Trial of Prophylactic Manual Rotation of Persistent Occiput Posterior Presentation During the Early Second Stage of Labor to Reduce Operative Delivery: a Prospective Multicenter Randomized Control Trial (PROPOP)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Persistent Occipital Posterior Presentation During Labor Delivery

Treatments

Procedure: Prophylactic Manual Rotation of persistent occipital posterior presentation

Study type

Interventional

Funder types

Other

Identifiers

NCT02695238
2015-A00225-44

Details and patient eligibility

About

Superiority multicenter prospective randomized study on operative delivery (instrumental delivery or caesarean section) of prophylactic manual rotation in case of persistent occipital posterior presentation during the second stage of labor compared to expectant management. A 15% reduction of operative delivery (instrumental delivery or caesarean section) is attempt in the prophylactic manual rotation group.

Enrollment

260 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years
  • Singleton pregnancy
  • Term ≥ 37 weeks of gestation
  • Early second stage of labor
  • Rupture membranes
  • Persistent occiput posterior position confirmed by ultrasound
  • Epidural anesthesia
  • Patient who agree to participate and sign consent form

Exclusion criteria

  • Age < 18 years
  • Term < 37 weeks of gestation
  • Vaginal and instrumental Delivery maternal contraindication
  • Antecedent of perineal injury type IV
  • Sensitive perineum
  • Crohn's disease with vaginal delivery contraindication
  • Instrumental fetal contraindication
  • Non reassuring fetal heart with impossibility of optimal maternal information
  • Known fetal malformation
  • Previous ceaserean section
  • Non cephalic presentation
  • Not affiliated to social security

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

260 participants in 2 patient groups

prophylactic manual rotation group
Experimental group
Description:
During persistent occipital posterior presentation during the second stage of labor, prophylactic manual rotation will be performed.
Treatment:
Procedure: Prophylactic Manual Rotation of persistent occipital posterior presentation
No prophylactic manual rotation group
No Intervention group
Description:
During persistent occipital posterior presentation during the second stage of labor, expectant management for delevery will be performed

Trial contacts and locations

1

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Central trial contact

Julie Blanc, MD

Data sourced from clinicaltrials.gov

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