- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03145155
Integrating Services for Noncommunicable Diseases in Continuum of Care for Mothers and Children
Integrating Services for Noncommunicable Diseases in Continuum of Care for Mothers and Children: a Cluster Randomized Control Trial in Myanmar
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tokyo
-
Bunkyō, Tokyo, Japan, 182-0025
- University of Tokyo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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
|
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
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Moe Moe Thandar, Tokyo University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11498 (REGISTRY: DAIDS ES Registry Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Noncommunicable Diseases
-
Azienda Sanitaria Locale CN2 Alba-BraUniversity of Eastern Piedmont; Eclectica Sas di Beccaria Franca, Ermacora...CompletedMajor Risk Factors for Noncommunicable DiseasesItaly
-
University of OxfordMahidol Oxford Tropical Medicine Research Unit; Chiang Rai Clinical Research... and other collaboratorsCompletedInfections | Risk Factors | Health Status | Noncommunicable DiseaseBangladesh, Cambodia, Myanmar, Thailand
-
Martina HorvatActive, not recruitingNoncommunicable Diseases | Vulnerable ElderlySlovenia
-
Johns Hopkins Bloomberg School of Public HealthMakerere University; The Bloomberg Family Foundation, Inc.; Institute of Epidemiology...CompletedNoncommunicable Diseases | Surveys and QuestionnairesBangladesh, Uganda
-
Johns Hopkins Bloomberg School of Public HealthMakerere University; Institute of Epidemiology, Disease Control and ResearchCompletedNoncommunicable Diseases | Surveys and QuestionnairesBangladesh, Uganda
-
Johns Hopkins Bloomberg School of Public HealthMakerere University; The Bloomberg Family Foundation, Inc.; Institute of Epidemiology...CompletedNoncommunicable Diseases | Surveys and QuestionnairesBangladesh, Uganda
-
Johns Hopkins Bloomberg School of Public HealthIfakara Health InstituteCompletedNoncommunicable Diseases | Surveys and QuestionnairesTanzania
-
Johns Hopkins Bloomberg School of Public HealthIfakara Health Institute; Pontificia Universidad Javeriana; The Bloomberg Family...CompletedNoncommunicable Diseases | Surveys and QuestionnairesTanzania, Colombia
-
The University of Hong KongCompletedNon-communicable DiseasesHong Kong
-
Unidad de Cirugía CardiovascularWashington University School of Medicine; International Development Research...CompletedNon-communicable DiseasesGuatemala
Clinical Trials on Integrating services for noncommunicable diseases in continuum of care for mothers and children
-
Centre hospitalier de l'Université de Montréal...Boehringer Ingelheim; GreyboxActive, not recruitingHeart Failure | Chronic Heart FailureCanada
-
Children's Treatment NetworkMcMaster UniversityCompletedCerebral Palsy | Brain Injury | Autism | Down's SyndromeCanada
-
Michigan State UniversitySpectrum Health Hospitals; Hurley MIHP and Healthy Start; Ascension MIHP and... and other collaboratorsEnrolling by invitationHealth Disparities | Maternal Morbidity and MortalityUnited States
-
Columbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedRespiratory Tract Infections | Otorhinolaryngologic Diseases | Urinary Tract Infections | PyelonephritisFrance
-
University of Colorado, DenverChildren's Hospital Colorado; American Psychological FoundationCompletedEmotional DisorderUnited States
-
Steven WeissCompletedAnxiety Disorder of Childhood or Adolescence
-
Institut National de la Santé Et de la Recherche...UNITAIDUnknownTuberculosis | Severe Acute MalnutritionZambia, Uganda
-
Centro Hospitalar Universitário de Santo AntónioNot yet recruitingPneumonia, Viral | Pneumonia | Pneumonia, Bacterial
-
Göteborg UniversitySwedish Childhood Cancer FundRecruitingCommunication | Childhood Cancer | Symptoms and SignsSweden