Health Knowledge, Attitudes, PracticeNCT01702402
Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh
A study testing Educational and Behavior Change intervention and Comparison Group in people with Health Knowledge, Attitudes, Practice, run by Johns Hopkins Bloomberg School of Public Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 minute to 49 years
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Educational and Behavior Change intervention and Comparison Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,916 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unions not adhering to inclusion criteria.
- Women not of reproductive age (unless they fall under other category)
- Infants- over age 1
About this study
Official title: Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh (Healthy Fertility Study)
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.
Read the 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
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Educational and Behavior Change intervention, Comparison Group
- Keywords
- intervention
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational and Behavior Change interventionBehavioural
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 GroupOther
A comparison area received standard government health services.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: Educational and Behavior Change intervention |
| Comparison | Other | A comparison area received standard government health services. Receives: Other: Comparison Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled women (15-49 yrs) using a contraceptive method at 3, 6, 12, 18, 24, 30 and 36 months
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.
Measured: 5 years
Secondary outcomes (2)
Probability of a subsequent birth within 24 months of index birth
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.
Measured: 5 years
Percentage of enrolled women with short birth intervals
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startJun 2007
- Primary completionSep 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,916 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Jhpiego, Johns Hopkins University, John Snow, Inc., Save the Children, PATH, Population Services International
- Responsible party
- Principal investigator, Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Abdullah H Baqui, MBBSMHSDrPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702402
- Sponsor's protocol ID
- 00000149
- Other IDs
- GHS-A-00-08-00002-00
- Status last verified
- Sep 2014
- First submitted
- 3 Nov 2011
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Stake S, Ahmed S, Tol W, Ahmed S, Begum N, Khanam R, Harrison M, Baqui AH. Prevalence, associated factors, and disclosure of intimate partner violence among mothers in rural Bangladesh. J Health Popul Nutr. 2020 Dec 7;39(1):14. doi: 10.1186/s41043-020-00223-w.
PubMed 33287907
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh (Healthy Fertility Study)
- ClinicalTrials.gov ID
- NCT01702402
- Acronym / sponsor ID
- 00000149
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,916 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Jhpiego, Johns Hopkins University, John Snow, Inc., Save the Children, PATH, Population Services International
- Study start
- Jun 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Educational and Behavior Change interventionIntervention 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. |
| Comparison | Other | Other: Comparison GroupA comparison area received standard government health services. |
Who may qualify
- Ages
- 1 minute to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Unions not adhering to inclusion criteria.
- Women not of reproductive age (unless they fall under other category)
- Infants- over age 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational and Behavior Change interventionIntegrate 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. | Behavioural | Intervention Arm |
| Comparison GroupA comparison area received standard government health services. | Other | Comparison |
Primary outcome
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.
2 secondary outcomes
Probability of a subsequent birth within 24 months of index birth
Time frame: 5 years
Percentage of enrolled women with short birth intervals
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
- Derived from this study: PubMed 33287907Stake S, Ahmed S, Tol W, Ahmed S, Begum N, Khanam R, Harrison M, Baqui AH. Prevalence, associated factors, and disclosure of intimate partner violence among mothers in rural Bangladesh. J Health Popul Nutr. 2020 Dec 7;39(1):14. doi: 10.1186/s41043-020-00223-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdullah H Baqui, MBBSMHSDrPH principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Educational and Behavior Change intervention and Comparison Group in people with Health Knowledge, Attitudes, Practice, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01702402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.