Maternal HealthNCT02517008
The Impact of Non-monetary Incentives on Facility Delivery in Rural Zambia
A study testing Mama kit in people with Maternal Health, run by IDinsight.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Health
- What is being tested?
- Mama kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,159 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
Official title: Measuring the Impact of Non-monetary Incentives on Facility Delivery in Rural Zambia: A Clustered Randomized Controlled Trial
This study measured the impact and cost-effectiveness of a low-cost, non-monetary incentive ("mama kit") on rural facility delivery rates in Zambia.
Read the detailed 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.
- Conditions
- Maternal Health
- Being tested
- Mama kit
- Keywords
- non-monetary incentive, institutional delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mama kitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mama kits intervention | Experimental | Health facilities randomized to this arm provided mama kits - packages of childcare materials including a cloth ("chitenge"), baby blanket, and diaper - to all mothers who delivered at these facilities between June 1, 2013 - Aug 31, 2013. Receives: Other: Mama kit |
| No intervention | No intervention | Health facilities randomized to this arm provided obstetric services as normal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At delivery, up to 10 months after the first antenatal care visit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,159 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDinsight
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Zambia, Minister of Community Development, Mother and Child Health, Zambia, UNICEF, Clinton Health Access Initiative Inc.
- Responsible party
- Sponsor
- Investigators
- Paul Wang, MPAID/MBA, Principal investigator, IDinsight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517008
- Sponsor's protocol ID
- 002
- Status last verified
- Aug 2015
- First submitted
- 27 Jul 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of Non-monetary Incentives on Facility Delivery in Rural Zambia: A Clustered Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02517008
- Acronym / sponsor ID
- 002
- Conditions
- Maternal Health
- Keywords
- non-monetary incentive, institutional delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,159 participants (actual)
- Lead sponsor
- IDinsightUniversity, hospital or other
- Collaborators
- Ministry of Health, Zambia, Minister of Community Development, Mother and Child Health, Zambia, UNICEF, Clinton Health Access Initiative Inc.
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study measured the impact and cost-effectiveness of a low-cost, non-monetary incentive ("mama kit") on rural facility delivery rates in Zambia.
Detailed 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mama kits intervention | Experimental | Other: Mama kitHealth facilities randomized to this arm provided mama kits - packages of childcare materials including a cloth ("chitenge"), baby blanket, and diaper - to all mothers who delivered at these facilities between June 1, 2013 - Aug 31, 2013. |
| No intervention | No intervention | –Health facilities randomized to this arm provided obstetric services as normal. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mama kitA 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. | Other | Mama kits intervention |
Primary outcome
Facility delivery ratios
Time frame: At delivery, up to 10 months after the first antenatal care visit date
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Wang, MPAID/MBA principal investigator
IDinsight
Questions about this trial
What is this clinical trial studying?
A study testing Mama kit in people with Maternal Health, run by IDinsight.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facility delivery ratios (time frame: At delivery, up to 10 months after the first antenatal care visit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.