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Register:	ISRCTN
Last refreshed on:	29 April 2019
Main ID:	ISRCTN18422527
Date of registration:	27/02/2017
Prospective Registration:	Yes
Primary sponsor:	Japanese Society for the Promotion of Science (Grant-in-Aid for Scientific Research)
Public title:	Combining health services for malaria and maternal and child health to improve health of mothers and children in rural communities
Scientific title:	Integration of malaria control activities and Maternal, Neonatal, and Child Health services to achieve malaria elimination and better maternal and child health
Date of first enrolment:	01/03/2017
Target sample size:	400
Recruitment status:	Recruiting
URL:	http://isrctn.com/ISRCTN18422527
Study type:	Interventional
Study design:	Non-randomised controlled trial (Prevention)
Phase:	Not Applicable

Countries of recruitment
Cambodia

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Junko Yasuoka
Address:	Department of Community and Global Health The University of Tokyo 7-3-1 Hongo, Bunkyo-ku 113-0033 Tokyo Japan
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Intervention arm:
1. Pregnant women
1.2. Between the ages of 18 and 49 years old (reproductive age)
2. Mothers with children under two

Control arm:
1. Pregnant women
1.2. Between the ages 18 and 49 years old (reproductive age)
2. Mothers with children under two

Exclusion criteria:
1. Refused participating with the intervention
2. Decline to be interviewed

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria and Maternal, Neonatal, and Child Health
Infections and Infestations
Malaria and Maternal, Neonatal, and Child Health

Intervention(s)

Participants are allocated into two study arms: the intervention arm and the control arm. Out of 62 Village Malaria Worker villages under six health centers, which are accessible throughout the year in Ratanakiri province, 30 villages under three health centers will be selected by convenience sampling.

The intervention arm involves 30 villages with Village Malaria Workers (VMWs) in Ratanakiri and will include the following:
1. Integrated Continuum of Care (ICoC) orientation
2. ICoC card utilization
3. Regular malaria test and health check-ups
4. Health education

The control arm involves 32 VMW villages and they receive standard care.

After two years from the initiation of the intervention, follow-up survey (face-to-face interviews using structured questionnaire) will be conducted, targeting
- Participants of the intervention in intervention villages
- Randomly selected mothers with children under two in control villages
The follow-up survey will ask about mothers' knowledge and health behavior during and after pregnancy.

Primary Outcome(s)

1. Percentage of pregnant women who receive malaria test measured using the Rapid Diagnostic Test four times during pregnancy (about 4 months, 6-7 months, 8 months, and 9 months)
2. Percentage of mothers, who receive all three maternal, neonatal, and child health (MHCH) services (antenatal care, delivery and postnatal care) or Village Malaria Workers’ health check-up four times during pregnancy and after delivery is measured using the integrated continuum care (ICoC) card and is done four times during antenatal care (about 4 months, 6-7 months, 8 months, and 9 months), at delivery, and three times for postnatal care (by 2 days, at 7 days, and at 6 weeks)

Secondary Outcome(s)

1. Pregnant women’s and mothers’ knowledge about danger signs, breastfeeding, and proper feeding practices for children under two is measured using face to face interviews using structured questionnaires at the end of the intervention
2. Rate of infectious diseases, including malaria, diarrhea, and pneumonia, among mothers and children under two is measured using records in the ICoC at the end of the intervention

Secondary ID(s)

N/A

Source(s) of Monetary Support

Japanese Society for the Promotion of Science (Grant-in-Aid for Scientific Research)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

1. Research Ethics Committee of the Graduate School of Medicine The University of Tokyo, 11/30/2015, ref: 11030 2. National Ethical Committee for Health Research Cambodia, 10/31/2016, ref: 368NECHR

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2020
URL:

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