- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01702402
Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh
Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh (Healthy Fertility Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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. |
Other: Comparison
A comparison area received standard government health services.
|
A comparison area received standard government health services.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
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.
|
5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Abdullah H Baqui, MBBSMHSDrPH, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 00000149
- GHS-A-00-08-00002-00 (Other Grant/Funding Number: USAID104309)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Health Knowledge, Attitudes, Practice
-
Amref Health AfricaRecruitingHealth Knowledge, Attitudes, PracticeKenya
-
Nigde Omer Halisdemir UniversityGazi University; Ankara Yildirim Beyazıt UniversityRecruitingHealth Knowledge, Attitudes, PracticeTurkey
-
Bournemouth UniversityUniversity College, London; University of Leeds; University of SouthamptonCompletedHealth Knowledge, Attitudes, PracticeUnited Kingdom
-
Galderma R&DCompletedHealth Knowledge, Attitudes, PracticeFrance, Germany, Spain, United Kingdom
-
Virginia Commonwealth UniversityCompletedHealth Knowledge, Attitudes, PracticeUnited States
-
Chang Gung Memorial HospitalCompletedHealth Knowledge, Attitudes, PracticeTaiwan
-
Goethe UniversityUnknownHealth Knowledge, Attitudes, PracticeGermany
-
Continuity Research NetworkCompletedHealth Knowledge, Attitudes, PracticeUnited States
-
Harvard School of Public Health (HSPH)RecruitingHealth Knowledge, Attitudes, PracticeUnited States
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingHealth Knowledge, Attitudes, PracticeTurkey
Clinical Trials on Educational and Behavior Change intervention
-
Universidade Norte do ParanáCompletedAsthma | Sedentary Behavior | Physical InactivityBrazil
-
Chulalongkorn UniversityUnknown
-
Columbia UniversityDoris Duke Charitable FoundationActive, not recruitingObesity, InfantUnited States
-
Bispebjerg HospitalTrygFonden, Denmark; Hartmann Fonden; Helsefonden, DenmarkCompletedArthroplasty, Replacement, HipDenmark
-
Kelowna General HospitalCompletedBacterial Infections | Behavior ChangeCanada
-
Seoul National University HospitalCompleted
-
Columbia UniversityNational Institute of Environmental Health Sciences (NIEHS); Kintampo Health...CompletedHealth Attitude | Health Knowledge, Attitudes, Practice | Behavior, ConsumerUnited States, Ghana
-
Gary MorrowNational Cancer Institute (NCI); Stanford UniversityCompletedSleep Disorder | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast CancerUnited States
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)RecruitingObesity | Overweight | Overweight and ObesityUnited States
-
Bispebjerg HospitalAAL; InnovationsfondenRecruitingHeart Failure | Arthritis | Parkinson Disease | Stroke Sequelae | COPD | Old Age; CachexiaDenmark