RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate (RMOS)

University Hospital, Angers

Status: Unknown

Conditions: Fetal Manual Rotation

Treatments: Other: prophylactic manual rotation

Study type: Interventional

Funder types: Other

Identifiers

NCT03009435

2016-A01456-45

Details and patient eligibility

About

Introduction:

The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in which 5% remain occiput posterior at the end of labor. Occiput posterior position is associated with higher risks of caesarean deliveries and operative vaginal deliveries. The manual rotation to promote rotation from a posterior to an anterior position has been proposed to reduce the extraction rate. There is no randomised trial comparing the effect of manual rotation and expectant management. We propose a protocol for a prospective, monocentric, randomised controlled clinical trial in order to show that the rate of spontaneous vaginal delivery is higher with manual rotation of occiput posterior position than with an expectative management.

Methods:

Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible. Participants will be randomised to either prophylactic manual rotation (experimental group) or expectative management (control group). Based on an alpha value of 0.05 and gaining 20% for spontaneous vaginal delivery, 238 participants will need to be enrolled.

The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be operative delivery rate (caesarean section , vacuum or forceps deliveries), significant maternal and perinatal mortality/morbidity.

Analysis will be by intention-to-treat averaging a 24-month period.

Enrollment: 238 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria:

   • age ≥ 18 years

   • singleton pregnancy

     -≥37 weeks of gestation

   • planned vaginal birth

   • cephalic presentation

   • occiput posterior position confirmed by ultrasound at full dilatation

2. Exclusion Criteria:

   • withdrawal of consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

238 participants in 2 patient groups

prophylactic manual rotation

Experimental group

Description:

Only obstetricians will participate in the study. Manual rotation is performed at full dilatation.The technique employed will be at the discretion of the operator performing the procedure : * Tarnier and Chantreuil technique * or SOGC technique

Treatment:

Other: prophylactic manual rotation

expectative management

No Intervention group

Description:

Expectative management . No manual rotation