NCT02620436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,798

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

2.7 years

First QC Date

November 25, 2015

Last Update Submit

June 14, 2019

Conditions

Keywords

Maternal & Child HealthMother SheltersMaternity Waiting Homes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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 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 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.

  • +5 more secondary outcomes

Study Arms (2)

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.

Other: Core Mother Shelter Model

Standard of Care

NO INTERVENTION

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

Interventions

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.

Also known as: Maternity Waiting Home
Core Mother Shelter Model

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbabala

Choma, Zambia

Location

Related Publications (16)

  • 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.

    PMID: 20382417BACKGROUND
  • 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.

    PMID: 21940916BACKGROUND
  • 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.

    PMID: 24922607BACKGROUND
  • Perez D, Lefevre P, Castro M, Sanchez 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.

    PMID: 21149346BACKGROUND
  • 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. doi: 10.1177/15648265130343S207.

    PMID: 24261078BACKGROUND
  • 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.

    PMID: 23152724BACKGROUND
  • Ngoma T, Kaiser JL, Morgan AJ, Vian T, Hamer DH, Rockers PC, Sakanga V, Biemba G, Bwalya M, Scott NA. Implementation fidelity of a multisite maternity waiting homes programme in rural Zambia: application of the conceptual framework for implementation fidelity to a complex, hybrid-design study. BMJ Public Health. 2025 Jan 16;3(1):e001215. doi: 10.1136/bmjph-2024-001215. eCollection 2025.

  • Kaiser JL, Fiorillo RM, Vian T, Ngoma T, Kuhfeldt KJ, Munro-Kramer ML, Hamer DH, Bwalya M, Sakanga VR, Lori JR, Ahmed Mdluli E, Rockers PC, Biemba G, Scott NA. Qualitative application of the diffusion of innovation theory to maternity waiting homes in rural Zambia. Implement Sci Commun. 2025 Feb 4;6(1):18. doi: 10.1186/s43058-025-00696-y.

  • Lee HE, Veliz PT, Maffioli EM, Munro-Kramer ML, Sakala I, Chiboola NM, Ngoma T, Kaiser JL, Rockers PC, Scott NA, Lori JR. The role of Savings and Internal Lending Communities (SILCs) in improving community-level household wealth, financial preparedness for birth, and utilization of reproductive health services in rural Zambia: a secondary analysis. BMC Public Health. 2022 Sep 12;22(1):1724. doi: 10.1186/s12889-022-14121-9.

  • Fong RM, Kaiser JL, Ngoma T, Vian T, Bwalya M, Sakanga VR, Lori JR, Kuhfeldt KJ, Musonda G, Munro-Kramer M, Rockers PC, Hamer DH, Ahmed Mdluli E, Biemba G, Scott NA. Barriers and facilitators to facility-based delivery in rural Zambia: a qualitative study of women's perceptions after implementation of an improved maternity waiting homes intervention. BMJ Open. 2022 Jul 25;12(7):e058512. doi: 10.1136/bmjopen-2021-058512.

  • Scott NA, Kaiser JL, Ngoma T, McGlasson KL, Henry EG, Munro-Kramer ML, Biemba G, Bwalya M, Sakanga VR, Musonda G, Hamer DH, Boyd CJ, Bonawitz R, Vian T, Kruk ME, Fong RM, Chastain PS, Mataka K, Ahmed Mdluli E, Veliz P, Lori JR, Rockers PC. If we build it, will they come? Results of a quasi-experimental study assessing the impact of maternity waiting homes on facility-based childbirth and maternity care in Zambia. BMJ Glob Health. 2021 Dec;6(12):e006385. doi: 10.1136/bmjgh-2021-006385.

  • Henry EG, Ngoma T, Kaiser JL, Fong RM, Vian T, Hamer DH, Rockers PC, Biemba G, Scott NA. Evaluating implementation effectiveness and sustainability of a maternity waiting homes intervention to improve access to safe delivery in rural Zambia: a mixed-methods protocol. BMC Health Serv Res. 2020 Mar 12;20(1):191. doi: 10.1186/s12913-020-4989-x.

  • Kaiser JL, Fong RM, Ngoma T, McGlasson KL, Biemba G, Hamer DH, Bwalya M, Chasaya M, Scott NA. The effects of maternity waiting homes on the health workforce and maternal health service delivery in rural Zambia: a qualitative analysis. Hum Resour Health. 2019 Dec 4;17(1):93. doi: 10.1186/s12960-019-0436-7.

  • Lori JR, Perosky J, Munro-Kramer ML, Veliz P, Musonda G, Kaunda J, Boyd CJ, Bonawitz R, Biemba G, Ngoma T, Scott N. Maternity waiting homes as part of a comprehensive approach to maternal and newborn care: a cross-sectional survey. BMC Pregnancy Childbirth. 2019 Jul 4;19(1):228. doi: 10.1186/s12884-019-2384-6.

  • Perosky JE, Munro-Kramer ML, Lockhart N, Musonda GK, Naggayi A, Lori JR. Maternity waiting homes as an intervention to increase facility delivery in rural Zambia. Int J Gynaecol Obstet. 2019 Aug;146(2):266-267. doi: 10.1002/ijgo.12864. Epub 2019 Jun 20.

  • Scott NA, Kaiser JL, Vian T, Bonawitz R, Fong RM, Ngoma T, Biemba G, Boyd CJ, Lori JR, Hamer DH, Rockers PC. Impact of maternity waiting homes on facility delivery among remote households in Zambia: protocol for a quasiexperimental, mixed-methods study. BMJ Open. 2018 Aug 10;8(8):e022224. doi: 10.1136/bmjopen-2018-022224.

Related Links

Study Officials

  • Nancy Scott, DrPH

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 3, 2015

Study Start

March 1, 2016

Primary Completion

October 31, 2018

Study Completion

December 31, 2018

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

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.

Locations