<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/NCT03271957</url>
  </required_header>
  <id_info>
    <org_study_id>ManualRotationULisbon</org_study_id>
    <nct_id>NCT03271957</nct_id>
  </id_info>
  <brief_title>Manual Rotation in Persistent Occiput Posterior Position</brief_title>
  <official_title>Relation of Ultrasound Parameters Associated to Labor Progression and Manual Rotation's Success in Persistent Occiput Posterior Position</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ana Catarina Reis de Carvalho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Lisbon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Lisbon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Is part of routine obstetric care to attempt a manual rotation in all fetus that are in a&#xD;
      persistent OP at delivery. Nevertheless, little is known about the success of this&#xD;
      intervention or about the relation of some ultrasound measures with the outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Persistent OP at delivery occurs in approximately 10% of fetuses and studies have shown an&#xD;
      increase in short-term and long-term maternal and fetal complications such as prolonged&#xD;
      labour, maternal exhaustion, fetal distress, instrumental delivery, caesarean delivery and&#xD;
      severe perineal tears. Manual rotation of the fetal occiput to OA position has been described&#xD;
      as a safe and effective intervention in the setting of labour arrest but evidence is limited.&#xD;
      Therefore, the investigators aim to evaluate:&#xD;
&#xD;
      1. The success of manual rotation of the fetal occiput in OP in 2nd stage of labour; The&#xD;
      relation of progression angle (PA) accessed by ultrasound and the success of manual rotation;&#xD;
      This is as prospective study with a sample size calculated of 50 participants.&#xD;
&#xD;
        1. º Identify an OP position during digital examination in the first evaluation at full&#xD;
           cervical dilatation (t=0)&#xD;
&#xD;
        2. º Get informed consent from the pregnant woman.&#xD;
&#xD;
        3. º Wait for the first urge to push or T=30 m (multiparous) or T=60 (nulliparous)&#xD;
&#xD;
        4. º Confirm fetal head position by ultrasound and measure PA.&#xD;
&#xD;
        5. º Attempt a manual rotation to anterior position accordingly to the protocol.&#xD;
&#xD;
        6. º Confirm fetal head position by ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 27, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Success of manual rotation of the fetal occiput in OP in 2nd stage of labour</measure>
    <time_frame>This outcome will be measure immediately after the attempt of manual rotation</time_frame>
    <description>After the attempt of manual rotation we will confirm if the fetal occiput, initially in Occiput-posterior (OP) position, is now in Occiput-anterior position (successful rotation) or if is still in OP position (unsuccessful rotation). This confirmation will be made through ultrasound observation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of ultrasound measures (progression angle (PA) and dorsal fetal position)</measure>
    <time_frame>The PA and dorsal fetal position will be measure after the diagnose of full dilatation when occurs the first urge to push or 30 minutes after the diagnose of full dilatation (multiparous) or 60 minutes after the diagnose of full dilatation (nulliparous)</time_frame>
    <description>The relation of PA and dorsal fetal position accessed by ultrasound and the success of manual rotation;</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Manual Rotation of A Liveborn</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Manual rotation</intervention_name>
    <description>Rotation of the fetal head to an anterior position at time of fuel dilation that is part of routine care</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant women in the delivery room that fulfill the inclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancies&#xD;
&#xD;
          -  &gt;37 weeks of pregnancy&#xD;
&#xD;
          -  Fetus in cephalic presentation&#xD;
&#xD;
          -  Fetal weight estimation P10-90&#xD;
&#xD;
          -  Fetal head in a posterior position in the moment of full cervical dilatation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - do not give or do not be able to give written consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women</gender_description>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nuno Clode, MD</last_name>
    <role>Study Director</role>
    <affiliation>Obstetrics' Director</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catarina R de Carvalho</last_name>
    <phone>+351919297913</phone>
    <email>catarinareiscarvalho@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Catarina R de Carvalho</last_name>
    <email>catarinareiscarvalho@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Departamento de Obstetrícia, Ginecologia e Medicina da Reprodução, Centro hospitalar lisboa norte</name>
      <address>
        <city>Lisboa</city>
        <zip>1600</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <contact>
      <last_name>Catarina Reis Carvalho, resident</last_name>
      <phone>+351919297913</phone>
      <email>catarinareiscarvalho@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Lisbon</investigator_affiliation>
    <investigator_full_name>Ana Catarina Reis de Carvalho</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03271957
org study id: ManualRotationULisbon
nct id: NCT03271957
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Is part of routine obstetric care to attempt a manual rotation in all fetus that are in a
      persistent OP at delivery. Nevertheless, little is known about the success of this
      intervention or about the relation of some ultrasound measures with the outcome.
Persistent OP at delivery occurs in approximately 10% of fetuses and studies have shown an
      increase in short-term and long-term maternal and fetal complications such as prolonged
      labour, maternal exhaustion, fetal distress, instrumental delivery, caesarean delivery and
      severe perineal tears. Manual rotation of the fetal occiput to OA position has been described
      as a safe and effective intervention in the setting of labour arrest but evidence is limited.
      Therefore, the investigators aim to evaluate:

      1. The success of manual rotation of the fetal occiput in OP in 2nd stage of labour; The
      relation of progression angle (PA) accessed by ultrasound and the success of manual rotation;
      This is as prospective study with a sample size calculated of 50 participants.

        1. º Identify an OP position during digital examination in the first evaluation at full
           cervical dilatation (t=0)

        2. º Get informed consent from the pregnant woman.

        3. º Wait for the first urge to push or T=30 m (multiparous) or T=60 (nulliparous)

        4. º Confirm fetal head position by ultrasound and measure PA.

        5. º Attempt a manual rotation to anterior position accordingly to the protocol.

        6. º Confirm fetal head position by ultrasound.
observational model: Cohort
time perspective: Prospective
measure: Success of manual rotation of the fetal occiput in OP in 2nd stage of labour
time frame: This outcome will be measure immediately after the attempt of manual rotation
description: After the attempt of manual rotation we will confirm if the fetal occiput, initially in Occiput-posterior (OP) position, is now in Occiput-anterior position (successful rotation) or if is still in OP position (unsuccessful rotation). This confirmation will be made through ultrasound observation.
measure: Impact of ultrasound measures (progression angle (PA) and dorsal fetal position)
time frame: The PA and dorsal fetal position will be measure after the diagnose of full dilatation when occurs the first urge to push or 30 minutes after the diagnose of full dilatation (multiparous) or 60 minutes after the diagnose of full dilatation (nulliparous)
description: The relation of PA and dorsal fetal position accessed by ultrasound and the success of manual rotation;
intervention type: Procedure
intervention name: Manual rotation
description: Rotation of the fetal head to an anterior position at time of fuel dilation that is part of routine care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women
minimum age: 17 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nuno Clode, MD
role: Study Director
affiliation: Obstetrics' Director
last name: Catarina R de Carvalho
phone: +351919297913
email: catarinareiscarvalho@gmail.com
last name: Catarina R de Carvalho
email: catarinareiscarvalho@gmail.com
facility: 
contact: 
country: Portugal
responsible party type: Sponsor-Investigator
investigator affiliation: University of Lisbon
investigator full name: Ana Catarina Reis de Carvalho
investigator title: Resident
sharing ipd: No