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)

July 17, 2019 updated by: Assistance Publique Hopitaux De Marseille
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

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
      • Marseille, France, 13354
        • Recruiting
        • Assistance Publique Hopitaux de Marseille
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prophylactic manual rotation group
During persistent occipital posterior presentation during the second stage of labor, prophylactic manual rotation will be performed.
Procedure: Prophylactic Manual Rotation of persistent occipital posterior presentation
prophylactic manual rotation of persistent occipital posterior presentation on operative delivery will be performed in the experimental group
No Intervention: No prophylactic manual rotation group
During persistent occipital posterior presentation during the second stage of labor, expectant management for delevery will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who will have a caesarean section or an instrumental delivery in each groups.
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with episiotomy, perineal lacerations from the 1st to the 4rth degree anglo-saxon classification
Time Frame: 4 hours
4 hours
Number of patients who will have bladder, urinary or bowel injuries during caesarean section
Time Frame: 5 hours maximum
5 hours maximum
Number of patients with post-partum hemorrhage defined by blood loss more than 500mL
Time Frame: 5 hours maximum
5 hours maximum

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-A00225-44

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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