Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07717619

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

0 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Maternal Near Miss

    Time frame: up to 60 days postpartum

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

Secondary outcomes

  1. Neonatal death

    Time frame: Up to 28 days after birth

    Number of neonatal deaths, defined as death of a liveborn infant within the first 28 days of life

  2. Low Apgar Score at 5 Minutes

    Time frame: At 5 minutes after birth

    Number of infants with an Apgar score less than 7 at 5 minutes after birth

  3. Neonatal Intensive Care Unit Admission

    Time frame: Up to 30 days after birth

    Number of infants admitted to a neonatal intensive care unit

  4. Need for Mechanical Ventilation

    Time frame: up to 30 days after birth

    Number of infants requiring mechanical ventilation

  5. Neonatal Respiratory Distress Syndrome

    Time frame: Up to 30 days after birth

    Number of infants diagnosed with respiratory distress syndrome

  6. Neonatal Hypoglycemia

    Time frame: Up to 48 hours after birth

    Number of infants with hypoglycemia, defined as less than 45 mg/dl

  7. Low Birth Weight

    Time frame: At birth

    Number of infants with birth weight less than 2500 grams

  8. Composite Adverse Neonatal Outcome

    Time frame: up to 30 days after birth

    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

  9. Antenatal Risk Screening Rate

    Time frame: Up to 24 months

    Proportion of pregnant women enrolled in the study who undergo antenatal risk screening using the Antenatal Risk-Score Checklist

  10. Referral Rate

    Time frame: Up to 24 months

    Percentage of pregnant women referred to higher levels of care based on risks identified through antenatal risk screening

  11. Telehealth Consultation Utilization Rate

    Time frame: Up to 24 months

    Proportion of pregnant women in the High Risk Pregnancy Bundle Intervention Arm who utilize at least 80% of their recommended telehealth consultations

Other outcomes

  1. Acceptability of Intervention Measure (AIM) Score

    Time frame: up to 24 months

    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.

  2. Intervention Appropriateness Measure (IAM) Score

    Time frame: Up to 24 months

    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.

  3. Feasibility of Intervention Measure (FIM) Score

    Time frame: Up to 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anju Ranjit, MD MPH

CONTACT

[email protected]

4153533400

Archana Shrestha, PhD

CONTACT

[email protected]

+9779801002245

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.