xml: <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/NCT05979194</url>
    </required_header>
    <id_info>
      <org_study_id>REC2023</org_study_id>
      <nct_id>NCT05979194</nct_id>
    </id_info>
    <brief_title>WHO Labor Care Guide for Obstetric Care Providers in Public Health Facilities in Mbarara, Southwestern Uganda</brief_title>
    <official_title>WHO Labour Care Guide Introduction, Implementation and Use as an Effective Decision-making Tool to Monitor Labor Among Obstetric Care Providers in Publicly Funded Health Facilities in Mbarara District and Mbarara City, Southwestern Uganda</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mbarara University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mbarara University of Science and Technology</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this mixed method multisite effectiveness-implementation study across all basic&#xD;
        and comprehensive emergency obstetric and newborn care facilities in Mbarara district and&#xD;
        Mbarara City in Southwestern Uganda is to identify unique challenges, facilitators and&#xD;
        patterns of potential and sustained uptake of the new WHO Labor Care Guide. Using these&#xD;
        baseline findings, I will characterize, and refine the LCG, and then develop a suitable&#xD;
        training strategy to effectively integrate/implement the new LCG into routine maternity care&#xD;
        in Mbarara district. I will then utilize the Proctor implementation outcome framework to&#xD;
        evaluate implementation outcomes of using the new labor care guide in routine maternity care&#xD;
        that include; acceptability, appropriateness, feasibility, fidelity, and effectiveness among&#xD;
        HCPs actively involved in deliveries across Mbarara District and Mbarara City. Finally, I&#xD;
        will assess the diagnostic predictability of the new LCG compared to the partogram in&#xD;
        effectively detecting prolonged labor among women delivering in Mbarara district and Mbarara&#xD;
        City.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        I will utilize an ambispective cohort; a combination of a historical cohort of mothers&#xD;
        monitored using a partograph and prospective cohort of women monitored using the new Labor&#xD;
        Care Guide to evaluate implementation success (effectiveness). As a concerted effort to&#xD;
        meaningfully implement a new intervention meant to reduce preventable maternal and perinatal&#xD;
        morbidity and mortality, these results will generate grounded, robust scientific data to&#xD;
        inform stakeholders and policy makers working towards effectively integrating and scaling up&#xD;
        of this new LCG into routine maternity care in similar settings across the country and&#xD;
        beyond. This study will also be able to show the effect of this intervention, and optimize&#xD;
        its implementation in routine maternity care practice to improve maternal-fetal outcomes in&#xD;
        similar settings.&#xD;
  &#xD;
        Participants will be adult HCPs actively involved in maternity care and conducting&#xD;
        deliveries, health facility managers in Mbarara district and officials from the reproductive&#xD;
        health division of the Ugandan Ministry of Health. For the effectiveness-implementation&#xD;
        trial, we shall enroll 520 mothers in active labor at the study facilities. Abstracted&#xD;
        partograph data from the records of 520 mothers whose labor was monitored using partograph&#xD;
        data will be used to compare the proportion of prolonged labor in addition to other&#xD;
        effectiveness outcomes.&#xD;
  &#xD;
        The main questions we aim&#xD;
  &#xD;
          -  To determine the effectiveness and other implementation outcomes of the new LCG using&#xD;
             Proctor implementation outcome framework among HCPs delivering women across Mbarara&#xD;
             District and Mbarara City and&#xD;
  &#xD;
          -  To evaluate the diagnostic accuracy of the new WHO LCG versus the partogram in detecting&#xD;
             prolonged labor and reducing rates of obstructed labor among women delivering in Mbarara&#xD;
             district Adult HCPs will participate in audio recorded in-dept face to face interviews&#xD;
             and adult mothers in labor will be monitored using the New WHO labor care guide to&#xD;
             document the proportion of prolonged labor defined as 1) labor crossing the action line&#xD;
             on the partograph and 2) labor lasting more than a specified centimeter cervical&#xD;
             dilation &quot;time lag&quot; in the alert column of section 5 of the LCG. Secondary outcome&#xD;
             measurements will include proportion of obstetric interventions such as caesarean&#xD;
             sections, labor augmentation, blood transfusion; quality-of-care; having a fresh still&#xD;
             birth; duration of 1st and 2ndstages of labor; 5-minute apgar score, need for&#xD;
             resuscitation /blood transfusion, mode of delivery; initiation of breastfeeding;&#xD;
             obstetric complications diagnosed and or managed during labor, childbirth or immediate&#xD;
             postpartum; ruptured uterus; postpartum hemorrhage; maternal/newborn sepsis; maternal,&#xD;
             fetal, and newborn deaths. Other quantitative data that will be collected from maternity&#xD;
             records of women that have delivered within one year before and a year after&#xD;
             implementation of the labor care guide will include; patient demographics e.g., age,&#xD;
             gravidity, parity, gestational age, prenatal, antepartum high-risk morbidities, NCDs,&#xD;
             and HCP demographics; age, education, experience, self-efficacy will be collected&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of women with prolonged labor</measure>
      <time_frame>6 months</time_frame>
      <description>We will define prolonged labor as 1) labor crossing the action line on the partograph, 2) labor lasting more than a specified centimeter cervical dilation &quot;time lag&quot; in the alert column of section 5 of the LCG</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of obstetric interventions</measure>
      <time_frame>6months</time_frame>
      <description>proportion of obstetric interventions such as caesarean sections, labour augmentation, blood transfusion; quality-of-care; having a fresh still birth; duration of 1st and 2nd stages of labor; 5-minute apgar score, need for rescuscitation/blood transfusion, mode of delivery; initiation of breastfeeding; obstetric complications diagnosed and or managed during labor, childbirth or immediate postpartum; ruptured uterus; postpartum hemorrhage; maternal/newborn sepsis; maternal, fetal, and newborn deaths</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">520</enrollment>
    <condition>Intrapartum Fetal Monitoring</condition>
    <arm_group>
      <arm_group_label>Labor care guide</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In this study, we shall determine the effectiveness and other implementation outcomes of the new LCG using Proctor implementation outcome framework among HCPs delivering women across Mbarara District and Mbarara City and evaluate the diagnostic accuracy of the new WHO LCG versus the partogram in detecting prolonged labour and reducing rates of obstructed labour among women delivering in Mbarara district. We shall use local contextualized data from qualitative one-on-one key informant interviews in objective 1 from HCPs and Ministry of Health official involved in labour monitoring and implementation. The WHO labour care guide shall be refined and a Ugandan Ministry of Health prototype designed. An appropriated training and implementation strategy informed by the HCPs themselves shall be used to deliver the content to HCPs in all pilot sites.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Labor Care Guide</intervention_name>
      <description>Identifying information and labor characteristics at admission, supportive care, care of the baby, care of the woman, labor progress, medication, and shared decision-making</description>
      <arm_group_label>Labor care guide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals with self-reported willingness to use the new LCG in monitoring of labor,&#xD;
               able and willing to provide informed consent will be invited to participate in this&#xD;
               study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals unwilling to use the LCG and unable to provide informed consent will not&#xD;
               be eligible to participate in this study.&#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_official>
      <last_name>Godfrey Mugyenyi, MMed</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mbarara University of Science and Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Senior Lecturer</last_name>
      <phone>+256772543238</phone>
      <email>gmugyenyi@must.ac.ug</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</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>
  
  
text: 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/NCT05979194
  org study id: REC2023
  nct id: NCT05979194
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this mixed method multisite effectiveness-implementation study across all basic
        and comprehensive emergency obstetric and newborn care facilities in Mbarara district and
        Mbarara City in Southwestern Uganda is to identify unique challenges, facilitators and
        patterns of potential and sustained uptake of the new WHO Labor Care Guide. Using these
        baseline findings, I will characterize, and refine the LCG, and then develop a suitable
        training strategy to effectively integrate/implement the new LCG into routine maternity care
        in Mbarara district. I will then utilize the Proctor implementation outcome framework to
        evaluate implementation outcomes of using the new labor care guide in routine maternity care
        that include; acceptability, appropriateness, feasibility, fidelity, and effectiveness among
        HCPs actively involved in deliveries across Mbarara District and Mbarara City. Finally, I
        will assess the diagnostic predictability of the new LCG compared to the partogram in
        effectively detecting prolonged labor among women delivering in Mbarara district and Mbarara
        City.
  I will utilize an ambispective cohort; a combination of a historical cohort of mothers
        monitored using a partograph and prospective cohort of women monitored using the new Labor
        Care Guide to evaluate implementation success (effectiveness). As a concerted effort to
        meaningfully implement a new intervention meant to reduce preventable maternal and perinatal
        morbidity and mortality, these results will generate grounded, robust scientific data to
        inform stakeholders and policy makers working towards effectively integrating and scaling up
        of this new LCG into routine maternity care in similar settings across the country and
        beyond. This study will also be able to show the effect of this intervention, and optimize
        its implementation in routine maternity care practice to improve maternal-fetal outcomes in
        similar settings.
  
        Participants will be adult HCPs actively involved in maternity care and conducting
        deliveries, health facility managers in Mbarara district and officials from the reproductive
        health division of the Ugandan Ministry of Health. For the effectiveness-implementation
        trial, we shall enroll 520 mothers in active labor at the study facilities. Abstracted
        partograph data from the records of 520 mothers whose labor was monitored using partograph
        data will be used to compare the proportion of prolonged labor in addition to other
        effectiveness outcomes.
  
        The main questions we aim
  
          -  To determine the effectiveness and other implementation outcomes of the new LCG using
             Proctor implementation outcome framework among HCPs delivering women across Mbarara
             District and Mbarara City and
  
          -  To evaluate the diagnostic accuracy of the new WHO LCG versus the partogram in detecting
             prolonged labor and reducing rates of obstructed labor among women delivering in Mbarara
             district Adult HCPs will participate in audio recorded in-dept face to face interviews
             and adult mothers in labor will be monitored using the New WHO labor care guide to
             document the proportion of prolonged labor defined as 1) labor crossing the action line
             on the partograph and 2) labor lasting more than a specified centimeter cervical
             dilation "time lag" in the alert column of section 5 of the LCG. Secondary outcome
             measurements will include proportion of obstetric interventions such as caesarean
             sections, labor augmentation, blood transfusion; quality-of-care; having a fresh still
             birth; duration of 1st and 2ndstages of labor; 5-minute apgar score, need for
             resuscitation /blood transfusion, mode of delivery; initiation of breastfeeding;
             obstetric complications diagnosed and or managed during labor, childbirth or immediate
             postpartum; ruptured uterus; postpartum hemorrhage; maternal/newborn sepsis; maternal,
             fetal, and newborn deaths. Other quantitative data that will be collected from maternity
             records of women that have delivered within one year before and a year after
             implementation of the labor care guide will include; patient demographics e.g., age,
             gravidity, parity, gestational age, prenatal, antepartum high-risk morbidities, NCDs,
             and HCP demographics; age, education, experience, self-efficacy will be collected
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Proportion of women with prolonged labor
  time frame: 6 months
  description: We will define prolonged labor as 1) labor crossing the action line on the partograph, 2) labor lasting more than a specified centimeter cervical dilation "time lag" in the alert column of section 5 of the LCG
  measure: Proportion of obstetric interventions
  time frame: 6months
  description: proportion of obstetric interventions such as caesarean sections, labour augmentation, blood transfusion; quality-of-care; having a fresh still birth; duration of 1st and 2nd stages of labor; 5-minute apgar score, need for rescuscitation/blood transfusion, mode of delivery; initiation of breastfeeding; obstetric complications diagnosed and or managed during labor, childbirth or immediate postpartum; ruptured uterus; postpartum hemorrhage; maternal/newborn sepsis; maternal, fetal, and newborn deaths
  arm group label: Labor care guide
  arm group type: Other
  description: In this study, we shall determine the effectiveness and other implementation outcomes of the new LCG using Proctor implementation outcome framework among HCPs delivering women across Mbarara District and Mbarara City and evaluate the diagnostic accuracy of the new WHO LCG versus the partogram in detecting prolonged labour and reducing rates of obstructed labour among women delivering in Mbarara district. We shall use local contextualized data from qualitative one-on-one key informant interviews in objective 1 from HCPs and Ministry of Health official involved in labour monitoring and implementation. The WHO labour care guide shall be refined and a Ugandan Ministry of Health prototype designed. An appropriated training and implementation strategy informed by the HCPs themselves shall be used to deliver the content to HCPs in all pilot sites.
  intervention type: Behavioral
  intervention name: Labor Care Guide
  description: Identifying information and labor characteristics at admission, supportive care, care of the baby, care of the woman, labor progress, medication, and shared decision-making
  arm group label: Labor care guide
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Godfrey Mugyenyi, MMed
  role: Principal Investigator
  affiliation: Mbarara University of Science and Technology
  last name: Senior Lecturer
  phone: +256772543238
  email: gmugyenyi@must.ac.ug
  responsible party type: Sponsor