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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03371186 |
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Date of registration:
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04/12/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot
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Scientific title:
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Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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12000 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03371186 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Nepal
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Contacts
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Name:
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Pushpa Chaudhari, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Government of Nepal, Ministry of Health |
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Name:
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Duncan Maru, MD, PhD |
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Address:
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Telephone:
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Email:
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duncan@possiblehealth.org |
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Affiliation:
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Name:
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Sheela Maru, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Possible |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Reproductive aged women 15-49;
2. Reproductive aged women 15-49; recently delivered in past two years;
3. Reproductive aged women 15-49; active pregnancy during study period and identified by
a CHW serving their village
4. Children aged 0-2; children of recently-delivered mothers (population #2 or #3 above);
5. 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
6. 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.
Age minimum:
15 Years
Age maximum:
49 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Reproductive, Maternal, Newborn, and Child Health
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Integrated, Community-Health Systems
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Intervention(s)
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Other: Community Health Worker
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Other: Balanced Post-Partum Contraceptive Counseling
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Other: CB-Integrated Management of Newborn and Childhood Illness
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Other: Continuous Surveillance
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Other: Group Antenatal and Postnatal Care
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Primary Outcome(s)
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Institutional Birth Rate
[Time Frame: 3 years]
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Post-Partum Contraceptive Prevalence Rate
[Time Frame: 3 years]
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Under-Two Mortality Rate
[Time Frame: 3 years]
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Secondary Outcome(s)
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First-Trimester Pregnancies Identified
[Time Frame: 3 months]
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Group Care Content Fidelity
[Time Frame: 3 months]
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Antenatal Care Completion
[Time Frame: 3 months]
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Contraceptive Method Mix
[Time Frame: 3 months]
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Group Participation
[Time Frame: 3 months]
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Pediatric Pneumonia Incidence
[Time Frame: 1 month]
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Pediatric Stunting Prevalence
[Time Frame: 1 month]
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Percent of postpartum women with unmet need for contraception
[Time Frame: 3 years]
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Home Visit Coverage
[Time Frame: 3 months]
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Cost-Effectiveness of Bundled Intervention
[Time Frame: 3 years]
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Pediatric Diarrhea Incidence
[Time Frame: 1 month]
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Exclusive Breastfeeding Prevalence
[Time Frame: 1 month]
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Session Completion
[Time Frame: 3 months]
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Total Intervention Cost
[Time Frame: 3 years]
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Secondary ID(s)
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AID-OAA-A-11-0001
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1DP5OD019894-01
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RMNCHnyaya
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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