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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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.


Condition or disease Intervention/treatment Phase
Fetal Manual Rotation Other: prophylactic manual rotation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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 :

  • Tarnier and Chantreuil technique
  • or SOGC technique
Other: prophylactic manual rotation
No Intervention: expectative management
Expectative management . No manual rotation



Primary Outcome Measures :
  1. Percentage of spontaneous vaginal delivery [ Time Frame: At the time of delivery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Caroline Verhaeghe +3364184459 verhaeghe.caroline@gmail.com

Sponsors and Collaborators
University Hospital, Angers

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03009435     History of Changes
Other Study ID Numbers: 2016-A01456-45
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016