Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal

NCT07717619 | Not Yet Recruiting

• 1 other identifier: 26-46873
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will assess and implement a comprehensive antenatal HRP screening and telehealth follow-up program in rural Nepal. The main questions it aims to answer are:

1. 1.To estimate the burden of HRPs using the existing Antenatal Risk-Score Checklist in rural Nepal
2. 2.Assess acceptability, feasibility, preliminary effectiveness, and implementation outcomes of the HRP bundle at the primary healthcare in Nepal

Conditions

High Risk Pregnancy

Keywords

high risk pregnancy; low and middle income countries; teleheatlh; pregnancy checklist

Outcome Measures

Primary Outcomes (1)

• Maternal Near Miss

  life-threatening complication during pregnancy, childbirth, or within 42 days postpartum, but survives with appropriate medical intervention (We will use WHO criteria)

  up to 60 days postpartum

Secondary Outcomes (11)

• Neonatal death

  Up to 28 days after birth

• Low Apgar Score at 5 Minutes

  At 5 minutes after birth

• Neonatal Intensive Care Unit Admission

  Up to 30 days after birth

• Need for Mechanical Ventilation

  up to 30 days after birth

• Neonatal Respiratory Distress Syndrome

  Up to 30 days after birth

Other Outcomes (3)

• Acceptability of Intervention Measure (AIM) Score

  up to 24 months

• Intervention Appropriateness Measure (IAM) Score

  Up to 24 months

• Feasibility of Intervention Measure (FIM) Score

  Up to 24 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Usual prenatal care, including on-site consultation and visits from health facility staff

High Risk Pregnancy (HRP) Bundle Intervention Arm

ACTIVE COMPARATOR

The intervention arm would include 1. identification of high-risk pregnancy 2. Teleconsultation with expert consultant 3. weekly call with patient navigator 4. training of health care provider for HRP care, and 5. visits in the weekly prenatal telehealth clinic

Other: High Risk Pregnancy Bundle

Interventions

High Risk Pregnancy Bundle OTHER

The intervention would include 1. identification of high-risk pregnancy 2. Teleconsultation with expert consultant 3. weekly call with patient navigator 4. training of health care provider for HRP care, and 5. visits in the weekly prenatal telehealth clinic

High Risk Pregnancy (HRP) Bundle Intervention Arm

Eligibility Criteria

• Age: 0 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all pregnant women above who are receiving antenatal care at Melamchi Primary Health Care Center

You may not qualify if:

• life-threatening maternal or fetal conditions requiring immediate tertiary-level care
• unable to provide informed consent due to cognitive or language barriers
• do not have access to a mobile phone for telehealth consultations.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Melamchi Primary Health Care Center

Melamchi, Bagmati, Nepal

Location

Study Officials

• Anju Ranjit, MD MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Archana Shrestha

  Kathmandu University School of Medicine/Dhulikhel Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anju Ranjit, MD MPH

CONTACT

4153533400; anju.ranjit@ucsf.edu

Archana Shrestha, PhD

CONTACT

+9779801002245; archana@kusms.edu.np

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data and supporting information will be available beginning at the time of publication of the associated study results. Data will remain available indefinitely upon request following publication, with no specified end date.
• Access Criteria: De-identified data will be accessible to qualified researchers and program implementers who submit a formal data request and agree to comply with applicable ethical guidelines and data use terms. Requestors will have access to de-identified quantitative datasets, qualitative transcripts, and associated metadata (questionnaire, codebook). Potentially identifying variables will be classified under restricted access and made available only through a secure virtual data enclave (e.g., DSDR/ICPSR) for approved researchers. Data will be archived on a secure server at Dhulikhel Hospital-Kathmandu University Hospital, with a backup at UCSF. Requests will be reviewed by the study's Principal Investigators or designated project coordinator. A Certificate of Confidentiality will safeguard participant information throughout the access process.

Locations

NE (1)