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Completed

NCT Number: NCT03145155

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Tokyo

Bunkyō, Tokyo, 182-0025, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrating services for noncommunicable diseases in continuum of care for mothers and children

Behavioral

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.

Ordinary health education for pregnant women

Behavioral

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.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tokyo University

Other

Collaborators

  • Japan Agency for Medical Research and Development

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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