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Not yet recruiting NCT07717619

Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal

No phase Interventional High Risk Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Risk Pregnancy Bundle.
Who it may be relevant to
Registry conditions: High Risk Pregnancy. Basic parameters: from 0 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Nepal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • Maternal Near Miss [Time frame: up to 60 days postpartum]
Secondary outcome measures (11)
  • Neonatal death [Time frame: Up to 28 days after birth]
  • Low Apgar Score at 5 Minutes [Time frame: At 5 minutes after birth]
  • Neonatal Intensive Care Unit Admission [Time frame: Up to 30 days after birth]
  • Need for Mechanical Ventilation [Time frame: up to 30 days after birth]
  • Neonatal Respiratory Distress Syndrome [Time frame: Up to 30 days after birth]
  • Neonatal Hypoglycemia [Time frame: Up to 48 hours after birth]
  • Low Birth Weight [Time frame: At birth]
  • Composite Adverse Neonatal Outcome [Time frame: up to 30 days after birth]
  • Antenatal Risk Screening Rate [Time frame: Up to 24 months]
  • Referral Rate [Time frame: Up to 24 months]
  • Telehealth Consultation Utilization Rate [Time frame: Up to 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Nepal · 1 center
  • Melamchi Primary Health Care Center — Melamchi

Identifiers

NCT: NCT07717619 · 26-46873

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗