Evaluation of the Impact of Rotating Posterior and Transverse Presentations At 2 Hours of Full Dilation

March 14, 2025 updated by: Hospices Civils de Lyon

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • France, France, 69001
        • Hopital de la croix rousse
      • France, France, 69500
        • Hôpital Femme Mère Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Woman in labor, not delivered at 2 hours of complete dilation, with a posterior or transverse fetal presentation

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: Mode of delivery

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

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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