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Clinical Trials/NCT02620436
NCT02620436CompletedNot Applicable

Increasing Equitable Access to Safe Deliveries in Zambia

Boston University1 site in 1 country4,798 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4,798
Locations
1
Primary Endpoint
Proportion of women living more than 10 km from the facility who deliver at a health facility

Study Overview

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.

Detailed Description

BACKGROUND: Although Zambia's maternal mortality rate has decreased from 591 maternal deaths per 100,000 live births since 2007 (2007 Zambia DHS), the maternal mortality rate in 2014 was unacceptably high at 398 maternal deaths per 100,000 live births. The WHO strongly recommends 'skilled care at every birth' as a strategy to reduce maternal deaths. However, it remains unanswered how to best deliver high-quality birth and postpartum care, particularly in rural and remote areas where distance and poor transportation services severely restrict access to care.

The Government of the Republic of Zambia (GRZ) is committed to improving maternal health and has initiated a large cooperative effort that aims to do so through the Ministry of Health (MOH), Ministry of Community Development, Mother and Child Health (MCDMCH), and several local and international organizations. Within this context, MHs-temporary lodgings located near health facilities with skilled care for pregnant mothers who are close to term-represent a potentially useful strategy to improve access to skilled obstetric care, particularly for those living farthest from the health facilities. MHs provide pregnant women with the option of planning ahead and traveling to health facilities well before labor begins, and have existed in various forms since the 1950s. However, there is insufficient evidence of the effectiveness of MHs in improving access to delivery services and improving maternal outcomes. While some evidence suggests MH utilization is correlated with improved maternal health outcomes (Gaym, Lori), a Cochrane review found no randomized, quasi-randomized or cluster-randomized trials assessing the effectiveness of MHs in low resource settings (van Lonkhuijzen L). Rigorous evidence on the impacts of MHs on maternal and perinatal health outcomes is needed.

The Maternity Homes Alliance (MHA) - a partnership between GRZ and implementing partners working in collaboration with academic institutions, and evaluation advisor, - seek to help women overcome the "distance problem" by implementing MHs, with the hypothesis that offering women access to quality MHs will bring women closer to facility-based delivery and postpartum care, ultimately improving health outcomes. If systematically implemented on a large scale with optimal maintenance, management and community acceptability and utilization, MHs have the potential to remove the distance barrier and increase access to safe delivery for women living farthest from the health facilities.

INTERVENTION: This project will implement high quality MHs in Southern, Eastern and Luapula Provinces in an effort to increase access to quality intrapartum care among the most vulnerable women. Following a formative evaluation that found that MHs could be an acceptable option to improve access to safe deliveries in rural Zambia, in-country partners, ZCAHRD and Africare, will implement a Core Maternity Home Intervention Model in 10 sites each, totaling 20 intervention sites.

OBJECTIVES: The main objective of the evaluation is to understand if MHs can effectively increase access to safe delivery, particularly for women living farthest from health facilities. Findings from this evaluation will be used to inform program decisions regarding implementation of the Maternity Home Model and, if applicable, to advocate for programmatic improvements as the Maternity Home Model is taken to scale beyond the districts proposed for this project.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Core Mother Shelter Model

Experimental

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.

Intervention: Core Mother Shelter Model (Other)

Standard of Care

No Intervention

Existing mother shelters with no changes made, except to ensure that they can provide standard of care.

Outcomes

Primary Outcomes

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 Outcomes

  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • Change in labor related expenditures(This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months.)
  • Change in delivery related expenditures(This outcome will be evaluated upon completion of the baseline and endline evaluations in up to 24 months.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nancy Scott

Assistant Professor

Boston University

Study Sites (1)

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