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OpenTrials
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NCT Number: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

15 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Hopital Femme Mere Enfant, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mode of delivery

Device

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.