Maternal DeathNCT02936869

Incentives for Postnatal Care Demand

A study testing Performance-based monetary incentives in people with Maternal Death and Neonatal Death, run by Harvard School of Public Health (HSPH).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to identify the causal impact of performance-based monetary incentives in increasing postnatal care (PNC) referrals by traditional birth attendants (TBAs), via a randomized controlled trial (RCT). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Maternal Death, Neonatal Death
What is being tested?: Performance-based monetary incentives
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 207 participants
Where: No sites listed yet
Study dates: Aug 2016to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

community-based providers of antenatal and/or delivery care, and who are non-formally trained
must be resident within the community
must not plan to relocate over the intervention duration
identified in partnership with community leadership
be willing to participate fully in the study, including having their clients contacted for verification

Who cannot join

plan to relocate over the intervention duration
refusal to provide informed consent for the entire study protocol including agreeing to have their delivery clients contacted for verification

About this study

Conditions: Maternal Death, Neonatal Death
Being tested: Performance-based monetary incentives
Medical subject headings: Maternal Death, Perinatal Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Performance-based monetary incentivesBehavioural

Study groups in NCT02936869
Study group	Role	What they receive
Control arm	No intervention	Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.
Referral incentive arm	Experimental	Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client. Traditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified. Receives: Behavioral: Performance-based monetary incentives

What is being measured

The primary outcome is the main question the study is designed to answer.

Maternal Postnatal Care Referral
The proportion of delivery clients that are successfully referred by the traditional birth attendant for postnatal care within 48 hours of delivery. For each delivery client that the traditional birth attendant reported, we visited at least three days after delivery to ascertain if they had been asked to visit the postnatal clinic, clarify if they had visited the clinic within 48 hours of delivery, and what care they had received (if yes). The team visited traditional birth attendants every two weeks to identify new clients. Where a new client was not up to three days post-delivery, the interview was postponed until the next visit by the team to the community. This occurred repeatedly, over a five-month frame.
Measured: Within 48 hours of delivery

Secondary outcomes (1)

Neonatal Postnatal Care Referral
Proportion of neonates delivered by the traditional birth attendant that are successfully referred for postnatal care within 48 hours of delivery
Measured: Within 48 hours of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Dec 2016

First posted18 Oct 2016 (estimated)
Study startAug 2016
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Maternal DeathStudies 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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02936869
Sponsor's protocol ID: HU-052
Status last verified: Jul 2019
First submitted: 14 Oct 2016
Last updated: 24 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: De-identified data for this study including all the variables used for the analysis are available for download on the Harvard Dataverse.

Publications

Itina SM. Characteristics of traditional birth attendants and their beliefs and practices in the Offot Clan, Nigeria. Bull World Health Organ. 1997;75(6):563-7.
PubMed 9509629
Sibley LM, Sipe TA, Barry D. Traditional birth attendant training for improving health behaviours and pregnancy outcomes. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD005460. doi: 10.1002/14651858.CD005460.pub3.
PubMed 22895949
Oyebola, B. C., Muhammad, F., Otunomeruke, A., & Galadima, A. (2014). Effect of Performance-Based Incentives for Traditional Birth Attendants on Access to Maternal and Newborn Health-care Facilities in Gombe State, Nigeria: A Pilot Study. Meeting Abstract. Lancet.
WHO. (2004). Making Pregnancy Safer: The Critical Role of the Skilled Attendant - A Joint Statement by WHO, ICM, and FIGO. Geneva: World Health Organization.
Chukwuma A, Mbachu C, McConnell M, Bossert TJ, Cohen J. The impact of monetary incentives on referrals by traditional birth attendants for postnatal care in Nigeria. BMC Pregnancy Childbirth. 2019 May 20;19(1):150. doi: 10.1186/s12884-019-2313-8.
PubMed 31104629

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Improving Maternal and Neonatal Care-seeking Through a Video-informed Training Session During the Third Trimester of Pregnancy
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The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity
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IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
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All Maternal Death trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incentives for Postnatal Care Demand
ClinicalTrials.gov ID: NCT02936869
Acronym / sponsor ID: HU-052
Conditions: Maternal Death, Neonatal Death
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Harvard School of Public Health (HSPH)University, hospital or other
Study start: Aug 2016 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 18 Oct 2016 (estimated)
Results: Posted 24 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control arm	No intervention	–Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.
Referral incentive arm	Experimental	Behavioral: Performance-based monetary incentivesTraditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client. Traditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

community-based providers of antenatal and/or delivery care, and who are non-formally trained
must be resident within the community
must not plan to relocate over the intervention duration
identified in partnership with community leadership
be willing to participate fully in the study, including having their clients contacted for verification

Key exclusion criteria (2 listed)

plan to relocate over the intervention duration
refusal to provide informed consent for the entire study protocol including agreeing to have their delivery clients contacted for verification

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
Performance-based monetary incentives	Behavioural	Referral incentive arm

Primary outcome

Maternal Postnatal Care Referral
Time frame: Within 48 hours of delivery
The proportion of delivery clients that are successfully referred by the traditional birth attendant for postnatal care within 48 hours of delivery. For each delivery client that the traditional birth attendant reported, we visited at least three days after delivery to ascertain if they had been asked to visit the postnatal clinic, clarify if they had visited the clinic within 48 hours of delivery, and what care they had received (if yes). The team visited traditional birth attendants every two weeks to identify new clients. Where a new client was not up to three days post-delivery, the interview was postponed until the next visit by the team to the community. This occurred repeatedly, over a five-month frame.

1 secondary outcome

Neonatal Postnatal Care Referral
Time frame: Within 48 hours of delivery

Results and safety

Results posted to the registry on 24 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Arm	104	102
Referral Incentive Arm	103	98

Primary outcome: Maternal Postnatal Care Referral

Time frame: Within 48 hours of delivery. Number (95% Confidence Interval). Unit: proportion of maternal clients referred

Measure	Control Arm n = 102	Referral Incentive Arm n = 98
Value	0.044 (-0.009 to 0.097)	0.154 (0.079 to 0.229)

Population analysed: The analysis did not include information from the 7 TBAs lost to follow-up.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Arm	0 of 104 (0%)	0 of 104 (0%)	0 of 104
Referral Incentive Arm	0 of 103 (0%)	0 of 103 (0%)	1 of 103

Limitations and caveats (from the sponsor): This study was concluded prior to schedule due to community conflict affecting the length of follow-up time; we relied on self-reports due to the poor information systems within the study context.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9509629Itina SM. Characteristics of traditional birth attendants and their beliefs and practices in the Offot Clan, Nigeria. Bull World Health Organ. 1997;75(6):563-7.
Background: PubMed 22895949Sibley LM, Sipe TA, Barry D. Traditional birth attendant training for improving health behaviours and pregnancy outcomes. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD005460. doi: 10.1002/14651858.CD005460.pub3.
BackgroundOyebola, B. C., Muhammad, F., Otunomeruke, A., & Galadima, A. (2014). Effect of Performance-Based Incentives for Traditional Birth Attendants on Access to Maternal and Newborn Health-care Facilities in Gombe State, Nigeria: A Pilot Study. Meeting Abstract. Lancet.
BackgroundWHO. (2004). Making Pregnancy Safer: The Critical Role of the Skilled Attendant - A Joint Statement by WHO, ICM, and FIGO. Geneva: World Health Organization.
Derived from this study: PubMed 31104629Chukwuma A, Mbachu C, McConnell M, Bossert TJ, Cohen J. The impact of monetary incentives on referrals by traditional birth attendants for postnatal care in Nigeria. BMC Pregnancy Childbirth. 2019 May 20;19(1):150. doi: 10.1186/s12884-019-2313-8.
Individual participant dataSharing planned: Yes. De-identified data for this study including all the variables used for the analysis are available for download on the Harvard Dataverse.

Related trials for Maternal Death

Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Not yet recruiting
Improving Maternal and Neonatal Care-seeking Through a Video-informed Training Session During the Third Trimester of Pregnancy
Maternal Health, Neonatal Health
Recruiting
The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity
Severe Maternal Morbidity, Maternal Death
Recruiting
IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Postpartum Complication
Active, not recruiting
Well-Mama Community Doula Navigator Study
Pregnancy Related

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.

Adanna Chukwuma, MBBS, MSc. principal investigator

Harvard School of Public Health (HSPH)

Margaret McConnell, PhD principal investigator

Harvard School of Public Health (HSPH)

Jessica Cohen, PhD principal investigator

Harvard School of Public Health (HSPH)

Questions about this trial

What is this clinical trial studying?

A study testing Performance-based monetary incentives in people with Maternal Death and Neonatal Death, run by Harvard School of Public Health (HSPH).

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 5 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 24 Jul 2019. 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?

Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maternal Postnatal Care Referral (time frame: Within 48 hours of delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02936869, which also lists 5 linked publications.

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 24 Jul 2019.