Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal

Implementing and Evaluating an Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal

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

Study Overview

• Status: Not yet recruiting
• Conditions: High Risk Pregnancy
• Intervention / Treatment: Other: High Risk Pregnancy Bundle

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Archana Shrestha, PhD; Phone Number: +9779801002245; Email: archana@kusms.edu.np
• Study Contact Backup: Name: Anju Ranjit, MD MPH; Phone Number: 4153533400; Email: anju.ranjit@ucsf.edu

Study Locations

• Nepal
  • Bagmati
    • Melamchi, Bagmati, Nepal
      • Melamchi Primary Health Care Center
      • Contact: Umang Raut (Medical Superintendent); Phone Number: +977 9860923221; Email: melamchiphc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Usual prenatal care, including on-site consultation and visits from health facility staff
Active Comparator: High Risk Pregnancy (HRP) Bundle Intervention Arm; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal death	Number of neonatal deaths, defined as death of a liveborn infant within the first 28 days of life	Up to 28 days after birth
Low Apgar Score at 5 Minutes	Number of infants with an Apgar score less than 7 at 5 minutes after birth	At 5 minutes after birth
Neonatal Intensive Care Unit Admission	Number of infants admitted to a neonatal intensive care unit	Up to 30 days after birth
Need for Mechanical Ventilation	Number of infants requiring mechanical ventilation	up to 30 days after birth
Neonatal Respiratory Distress Syndrome	Number of infants diagnosed with respiratory distress syndrome	Up to 30 days after birth
Neonatal Hypoglycemia	Number of infants with hypoglycemia, defined as less than 45 mg/dl	Up to 48 hours after birth
Low Birth Weight	Number of infants with birth weight less than 2500 grams	At birth
Composite Adverse Neonatal Outcome	Number of infants with at least one of the following: neonatal death, Apgar score less than 7 at 5 minutes, NICU admission, need for mechanical ventilation, respiratory distress syndrome, hypoglycemia	up to 30 days after birth
Antenatal Risk Screening Rate	Proportion of pregnant women enrolled in the study who undergo antenatal risk screening using the Antenatal Risk-Score Checklist	Up to 24 months
Referral Rate	Percentage of pregnant women referred to higher levels of care based on risks identified through antenatal risk screening	Up to 24 months
Telehealth Consultation Utilization Rate	Proportion of pregnant women in the High Risk Pregnancy Bundle Intervention Arm who utilize at least 80% of their recommended telehealth consultations	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM) Score	We will assess the acceptability of each intervention component (risk-screening scoring system, teleconsultation, weekly patient navigator calls, and provider training) using the mean total score and standard deviation (SD) of the Acceptability of Intervention Measure (AIM), administered at both the patient and provider level.	up to 24 months
Intervention Appropriateness Measure (IAM) Score	We will assess the appropriateness of each intervention component (risk-screening scoring system, teleconsultation, weekly patient navigator calls, and provider training) using the mean total score and standard deviation (SD) of the Intervention Appropriateness Measure (IAM), administered at both the patient and provider level.	Up to 24 months
Feasibility of Intervention Measure (FIM) Score	We will assess the feasibility of each intervention component (risk-screening scoring system, teleconsultation, weekly patient navigator calls, and provider training) using the mean total score and standard deviation (SD) of the Feasibility of Intervention Measure (FIM), administered at both the patient and provider level.	Up to 24 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Anju Ranjit, MD MPH, University of California, San Francisco; Principal Investigator: Archana Shrestha, Kathmandu University School of Medicine/Dhulikhel Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: low and middle income countries; high risk pregnancy; teleheatlh; pregnancy checklist
• Other Study ID Numbers: 26-46873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared, including quantitative survey data on primary outcomes (maternal near-miss) and secondary outcomes (maternal mortality, composite neonatal outcomes, stillbirth rate, preterm delivery, implementation outcomes), socio-demographic and reproductive health data, and chronic health condition data. Qualitative data (de-identified transcripts) from focus group discussions and in-depth interviews on implementation barriers and facilitators will also be shared. Process tracking data (service utilization records, monthly reports) may be shared in aggregate form. Personally identifiable information will be removed prior to sharing. Data will be shared in standard formats (e.g., Stata) in accordance with ICPSR standards, accompanied by a codebook and questionnaire to support interpretation.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No