Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh
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ClinicalTrials.gov Identifier: NCT01702402 |
Recruitment Status :
Completed
First Posted : October 8, 2012
Last Update Posted : September 16, 2014
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Condition or disease | Intervention/treatment | Phase |
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Health Knowledge, Attitudes, Practice | Behavioral: Educational and Behavior Change intervention Other: Comparison Group | Not Applicable |
The specific objectives of this operations research are:
- 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.
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Integrated Service Delivery Approach: To assess the strengths and limitations of integrating family planning into an ongoing community-based maternal and newborn care program.
- 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
- 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
- To determine factors that affect the quality of care provided by CHWs in both the intervention and control arms in Sylhet district, Bangladesh
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 |

Arm | Intervention/treatment |
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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.
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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.
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Other: Comparison Group
A comparison area received standard government health services. |
- 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.
- 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.
- 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.

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

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
Principal Investigator: | Abdullah H Baqui, MBBSMHSDrPH | Johns Hopkins University |
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 |
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