 2 Hours of Full Dilation
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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France, France, 69001
- Hôpital de La Croix Rousse
-
France, France, 69500
- Hopital Femme Mere Enfant
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- - 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
- Normal fetal heart rate
- Epidural anesthesia in place
- Bladder catheterized
Exclusion Criteria:
- - Multiparous uterus with scars
- Breech presentation
- Fetus > 5000 g
- Patient refusal
- Inadequate analgesia
- Fetal hypoxia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Collected at the time of delivery.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-5373
Drug and device information, study documents
product manufactured in and exported from the U.S.
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