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

January 29, 2026 updated by: Moe Moe Thandar, Tokyo University

Integrating Services for Noncommunicable Diseases in Continuum of Care for Mothers and Children: a Cluster Randomized Control Trial in Myanmar

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
630

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Bunkyō, Tokyo, Japan, 182-0025
        • University of Tokyo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 3 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokyo University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Japan Agency for Medical Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Moe Moe Thandar, Tokyo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11498 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw dataset with unique ID

IPD Sharing Time Frame

29 January 2026 to 31 Jauary 2030

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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