<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/NCT01720004</url>
  </required_header>
  <id_info>
    <org_study_id>IGO-103690</org_study_id>
    <nct_id>NCT01720004</nct_id>
  </id_info>
  <brief_title>A Pilot Randomized Controlled Trial of Repeated Hands-and-Knees Positioning During Labour</brief_title>
  <acronym>LPT2</acronym>
  <official_title>Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators designed a pilot randomized controlled trial to assess the feasibility and&#xD;
      acceptability of repeated hands-and-knees positioning during labour. The objectives were 1)&#xD;
      to provide an estimate of enrollment rates, 2) to assess compliance with the study protocol&#xD;
      by participants and care providers, 3) to obtain women's views about their experiences using&#xD;
      the hands-and-knees position, and 4) to provide estimates of treatment effects to inform the&#xD;
      sample size calculation for a large trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women were enrolled in the pilot randomized controlled trial at two hospitals, one in Canada&#xD;
      and one in the USA. Nurses at both hospitals were trained in how to assist women into the&#xD;
      hands-and-knees position in bed. Repeated hands-and-knees position was defined as attempts to&#xD;
      use the position for 15 minutes, hourly from randomization until delivery. Women were not&#xD;
      asked to assume hands-and-knees for delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>Phase 1</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance</measure>
    <time_frame>from randomization to delivery</time_frame>
    <description>Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Persistent back pain</measure>
    <time_frame>hourly during labour, from randomization to delivery</time_frame>
    <description>Persistent back pain intensity rating measured hourly during hospital labour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>women's views</measure>
    <time_frame>assessed prior to hospital discharge</time_frame>
    <description>women's views of their birth experiences, including satisfaction with care and care providers, views about hands-and-knees positioning, willingness to use hands-and-knees position in a subsequent labour, comparison of expectations versus experiences of labour. The measures used to assess women's views had been developed for and used in prior trials of forms of intrapartum care by Hodnett and colleagues. Most questions were Likert scales or categorical items.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Method of birth</measure>
    <time_frame>at delivery</time_frame>
    <description>Spontaneous vaginal, assisted vaginal (vacuum or forceps), Caesarean</description>
  </other_outcome>
  <other_outcome>
    <measure>pharmacologic analgesia</measure>
    <time_frame>Initiated during labour</time_frame>
    <description>regional analgesia or intramuscular analgesia administered during first or second stage labour</description>
  </other_outcome>
  <other_outcome>
    <measure>oxytocin during first or second stage labour</measure>
    <time_frame>from randomization until end of second stage</time_frame>
    <description>any oxytocin infusion</description>
  </other_outcome>
  <other_outcome>
    <measure>dislodged epidural catheter</measure>
    <time_frame>from randomization until delivery</time_frame>
    <description>dislodged epidural catheter</description>
  </other_outcome>
  <other_outcome>
    <measure>Fall</measure>
    <time_frame>from randomization until delivery</time_frame>
    <description>Mother fell while attempting hands-and-knees position</description>
  </other_outcome>
  <other_outcome>
    <measure>perineal trauma</measure>
    <time_frame>at delivery</time_frame>
    <description>any perineal trauma (episiotomy and/or laceration0 requiring suturing</description>
  </other_outcome>
  <other_outcome>
    <measure>maternal postpartum complications</measure>
    <time_frame>between delivery and hospital discharge</time_frame>
    <description>postpartum hemorrhage or complication requiring prolonged stay</description>
  </other_outcome>
  <other_outcome>
    <measure>Apgar Score</measure>
    <time_frame>at one and five minutes after birth</time_frame>
    <description>Neonatal Apgar Score</description>
  </other_outcome>
  <other_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>from delivery to discharge</time_frame>
    <description>length of stay for mother and baby after birth</description>
  </other_outcome>
  <other_outcome>
    <measure>admission to neonatal intensive care unit</measure>
    <time_frame>between birth and hospital discharge</time_frame>
    <description>newborn admitted to neonatal intensive care unit</description>
  </other_outcome>
  <other_outcome>
    <measure>labour length</measure>
    <time_frame>from randomization until delivery</time_frame>
    <description>Length of time between randomization and delivery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pregnancy, Childbirth and the Puerperium</condition>
  <arm_group>
    <arm_group_label>Repeated Use of Hands-and-Knees</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention was repeated use of hands-and-knees position during labour. Participants were asked to try it for at least 15 minutes every hour, from randomization until delivery. They were not required to use it for delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants were asked to refrain from using hands-and-knees position at any time from randomization to delivery. They were free to use any other position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Repeated hands-and-knees positioning during labour</intervention_name>
    <description>Details are in the Arm Description.</description>
    <arm_group_label>Repeated Use of Hands-and-Knees</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  nulliparous;&#xD;
&#xD;
          -  &gt;37 weeks 0 days gestation&#xD;
&#xD;
          -  in established early labour&#xD;
&#xD;
          -  anticipating a vaginal delivery of a single fetus in the cephalic position&#xD;
&#xD;
          -  competent to give informed consent .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  delivery was anticipated within 3 hours&#xD;
&#xD;
          -  a medical contraindication or physical limitation such that hands-and- knees position&#xD;
             was contraindicated&#xD;
&#xD;
          -  had a doula or midwife who encouraged the use of hands-and-knees position.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Texas Health Harris Methodist Hospital</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto East General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4C 3E7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Ellen Hodnett</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>human labour</keyword>
  <keyword>hands-and-knees positioning</keyword>
  <keyword>pilot trial</keyword>
  <!-- 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/NCT01720004
org study id: IGO-103690
nct id: NCT01720004
lead sponsor: 
collaborator: 
has dmc: No
The investigators designed a pilot randomized controlled trial to assess the feasibility and
      acceptability of repeated hands-and-knees positioning during labour. The objectives were 1)
      to provide an estimate of enrollment rates, 2) to assess compliance with the study protocol
      by participants and care providers, 3) to obtain women's views about their experiences using
      the hands-and-knees position, and 4) to provide estimates of treatment effects to inform the
      sample size calculation for a large trial.
Women were enrolled in the pilot randomized controlled trial at two hospitals, one in Canada
      and one in the USA. Nurses at both hospitals were trained in how to assist women into the
      hands-and-knees position in bed. Repeated hands-and-knees position was defined as attempts to
      use the position for 15 minutes, hourly from randomization until delivery. Women were not
      asked to assume hands-and-knees for delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Compliance
time frame: from randomization to delivery
description: Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.
measure: Persistent back pain
time frame: hourly during labour, from randomization to delivery
description: Persistent back pain intensity rating measured hourly during hospital labour.
measure: women's views
time frame: assessed prior to hospital discharge
description: women's views of their birth experiences, including satisfaction with care and care providers, views about hands-and-knees positioning, willingness to use hands-and-knees position in a subsequent labour, comparison of expectations versus experiences of labour. The measures used to assess women's views had been developed for and used in prior trials of forms of intrapartum care by Hodnett and colleagues. Most questions were Likert scales or categorical items.
measure: Method of birth
time frame: at delivery
description: Spontaneous vaginal, assisted vaginal (vacuum or forceps), Caesarean
measure: pharmacologic analgesia
time frame: Initiated during labour
description: regional analgesia or intramuscular analgesia administered during first or second stage labour
measure: oxytocin during first or second stage labour
time frame: from randomization until end of second stage
description: any oxytocin infusion
measure: dislodged epidural catheter
time frame: from randomization until delivery
description: dislodged epidural catheter
measure: Fall
time frame: from randomization until delivery
description: Mother fell while attempting hands-and-knees position
measure: perineal trauma
time frame: at delivery
description: any perineal trauma (episiotomy and/or laceration0 requiring suturing
measure: maternal postpartum complications
time frame: between delivery and hospital discharge
description: postpartum hemorrhage or complication requiring prolonged stay
measure: Apgar Score
time frame: at one and five minutes after birth
description: Neonatal Apgar Score
measure: length of hospital stay
time frame: from delivery to discharge
description: length of stay for mother and baby after birth
measure: admission to neonatal intensive care unit
time frame: between birth and hospital discharge
description: newborn admitted to neonatal intensive care unit
measure: labour length
time frame: from randomization until delivery
description: Length of time between randomization and delivery
arm group label: Repeated Use of Hands-and-Knees
arm group type: Experimental
description: The intervention was repeated use of hands-and-knees position during labour. Participants were asked to try it for at least 15 minutes every hour, from randomization until delivery. They were not required to use it for delivery.
arm group label: Usual care
arm group type: No Intervention
description: Participants were asked to refrain from using hands-and-knees position at any time from randomization to delivery. They were free to use any other position.
intervention type: Other
intervention name: Repeated hands-and-knees positioning during labour
description: Details are in the Arm Description.
arm group label: Repeated Use of Hands-and-Knees
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Canada
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Ellen Hodnett
investigator title: Professor