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Impact Evaluation of Maternity Homes Access in Zambia (MAHMAZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02620436
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
University of Michigan
Right to Care
Merck for Mothers
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Nancy Scott, Boston University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Maternal Health Other: Core Mother Shelter Model Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4798 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Equitable Access to Safe Deliveries in Zambia
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Core Mother Shelter Model
Existing mother shelters will be renovated, and mother shelters will be built at intervention sites, to meet the Core Mother Shelter Model. This model includes ensuring a safe infrastructure with four walls, a roof, doors and windows that lock, a toilet, running water, and beds.
Other: Core Mother Shelter Model
  1. Infrastructure, Supplies, Equipment: All MHs will have: latrines, lockable cupboards, doors, windows, lighting, mattresses, mosquito nets, cooking space and utensils, and a bathing site.
  2. Policies, Management, Finances:. The policies, management, and financial structures will follow the same general principles, but will be site-specific to account for cultural variation.
  3. Linkages with Health Facilities: Each MH will be operationally linked to the health facility and 1) ensure daily check-ins by a health facility staff; 2) ensure every pregnant woman has someone able to contact a staff if she is incapacitated; and 3) will orient women to procedures upon arrival. Clinical services will be conducted at the health facility.
Other Name: Maternity Waiting Home

No Intervention: Standard of Care
Existing mother shelters with no changes made, except to ensure that they can provide standard of care.



Primary Outcome Measures :
  1. Proportion of women living more than 10 km from the facility who deliver at a health facility [ Time Frame: This outcome will be evaluated upon completion of the baseline evaluation in up to 24 months. ]

Secondary Outcome Measures :
  1. C-section rates among women living >10 km away from facility [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]
  2. Maternal case fatality rate among women living >10 km away from facility [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]
  3. Neonatal case fatality rate among women living >10 km away from facility [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]
  4. Proportion of deliveries in catchment area that occurred at: home, health facility, district hospital, etc. [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]
  5. Proportion of women who live >10 km away who utilize MHs [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]
  6. Proportion of women who utilize post-natal care services [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]
  7. Change in perceptions of delivery place (including MHs) [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]
  8. Change in value of delivery place (including MHs) [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]
  9. Change in labor related expenditures [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]
  10. Change in delivery related expenditures [ Time Frame: This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620436


Locations
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Zambia
Mbabala
Choma, Zambia
Sponsors and Collaborators
Boston University
University of Michigan
Right to Care
Merck for Mothers
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Nancy Scott, DrPH Boston University

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nancy Scott, Assistant Professor, Boston University
ClinicalTrials.gov Identifier: NCT02620436    
Other Study ID Numbers: H-34526
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will first ensure data are fully deidentified, then share them with academic partners at the University of Michigan and, once finalized, on a an open access site.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nancy Scott, Boston University:
Maternal & Child Health
Mother Shelters
Maternity Waiting Homes