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

NCT03009435 | Unknown

• 1 other identifier: 2016-A01456-45
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fetal Manual Rotation

Outcome Measures

Primary Outcomes (1)

• Percentage of spontaneous vaginal delivery

  At the time of delivery

Study Arms (2)

prophylactic manual rotation

EXPERIMENTAL

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

Other: prophylactic manual rotation

expectative management

NO INTERVENTION

Expectative management . No manual rotation

Interventions

prophylactic manual rotation OTHER

prophylactic manual rotation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• singleton pregnancy
• ≥37 weeks of gestation
• planned vaginal birth
• cephalic presentation
• occiput posterior position confirmed by ultrasound at full dilatation

You may not qualify if:

• withdrawal of consent

Sponsors & Collaborators

• University Hospital, Angers: lead

Related Publications (2)

• 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.

  PMID: 33957650 DERIVED

• 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.

  PMID: 29444695 DERIVED

Central Study Contacts

Caroline Verhaeghe

CONTACT

+3364184459; verhaeghe.caroline@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 4, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Last Updated: January 4, 2017

Record last verified: 2016-12