<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/NCT04442997</url>
  </required_header>
  <id_info>
    <org_study_id>20-0468</org_study_id>
    <secondary_id>NICHD/K12 HD001271-21</secondary_id>
    <nct_id>NCT04442997</nct_id>
  </id_info>
  <brief_title>Use of Cesarean Birth at Private Health Facilities in Lilongwe and Blantyre, Malawi</brief_title>
  <official_title>Use of Cesarean Birth at Private Health Facilities in Lilongwe and Blantyre, Malawi</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</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 purpose of the research study is to collect preliminary data to which future outcomes&#xD;
      after implementing quality improvement projects or research will be compared. There will be&#xD;
      observation of the labor and delivery services received and resulting outcomes of women and&#xD;
      infants who deliver at private health facilities in urban Malawi. Data will be collected at&#xD;
      admission, delivery, and discharge from women and providers on patient characteristics, labor&#xD;
      and obstetric characteristics, delivery factors, and pregnancy outcomes that result during&#xD;
      the course of the hospitalization. This will include the vital status of the mother and the&#xD;
      infant. The overall hypothesis is that cesarean birth rates will be higher than the&#xD;
      ecologically supported 10% cesarean birth rate, and that there may be cesareans that are&#xD;
      performed without clear medical indication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Cesarean birth is the most commonly performed surgery in the world. It is a major abdominal&#xD;
      procedure that can save maternal and perinatal lives when properly indicated, but when&#xD;
      performed without medical necessity, is associated with adverse outcomes. Global cesarean&#xD;
      birth rates are increasing, but there has been a less pronounced rise in sub-Saharan Africa&#xD;
      (SSA) where rates tend to be below 5.0%. However, in Sub-Saharan Africa (SSA) and other low-&#xD;
      and middle-income countries (LMIC), there is a recognition that significant in-country&#xD;
      disparities in the use of cesarean birth exist. Rates are higher in urban settings, and there&#xD;
      is evidence that they are higher in private versus public facilities.&#xD;
&#xD;
      Objective and Aims:&#xD;
&#xD;
      The main objective of this prospective, cross-sectional, observational study is to observe&#xD;
      the use of cesarean birth at three private health facilities in urban Malawi by the end of&#xD;
      the study. This will be achieved by getting an understanding of the current delivery&#xD;
      practices and patient characteristics, as well as associated outcomes of women who choose to&#xD;
      deliver at these private facilities in order to understand how and under what circumstances&#xD;
      the surgery is being used.&#xD;
&#xD;
      Aim 1: Observe prevalence of and indications for cesarean birth in three private health&#xD;
      facilities in urban Malawi in the overall cohort and in ten mutually exclusive subgroups&#xD;
      defined by the WHO-endorsed Robson Classification for cesarean birth&#xD;
&#xD;
      Aim 2: Determine risk factors associated with cesarean birth among Robson subpopulations of&#xD;
      women at study sites, and the distribution of adverse pregnancy outcomes across those&#xD;
      subgroups&#xD;
&#xD;
      Aim 3: Identify target modifiable risk factors or areas for potential quality improvement or&#xD;
      prospective research studies to optimize the use of cesarean birth within these facilities&#xD;
      that may have generalizable implications&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2022</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of participants using cesarean section delivery as assessed by survey questionnaires</measure>
    <time_frame>Hospital admission to discharge, about 3-4 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Types of indications for cesarean birth</measure>
    <time_frame>Hospital admission to discharge, about 3-4 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Types of adverse pregnancy outcomes among participants using cesarean section</measure>
    <time_frame>Hospital admission to discharge, up to 1 week</time_frame>
    <description>The types of adverse pregnancy outcomes reported among participants with cesarean section deliveries will be assessed via survey questionnaires. Data will be reported by population subgroup. Population subgroups will be defined by the World Health Organization-endorsed Robson Classification for Cesarean Birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Types of risk factors for Cesarean birth</measure>
    <time_frame>Hospital admission to discharge, about 3-4 days</time_frame>
    <description>The types of modifiable risk factors for cesarean birth reported among participants that use cesarean section delivery will be assessed via survey questionnaires</description>
  </secondary_outcome>
  <enrollment type="Actual">260</enrollment>
  <condition>Cesarean Section</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant women admitted for observation or delivery at 3 private health facilities in&#xD;
        Malawi.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Admitted for delivery or observation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Margo Harrison, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado - Anschutz Medical Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mwaiwathu Private Hospital</name>
      <address>
        <city>Blantyre</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Area 18 Medi Clinic - Asamala Health Services</name>
      <address>
        <city>Lilongwe</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Hope Private Clinic</name>
      <address>
        <city>Lilongwe</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 24, 2022</last_update_submitted>
  <last_update_submitted_qc>July 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cesarean section</keyword>
  <keyword>Cesarean birth</keyword>
  <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/NCT04442997
org study id: 20-0468
secondary id: NICHD/K12 HD001271-21
nct id: NCT04442997
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the research study is to collect preliminary data to which future outcomes
      after implementing quality improvement projects or research will be compared. There will be
      observation of the labor and delivery services received and resulting outcomes of women and
      infants who deliver at private health facilities in urban Malawi. Data will be collected at
      admission, delivery, and discharge from women and providers on patient characteristics, labor
      and obstetric characteristics, delivery factors, and pregnancy outcomes that result during
      the course of the hospitalization. This will include the vital status of the mother and the
      infant. The overall hypothesis is that cesarean birth rates will be higher than the
      ecologically supported 10% cesarean birth rate, and that there may be cesareans that are
      performed without clear medical indication.
Background:

      Cesarean birth is the most commonly performed surgery in the world. It is a major abdominal
      procedure that can save maternal and perinatal lives when properly indicated, but when
      performed without medical necessity, is associated with adverse outcomes. Global cesarean
      birth rates are increasing, but there has been a less pronounced rise in sub-Saharan Africa
      (SSA) where rates tend to be below 5.0%. However, in Sub-Saharan Africa (SSA) and other low-
      and middle-income countries (LMIC), there is a recognition that significant in-country
      disparities in the use of cesarean birth exist. Rates are higher in urban settings, and there
      is evidence that they are higher in private versus public facilities.

      Objective and Aims:

      The main objective of this prospective, cross-sectional, observational study is to observe
      the use of cesarean birth at three private health facilities in urban Malawi by the end of
      the study. This will be achieved by getting an understanding of the current delivery
      practices and patient characteristics, as well as associated outcomes of women who choose to
      deliver at these private facilities in order to understand how and under what circumstances
      the surgery is being used.

      Aim 1: Observe prevalence of and indications for cesarean birth in three private health
      facilities in urban Malawi in the overall cohort and in ten mutually exclusive subgroups
      defined by the WHO-endorsed Robson Classification for cesarean birth

      Aim 2: Determine risk factors associated with cesarean birth among Robson subpopulations of
      women at study sites, and the distribution of adverse pregnancy outcomes across those
      subgroups

      Aim 3: Identify target modifiable risk factors or areas for potential quality improvement or
      prospective research studies to optimize the use of cesarean birth within these facilities
      that may have generalizable implications
observational model: Ecologic or Community
time perspective: Retrospective
measure: Rate of participants using cesarean section delivery as assessed by survey questionnaires
time frame: Hospital admission to discharge, about 3-4 days
measure: Types of indications for cesarean birth
time frame: Hospital admission to discharge, about 3-4 days
measure: Types of adverse pregnancy outcomes among participants using cesarean section
time frame: Hospital admission to discharge, up to 1 week
description: The types of adverse pregnancy outcomes reported among participants with cesarean section deliveries will be assessed via survey questionnaires. Data will be reported by population subgroup. Population subgroups will be defined by the World Health Organization-endorsed Robson Classification for Cesarean Birth
measure: Types of risk factors for Cesarean birth
time frame: Hospital admission to discharge, about 3-4 days
description: The types of modifiable risk factors for cesarean birth reported among participants that use cesarean section delivery will be assessed via survey questionnaires
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
last name: Margo Harrison, MD, MPH
role: Principal Investigator
affiliation: University of Colorado - Anschutz Medical Campus
facility: 
facility: 
facility: 
country: Malawi
responsible party type: Sponsor
sharing ipd: No