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Trial record 2 of 179 for:    CONTINUUM

Integrating Services for Noncommunicable Diseases in Continuum of Care for Mothers and Children

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Moe Moe Thandar, Tokyo University
Sponsor:
Collaborator:
Japan Agency for Medical Research and Development
Information provided by (Responsible Party):
Moe Moe Thandar, Tokyo University
ClinicalTrials.gov Identifier:
NCT03145155
First received: April 20, 2017
Last updated: May 29, 2017
Last verified: May 2017
  Purpose
The objectives of this cluster randomized control trial are to examine the effect of combined intervention of the utilization of continuum of care (CoC) card and health education on the completion of CoC services among mothers and to examine the effect of health education on NCDs and nutrition on mothers' knowledge on NCDs and nutrition in Myanmar. Pregnant women between 12-20 weeks of pregnancy will be recruited and assigned into intervention arm (n=600) and control arm (n=600). The intervention package will comprise of two components, (1) utilization of CoC card and (2) health education on CoC in maternal, newborn and child health (MNCH), NCD and nutrition. The CoC card will include CoC services from first antenatal care(ANC) to last postnatal care(PNC) including four ANC, skilled birth attendance (SBA) and four PNC and essential services. Pregnant women will get stickers if they receive above services. Health education will be given three times during pregnancy and one time during postpartum period. Health education will include importance of continuous uptake of MNCH services, NCDs and nutrition. The outcomes are proportion of completion of CoC services and knowledge on NCDs and nutrition.

Condition Intervention
Continuum of Care Noncommunicable Diseases Behavioral: Integrating services for noncommunicable diseases in continuum of care for mothers and children Behavioral: Ordinary health education for pregnant women

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Integrating Services for Noncommunicable Diseases in Continuum of Care for Mothers and Children: a Cluster Randomized Control Trial in Myanmar

Resource links provided by NLM:


Further study details as provided by Moe Moe Thandar, Tokyo University:

Primary Outcome Measures:
  • Completion of continuum of care [ Time Frame: 3 months after delivery ]
    Proportion of mothers who complete four antenatal care visits, skilled birth attendance and four postnatal care visits


Secondary Outcome Measures:
  • Change in knowledge on NCDs and nutrition [ Time Frame: Baseline and 3 months after delivery ]
    Proportion of mothers who change their knowledge related to NCDs after health education on NCDs and nutrition


Estimated Enrollment: 1200
Actual Study Start Date: May 22, 2017
Estimated Study Completion Date: March 31, 2018
Estimated Primary Completion Date: July 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Pregnant women in intervention arm will receive CoC card and health education on CoC in maternal, newborn and child health (MNCH), NCD and nutrition. The CoC card will include CoC services from first antenatal care(ANC) to last postnatal care(PNC) including four ANC, skilled birth attendance (SBA) and four PNC and essential services. Pregnant women will get stickers if they receive above services. Health education will be given three times during pregnancy and one time during postpartum period.
Behavioral: Integrating services for noncommunicable diseases in continuum of care for mothers and children
The intervention package will comprise of two components, (1) utilization of CoC card and (2) health education on CoC in maternal, newborn and child health (MNCH), NCD and nutrition. The CoC card will be distributed to mothers by midwives at the time of receiving ANC. The CoC card includes CoC services from first antenatal care(ANC) to last postnatal care(PNC) including four ANC, skilled birth attendance (SBA) and four PNC and essential services. Pregnant women will get stickers if they receive above services. Health education will be given by Public Health Supervisors 2 at the health facilities. Health education will be given three times during pregnancy and one time during postpartum period with pamphlets and posters.
Placebo Comparator: Control
Pregnant women in control arm will receive ordinary health education on pregnancy care
Behavioral: Ordinary health education for pregnant women
The ordinary health education intervention will cover schedule for ANC, delivery and PNC; danger signs; birth preparedness and nutrition. Health education will be given three times during pregnancy and one time during postpartum period with pamphlets and posters.

Detailed Description:

Antenatal care (ANC) is an important entry point for subsequent use of delivery and postnatal care (PNC) services. When women receive high-quality ANC, they will have skilled birth attendant (SBA) at delivery and continue to receive postnatal care. Continuous uptake of above services is necessary to improve health and well being of maternal, newborn and child health (MNCH). Moreover, the continuum of Care (CoC) offers the critical entry point for women and children for preventive care and health promotion on noncommunicable diseases (NCDs). ANC and PNC visits for women and a series of immunization for children are crucial opportunities to provide integrated services of NCDs. The integration of NCDs prevention and control programs in MNCH services would empower women to control NCDs in their families. However, no study has examined the effect of antenatal health education on CoC on completion of CoC among mothers in Myanmar. In addition, no study has examined the effect of antenatal health education on NCDs and nutrition on knowledge on NCDs and nutrition, and on maternal complications among mothers in Myanmar.

A cluster randomized controlled trial will be done among pregnant women living in study area. The unit of randomization in this study will be "rural health center (RHC)". In each RHC, there are at least four Sub-centers (SCs). RHC including SCs will be considered as one cluster. The investigators will advocate midwives (MW) on the CoC in MNCH and introduce the CoC card. The investigators will also recruit and train Public Health Supervisors 2 (PHS2) in each cluster to provide health education to pregnant women on CoC in MNCH, NCDs and nutrition.

We will conduct the study in three townships (Pantanaw, Inapu, Wakema,) in Ayeyarwaddy region, Myanmar from May 2017 to March 2018. There are a total of 22 health facilities. Out of 22 health facilities in 3 townships, eleven will be allocated into intervention arm and another 11 into control arm. An analyst, who will not be a primary member of the study team, will conduct randomization of clusters using computer-generated random sequences. Estimated sample size of 1200 pregnant women will be recruited, roughly 400 pregnant women in each township. The investigators estimate that about 28 women will seek ANC within one month in each cluster. In total of 22 clusters, the investigators estimate 600 women will seek ANC within one month; therefore, the enrollment period will take two months to get the targeted sample size of 1,200 pregnant women.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women
  • 18 years and above
  • between 12-20 weeks of pregnancy at the time of first ANC

Exclusion Criteria:

  • younger than 18 years
  • first ANC before 12 weeks or after 20 weeks
  • mentally ill
  • migrant and mobile people
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03145155

Contacts
Contact: Moe Moe Thandar, MHS +818048072107 moe2thandar@gmail.com
Contact: Junko Kiriya, PhD jkiriya@m.u-tokyo.ac.jp

Locations
Japan
Rural Health Centers Recruiting
Pantanaw township, Wakema township, Ingapu township, Ayeyarwaddy, Japan, 182-0025
Contact: Moe Moe Thandar       moe2thandar@gmail.com   
Sponsors and Collaborators
Tokyo University
Japan Agency for Medical Research and Development
Investigators
Principal Investigator: Moe Moe Thandar Tokyo University
  More Information

Publications:

Responsible Party: Moe Moe Thandar, PhD candidate, Department of Community and Global Health, School of International Health, Graduate School of Medicine, Tokyo University
ClinicalTrials.gov Identifier: NCT03145155     History of Changes
Other Study ID Numbers: 11498
Study First Received: April 20, 2017
Last Updated: May 29, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Moe Moe Thandar, Tokyo University:
continuum of care
maternal
newborn
child health
noncommunicable diseases

ClinicalTrials.gov processed this record on August 18, 2017