Clinical trial NCT02695238: 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
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Occipital Posterior Presentation During Labor Delivery
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who will have a caesarean section or an instrumental delivery in each groups.
timeFrame: 4 hours
Secondary outcomes:
measure: Number of patients with episiotomy, perineal lacerations from the 1st to the 4rth degree anglo-saxon classification
timeFrame: 4 hours
measure: Number of patients who will have bladder, urinary or bowel injuries during caesarean section
timeFrame: 5 hours maximum
measure: Number of patients with post-partum hemorrhage defined by blood loss more than 500mL
timeFrame: 5 hours maximum
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
citation: Blanc J, Castel P, Mauviel F, Baumstarck K, Bretelle F, D'Ercole C, Haumonte JB. Prophylactic manual rotation of occiput posterior and transverse positions to decrease operative delivery: the PROPOP randomized clinical trial. Am J Obstet Gynecol. 2021 Oct;225(4):444.e1-444.e8. doi: 10.1016/j.ajog.2021.05.020. Epub 2021 May 24.