NCT03145155

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

April 20, 2017

Last Update Submit

January 29, 2026

Conditions

Keywords

continuum of carematernalnewbornchild healthnoncommunicable diseases

Outcome Measures

Primary Outcomes (1)

  • Completion of continuum of care

    Proportion of mothers who complete four antenatal care visits, skilled birth attendance and four postnatal care visits

    3 months after delivery

Secondary Outcomes (1)

  • Change in knowledge on NCDs and nutrition

    Baseline and 3 months after delivery

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Pregnant women in control arm will receive ordinary health education on pregnancy care

Behavioral: Ordinary health education for pregnant women

Interventions

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.

Control

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.

Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • younger than 18 years
  • first ANC before 12 weeks or after 20 weeks
  • mentally ill
  • migrant and mobile people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tokyo

Bunkyō, Tokyo, 182-0025, Japan

Location

Related Publications (7)

  • Wang W, Hong R. Levels and determinants of continuum of care for maternal and newborn health in Cambodia-evidence from a population-based survey. BMC Pregnancy Childbirth. 2015 Mar 19;15:62. doi: 10.1186/s12884-015-0497-0.

    PMID: 25885596BACKGROUND
  • Kerber KJ, de Graft-Johnson JE, Bhutta ZA, Okong P, Starrs A, Lawn JE. Continuum of care for maternal, newborn, and child health: from slogan to service delivery. Lancet. 2007 Oct 13;370(9595):1358-69. doi: 10.1016/S0140-6736(07)61578-5.

    PMID: 17933651BACKGROUND
  • Tinker A, ten Hoope-Bender P, Azfar S, Bustreo F, Bell R. A continuum of care to save newborn lives. Lancet. 2005 Mar 5-11;365(9462):822-5. doi: 10.1016/S0140-6736(05)71016-3. No abstract available.

    PMID: 15752509BACKGROUND
  • Yeji F, Shibanuma A, Oduro A, Debpuur C, Kikuchi K, Owusu-Agei S, Gyapong M, Okawa S, Ansah E, Asare GQ, Nanishi K, Williams J, Addei S, Tawiah C, Yasuoka J, Enuameh Y, Sakeah E, Wontuo P, Jimba M, Hodgson A; Ghana EMBRACE Implementation Research Project Team. Continuum of Care in a Maternal, Newborn and Child Health Program in Ghana: Low Completion Rate and Multiple Obstacle Factors. PLoS One. 2015 Dec 9;10(12):e0142849. doi: 10.1371/journal.pone.0142849. eCollection 2015.

    PMID: 26650388BACKGROUND
  • Gounder CR, Chaisson RE. A diagonal approach to building primary healthcare systems in resource-limited settings: women-centred integration of HIV/AIDS, tuberculosis, malaria, MCH and NCD initiatives. Trop Med Int Health. 2012 Dec;17(12):1426-31. doi: 10.1111/j.1365-3156.2012.03100.x. Epub 2012 Nov 1. No abstract available.

    PMID: 23113824BACKGROUND
  • Kapur A. Links between maternal health and NCDs. Best Pract Res Clin Obstet Gynaecol. 2015 Jan;29(1):32-42. doi: 10.1016/j.bpobgyn.2014.04.016. Epub 2014 Aug 17.

    PMID: 25199858BACKGROUND
  • Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

    PMID: 25103301BACKGROUND

MeSH Terms

Conditions

Noncommunicable Diseases

Interventions

Continuity of Patient Care

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Moe Moe Thandar

    Tokyo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate, Department of Community and Global Health, School of International Health, Graduate School of Medicine

Study Record Dates

First Submitted

April 20, 2017

First Posted

May 9, 2017

Study Start

May 22, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Raw dataset with unique ID

Shared Documents
STUDY PROTOCOL
Time Frame
29 January 2026 to 31 Jauary 2030
More information

Locations