Condition category
Not Applicable
Date applied
31/05/2019
Date assigned
04/06/2019
Last edited
05/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Current plain English summary as of 05/06/2019:
Background and study aims
The Republic of Angola (RoA) has achieved rapid economic growth in recent years, but health indicators, especially with regards to maternal and child health (MCH) remain poor. Maternal and neonatal conditions account for the leading causes of preventable deaths in the country. Recent data shows remarkable progress in achieving an under-under-five mortality rate from 227 per 1000 live births in 1990 to 65 per 1000 live births in 2017. Notwithstanding, health outcomes are yet to reach adequate standards compared to other upper-middle-income countries in the region and beyond.

Towards improving maternal and child health indicators, the Ministry of Health (MoH) in the RoA developed the National Plan for Health Development 2012-2025, prioritizing pregnant women, infants, and young children as the key target populations. A mechanism for attaining this goal involves an emphasis on strengthening institutional and management capacity and capacity building for health workers through long or short-term training. Given the political will, the Japan International Cooperation Agency (JICA), through its health sector cooperation is providing its support with the RoA to enhance healthcare service delivery. Moreover, JICA is also supporting the MoH through its Technical Cooperation Project (TCP) “Project for Improving Maternal and Child Health Services through the implementation of the Maternal and Child Health Handbook”. The MCH Handbook is part of a scheme designed to record, in a single document, all the information and data regarding the health services provided to; and the health condition of a mother and her child during the course of pregnancy, delivery and after birth, such as maternal care and the child's growth pattern and immunization schedule, thus promoting a continuum of care (CoC).

In this study, we will estimate the impact of an intervention package including distribution of MCH handbook and its supplementary interventions to women, on utilization of services provided at healthcare facilities from pregnancy through the postnatal and early childhood period.

Who can participate?
Women who seek and receive MNCH services in participating healthcare facilities within Benguela province can participate in the study.

What does the study involve?
The study is a cluster randomised controlled trial. All 10 municipalities in Benguela province will be randomly allocated to the intervention or control arm. The intervention package consisting of distribution of MCH Handbook to women, healthcare provider training on MCH Handbook operation and utilization and community sensitization and mobilization among women on the use of the MCH Handbook will be administered in the intervention arm. The control arm will receive standard care.

What are the possible benefits and risks of participating?
The intervention in this study is non-invasive and will be conducted following standard guidelines. Therefore, it carries a less than minimal risk for participating women. Potential benefits to participants in the study include improved CoC completion, knowledge of recommended health practices during pregnancy, recognition of danger signs and care of mothers and newborn.

Where is the study run from?
The study is run from Benguela province in Angola.

When is the study starting and how long is it expected to run for?
The study starts from 8th June 2019 and is expected to run through 30th June 2020.

Who is funding the study?
The study is funded by the Japan International Cooperation Agency (JICA)

Who is the main contact?
Dr. Kenji Takehara
takehara-k@ncchd.go.jp


Previous plain English summary:
Background and study aims
The Republic of Angola (RoA) has achieved rapid economic growth in recent years, but health indicators, especially with regards to maternal and child health (MCH) remain poor. Maternal and neonatal conditions account for the leading causes of preventable deaths in the country. Recent data shows remarkable progress in achieving an under-under-five mortality rate from 227 per 1000 live births in 1990 to 65 per 1000 live births in 2017. Notwithstanding, health outcomes are yet to reach adequate standards compared to other upper-middle-income countries in the region and beyond.

Towards improving maternal and child health indicators, the Ministry of Health (MoH) in the RoA developed the National Plan for Health Development 2012-2025, prioritizing pregnant women, infants, and young children as the key target populations. A mechanism for attaining this goal involves an emphasis on strengthening institutional and management capacity and capacity building for health workers through long or short-term training. Given the political will, the Japan International Cooperation Agency (JICA), through its health sector cooperation is providing its support with the RoA to enhance healthcare service delivery. Moreover, JICA is also supporting the MoH through its Technical Cooperation Project (TCP) “Project for Improving Maternal and Child Health Services through the implementation of the Maternal and Child Health Handbook”. The MCH Handbook is part of a scheme designed to record, in a single document, all the information and data regarding the health services provided to; and the health condition of a mother and her child during the course of pregnancy, delivery and after birth, such as maternal care and the child's growth pattern and immunization schedule, thus promoting a continuum of care (CoC).

In this study, we will estimate the impact of an intervention package including distribution of MCH handbook and its supplementary interventions to women, on utilization of services provided at healthcare facilities from pregnancy through the postnatal and early childhood period.

Who can participate?
Women who seek and receive MNCH services in participating healthcare facilities within Benguela province can participate in the study.

What does the study involve?
The study is a cluster randomised controlled trial. All 10 municipalities in Benguela province will be randomly allocated to the intervention or control arm. The intervention package consisting of distribution of MCH Handbook to women, healthcare provider training on MCH Handbook operation and utilization and community sensitization and mobilization among women on the use of the MCH Handbook will be administered in the intervention arm. The control arm will receive standard care.

What are the possible benefits and risks of participating?
The intervention in this study is non-invasive and will be conducted following standard guidelines. Therefore, it carries a less than minimal risk for participating women. Potential benefits to participants in the study include improved CoC completion, knowledge of recommended health practices during pregnancy, recognition of danger signs and care of mothers and newborn.

Where is the study run from?
The study is run from Benguela province in Angola.

When is the study starting and how long is it expected to run for?
The study starts from 1st June 2019 and is expected to run through 30th June 2020.

Who is funding the study?
The study is funded by the Japan International Cooperation Agency (JICA)

Who is the main contact?
Dr. Kenji Takehara
takehara-k@ncchd.go.jp

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olukunmi Balogun

ORCID ID

http://orcid.org/0000-0002-1684-3446

Contact details

Department of Health Policy
National Center for Child Health and Development
10-1
Okura-2-chome
Setagaya
Tokyo
157-8535
Japan
+81-3-3416-0181
balogun-o@ncchd.go.jp

Type

Scientific

Additional contact

Dr Kenji Takehara

ORCID ID

http://orcid.org/0000-0002-5957-600X

Contact details

Department of Health Policy
National Center for Child Health and Development
10-1
Okura-2-chome
Setagaya
Tokyo
157-8535
Japan
+81-3-3416-0181
takehara-k@ncchd.go.jp

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Impact of the maternal and child health handbook in Angola for improving the continuum of care and other maternal and child health indicators: a cluster randomized controlled trial

Acronym

Study hypothesis

Distribution and utilization of the Maternal and Child Health (MCH) handbook to women will improve the continuum of care (CoC) by 15% in the intervention sites. This impact will be achieved through improved knowledge leading to better maternal, newborn and child health (MNCH) service utilization

Ethics approval

1. Approved 01/02/2018, Ethics Committee of the National Center for Child Health and Development (10-1, Okura 2-Chōme, Setagaya, Tokyo, Japan 157-0074; rinri@ncchd.go.jp; +81 3 3416 0181), ref: 1721.
2. Approved 12/04/2018, Ethics committee of the Ministry of Health of the Republic of Angola (Rua 17 de Setembro, Luanda, Angola; http://www.minsa.gov.ao; +244 222 338 052), ref: 15/2018.

Study design

Two arm multi-center cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Health service utilization

Intervention

Intervention arm treatment: Distribution of MCH Handbook to women seeking MNCH services at public healthcare facilities in intervention municipalities, healthcare provider training on MCH Handbook operation and utilization and community sensitization and mobilization among women on the use of the MCH Handbook.

Control arm treatment: Distribution of mother’s card/book to pregnant women and child’s card for infants and healthcare provider training on the estimation of the probable delivery date (PDD) only.

The total duration of treatment and follow-up: 13 months.

Randomisation process: The unit of randomisation in this trial is the municipality. Benguela province consists of 10 municipalities of varying sizes - Baia Farta, Balombo, Benguela, Bocoio, Caimbambo, Catumbela, Chongoroi, Cubal, Ganda and Lobito. All ten municipalities will be included in the study. Municipalities were allocated to either intervention or control arms using block randomization taking into consideration the size and baseline characteristics of each municipality. The intervention and control arms each consist of five municipalities namely: Lobito, Cubal, Chongoroi, Bocoio and Balonmo and Benguela, Catumbela, Baia Farta, Ganda and Caimbambo respectively.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Continuum of care (CoC) completion rate. CoC completion is a time-dependent composite outcome to be measured during follow- up at 2~3 months postpartum among all pregnant women recruited into the study. CoC completion will consist of a minimum number of ANC visits, facility-based delivery, postnatal check-ups of mother and newborn and full child immunization up to 2~3 months’ infant age. As a sub-group analysis, the stratified analysis by the timing of the first ANC visit will be performed.

Secondary outcome measures

1. Rate of MNCH service utilisation is measured at follow-up. Data will be collected through structured interviews and abstracted from home-based record books.
2. Overall CoC completion rate is measured at follow-up. Data will be collected through structured interviews and abstracted from home-based record books.
3. Neonatal mortality rate is measured at follow-up. Data will be collected through structured interviews and abstracted from home-based record books.
4. ANC service utilization is measured at follow-up. Data will be collected through structured interviews and abstracted from home-based record books.
5. Facility-based delivery is measured at follow-up. Data will be collected through structured interviews or abstracted from home-based record books.
6. Infant health check-up is measured by maternal recall through structured interviews and records abstracted from home-based record books. Data will be collected at follow-up.
7. Maternal morbidity and pregnancy complications detection rate is measured at follow-up. Data will be collected through structured interviews and abstracted from home-based record books.
8. Infant morbidity rate is measured at follow-up. Data will be collected through structured interviews and abstracted from home-based record books.
9. Number of infant deaths is measured at follow-up. Data will be collected through structured interviews and abstracted from home-based record books.
10. Maternal health behavior is measured using structured interviews at baseline and follow-up.
11. Maternal depression is measured using the Edinburgh Postpartum Depression Scale at follow-up.
12. Infant feeding practices are measured using structured interviews at follow-up
13. Child vaccination rate is measured at follow-up. Data will be collected through structured interviews and abstracted from home-based record books.
14. Utilisation of postnatal care services is measured at follow-up. Data will be collected through structured interviews and abstracted from home-based record books.

Overall trial start date

01/02/2018

Overall trial end date

31/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Became pregnant at the beginning of the trial period.
2. Probable date of delivery (PDD) date from 01/12/2019 to 31/01/2020 or last menstrual period (LMP) between 01/03/2019 to 30/04/2019.

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

10,000

Participant exclusion criteria

1. Planning to move out of the study area while the impact evaluation study is ongoing.
2. Extreme disability or those judged by a healthcare provider as unable to participate.

Recruitment start date

08/06/2019

Recruitment end date

30/06/2019

Locations

Countries of recruitment

Angola

Trial participating centre

National Center for Child Health and Development
10-1, Okura-2-chome
Setagaya, Tokyo
157-8535
Japan

Sponsor information

Organisation

Japan International Cooperation Agency (JICA)

Sponsor details

1F–6F Nibancho Center Building
5-25 Niban-cho
Chiyoda
Tokyo
102-8012
Japan
+81-3-5226-6660
Hiraoka.Hisakazu@jica.go.jp

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Japan International Cooperation Agency

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/07/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/06/2019: The following changes were made: 1. The recruitment start date was updated from 01/06/2019 to 08/06/2019. 2. The plain English summary was updated. 03/06/2019: Trial's existence confirmed by the Ministry of Health of the Republic of Angola.