ClinicalTrials.gg
CompletedNCT02936869Updated Jul 24, 2019Results posted

Incentives for Postnatal Care Demand

An interventional study of Performance-based monetary incentives in Maternal Death and Neonatal Death, sponsored by Harvard School of Public Health (HSPH). Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
207
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Maternal Death
  • Neonatal Death
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In context

Maternal Death

77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.

This study's enrollment of 207 is below the median of 1,126 across 57 interventional studies indexed under Maternal Death.

Browse Maternal Death studies →

Lead sponsor

Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • plan to relocate over the intervention duration
  • refusal to provide for the entire study protocol including agreeing to have their delivery clients contacted for verification
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
207 participants (actual)

Study arms

  • No intervention
    Control arm

    Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.

  • Experimental
    Referral incentive arm

    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.

    Behavioral: Performance-based monetary incentives

Interventions

  • BehavioralPerformance-based monetary incentives
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: Within 48 hours of delivery

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Results

Posted Jul 24, 2019
Limitations and caveats
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.

Participant flow

Participants were recruited from the community within 128 wards in Ebonyi State in August 2016.

Participant flow — Overall Study
MilestoneControl ArmReferral Incentive Arm
Started104103
Completed10298
Not completed25
Withdrew: Lost to follow-up13
Withdrew: Death01
Withdrew: Legal case01
Withdrew: Protocol violation10

Outcome measures

PrimaryMaternal 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.

Time frame:
Within 48 hours of delivery
Reported as:
Number · proportion of maternal clients referred
Maternal Postnatal Care Referral
proportion of maternal clients referredControl ArmReferral Incentive Arm
Maternal Postnatal Care Referral0.044 (-0.009 to 0.097)0.154 (0.079 to 0.229)
SecondaryNeonatal Postnatal Care Referral

Proportion of neonates delivered by the traditional birth attendant that are successfully referred for postnatal care within 48 hours of delivery

Time frame:
Within 48 hours of delivery
Reported as:
Number · proportion of neonates referred
Neonatal Postnatal Care Referral
proportion of neonates referredControl ArmReferral Incentive Arm
Neonatal Postnatal Care Referral0.032 (-0.015 to 0.079)0.126 (0.059 to 0.193)

Adverse events

Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Arm0/104 (0%)0/104 (0%)0/104 (0%)
Referral Incentive Arm1/103 (1%)0/103 (0%)0/103 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Control ArmReferral Incentive ArmTotal
Mean51.42308 ± 19.6724144.75728 ± 16.2320648.10628 ± 18.30641
Sex: Female, Male
Sex: Female, Male(Participants)Control ArmReferral Incentive ArmTotal
Female10197198
Male369
Number of participants lacking formal education
Number of participants lacking formal education(Participants)Control ArmReferral Incentive ArmTotal
Number474087
Average income per pregnancy
Average income per pregnancy(Naira)Control ArmReferral Incentive ArmTotal
Mean1790.962 ± 1852.5232265.437 ± 2992.0712027.053 ± 2491.036
Number of participants offering postnatal care
Number of participants offering postnatal care(Participants)Control ArmReferral Incentive ArmTotal
Number7060130
Monthly average of delivery clients
Monthly average of delivery clients(clients)Control ArmReferral Incentive ArmTotal
Mean13.80769 ± 97.705539.553398 ± 48.9062211.69082 ± 77.21418
Number of participants that are literate in English
Number of participants that are literate in English(Participants)Control ArmReferral Incentive ArmTotal
Number444791
Number of participants that are literate in non-English Language
Number of participants that are literate in non-English Language(Participants)Control ArmReferral Incentive ArmTotal
Number262955

3 further baseline measures are reported on the registry.

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Study locations

No study locations are listed for this record.

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References and documents

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;8(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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — De-identified data for this study including all the variables used for the analysis are available for download on the Harvard Dataverse.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: The data on the Harvard Dataverse are available indefinitely as long as the website continues to host datasets.

Access criteria: The data can be freely downloaded without permission.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2016 to primary completion in Dec 2016, 4 months.

Results were first posted in Jul 2019, 2 years 7 months after primary completion.

Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2016
First posted
Oct 18, 2016
StartActual
Aug 2016
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Results first posted
Jul 24, 2019
Last update
Jul 24, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02936869
Responsible party
Adanna Chukwuma (Doctoral Candidate, Harvard School of Public Health (HSPH)) — Principal investigator
First posted
Oct 18, 2016
Start date
Aug 2016
Primary completion
Dec 2016
Completion
Dec 2016
Results posted
Jul 24, 2019
Last update
Jul 24, 2019

Study contacts

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)
Chinyere Mbachu, MBBS, MPH
principal investigator · Health Policy Research Group
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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