search
Back to results

Safe Motherhood Promotion and Newborn Survival (SMPNS)

Primary Purpose

Neonatal Death, Maternal Death

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Safe motherhood and newborn health promotion package
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neonatal Death focused on measuring Safe motherhood, Newborn survival, Community, Cluster Randomized Trial

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with birth outcome in last three years

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Comparison

    Arm Description

    "'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).

    Another 15 union will be selected where no intervention will be implemented

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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.

    Full Information

    First Posted
    January 11, 2017
    Last Updated
    February 9, 2022
    Sponsor
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Collaborators
    Government of Bangladesh, Tokyo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03032276
    Brief Title
    Safe Motherhood Promotion and Newborn Survival
    Acronym
    SMPNS
    Official Title
    Impact and Operational Assessment of an Integrated Safe Motherhood and Newborn Health Promotion Package: a Community-based Cluster Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Collaborators
    Government of Bangladesh, Tokyo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Death, Maternal Death
    Keywords
    Safe motherhood, Newborn survival, Community, Cluster Randomized Trial

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    "'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).
    Arm Title
    Comparison
    Arm Type
    No Intervention
    Arm Description
    Another 15 union will be selected where no intervention will be implemented
    Intervention Type
    Other
    Intervention Name(s)
    Safe motherhood and newborn health promotion package
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Reduction of neonatal mortality rate (NMR)
    Description
    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
    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
    Secondary Outcome Measure Information:
    Title
    Changes in coverage and utilization of maternal and newborn health services
    Description
    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
    Time Frame
    At year 1 (baseline), year 2 and 3 (mid lines) and year 4 (end line)
    Title
    Cost effectiveness of implementing the interventions
    Description
    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.
    Time Frame
    Every six months for programme costs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women with birth outcome in last three years Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shams El Arifeen, DrPH, MBBS
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    D M Emdadul Hoque, MPH, MBBS
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sanwarul Bari, MBBS
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Masum Billah, MPH, BURP
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ahmed Ehsanur Rahman, MPH, MBBS
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Tazeen Tahsina, MS Economics
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohiuddin Ahsanul Kabir Chowdhury, MPH, MBBS
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohammad Mehedi Hasan, MPH, MSc
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sajia Islam, MPH, BDS
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohammad Masudur Rahman, MPS, MBBS
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Nazia Binte Ali, MPH, MBBS
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Jasmin Khan, MPH, MSS
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25530442
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15213048
    Citation
    Caulfield 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.
    Results Reference
    background
    PubMed Identifier
    12853204
    Citation
    Jones 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.
    Results Reference
    background
    PubMed Identifier
    12885488
    Citation
    Victora 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.
    Results Reference
    background
    PubMed Identifier
    15752534
    Citation
    Lawn 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.
    Results Reference
    background
    PubMed Identifier
    11072887
    Citation
    Terra 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.
    Results Reference
    background
    PubMed Identifier
    19289979
    Citation
    Baqui 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.
    Results Reference
    background
    PubMed Identifier
    15820589
    Citation
    Wakefield 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.
    Results Reference
    background
    PubMed Identifier
    10972431
    Citation
    Hawe 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.
    Results Reference
    background
    PubMed Identifier
    21672223
    Citation
    Pagel 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.
    Results Reference
    background
    PubMed Identifier
    16095787
    Citation
    De 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.
    Results Reference
    background
    PubMed Identifier
    9055718
    Citation
    Bland JM, Altman DG. Cronbach's alpha. BMJ. 1997 Feb 22;314(7080):572. doi: 10.1136/bmj.314.7080.572. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24990814
    Citation
    El 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.
    Results Reference
    background
    PubMed Identifier
    29724194
    Citation
    Hoque 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.
    Results Reference
    derived

    Learn more about this trial

    Safe Motherhood Promotion and Newborn Survival

    We'll reach out to this number within 24 hrs