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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Persistent Occipital Posterior Presentation During Labor Delivery

Intervention / Treatment
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* Procedure: Prophylactic Manual Rotation of persistent occipital posterior presentation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prophylactic manual rotation group<br>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<br>* prophylactic manual rotation of persistent occipital posterior presentation on operative delivery will be performed in the experimental group<br>|
| No Intervention: No prophylactic manual rotation group<br>During persistent occipital posterior presentation during the second stage of labor, expectant management for delevery will be performed | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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