RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate (RMOS) (RMOS)
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|ClinicalTrials.gov Identifier: NCT03009435|
Recruitment Status : Not yet recruiting
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Fetal Manual Rotation||Other: prophylactic manual rotation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2020|
Experimental: prophylactic manual rotation
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 :
Other: prophylactic manual rotation
No Intervention: expectative management
Expectative management . No manual rotation
- Percentage of spontaneous vaginal delivery [ Time Frame: At the time of delivery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009435
|Contact: Caroline Verhaeghefirstname.lastname@example.org|