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Clinical Trials/NCT03371186
NCT03371186
Unknown
Not Applicable

Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot

Possible2 sites in 1 country12,000 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Reproductive, Maternal, Newborn, and Child Health
Sponsor
Possible
Enrollment
12000
Locations
2
Primary Endpoint
Institutional Birth Rate
Last Updated
6 years ago

Overview

Brief Summary

The investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. This intervention integrates five evidence-based approaches for reproductive, maternal, newborn, and child health focused on the "golden 1000 days" from conception through age two: 1) Community Health Worker model of home-based care to monitor and increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children via an integrated electronic medical record; 3) Delivering community-based integrated management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and postnatal care to improve care delivery and reduce mortality during the "golden 1000 days" from conception to age two; and 5) Balanced counseling to increase post-partum contraception.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
February 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Possible
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Reproductive aged women 15-49;
  • Reproductive aged women 15-49; recently delivered in past two years;
  • Reproductive aged women 15-49; active pregnancy during study period and identified by a CHW serving their village
  • Children aged 0-2; children of recently-delivered mothers (population #2 or #3 above);
  • Healthcare staff; CHWs serving village clusters, CHW Leaders serving one of the village clusters, Nyaya Health Nepal and Government of Nepal employees involved in study design, program implementation, data collection, or data analysis processes; and
  • Must reside in either Achham or Dolakha District, Nepal.

Exclusion Criteria

  • Patients meeting inclusion criteria and consenting to study enrollment, as stated above, will be included in the study unless 1) patients migrate from the study are before completion of any of the bundled interventions; 2) patients request exclusion from the study at any point during the bundled intervention.

Outcomes

Primary Outcomes

Institutional Birth Rate

Time Frame: 3 years

The percentage of births in a healthcare facility with a healthcare professional present.

Under-Two Mortality Rate

Time Frame: 3 years

The under-2 mortality rate is the probability (expressed as a rate per 1,000 live births) of a child born in a specified year dying before reaching the age of two if subject to current age-specific mortality rates.

Post-Partum Contraceptive Prevalence Rate

Time Frame: 3 years

The post-partum contraceptive prevalence rate is number of married reproductive aged women (15-49) in the study population who delivered in the past two years who are using a modern contraceptive method out of the total number of married reproductive aged women (15-49) in the study population who delivered in the past two years.

Secondary Outcomes

  • Home Visit Coverage(3 months)
  • Group Care Content Fidelity(3 months)
  • Group Participation(3 months)
  • Session Completion(3 months)
  • Pediatric Stunting Prevalence(1 month)
  • First-Trimester Pregnancies Identified(3 months)
  • Contraceptive Method Mix(3 months)
  • Antenatal Care Completion(3 months)
  • Pediatric Diarrhea Incidence(1 month)
  • Total Intervention Cost(3 years)
  • Cost-Effectiveness of Bundled Intervention(3 years)
  • Pediatric Pneumonia Incidence(1 month)
  • Exclusive Breastfeeding Prevalence(1 month)
  • Percent of postpartum women with unmet need for contraception(3 years)

Study Sites (2)

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