Clinical trial NCT03009435: RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate (RMOS)
Official title: RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Manual Rotation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-01-04
Enrollment: 238
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of spontaneous vaginal delivery
timeFrame: At the time of delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Verhaeghe C, Corroenne R, Spiers A, Descamps P, Gascoin G, Bouet PE, Parot-Schinkel E, Legendre G. Delivery Mode After Manual Rotation of Occiput Posterior Fetal Positions: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):999-1006. doi: 10.1097/AOG.0000000000004386.
citation: Verhaeghe C, Parot-Schinkel E, Bouet PE, Madzou S, Biquard F, Gillard P, Descamps P, Legendre G. The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS). Trials. 2018 Feb 14;19(1):109. doi: 10.1186/s13063-018-2497-7.