Persistent Occipital Posterior Presentation During Labor Delivery
Conditions
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.
Interventions
PROCEDUREProphylactic 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
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who will have a caesarean section or an instrumental delivery in each groups. | 4 hours |
Secondary
| Measure | 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 |
Countries
France
Contacts
Primary ContactJulie Blanc, MD
Outcome results
None listed