<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/NCT01702402</url>
  </required_header>
  <id_info>
    <org_study_id>00000149</org_study_id>
    <secondary_id>GHS-A-00-08-00002-00</secondary_id>
    <nct_id>NCT01702402</nct_id>
  </id_info>
  <brief_title>Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh</brief_title>
  <official_title>Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh (Healthy Fertility Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jhpiego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>John Snow, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Save the Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Population Services International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed operations research study is designed to evaluate a package of family planning&#xD;
      services and related behavior change interventions aimed at addressing the unmet need for&#xD;
      family planning in postpartum women, integrated with an ongoing maternal and newborn health&#xD;
      program, and to assess the program's impact (1) on knowledge of healthy fertility practices,&#xD;
      (2) on contraceptive use prevalence in women during the postpartum period, (3) on postpartum&#xD;
      birth spacing, and (4) to examine the feasibility and sustainability of the proposed&#xD;
      integrated service delivery approach. The study will have a quasi-experimental design, with&#xD;
      evaluation primarily through household surveys in four intervention unions and four&#xD;
      comparison unions (unions are lowest local government entities with an average population of&#xD;
      about 20,000) in rural Sylhet District, Bangladesh.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific objectives of this operations research are:&#xD;
&#xD;
        1. Integrated Family Planning/Maternal Neonatal Health Intervention: To develop and test an&#xD;
           integrated Family Planning and Maternal and Neonatal Health (FP/MNH) service delivery&#xD;
           approach in the Bangladesh setting, building on the ongoing Projahnmo study.&#xD;
           Intervention activities will include behaviour change communications on healthy timing&#xD;
           and spacing of pregnancy, couples counseling, social networking and expansion of&#xD;
           contraceptive options for postpartum women, including provision of oral contraceptive&#xD;
           pills and condoms in the home.&#xD;
&#xD;
        2. Integrated Service Delivery Approach: To assess the strengths and limitations of&#xD;
           integrating family planning into an ongoing community-based maternal and newborn care&#xD;
           program.&#xD;
&#xD;
             1. To compare the quality of counseling provided by CHWs in the integrated (MNH+FP)&#xD;
                intervention arm versus regular (MNH) control arm in Sylhet district, Bangladesh&#xD;
&#xD;
             2. To assess the knowledge of CHWs providing integrated (MNH+FP) counseling in the&#xD;
                intervention arm versus CHWs providing regular MNH counseling in the control arm in&#xD;
                Sylhet district, Bangladesh&#xD;
&#xD;
             3. To determine factors that affect the quality of care provided by CHWs in both the&#xD;
                intervention and control arms in Sylhet district, Bangladesh&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of enrolled women (15-49 yrs) using a contraceptive method at 3, 6, 12, 18, 24, 30 and 36 months</measure>
    <time_frame>5 years</time_frame>
    <description>Determine the impact of the maternal and neonatal health (MNH) intervention package on the contraceptive prevalence rate (CPR) among enrolled women (15-49 yrs) at 3, 6, 12, 18, 24, 30 and 36 months among the study sample. CPR is defined as the number of enrolled women using a contraceptive method divided by the total number of women enrolled at a point in time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probability of a subsequent birth within 24 months of index birth</measure>
    <time_frame>5 years</time_frame>
    <description>Probability of a subsequent birth within 24 months from the index birth assessed by the lifetable method in enrolled women (15-49 yrs) among the study sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of enrolled women with short birth intervals</measure>
    <time_frame>5 years</time_frame>
    <description>Percentage of enrolled women (15-49 yrs) with short birth intervals (birth-interval &lt;24 months between the index child and any subsequent births) among the study sample.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">6916</enrollment>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention activities will include behaviour change communications on healthy timing and spacing of pregnancy, couples counselling, social networking and expansion of contraceptive options for postpartum women, including provision of oral contraceptive pills and condoms in the home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A comparison area received standard government health services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational and Behavior Change intervention</intervention_name>
    <description>Integrate post-partum family planning education and counselling into 2nd Antenatal Home visit by CHW (at approximately 32 weeks of pregnancy) Integrate post-partum family planning education and counselling into post-partum visits by CHWs during first month Continue providing family planning education and counselling to women through CHW home visits after first month.&#xD;
Promote discussion and acceptance of post-partum family planning methods among key household members.&#xD;
Facility level Ensure availability of postpartum contraceptive methods such as progestin-only pill.&#xD;
Ensure availability of post-partum family planning and post-natal services. Community level Increase community awareness of the importance of birth spacing and benefits of LAM Educate influential community members on the importance of birth spacing and benefits of LAM.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comparison Group</intervention_name>
    <description>A comparison area received standard government health services.</description>
    <arm_group_label>Comparison</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unions have been selected by the following criteria: 1) currently implementing&#xD;
             Projahnmo MNH program; 2) Similar demographics between intervention and comparison&#xD;
             unions; 3) Input from local health officials regarding the most suitable Unions to&#xD;
             work in; and 4) Capacity and demonstrated willingness of health workers at the Union&#xD;
             level based in Union Health and Family Welfare Centers to collaborate with the project&#xD;
             and work to achieve its objectives.&#xD;
&#xD;
        Recently delivered women Infants Community providers Husbands Mothers-in-law Community&#xD;
        providers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unions not adhering to inclusion criteria.&#xD;
&#xD;
          -  Women not of reproductive age (unless they fall under other category)&#xD;
&#xD;
          -  Infants- over age 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdullah H Baqui, MBBSMHSDrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>November 3, 2011</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>September 12, 2014</last_update_submitted>
  <last_update_submitted_qc>September 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins Bloomberg School of Public Health</investigator_affiliation>
    <investigator_full_name>Abdullah Baqui</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>intervention</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/NCT01702402
org study id: 00000149
secondary id: GHS-A-00-08-00002-00
nct id: NCT01702402
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The proposed operations research study is designed to evaluate a package of family planning
      services and related behavior change interventions aimed at addressing the unmet need for
      family planning in postpartum women, integrated with an ongoing maternal and newborn health
      program, and to assess the program's impact (1) on knowledge of healthy fertility practices,
      (2) on contraceptive use prevalence in women during the postpartum period, (3) on postpartum
      birth spacing, and (4) to examine the feasibility and sustainability of the proposed
      integrated service delivery approach. The study will have a quasi-experimental design, with
      evaluation primarily through household surveys in four intervention unions and four
      comparison unions (unions are lowest local government entities with an average population of
      about 20,000) in rural Sylhet District, Bangladesh.
The specific objectives of this operations research are:

        1. Integrated Family Planning/Maternal Neonatal Health Intervention: To develop and test an
           integrated Family Planning and Maternal and Neonatal Health (FP/MNH) service delivery
           approach in the Bangladesh setting, building on the ongoing Projahnmo study.
           Intervention activities will include behaviour change communications on healthy timing
           and spacing of pregnancy, couples counseling, social networking and expansion of
           contraceptive options for postpartum women, including provision of oral contraceptive
           pills and condoms in the home.

        2. Integrated Service Delivery Approach: To assess the strengths and limitations of
           integrating family planning into an ongoing community-based maternal and newborn care
           program.

             1. To compare the quality of counseling provided by CHWs in the integrated (MNH+FP)
                intervention arm versus regular (MNH) control arm in Sylhet district, Bangladesh

             2. To assess the knowledge of CHWs providing integrated (MNH+FP) counseling in the
                intervention arm versus CHWs providing regular MNH counseling in the control arm in
                Sylhet district, Bangladesh

             3. To determine factors that affect the quality of care provided by CHWs in both the
                intervention and control arms in Sylhet district, Bangladesh
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Proportion of enrolled women (15-49 yrs) using a contraceptive method at 3, 6, 12, 18, 24, 30 and 36 months
time frame: 5 years
description: Determine the impact of the maternal and neonatal health (MNH) intervention package on the contraceptive prevalence rate (CPR) among enrolled women (15-49 yrs) at 3, 6, 12, 18, 24, 30 and 36 months among the study sample. CPR is defined as the number of enrolled women using a contraceptive method divided by the total number of women enrolled at a point in time.
measure: Probability of a subsequent birth within 24 months of index birth
time frame: 5 years
description: Probability of a subsequent birth within 24 months from the index birth assessed by the lifetable method in enrolled women (15-49 yrs) among the study sample.
measure: Percentage of enrolled women with short birth intervals
time frame: 5 years
description: Percentage of enrolled women (15-49 yrs) with short birth intervals (birth-interval <24 months between the index child and any subsequent births) among the study sample.
arm group label: Intervention Arm
arm group type: Experimental
description: Intervention activities will include behaviour change communications on healthy timing and spacing of pregnancy, couples counselling, social networking and expansion of contraceptive options for postpartum women, including provision of oral contraceptive pills and condoms in the home.
arm group label: Comparison
arm group type: Other
description: A comparison area received standard government health services.
intervention type: Behavioral
intervention name: Educational and Behavior Change intervention
description: Integrate post-partum family planning education and counselling into 2nd Antenatal Home visit by CHW (at approximately 32 weeks of pregnancy) Integrate post-partum family planning education and counselling into post-partum visits by CHWs during first month Continue providing family planning education and counselling to women through CHW home visits after first month.
Promote discussion and acceptance of post-partum family planning methods among key household members.
Facility level Ensure availability of postpartum contraceptive methods such as progestin-only pill.
Ensure availability of post-partum family planning and post-natal services. Community level Increase community awareness of the importance of birth spacing and benefits of LAM Educate influential community members on the importance of birth spacing and benefits of LAM.
arm group label: Intervention Arm
intervention type: Other
intervention name: Comparison Group
description: A comparison area received standard government health services.
arm group label: Comparison
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 49 Years
healthy volunteers: No
last name: Abdullah H Baqui, MBBSMHSDrPH
role: Principal Investigator
affiliation: Johns Hopkins University
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins Bloomberg School of Public Health
investigator full name: Abdullah Baqui
investigator title: Professor