Maternal Health Clinical Trial
— MAHMAZOfficial title:
Increasing Equitable Access to Safe Deliveries in Zambia
NCT number | NCT02620436 |
Other study ID # | H-34526 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | December 31, 2018 |
Verified date | June 2019 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objectives: The primary objective of this evaluation is to determine if well-constructed and
well-resourced Maternity Waiting Homes are utilized by pregnant women living at distance from
the health facility and are associated with improved pregnancy outcomes, particularly for
women living farthest from health facilities. Findings from this evaluation will be provided
to policymakers formulating policy decisions affecting the implementation of the Maternity
Home Model and, if applicable, will be used as evidence for programmatic decisions made by
the Ministry in deciding to take this model to scale beyond the districts proposed for this
project.
Primary Impact Evaluation Question: Does the Minimum Core Maternity Home Model increase
access to high quality intrapartum care among mothers living more than 10 km from the
facilities compared to the standard of care?
Study Design: We propose a quasi-experimental pre-post design wherein one implementing
partner (BU/ZCAHRD) will use a cluster-randomized matched pair design and one implementing
partner (University of Michigan/Africare) will utilize a matched-pair, two-group comparison
design with no randomization.
Methods: Using mixed-methods, we will collect data from two main sources: 1) Household
Surveys and 2) In-depth Interviews. A quantitative household survey will be conducted among
2,400 randomly-selected households at both baseline (2015) and endline (2018) among recently
delivered women (delivered in the last 12 months) living more than 10 km from the
intervention and comparison facilities.
15% of the households enrolled in the study will be randomly selected to participate in an
In-Depth Interview (IDI). Content will include perceptions of labor and delivery practices,
barriers to accessing care, knowledge and awareness of MSs, perceptions of the quality of MS,
perceptions of respectful care at the facility, post-natal care, costs, and perceptions of MS
ownership.
Status | Completed |
Enrollment | 4798 |
Est. completion date | December 31, 2018 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria - Intervention sites The target population includes all pregnant women within 1-2 weeks of estimated delivery date resident within the 20 intervention site catchment areas, particularly those living at the greatest distant from care (i.e. resident > 10 km from the health facility). To insure that the facility is resourced appropriately to adequately manage obstetric complications, the study MSs will be selected from among a list of eligible facilities with a minimum standard of available care, defined as either A or B, below: Criteria for A: - Able to provide at least 5 of 7 BEmONC signal functions - <2 hours travel time to a CEmONC referral facility, and - Have a minimum of 150 deliveries per year Criteria for B: - At least one skilled birth attendant on staff - Routinely provide active management of third stage of labor (AMTSL) - No stock outs of oxytocin in the last 12 months - No stock outs of magnesium sulfate in the last 12 months, and - <2 hours travel time to a referral facility Inclusion Criteria - Household Survey For the purposes of this evaluation, a household is defined as a group of people who regularly cook together. Inclusion criteria for the household survey are: - Household with someone who has delivered a baby within the past 12 months - Respondent must be age 15 or older (emancipated minor) - Proxy respondent (if woman deceased) must be over the age of 18 - Resident of the village identified for sampling (>10 km from the facility) Exclusion Criteria: Those who do not meet the inclusion criteria |
Country | Name | City | State |
---|---|---|---|
Zambia | Mbabala | Choma |
Lead Sponsor | Collaborator |
---|---|
Boston University | Bill and Melinda Gates Foundation, Merck for Mothers, Right to Care, University of Michigan |
Zambia,
Eckermann S, Dawber J, Yeatman H, Quinsey K, Morris D. Evaluating return on investment in a school based health promotion and prevention program: the investment multiplier for the Stephanie Alexander Kitchen Garden National Program. Soc Sci Med. 2014 Aug;114:103-12. doi: 10.1016/j.socscimed.2014.05.056. Epub 2014 Jun 2. — View Citation
Gabrysch S, Civitelli G, Edmond KM, Mathai M, Ali M, Bhutta ZA, Campbell OM. New signal functions to measure the ability of health facilities to provide routine and emergency newborn care. PLoS Med. 2012;9(11):e1001340. doi: 10.1371/journal.pmed.1001340. Epub 2012 Nov 13. — View Citation
Hogan MC, Foreman KJ, Naghavi M, Ahn SY, Wang M, Makela SM, Lopez AD, Lozano R, Murray CJ. Maternal mortality for 181 countries, 1980-2008: a systematic analysis of progress towards Millennium Development Goal 5. Lancet. 2010 May 8;375(9726):1609-23. doi: 10.1016/S0140-6736(10)60518-1. Epub 2010 Apr 9. — View Citation
Pérez D, Lefèvre P, Castro M, Sánchez L, Toledo ME, Vanlerberghe V, Van der Stuyft P. Process-oriented fidelity research assists in evaluation, adjustment and scaling-up of community-based interventions. Health Policy Plan. 2011 Sep;26(5):413-22. doi: 10.1093/heapol/czq077. Epub 2010 Dec 12. — View Citation
Rawat R, Nguyen PH, Ali D, Saha K, Alayon S, Kim SS, Ruel M, Menon P. Learning how programs achieve their impact: embedding theory-driven process evaluation and other program learning mechanisms in alive & thrive. Food Nutr Bull. 2013 Sep;34(3 Suppl):S212-25. — View Citation
Scheirer MA, Dearing JW. An agenda for research on the sustainability of public health programs. Am J Public Health. 2011 Nov;101(11):2059-67. doi: 10.2105/AJPH.2011.300193. Epub 2011 Sep 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of women living more than 10 km from the facility who deliver at a health facility | This outcome will be evaluated upon completion of the baseline evaluation in up to 24 months. | ||
Secondary | C-section rates among women living >10 km away from facility | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. | ||
Secondary | Maternal case fatality rate among women living >10 km away from facility | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. | ||
Secondary | Neonatal case fatality rate among women living >10 km away from facility | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. | ||
Secondary | Proportion of deliveries in catchment area that occurred at: home, health facility, district hospital, etc. | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. | ||
Secondary | Proportion of women who live >10 km away who utilize MHs | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. | ||
Secondary | Proportion of women who utilize post-natal care services | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. | ||
Secondary | Change in perceptions of delivery place (including MHs) | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. | ||
Secondary | Change in value of delivery place (including MHs) | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. | ||
Secondary | Change in labor related expenditures | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. | ||
Secondary | Change in delivery related expenditures | This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. |
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