CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,798 enrolled
Drug / intervention
Core Mother Shelter Modelother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02620436
NCT02620436N/ACompleted

Increasing Equitable Access to Safe Deliveries in Zambia

Boston University·interventional·Posted Dec 3, 2015·Updated Jun 18, 2019

In Brief

A clinical study evaluating Core Mother Shelter Model for Maternal Health. Completed, enrolled 4,798 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMaternal Health
CountriesZambia

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 3, 2015
Enrollment StartMar 1, 2016
Primary CompletionOct 31, 2018
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.6 years ago

Interventions

Core Mother Shelter Modelother

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.