Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03009435
Acronym
RMOS
Enrollment
238
Registered
2017-01-04
Start date
2017-01-31
Completion date
Unknown
Last updated
2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Manual Rotation

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.

Interventions

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Percentage of spontaneous vaginal deliveryAt the time of delivery

Contacts

Primary ContactCaroline Verhaeghe
verhaeghe.caroline@gmail.com+3364184459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026