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Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01702402
Recruitment Status : Completed
First Posted : October 8, 2012
Last Update Posted : September 16, 2014
Sponsor:
Collaborators:
Jhpiego
Johns Hopkins University
John Snow, Inc.
Save the Children
PATH
Population Services International
Information provided by (Responsible Party):
Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Health Knowledge, Attitudes, Practice Behavioral: Educational and Behavior Change intervention Other: Comparison Group Not Applicable

Detailed Description:

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6916 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh (Healthy Fertility Study)
Study Start Date : June 2007
Actual Primary Completion Date : September 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Arm
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.
 Behavioral: Educational and Behavior Change intervention

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.
Comparison
A comparison area received standard government health services.
 Other: Comparison Group
A comparison area received standard government health services.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Probability of a subsequent birth within 24 months of index birth [ Time Frame: 5 years ]
    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.

  2. Percentage of enrolled women with short birth intervals [ Time Frame: 5 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   1 Minute to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unions have been selected by the following criteria: 1) currently implementing Projahnmo MNH program; 2) Similar demographics between intervention and comparison unions; 3) Input from local health officials regarding the most suitable Unions to work in; and 4) Capacity and demonstrated willingness of health workers at the Union level based in Union Health and Family Welfare Centers to collaborate with the project and work to achieve its objectives.

Recently delivered women Infants Community providers Husbands Mothers-in-law Community providers

Exclusion Criteria:

  • Unions not adhering to inclusion criteria.
  • Women not of reproductive age (unless they fall under other category)
  • Infants- over age 1
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702402


Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Jhpiego
Johns Hopkins University
John Snow, Inc.
Save the Children
PATH
Population Services International
Investigators
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Principal Investigator: Abdullah H Baqui, MBBSMHSDrPH Johns Hopkins University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abdullah Baqui, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01702402    
Other Study ID Numbers: 00000149
GHS-A-00-08-00002-00 ( Other Grant/Funding Number: USAID104309 )
First Posted: October 8, 2012    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Keywords provided by Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health:
intervention