Condition category
Neonatal Diseases
Date applied
25/08/2014
Date assigned
03/09/2014
Last edited
26/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Global health agencies have advocated continuum of care (CoC) in order to improve maternal, newborn and child health (MNCH) care. Although CoC-related interventions have improved care, it is unclear whether they were effective in current practices in more 'real-world' scenarios. Moreover, it is unclear whether health outcomes will be improved by filling the gaps of CoC. As a result, the Japanese government launched the MNCH model project in 2012, Ghana Ensure Mothers and Babies Regular Access to Care (EMBRACE) implementation research project, to improve care. Ghana is one of the countries which have faced a significant challenge to improve MNCH status. In particular, MNCH status was poor in remote areas and care-seeking decisions were delayed for ill mothers and babies. Additionally, not all of MNCH services are used by mothers and infants continuously. Especially, the neonatal care is less paid attention. However, when health services during pregnancy, at the time of birth and after the birth of the baby were appropriately used, the risk of death of newborn babies could be reduced. Moreover, Ghana has multiple localities which are formed by particular characteristics of each area. The diversity of local characteristics implies the need for flexibility in health service provision. It explains why the implementation studies should be conducted in Ghana in different real contexts. Thus, this study aims to evaluate the impact of increased CoC completion on MNCH status in Ghana. Specific objectives are proposed for intervention and implementation phases. We want to see the effect of the EMBRACE interventions on the CoC completion, and to evaluate the impact of the interventions on MNCH status.

Who can participate?
Women of reproductive age between the ages of 15 and 49 years who live in the areas of Dodowa, Kintampo and Navrongo in Ghana.

What does the study involve?
Areas will be randomly allocated to the intervention or the control group. We will conduct a CoC intervention package to the target population in the intervention group. The MNCH service providers will receive a training session regarding CoC and the procedures to be performed. For the control group, we will introduce the intervention to them immediately when a positive impact is seen.

What are the possible benefits and risks of participating?
This intervention package is not invasive and will be conducted following the national guidelines. Thus, the participants will not be exposed to specific risks. By participating in this study, they benefit by improved knowledge and care of mothers and newborn babies. Health facilities of the intervention group will receive a set of services after birth, motorbikes, or rest beds, if there are no available ones.

Where is the study run from?
The study is run from Dodowa, Kintampo and Navrongo in Ghana.

When is the study starting and how long is it expected to run for?
The study starts in October 2014 and is expected to run until March 2016.

Who is funding the study?
Japan International Cooperation Agency (JICA), Japan.

Who is the main contact?
Prof. Masamine Jimba
mjimba@m.u-tokyo.ac.jp

Trial website

Contact information

Type

Scientific

Primary contact

Prof Masamine Jimba

ORCID ID

Contact details

Department of Community and Global Health
Graduate School of Medicine
The University of Tokyo
7-3-1
Hongo
Bunkyo-ku
Tokyo
113-0033
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Study protocol for Ghana's Ensure Mothers and Babies Regular Access to Care (EMBRACE) program: an effectiveness-implementation hybrid research trial

Acronym

Study hypothesis

Maternal and child health can be improved if continuum of care (CoC) is properly completed in maternal, newborn, and child health (MNCH). The CoC completion will be attained by filling the gaps of health service coverage, and linking the health service delivery from pre-pregnancy to postnatal care, at home, community, and health facilities. Thus, the hypothesis of this study is that the MNCH will be improved by filling the gaps of CoC coverage.

Ethics approval

1. Research Ethics Committee of the Graduate School of Medicine, the University of Tokyo; 19/06/2014; ref: 10513
2. Research Ethics Committee of Ghana Health Service: 31/07/2014; ref: GHS-ERC: 13/03/14
3. Institutional Review Board in Dodowa Health Research Center: 14/07/2014; ref: GHS-DHRC: 280214
4. Institutional Review Board in Kintampo Health Research Center: 04/06/2014; ref: 2014-11
5. Institutional Review Board in Navrongo Health Research Center: 28/05/2014; ref: NHRCIRB137

Study design

Effectiveness-implementation hybrid design by multicenter approach cluster randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

CoC in MNCH/pregnant woman, mother, newborn baby/maternal and neonatal morbidity, neonatal mortality

Intervention

In each area of the HDSS site, we will assign sub-district based clusters randomly (Dodowa: 8, Kintampo: 12, Navrongo: 12 clusters) to either the intervention or the control arm.

1. Interventions commonly implemented in Dodowa, Kintampo, and Navrongo HDSS sites
1.1. Utilization of CoC card
1.2. CoC orientation for health service providers
1.3. Home visit postnatal care (PNC)

2. Interventions implemented in Dodowa and Navrongo HDSS sites only: 24-hours retention of mothers and newborn babies after delivery at health facility

Control arm receives the intevention as soon as a positive impact is seen in the intervention group.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

CoC completion rate among mothers and newborn babies. The CoC completion is defined as taking following all health services: antenatal care four times, delivery assisted by skilled birth attendants, PNC three times (within 48 hours, at 7 days, at 6 weeks after delivery).

Secondary outcome measures

Intervention outcomes:
1. PNC rate within 48 hours after delivery
2. Complication rate which requires mothers or newborn babies’ hospitalization of more than 24 hours
3. Perinatal mortality rate (PMR), neonatal mortality rate (NMR)

Implementation outcomes:
1. Intervention coverage of target population
2. Adoption in CoC card utilization or PNC within 48 hours by mothers’ retention at health facility or by home visit
3. Fidelity in CoC card utilization or PNC within 48 hours by mothers’ retention at health facility or by home visit
4. Implementation cost
5. Sustainability

Overall trial start date

01/10/2014

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Women at reproductive age between 15 and 49 years old and match to the following criteria:
1. Participants of the baseline survey: Those who gave birth between 1st September 2012 and 30th June 2014
2. Participants of the follow-up survey: Those who passed all the period from their 1st ANC to six weeks postpartum during the intervention period (1st October 2014 and 30th September 2015)
3. Participants of the intervention: Those who are in the period between pregnancy and six weeks postpartum during the intervention period (1st October 2014 and 30th September 2015)
4. Targets of the Health and Demographic Surveillance System (HDSS) data:
4.1. Those who have given birth between 1st September 2012 and 30th June 2014 for baseline HDSS data
4.2. Those who are in the period between pregnancy and six weeks postpartum during the intervention period (1st October 2014 and 30th September 2015) for follow-up HDSS data

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

1. Participants of the baseline survey and follow-up survey: 1,500 women for each survey (intervention: 750, control: 750) 2. Participants of the intervention: 8,500 women for the intervention

Participant exclusion criteria

Women:
1. Who refused participating with the intervention
2. Who decline to be interviewed
3. Who have migrated out of the HDSS sites

Recruitment start date

01/10/2014

Recruitment end date

31/03/2016

Locations

Countries of recruitment

Ghana

Trial participating centre

The University of Tokyo
Tokyo
113-0033
Japan

Sponsor information

Organisation

Japan International Cooperation Agency (JICA) (Japan)

Sponsor details

1-6th floor
Nibancho Center Building 5-25
Niban-cho
Chiyoda-ku
Tokyo
102-8012
Japan

Sponsor type

Government

Website

http://www.jica.go.jp/english/index.html

Funders

Funder type

Government

Funder name

Japan International Cooperation Agency (JICA) (Japan)

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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25778557

Publication citations

Additional files

Editorial Notes