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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02517008
Other study ID # 002
Secondary ID
Status Completed
Phase N/A
First received July 27, 2015
Last updated August 4, 2015
Start date June 2013
Est. completion date September 2013

Study information

Verified date August 2015
Source IDinsight
Contact n/a
Is FDA regulated No
Health authority Zambia: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study measured the impact and cost-effectiveness of a low-cost, non-monetary incentive ("mama kit") on rural facility delivery rates in Zambia.


Description:

This clustered randomized controlled trial assessed the impact of providing a package of childcare items (a cloth, baby diaper, and blanket) to women conditional upon delivering at a facility on facility delivery rates in rural Serenje and Chadiza Districts in Zambia. Facilities were randomized to either provide the intervention or not. Facility-level antenatal care (ANC) and delivery registers were used to measure the percentage of women attending antenatal care who delivered at a study facility during the intervention period. Results from the trial were then used to model the cost-effectiveness of mama kits at-scale in terms of cost per death averted.


Recruitment information / eligibility

Status Completed
Enrollment 2159
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Had an antenatal care record at one of the study facilities

- Had an estimated date of delivery (as measured by estimated date of last menstrual period, estimated date of delivery, or estimated gestational age in weeks as recorded in the antenatal care register) between June 1, 2013 - Aug 31, 2013.

Exclusion Criteria:

- Did not have an antenatal care record at one of the study facilities

- Had an estimated date of delivery outside of the intervention window (June 1, 2013 - Aug 31, 2013)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Mama kit
A low-cost non-monetary incentive (mama kit) was provided to all women who delivered at the facility between June 1, 2013 - Aug 31, 2013. Women were told about the intervention during ANC, and safe motherhood groups in the community promoted the intervention in the catchment areas of the treatment facilities.

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
IDinsight Clinton Health Access Initiative Inc., Minister of Community Development, Mother and Child Health, Zambia, Ministry of Health, Zambia, UNICEF

Outcome

Type Measure Description Time frame Safety issue
Primary Facility delivery ratios Administrative data were used to measure the outcome. Antenatal care and delivery records were linked across registers. Women who had attended ANC and were linked to a record in the registry was counted as having delivered at a facility. At delivery, up to 10 months after the first antenatal care visit date No
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