NCT02936869

Brief 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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 24, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

October 14, 2016

Results QC Date

November 21, 2017

Last Update Submit

July 22, 2019

Conditions

Outcome Measures

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.

    Within 48 hours of delivery

Secondary Outcomes (1)

  • Neonatal Postnatal Care Referral

    Within 48 hours of delivery

Study Arms (2)

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.

Behavioral: Performance-based monetary incentives

Interventions

Referral incentive arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 9509629BACKGROUND
  • 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.

    PMID: 22895949BACKGROUND
  • 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.

    BACKGROUND
  • WHO. (2004). Making Pregnancy Safer: The Critical Role of the Skilled Attendant - A Joint Statement by WHO, ICM, and FIGO. Geneva: World Health Organization.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Maternal DeathPerinatal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

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.

Results Point of Contact

Title
Dr. Adanna Chukwuma
Organization
World Bank

Study Officials

  • Adanna Chukwuma, MBBS, MSc.

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR
  • Margaret McConnell, PhD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR
  • Jessica Cohen, PhD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR
  • Chinyere Mbachu, MBBS, MPH

    Health Policy Research Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 18, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 24, 2019

Results First Posted

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

De-identified data for this study including all the variables used for the analysis are available for download on the Harvard Dataverse.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.