Condition category
Pregnancy and Childbirth
Date applied
30/08/2013
Date assigned
06/09/2013
Last edited
11/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In 2012, the Nigerian government established the Subsidy Reinvestment & Empowerment Programme (SURE-P) to reinvest the savings. SURE-P - Maternal and Child Health (SURE-P MCH) is a sub-component of this large programme, which aims to reduce mother and newborn deaths and diseases. It also aims at increasing access to and providing quality health services to Nigerians. SURE-P will improve the infrastructure of hospitals’ maternity sections as well as Primary Health Centres (PHCs). Within those SURE-P facilities, the study will find out the impact of some individual components of SURE-P MCH: 1. incentives to increase the retention of midwives, 2. information and community mobilization campaigns to reduce drug stock outs in primary health centres, and 3. cash transfers to pregnant women provided they attend antenatal care and delivery in a health facility. The study will also assess non-experimentally the impact of the overall SURE-P MCH programme.

Who can participate?
SURE-P midwives, women who gave birth in the 3 months prior to the data collection, managers of Primary Health Centers, and local community leaders can participate in the study.

What does the study involve?
The study will take place in two phases. In Phase I, two interventions will be studied: one study will be on incentives to improve midwife retention, and the other will be an information campaign to reduce drug stock outs in PHCs. The study dedicated to improve midwife retention will have the following arms: (1) monetary incentives (money related), (2) non-monetary incentives, (3) monetary plus non-monetary incentives, (4) no incentives. The study dedicated to reduce drug stock outs will have two arms: (1) implementation of information and community mobilization campaign, (2) no implementation of information campaigns. Phase II consists of the same study on incentives to improve midwife retention as in Phase I and a second study consisting on a conditional cash transfer program (CCT) to increase antenatal care and delivery in PHCs. The latter will have two arms: (1) implementation of the CCT program, (2) no implementation of the CCT program. The study on incentives to improve midwife retention will be analyzed by pooling together the information from Phase I and Phase II. Data collection will take place before the start of each of the phases, and one year later.

What are the possible benefits and risks of participating?
Households and midwives will benefit from the improvement carried out in SURE-P facilities, as well as of the deployment of midwives and the cash transfer to the mothers. Midwives will also benefit from the monetary and non-monetary incentives. We are not aware of risks related to the participation in the study.

Where is the study run from?
The study takes place in 1200 primary health facilities and their catchment areas, spread across Nigeria's 36 states and the Federal Capital Territory.

When is study starting and how long is it expected to run for?
The data collection is starting in September 2013 and the study is expected to finish in December 2015.

Who is funding the study?
The study is funded through World Bank-administered trust funds financed by the Bill and Melinda Gates Foundation and the UK Department for International Development (DFID).

Who is the main contact?
Mr Marcus Holmlund
mholmlund@worldbank.org
The World Bank
MSN MC 4-404
1818 H St. NW
Washington, DC 20433
USA

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marcos Vera-Hernandez

ORCID ID

Contact details

Dr Marcos Vera-Hernandez
Department of Economics
University College London
Gower Street
Dr Pedro Rosa Dias is also Co-PI of the research. Please
see his details in the lay summary
London
WC1E 6BT
United Kingdom
m.vera@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Improving maternal and child health care in Nigeria: three randomised control trials and one observational study to assess the impact of SURE-P MCH

Acronym

SURE-P MCH

Study hypothesis

1. Retention of midwives in primary healthcare facilities in rural areas will improve if midwives are provided by either monetary or non-monetary retention bonuses
2. Higher retention of midwives in a given primary healthcare facility will improve pregnancy and obstretic related healthcare practices, as well as maternal and neo-natal health in that facility’s catchment area.
3. Stockouts of essential drugs for pregnant women will be reduced if information on stockouts at the primary health center is disseminated in the community
4. Antenatal care and delivery in health care facility will increase if women are offered a cash transfer conditional on attending antenatal care and delivering in a healthcare facility
5. A cash transfer program conditional on pregnant women attending antenatal care and delivering in a healthcare facility will improve maternal and neo-natal health.

Ethics approval

1. National Health Research Ethics Committee of Nigeria, NHREC/01/01/2007
2. University College London Research Ethics Committee 1827/004

Study design

Phase 1: 4x2 Factorial Cluster Randomized Trial
Phase 2: 4x2 Factorial Cluster Randomized Trial
Phase 2: observational study (difference-in-differences) for the overall evaluation of SURE-P MCH

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Maternal and Child Health

Intervention

The study will be implemented in two phases. In Phase I, two interventions will be studied using a 4x2 factorial: one trial will be on incentives aimed at improving midwife retention; the other trial will be an information and community mobilization campaign designed to reduce drug stockouts at the primary health centre level. The trial dedicated to improve midwife retention will have the following arms (1) monetary incentives, (2) non-monetary incentives, (3) monetary plus non-monetary incentives, (4) no incentives. The incentives will be paid every three months to the midwives that stay in their post. The trial dedicated to reduce drug stock outs will only have two arms: (1) implementation of information campaign, (2) no implementation of information campaigns. Details on the implementation of the information campaign must still be decided. Phase I will start in September 2013.

In Phase II, another 4x2 factorial design will be implemented: the same trial on incentives to improve midwife retention as in Phase I and a second trial consisting on a conditional cash transfer program (CCT) to increase antenatal care and delivery in PHCs. This latter trial will have two arms: (1) implementation of the CCT program, (2) no implementation of the CCT program. The CCT amounts to N5,000 and is payable to mothers who meet the following pre-conditions: at least 4 ante-natal care visits, delivery by skilled birth attendants and immediate postnatal care visit. Phase II will start in November 2014.

SURE-P is an intervention that combines the interventions above with the deployment of midwives and upgrading of primary health centres. Its overall impact will be assessed non-experimentally during Phase II of the study. The control group for this observational component will comprise clusters where SURE-P is not implemented.

Details of the Co- PIs:
1. Dr Pedro Rosa Dias
Lecturer in Economics
Room 264, Jubilee Building,
University of Sussex,
Falmer, Brighton,
BN1 9SL. UK

2. Dr Marcos Vera-Hernandez
Department of Economics
University College London
Gower Street
London WC1E 6BT. UK

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

All primary outcomes will be measured using structured questionnaires.

For the trial on incentives to improve midwife retention:
1. Percentage of SURE-P midwives that were working in a SURE-P Primary Health Centre at follow-up amongst those midwives that were working in a SURE-P Primary Health Facility at baseline.

For the trial on Conditional Cash Transfer:
1. Percentage of women that had an institutional delivery. Information will be collected using structured questionnaires administered to women who gave birth 3 months prior to the follow-up interview.
2. Percentage of women that attended 4 or more antenatal visits. Information will be collected using structured questionnaires administered to women who gave birth 3 months prior to the follow-up interview.

For the trial on reducing drug stock outs
1. Average number of days that that essential drugs for antenatal and obstetric care were not available in SURE-P Primary Health Centres.

For the overall evaluation of SURE-P:
1. Percentage of women who had an institutional delivery. Information will be collected using structured questionnaires administered to women who gave birth 3 months prior to the follow-up interview.
2. Percentage of women who attended 4 or more antenatal visits. Information will be collected using structured questionnaires administered to women who gave birth 3 months prior to the follow-up interview.

Secondary outcome measures

For the trial on incentives to improve midwife retention:
1. Maslach Burnout Inventory of Midwives
2. Midwives absenteeism
3. Infant mortality collected through an extension of the sisterhood method
4. Average consultation time in the last antenatal visit
5. Readmissions and other measures of midwives’ performance
6. Pregnancy and obstetric related health care practices

For the trial on Conditional Cash Transfer:
1. Post partum depression assessed using the Edinburgh Post Partum Depression Scale
2. Infant mortality collected through an extension of the sisterhood method
3. Pregnancy and obstetric related health care practices

For the trial on reducing drug stock outs
1. Out of pocket payments for antenatal care drugs
2. Proportion of women who could not obtain from the Primary Health Centre antenatal care drugs recommended to her by the primary health centre clinical staff.

For the overall evaluation of SURE-P:
1. Post partum depression assessed using the Edinburgh Post Partum Depression Scale
2. Infant mortality collected through an extension of the sisterhood method
3. Pregnancy and obstetric related health care practices

Overall trial start date

09/09/2013

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. SURE-P midwives deployed in a Primary Health Centre
2. Women who have given birth in the three months prior to the beginning of the study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

7400

Participant exclusion criteria

1. Individuals who do not agree to participate

Recruitment start date

09/09/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Nigeria

Trial participating centre

Dr Marcos Vera-Hernandez
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

The World Bank (USA)

Sponsor details

c/o Marcus Holmlund
MSN MC 4-404
1818 H St. NW
Washington
DC
20433
United States of America
+1 (202) 473 4599
mholmlund@worldbank.org

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The study is funded through World Bank-administered trust funds financed by the Bill and Melinda Gates Foundation (USA) and the UK Department for International Development (DFID).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes