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

Primary Purpose

Continuum of Care, Noncommunicable Diseases

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Integrating services for noncommunicable diseases in continuum of care for mothers and children
Ordinary health education for pregnant women
Sponsored by
Tokyo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Continuum of Care focused on measuring continuum of care, maternal, newborn, child health, noncommunicable diseases

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Tokyo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Completion of continuum of care
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
Proportion of mothers who change their knowledge related to NCDs after health education on NCDs and nutrition

Full Information

First Posted
April 20, 2017
Last Updated
July 30, 2018
Sponsor
Tokyo University
Collaborators
Japan Agency for Medical Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03145155
Brief Title
Integrating Services for Noncommunicable Diseases in Continuum of Care for Mothers and Children
Official Title
Integrating Services for Noncommunicable Diseases in Continuum of Care for Mothers and Children: a Cluster Randomized Control Trial in Myanmar
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokyo University
Collaborators
Japan Agency for Medical Research and Development

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Continuum of Care, Noncommunicable Diseases
Keywords
continuum of care, maternal, newborn, child health, noncommunicable diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Pregnant women in control arm will receive ordinary health education on pregnancy care
Intervention Type
Behavioral
Intervention Name(s)
Integrating services for noncommunicable diseases in continuum of care for mothers and children
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Ordinary health education for pregnant women
Intervention Description
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 Outcome Measure Information:
Title
Completion of continuum of care
Description
Proportion of mothers who complete four antenatal care visits, skilled birth attendance and four postnatal care visits
Time Frame
3 months after delivery
Secondary Outcome Measure Information:
Title
Change in knowledge on NCDs and nutrition
Description
Proportion of mothers who change their knowledge related to NCDs after health education on NCDs and nutrition
Time Frame
Baseline and 3 months after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moe Moe Thandar
Organizational Affiliation
Tokyo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tokyo
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
182-0025
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25885596
Citation
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.
Results Reference
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PubMed Identifier
17933651
Citation
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.
Results Reference
background
PubMed Identifier
15752509
Citation
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.
Results Reference
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PubMed Identifier
26650388
Citation
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.
Results Reference
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PubMed Identifier
23113824
Citation
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.
Results Reference
background
PubMed Identifier
25199858
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Integrating Services for Noncommunicable Diseases in Continuum of Care for Mothers and Children

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