<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/NCT02209090</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AMI)182/2012</org_study_id>
    <nct_id>NCT02209090</nct_id>
  </id_info>
  <brief_title>Modified Intrapartum Sims Position-related Efficiency in Correction of Persistent Foetal OP Positions</brief_title>
  <acronym>MSIMSFPOP</acronym>
  <official_title>Randomised Clinical Trial: Modified Intrapartum Maternal Sims Position-related Efficiency in the Correction of Persistent Foetal Occipito-posterior Position</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions&#xD;
      in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant&#xD;
      women with epidural anaesthesia.&#xD;
&#xD;
      Design: An open, randomised, controlled and parallel clinical trial will be conducted at the&#xD;
      Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona,&#xD;
      Spain.&#xD;
&#xD;
      Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be&#xD;
      selected. Each woman will be assigned to a control or experimental group via an opaque&#xD;
      envelope at a 1:1 ratio.&#xD;
&#xD;
      The control group will deliver in free intrapartum positions, and the experimental group in a&#xD;
      modified Sims position. Correction of foetal position is the key study variable, and delivery&#xD;
      type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions&#xD;
      in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant&#xD;
      women with epidural anaesthesia.&#xD;
&#xD;
      Background: There is a theoretical basis for the possible effects of maternal positions on&#xD;
      foetal positions. Despite all the studies published in recent years, conclusive trials&#xD;
      providing significant scientific evidence are lacking.&#xD;
&#xD;
      Design: An open, randomised, controlled and parallel clinical trial will be conducted at the&#xD;
      Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona,&#xD;
      Spain.&#xD;
&#xD;
      Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be&#xD;
      selected. Each woman will be assigned to a control or experimental group via an opaque&#xD;
      envelope at a 1:1 ratio.&#xD;
&#xD;
      The control group will deliver in free intrapartum positions, and the experimental group in a&#xD;
      modified Sims position. Correction of foetal position is the key study variable, and delivery&#xD;
      type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.&#xD;
&#xD;
      Discussion: If the modified maternal Sims position proved to correct persistent foetal&#xD;
      occipito-posterior positions and being a non-invasive, low-cost, non-prejudicial method for&#xD;
      both mother and foetus, maternal and foetal morbidity problem would be reduced&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rotation</measure>
    <time_frame>During labour</time_frame>
    <description>the foetal head's capacity to rotate 145º clockwise until the minor fontanelle is situated under the pubic bone, expressed as yes or no, depending on whether there is rotation or not.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rotating to OA</measure>
    <time_frame>During labour</time_frame>
    <description>length of time taken by the foetal head to reach OA expressed in minutes from the start of the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delivery mode</measure>
    <time_frame>The first two hours after delivery</time_frame>
    <description>eutocic: vaginal delivery, foetal head expulsion in vertex position, spontaneous</description>
  </secondary_outcome>
  <other_outcome>
    <measure>uterine dynamics</measure>
    <time_frame>During labour</time_frame>
    <description>assessed by frequency and intensity according to Monteviedo unit calculation</description>
  </other_outcome>
  <other_outcome>
    <measure>first stage in minutes</measure>
    <time_frame>During labour</time_frame>
    <description>timed in minutes, from 3cm with cervix shortened until complete diltation.</description>
  </other_outcome>
  <other_outcome>
    <measure>second stage in minutes</measure>
    <time_frame>The first two hours after delivery</time_frame>
    <description>timed from complete dilation to foetal head expulsion</description>
  </other_outcome>
  <other_outcome>
    <measure>epidural anaesthesia</measure>
    <time_frame>During labour</time_frame>
    <description>doses of epidural anaesthesia required, concentration and ml.</description>
  </other_outcome>
  <other_outcome>
    <measure>episiotomy</measure>
    <time_frame>The first two hours after delivery</time_frame>
    <description>whether performed or not to gain a major opening from the soft parts of the birth canal.</description>
  </other_outcome>
  <other_outcome>
    <measure>tear</measure>
    <time_frame>The first two hours after delivery</time_frame>
    <description>trauma occurring spontaneously by the foetal head passing through the vaginal cavity and/or perineum:</description>
  </other_outcome>
  <other_outcome>
    <measure>reason to end labour earlier</measure>
    <time_frame>The first two hours after delivery</time_frame>
    <description>cause that occurs on ending labour before it concludes spontaneously. Reasons may be foetal: risk of loss of foetal wellbeing, or maternal: pelvic foetal disproportion or stopped labour</description>
  </other_outcome>
  <other_outcome>
    <measure>maternal comfort during labour</measure>
    <time_frame>The first two hours after delivery</time_frame>
    <description>MACKEY SATISFACTION CHILDBIRTH RATING SCALE validated in Spanish</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Persistent Occiput Posterior Position During Labor</condition>
  <arm_group>
    <arm_group_label>maternal modified sims position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in this group will adopt the modified Sims position, lying on the side of the foetal back.&#xD;
This position is maintained for the greater part of labour, at least 40 minutes, every hour. The mother can use other positions during resting time of no more than 20 minutes each hour, but never use a lateral position against the side of the foetal back.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>maternal free positions</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Women can adopt the position they wish and which is most comfortable, except for lateral positions which can only be used for a maximum of 20 minutes each hour to avoid confounding factors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>maternal modified sims position</intervention_name>
    <description>Maternal Modified Sims position during at least 40 minutes for each 60 minutes</description>
    <arm_group_label>maternal modified sims position</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>maternal free positions</intervention_name>
    <description>At least 40 minutes each hour during labour</description>
    <arm_group_label>maternal free positions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult pregnant women (&gt;18 years of age)&#xD;
&#xD;
          -  persistent posterior foetal position diagnosed during labour through two vaginal&#xD;
             examinations two hours apart.&#xD;
&#xD;
          -  at-term gestations (37 to 42 weeks)&#xD;
&#xD;
          -  women in labour with epidural anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple gestations&#xD;
&#xD;
          -  previous severe foetal malformation diagnosed&#xD;
&#xD;
          -  macrosomic foetus diagnosed by ultrasound in the 3rd trimester (&gt; percentile 95), or&#xD;
             IUGR (&lt; percentile 10)&#xD;
&#xD;
          -  women with contraindicated vaginal delivery owing to previous vaginal surgeries&#xD;
&#xD;
          -  women with severe heart diseases&#xD;
&#xD;
          -  diabetic pregnant women (types I, II and gestational)&#xD;
&#xD;
          -  hypertension problems during labour&#xD;
&#xD;
          -  myopathies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vanessa Bueno, PhDcandidate</last_name>
    <role>Principal Investigator</role>
    <affiliation>HUValldebronRI</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vanessa Bueno, Midwife</last_name>
    <email>vanessabuenolopez@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Area Materno Infantil of the Hospital Univeristario Vall d'Hebron (AMI HUVH),</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanessa Bueno, Midwife</last_name>
      <phone>0034934893086</phone>
      <email>vanessabuenolopez@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Vanessa Bueno, Midwife</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Terré Carmen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Casellas Manel, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Teva Asunción, midwife</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 1, 2014</last_update_submitted>
  <last_update_submitted_qc>August 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>occiput-posterior</keyword>
  <keyword>occipitoposterior</keyword>
  <keyword>labour</keyword>
  <pending_results>
    <submitted>April 5, 2017</submitted>
    <returned>June 19, 2017</returned>
  </pending_results>
  <!-- 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/NCT02209090
org study id: PR(AMI)182/2012
nct id: NCT02209090
lead sponsor: 
collaborator: 
has dmc: No
Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions
      in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant
      women with epidural anaesthesia.

      Design: An open, randomised, controlled and parallel clinical trial will be conducted at the
      Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona,
      Spain.

      Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be
      selected. Each woman will be assigned to a control or experimental group via an opaque
      envelope at a 1:1 ratio.

      The control group will deliver in free intrapartum positions, and the experimental group in a
      modified Sims position. Correction of foetal position is the key study variable, and delivery
      type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.
Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions
      in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant
      women with epidural anaesthesia.

      Background: There is a theoretical basis for the possible effects of maternal positions on
      foetal positions. Despite all the studies published in recent years, conclusive trials
      providing significant scientific evidence are lacking.

      Design: An open, randomised, controlled and parallel clinical trial will be conducted at the
      Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona,
      Spain.

      Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be
      selected. Each woman will be assigned to a control or experimental group via an opaque
      envelope at a 1:1 ratio.

      The control group will deliver in free intrapartum positions, and the experimental group in a
      modified Sims position. Correction of foetal position is the key study variable, and delivery
      type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.

      Discussion: If the modified maternal Sims position proved to correct persistent foetal
      occipito-posterior positions and being a non-invasive, low-cost, non-prejudicial method for
      both mother and foetus, maternal and foetal morbidity problem would be reduced
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Rotation
time frame: During labour
description: the foetal head's capacity to rotate 145º clockwise until the minor fontanelle is situated under the pubic bone, expressed as yes or no, depending on whether there is rotation or not.
measure: rotating to OA
time frame: During labour
description: length of time taken by the foetal head to reach OA expressed in minutes from the start of the intervention
measure: Delivery mode
time frame: The first two hours after delivery
description: eutocic: vaginal delivery, foetal head expulsion in vertex position, spontaneous
measure: uterine dynamics
time frame: During labour
description: assessed by frequency and intensity according to Monteviedo unit calculation
measure: first stage in minutes
time frame: During labour
description: timed in minutes, from 3cm with cervix shortened until complete diltation.
measure: second stage in minutes
time frame: The first two hours after delivery
description: timed from complete dilation to foetal head expulsion
measure: epidural anaesthesia
time frame: During labour
description: doses of epidural anaesthesia required, concentration and ml.
measure: episiotomy
time frame: The first two hours after delivery
description: whether performed or not to gain a major opening from the soft parts of the birth canal.
measure: tear
time frame: The first two hours after delivery
description: trauma occurring spontaneously by the foetal head passing through the vaginal cavity and/or perineum:
measure: reason to end labour earlier
time frame: The first two hours after delivery
description: cause that occurs on ending labour before it concludes spontaneously. Reasons may be foetal: risk of loss of foetal wellbeing, or maternal: pelvic foetal disproportion or stopped labour
measure: maternal comfort during labour
time frame: The first two hours after delivery
description: MACKEY SATISFACTION CHILDBIRTH RATING SCALE validated in Spanish
arm group label: maternal modified sims position
arm group type: Experimental
description: Women in this group will adopt the modified Sims position, lying on the side of the foetal back.
This position is maintained for the greater part of labour, at least 40 minutes, every hour. The mother can use other positions during resting time of no more than 20 minutes each hour, but never use a lateral position against the side of the foetal back.
arm group label: maternal free positions
arm group type: Sham Comparator
description: Women can adopt the position they wish and which is most comfortable, except for lateral positions which can only be used for a maximum of 20 minutes each hour to avoid confounding factors.
intervention type: Procedure
intervention name: maternal modified sims position
description: Maternal Modified Sims position during at least 40 minutes for each 60 minutes
arm group label: maternal modified sims position
intervention type: Procedure
intervention name: maternal free positions
description: At least 40 minutes each hour during labour
arm group label: maternal free positions
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vanessa Bueno, PhDcandidate
role: Principal Investigator
affiliation: HUValldebronRI
last name: Vanessa Bueno, Midwife
email: vanessabuenolopez@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor
submitted: April 5, 2017
returned: June 19, 2017