<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03009435</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01456-45</org_study_id>
    <nct_id>NCT03009435</nct_id>
  </id_info>
  <brief_title>RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate (RMOS)</brief_title>
  <acronym>RMOS</acronym>
  <official_title>RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <brief_summary>
    <textblock>
      Introduction:&#xD;
&#xD;
      The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in&#xD;
      which 5% remain occiput posterior at the end of labor. Occiput posterior position is&#xD;
      associated with higher risks of caesarean deliveries and operative vaginal deliveries. The&#xD;
      manual rotation to promote rotation from a posterior to an anterior position has been&#xD;
      proposed to reduce the extraction rate. There is no randomised trial comparing the effect of&#xD;
      manual rotation and expectant management. We propose a protocol for a prospective,&#xD;
      monocentric, randomised controlled clinical trial in order to show that the rate of&#xD;
      spontaneous vaginal delivery is higher with manual rotation of occiput posterior position&#xD;
      than with an expectative management.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position&#xD;
      suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible.&#xD;
      Participants will be randomised to either prophylactic manual rotation (experimental group)&#xD;
      or expectative management (control group). Based on an alpha value of 0.05 and gaining 20%&#xD;
      for spontaneous vaginal delivery, 238 participants will need to be enrolled.&#xD;
&#xD;
      The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be&#xD;
      operative delivery rate (caesarean section , vacuum or forceps deliveries), significant&#xD;
      maternal and perinatal mortality/morbidity.&#xD;
&#xD;
      Analysis will be by intention-to-treat averaging a 24-month period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of spontaneous vaginal delivery</measure>
    <time_frame>At the time of delivery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">238</enrollment>
  <condition>Fetal Manual Rotation</condition>
  <arm_group>
    <arm_group_label>prophylactic manual rotation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 :&#xD;
Tarnier and Chantreuil technique&#xD;
or SOGC technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>expectative management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Expectative management . No manual rotation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>prophylactic manual rotation</intervention_name>
    <arm_group_label>prophylactic manual rotation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Inclusion Criteria:&#xD;
&#xD;
               -  age ≥ 18 years&#xD;
&#xD;
               -  singleton pregnancy&#xD;
&#xD;
                  -≥37 weeks of gestation&#xD;
&#xD;
               -  planned vaginal birth&#xD;
&#xD;
               -  cephalic presentation&#xD;
&#xD;
               -  occiput posterior position confirmed by ultrasound at full dilatation&#xD;
&#xD;
          2. Exclusion Criteria:&#xD;
&#xD;
               -  withdrawal of consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Caroline Verhaeghe</last_name>
    <phone>+3364184459</phone>
    <email>verhaeghe.caroline@gmail.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03009435
org study id: 2016-A01456-45
nct id: NCT03009435
lead sponsor: 
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of spontaneous vaginal delivery
time frame: At the time of delivery
arm group label: prophylactic manual rotation
arm group type: Experimental
description: 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
arm group label: expectative management
arm group type: No Intervention
description: Expectative management . No manual rotation
intervention type: Other
intervention name: prophylactic manual rotation
arm group label: prophylactic manual rotation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Caroline Verhaeghe
phone: +3364184459
email: verhaeghe.caroline@gmail.com
responsible party type: Sponsor