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
Not Applicable
- Conditions
- Persistent Occipital Posterior Presentation During Labor Delivery
- Interventions
- Procedure: Prophylactic Manual Rotation of persistent occipital posterior presentation
- Registration Number
- NCT02695238
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 260
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description prophylactic manual rotation group Prophylactic Manual Rotation of persistent occipital posterior presentation During persistent occipital posterior presentation during the second stage of labor, prophylactic manual rotation will be performed.
- Primary Outcome Measures
Name Time Method Number of patients who will have a caesarean section or an instrumental delivery in each groups. 4 hours
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Assistance Publique Hopitaux de Marseille
🇫🇷Marseille, France