Safe Motherhood Promotion and Newborn Survival

NCT03032276 | Unknown

• 1 other identifier: PR-16013
• Study Type: interventional
• Target: 50,400
• Locations: 0 countries
• Sites: N/A

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

Conditions

Neonatal Death; Maternal Death

Keywords

Safe motherhood; Newborn survival; Community; Cluster Randomized Trial

Outcome Measures

Primary Outcomes (1)

• 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

  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

  At year 1 (baseline), year 2 and 3 (mid lines) and year 4 (end line)

• Cost effectiveness of implementing the interventions

  Every six months for programme costs

Study Arms (2)

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).

Other: Safe motherhood and newborn health promotion package

Comparison

NO INTERVENTION

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

Interventions

Safe motherhood and newborn health promotion package OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with birth outcome in last three years

You may not qualify if:

• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Government of Bangladesh: collaborator
• Tokyo University: collaborator

Related Publications (14)

• 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.

  PMID: 25530442 BACKGROUND

• 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.

  PMID: 15213048 BACKGROUND

• 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.

  PMID: 12853204 BACKGROUND

• 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.

  PMID: 12885488 BACKGROUND

• 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.

  PMID: 15752534 BACKGROUND

• 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.

  PMID: 11072887 BACKGROUND

• 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.

  PMID: 19289979 BACKGROUND

• 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.

  PMID: 15820589 BACKGROUND

• 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.

  PMID: 10972431 BACKGROUND

• 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.

  PMID: 21672223 BACKGROUND

• 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.

  PMID: 16095787 BACKGROUND

• Bland JM, Altman DG. Cronbach's alpha. BMJ. 1997 Feb 22;314(7080):572. doi: 10.1136/bmj.314.7080.572. No abstract available.

  PMID: 9055718 BACKGROUND

• 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.

  PMID: 24990814 BACKGROUND

• 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.

  PMID: 29724194 DERIVED

MeSH Terms

Conditions

Perinatal Death; Maternal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parental Death

Study Officials

• Shams El Arifeen, DrPH, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

• D M Emdadul Hoque, MPH, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Sanwarul Bari, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Masum Billah, MPH, BURP

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Ahmed Ehsanur Rahman, MPH, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Tazeen Tahsina, MS Economics

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Mohiuddin Ahsanul Kabir Chowdhury, MPH, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Mohammad Mehedi Hasan, MPH, MSc

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Sajia Islam, MPH, BDS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Mohammad Masudur Rahman, MPS, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Nazia Binte Ali, MPH, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

• Jasmin Khan, MPH, MSS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 26, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share