Neonatal DeathSMPNSNCT03032276
Safe Motherhood Promotion and Newborn Survival
A study testing Safe motherhood and newborn health promotion package in people with Neonatal Death and Maternal Death, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
Trial summary
Primary objective of the study is to measure the impact of a comprehensive package of interventions introduced by the Safe Motherhood Promotion and Newborn Survival project on neonatal mortality in three Upazila of Chandpur district, Bangladesh Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Neonatal Death, Maternal Death
- What is being tested?
- Safe motherhood and newborn health promotion package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,400 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2022
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Women with birth outcome in last three years
Who cannot join
- Unusual unions as per the contextual factors (demographics, terrain, functionality of health services, etc.) will be excluded.
- If a union has a total population of less than 12,000 (the minimum required to get adequate sample of neonates) they will either be excluded
About this study
Official title: Impact and Operational Assessment of an Integrated Safe Motherhood and Newborn Health Promotion Package: a Community-based Cluster Randomized Controlled Trial
Primary objective of the study is to measure the impact of a comprehensive package of interventions introduced by the Safe Motherhood Promotion and Newborn Survival project on neonatal mortality in three Upazila of Chandpur district, Bangladesh
Read the detailed description
Burden: Globally around 6.3 million children under five years of age died in 2013, two third of which occur in the low \& middle income countries. Bangladesh is one of the LMICs countries with high burden of maternal and neonatal mortalities. In Bangladesh, there has been a considerable progress in reduction of both child and maternal mortality in recent decades. From 1994 to 2014 under-5 mortality rate has reduced from 133 to 46 per 1000 live births in Bangladesh; however, within the same timeframe neonatal mortality declined from 52 to 28 per 1000 live births. This slow decrease in newborn deaths means that it now constitutes a greater share of total under-5 deaths. At present, neonatal mortality accounts for 74% of deaths in infants and 61% in children aged less than 5 years. Similarly, the country was able to decline MMR by 70% between 1990 and 2013, from 574 to 170 per 100,000 live births, with an annual reduction rate of 5.0%. Such statistics highlights the importance of focusing on perinatal and early postnatal periods to prevent maternal and neonatal mortalities.
Knowledge gap: Safe motherhood promotion project (SMPP) was a five (5 yr) year pilot project, launched in July 2006, by the Government of Bangladesh (GOB) in collaboration with JICA. The aim of the project was to improve the health status of pregnant and postpartum women and neonates. SMPP implemented three linked activities i.e., advocacy at the central level, strengthening of health facilities and empowerment of community. Evaluation of SMPP found positive changes in UN process indicators on EmOC including met needs (up from 31% to 55%), case fatality rate (<0.1%) and skilled birth attendance rate (from 18% to 25%). The major weakness of the previous assessment of SMPP were use of a before-after design without any concurrent comparison area and the assessment lacked population based mortality estimates, only measured hospital case fatality rate. Hence, there is lack of strong evidences regarding the impact of the project.
Relevance: The proposed project is expected to provide essential evidences to the GOB and other development partners with the help of stronger design and valid evaluation processes. It would help not only in prioritizing, planning, and further scaling-up of SMPNS interventions in other areas of Bangladesh but in informing other developing countries in similar settings also.
Hypothesis: Safe Motherhood and Newborn Survival intervention package will reduce neonatal mortality by 25%, in comparison to the routine services in Chandpur district, Bangladesh
Methods: A community-based, cluster-randomized design will be used to evaluate the effectiveness of an integrated "Safe Motherhood and Newborn Health Promotion Package" in Chandpur district, Bangladesh. Both quantitative and qualitative approaches will be employed to address the primary and secondary objectives. Baseline, midterm and end of intervention household survey will be conducted using validated structured questionnaire to assess the coverage of maternal \& newborn health interventions. Health facility assessments surveys will be conducted periodically to assess facility readiness and utilization of maternal and neonatal health services in the participating health facilities. Additionally, relevant data from routine Health Management Information System (HMIS) will be regularly collected and extracted An ongoing investigating system will be in place at the health facilities to identify and document maternal near miss cases.
Qualitative data will be collected for process documentation and in depth exploration of implementation challenges and contextual factors. Social capitals will be measured both quantitatively and qualitatively to assess the non health impact of the interventions. Qualitative data collection methods will include stakeholders' meeting, focus group discussions (FGD), periodic in-depth assessments, social mapping and other participatory exercises.
Outcome measures/variables: The primary outcome measure for evaluation of SMPNS intervention is reduction of neonatal mortality. In addition, changes in coverage and utilization of maternal \& newborn health services, cost effectiveness of implementation of intervention will also be measured.
- Conditions
- Neonatal Death, Maternal Death
- Being tested
- Safe motherhood and newborn health promotion package
- Keywords
- Safe motherhood, Newborn survival, Community, Cluster Randomized Trial
- Medical subject headings
- Perinatal Death, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe motherhood and newborn health promotion packageOther
The intervention package consists of three components: facility, community and linkages between the community and health facilities. Facility based interventions will serve both the comparison and intervention arms. However, other two interventions will serve the intervention arm only. Specific interventions and approaches for the three components will be implemented within the MOH\&FW service delivery system to improve MNH practices in families and communities and to increase the use of MNH services from appropriate facilities/providers. The intervention package has been developed based on the experiences from SMPP in Narsingdi district and on the basis of consultations with the International Advisory Body (IAB) that included GoB, JICA, ICDDR,B, other experts and stakeholders.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | "'Safe motherhood and newborn health promotion package'" will be implemented in the intervention arm which comprise 15 randomly selected unions (lowest level of administrative unit). Receives: Other: Safe motherhood and newborn health promotion package |
| Comparison | No intervention | Another 15 union will be selected where no intervention will be implemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of neonatal mortality rate (NMR)
NMR will be assessed at the beginning of the project. after that it will also assessed by two midline assessment after starting the intervention and finally it will be assessed during the endline survey
Measured: During baseline at year 1, in two mid-line at year 2 & 3 and finally after completion of the of the intervention at year 4
Secondary outcomes (2)
Changes in coverage and utilization of maternal and newborn health services
This will be assessed to evaluate the effect of the comprehensive package of interventions on health and care seeking behavior for neonates and women during antepartum, intrapartum and postpartum period at baseline and end line survey on total population and during two mid line surveys in a sub set of population
Measured: At year 1 (baseline), year 2 and 3 (mid lines) and year 4 (end line)
Cost effectiveness of implementing the interventions
Costs for improved neonatal health outcomes and related health services. This will be assessed by analyzing Costs per DALY averted, Costs per life-year gained; Costs per case of delivery by skilled attendance; Costs per case of essential neonatal care, Program cost, both start up and post implementation, Incremental health service costs for providing quality services, Out of pocket expenditure etc.
Measured: Every six months for programme costs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Neonatal DeathStudies of the same condition, open and under way.
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Bangladesh, Tokyo University
- Responsible party
- Sponsor
- Investigators
- Shams El Arifeen, DrPH, MBBS, Principal investigator, International Centre for Diarrhoeal Disease Research, BangladeshD M Emdadul Hoque, MPH, MBBS, Study director, International Centre for Diarrhoeal Disease Research, BangladeshSanwarul Bari, MBBS, Study director, International Centre for Diarrhoeal Disease Research, BangladeshMasum Billah, MPH, BURP, Study director, International Centre for Diarrhoeal Disease Research, BangladeshAhmed Ehsanur Rahman, MPH, MBBS, Study director, International Centre for Diarrhoeal Disease Research, BangladeshTazeen Tahsina, MS Economics, Study director, International Centre for Diarrhoeal Disease Research, BangladeshMohiuddin Ahsanul Kabir Chowdhury, MPH, MBBS, Study director, International Centre for Diarrhoeal Disease Research, BangladeshMohammad Mehedi Hasan, MPH, MSc, Study director, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032276
- Sponsor's protocol ID
- PR-16013
- Acronym
- SMPNS
- Status last verified
- Dec 2021
- First submitted
- 11 Jan 2017
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.
PubMed 25530442Caulfield LE, de Onis M, Blossner M, Black RE. Undernutrition as an underlying cause of child deaths associated with diarrhea, pneumonia, malaria, and measles. Am J Clin Nutr. 2004 Jul;80(1):193-8. doi: 10.1093/ajcn/80.1.193.
PubMed 15213048Jones G, Steketee RW, Black RE, Bhutta ZA, Morris SS; Bellagio Child Survival Study Group. How many child deaths can we prevent this year? Lancet. 2003 Jul 5;362(9377):65-71. doi: 10.1016/S0140-6736(03)13811-1.
PubMed 12853204Victora CG, Wagstaff A, Schellenberg JA, Gwatkin D, Claeson M, Habicht JP. Applying an equity lens to child health and mortality: more of the same is not enough. Lancet. 2003 Jul 19;362(9379):233-41. doi: 10.1016/S0140-6736(03)13917-7.
PubMed 12885488Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
PubMed 15752534Terra de Souza AC, Peterson KE, Andrade FM, Gardner J, Ascherio A. Circumstances of post-neonatal deaths in Ceara, Northeast Brazil: mothers' health care-seeking behaviors during their infants' fatal illness. Soc Sci Med. 2000 Dec;51(11):1675-93. doi: 10.1016/s0277-9536(00)00100-3.
PubMed 11072887Baqui AH, Arifeen SE, Williams EK, Ahmed S, Mannan I, Rahman SM, Begum N, Seraji HR, Winch PJ, Santosham M, Black RE, Darmstadt GL. Effectiveness of home-based management of newborn infections by community health workers in rural Bangladesh. Pediatr Infect Dis J. 2009 Apr;28(4):304-10. doi: 10.1097/INF.0b013e31819069e8.
PubMed 19289979Wakefield SE, Poland B. Family, friend or foe? Critical reflections on the relevance and role of social capital in health promotion and community development. Soc Sci Med. 2005 Jun;60(12):2819-32. doi: 10.1016/j.socscimed.2004.11.012. Epub 2004 Dec 24.
PubMed 15820589Hawe P, Shiell A. Social capital and health promotion: a review. Soc Sci Med. 2000 Sep;51(6):871-85. doi: 10.1016/s0277-9536(00)00067-8.
PubMed 10972431Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, Azad K, Costello A, Osrin D. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. Trials. 2011 Jun 14;12:151. doi: 10.1186/1745-6215-12-151.
PubMed 21672223De Silva MJ, Harpham T, Tuan T, Bartolini R, Penny ME, Huttly SR. Psychometric and cognitive validation of a social capital measurement tool in Peru and Vietnam. Soc Sci Med. 2006 Feb;62(4):941-53. doi: 10.1016/j.socscimed.2005.06.050. Epub 2005 Aug 10.
PubMed 16095787Bland JM, Altman DG. Cronbach's alpha. BMJ. 1997 Feb 22;314(7080):572. doi: 10.1136/bmj.314.7080.572. No abstract available.
PubMed 9055718El Arifeen S, Hill K, Ahsan KZ, Jamil K, Nahar Q, Streatfield PK. Maternal mortality in Bangladesh: a Countdown to 2015 country case study. Lancet. 2014 Oct 11;384(9951):1366-74. doi: 10.1016/S0140-6736(14)60955-7. Epub 2014 Jun 29.
PubMed 24990814Hoque DME, Chowdhury MAK, Rahman AE, Billah SM, Bari S, Tahsina T, Hasan MM, Islam S, Islam T, Mori R, Arifeen SE. A community-based cluster randomized controlled trial (cRCT) to evaluate the impact and operational assessment of "safe motherhood and newborn health promotion package": study protocol. BMC Public Health. 2018 May 3;18(1):592. doi: 10.1186/s12889-018-5478-6.
PubMed 29724194
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Operational Assessment of an Integrated Safe Motherhood and Newborn Health Promotion Package: a Community-based Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03032276
- Acronym / sponsor ID
- SMPNS / PR-16013
- Conditions
- Neonatal Death, Maternal Death
- Keywords
- Safe motherhood, Newborn survival, Community, Cluster Randomized Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50,400 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Government of Bangladesh, Tokyo University
- Study start
- Jul 2016
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 26 Jan 2017 (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.
Primary objective of the study is to measure the impact of a comprehensive package of interventions introduced by the Safe Motherhood Promotion and Newborn Survival project on neonatal mortality in three Upazila of Chandpur district, Bangladesh
Detailed description
Burden: Globally around 6.3 million children under five years of age died in 2013, two third of which occur in the low \& middle income countries. Bangladesh is one of the LMICs countries with high burden of maternal and neonatal mortalities. In Bangladesh, there has been a considerable progress in reduction of both child and maternal mortality in recent decades. From 1994 to 2014 under-5 mortality rate has reduced from 133 to 46 per 1000 live births in Bangladesh; however, within the same timeframe neonatal mortality declined from 52 to 28 per 1000 live births. This slow decrease in newborn deaths means that it now constitutes a greater share of total under-5 deaths. At present, neonatal mortality accounts for 74% of deaths in infants and 61% in children aged less than 5 years. Similarly, the country was able to decline MMR by 70% between 1990 and 2013, from 574 to 170 per 100,000 live births, with an annual reduction rate of 5.0%. Such statistics highlights the importance of focusing on perinatal and early postnatal periods to prevent maternal and neonatal mortalities.
Knowledge gap: Safe motherhood promotion project (SMPP) was a five (5 yr) year pilot project, launched in July 2006, by the Government of Bangladesh (GOB) in collaboration with JICA. The aim of the project was to improve the health status of pregnant and postpartum women and neonates. SMPP implemented three linked activities i.e., advocacy at the central level, strengthening of health facilities and empowerment of community. Evaluation of SMPP found positive changes in UN process indicators on EmOC including met needs (up from 31% to 55%), case fatality rate (<0.1%) and skilled birth attendance rate (from 18% to 25%). The major weakness of the previous assessment of SMPP were use of a before-after design without any concurrent comparison area and the assessment lacked population based mortality estimates, only measured hospital case fatality rate. Hence, there is lack of strong evidences regarding the impact of the project.
Relevance: The proposed project is expected to provide essential evidences to the GOB and other development partners with the help of stronger design and valid evaluation processes. It would help not only in prioritizing, planning, and further scaling-up of SMPNS interventions in other areas of Bangladesh but in informing other developing countries in similar settings also.
Hypothesis: Safe Motherhood and Newborn Survival intervention package will reduce neonatal mortality by 25%, in comparison to the routine services in Chandpur district, Bangladesh
Methods: A community-based, cluster-randomized design will be used to evaluate the effectiveness of an integrated "Safe Motherhood and Newborn Health Promotion Package" in Chandpur district, Bangladesh. Both quantitative and qualitative approaches will be employed to address the primary and secondary objectives. Baseline, midterm and end of intervention household survey will be conducted using validated structured questionnaire to assess the coverage of maternal \& newborn health interventions. Health facility assessments surveys will be conducted periodically to assess facility readiness and utilization of maternal and neonatal health services in the participating health facilities. Additionally, relevant data from routine Health Management Information System (HMIS) will be regularly collected and extracted An ongoing investigating system will be in place at the health facilities to identify and document maternal near miss cases.
Qualitative data will be collected for process documentation and in depth exploration of implementation challenges and contextual factors. Social capitals will be measured both quantitatively and qualitatively to assess the non health impact of the interventions. Qualitative data collection methods will include stakeholders' meeting, focus group discussions (FGD), periodic in-depth assessments, social mapping and other participatory exercises.
Outcome measures/variables: The primary outcome measure for evaluation of SMPNS intervention is reduction of neonatal mortality. In addition, changes in coverage and utilization of maternal \& newborn health services, cost effectiveness of implementation of intervention will also be measured.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Safe motherhood and newborn health promotion package"'Safe motherhood and newborn health promotion package'" will be implemented in the intervention arm which comprise 15 randomly selected unions (lowest level of administrative unit). |
| Comparison | No intervention | –Another 15 union will be selected where no intervention will be implemented |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with birth outcome in last three years
Key exclusion criteria (2 listed)
- Unusual unions as per the contextual factors (demographics, terrain, functionality of health services, etc.) will be excluded.
- If a union has a total population of less than 12,000 (the minimum required to get adequate sample of neonates) they will either be excluded
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 |
|---|---|---|
| Safe motherhood and newborn health promotion packageThe intervention package consists of three components: facility, community and linkages between the community and health facilities. Facility based interventions will serve both the comparison and intervention arms. However, other two interventions will serve the intervention arm only. Specific interventions and approaches for the three components will be implemented within the MOH\&FW service delivery system to improve MNH practices in families and communities and to increase the use of MNH services from appropriate facilities/providers. The intervention package has been developed based on the experiences from SMPP in Narsingdi district and on the basis of consultations with the International Advisory Body (IAB) that included GoB, JICA, ICDDR,B, other experts and stakeholders. | Other | Intervention |
Primary outcome
Reduction of neonatal mortality rate (NMR)
Time frame: During baseline at year 1, in two mid-line at year 2 & 3 and finally after completion of the of the intervention at year 4
NMR will be assessed at the beginning of the project. after that it will also assessed by two midline assessment after starting the intervention and finally it will be assessed during the endline survey
2 secondary outcomes
Changes in coverage and utilization of maternal and newborn health services
Time frame: At year 1 (baseline), year 2 and 3 (mid lines) and year 4 (end line)
Cost effectiveness of implementing the interventions
Time frame: Every six months for programme costs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Background: PubMed 25530442GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.
- Background: PubMed 15213048Caulfield LE, de Onis M, Blossner M, Black RE. Undernutrition as an underlying cause of child deaths associated with diarrhea, pneumonia, malaria, and measles. Am J Clin Nutr. 2004 Jul;80(1):193-8. doi: 10.1093/ajcn/80.1.193.
- Background: PubMed 12853204Jones G, Steketee RW, Black RE, Bhutta ZA, Morris SS; Bellagio Child Survival Study Group. How many child deaths can we prevent this year? Lancet. 2003 Jul 5;362(9377):65-71. doi: 10.1016/S0140-6736(03)13811-1.
- Background: PubMed 12885488Victora CG, Wagstaff A, Schellenberg JA, Gwatkin D, Claeson M, Habicht JP. Applying an equity lens to child health and mortality: more of the same is not enough. Lancet. 2003 Jul 19;362(9379):233-41. doi: 10.1016/S0140-6736(03)13917-7.
- Background: PubMed 15752534Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
- Background: PubMed 11072887Terra de Souza AC, Peterson KE, Andrade FM, Gardner J, Ascherio A. Circumstances of post-neonatal deaths in Ceara, Northeast Brazil: mothers' health care-seeking behaviors during their infants' fatal illness. Soc Sci Med. 2000 Dec;51(11):1675-93. doi: 10.1016/s0277-9536(00)00100-3.
- Background: PubMed 19289979Baqui AH, Arifeen SE, Williams EK, Ahmed S, Mannan I, Rahman SM, Begum N, Seraji HR, Winch PJ, Santosham M, Black RE, Darmstadt GL. Effectiveness of home-based management of newborn infections by community health workers in rural Bangladesh. Pediatr Infect Dis J. 2009 Apr;28(4):304-10. doi: 10.1097/INF.0b013e31819069e8.
- Background: PubMed 15820589Wakefield SE, Poland B. Family, friend or foe? Critical reflections on the relevance and role of social capital in health promotion and community development. Soc Sci Med. 2005 Jun;60(12):2819-32. doi: 10.1016/j.socscimed.2004.11.012. Epub 2004 Dec 24.
- Background: PubMed 10972431Hawe P, Shiell A. Social capital and health promotion: a review. Soc Sci Med. 2000 Sep;51(6):871-85. doi: 10.1016/s0277-9536(00)00067-8.
- Background: PubMed 21672223Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, Azad K, Costello A, Osrin D. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. Trials. 2011 Jun 14;12:151. doi: 10.1186/1745-6215-12-151.
- Background: PubMed 16095787De Silva MJ, Harpham T, Tuan T, Bartolini R, Penny ME, Huttly SR. Psychometric and cognitive validation of a social capital measurement tool in Peru and Vietnam. Soc Sci Med. 2006 Feb;62(4):941-53. doi: 10.1016/j.socscimed.2005.06.050. Epub 2005 Aug 10.
- Background: PubMed 9055718Bland JM, Altman DG. Cronbach's alpha. BMJ. 1997 Feb 22;314(7080):572. doi: 10.1136/bmj.314.7080.572. No abstract available.
- Individual participant dataSharing planned: No
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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.
Shams El Arifeen, DrPH, MBBS principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
D M Emdadul Hoque, MPH, MBBS study director
International Centre for Diarrhoeal Disease Research, Bangladesh
Sanwarul Bari, MBBS study director
International Centre for Diarrhoeal Disease Research, Bangladesh
Questions about this trial
What is this clinical trial studying?
A study testing Safe motherhood and newborn health promotion package in people with Neonatal Death and Maternal Death, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Feb 2022. 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?
Results are not available in the source record.
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?
Reduction of neonatal mortality rate (NMR) (time frame: During baseline at year 1, in two mid-line at year 2 & 3 and finally after completion of the of the intervention at year 4). 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 NCT03032276, which also lists 14 linked publications.
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 11 Feb 2022.