Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal

ConditionHigh Risk Pregnancy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age0+

SponsorUniversity of California, San Francisco

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

High Risk Pregnancy Bundle
Other intervention
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

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Standard of CareNo intervention 0 interventions

Group B: High Risk Pregnancy (HRP) Bundle Intervention ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

up to 60 days postpartum

Secondary outcomes

Neonatal death

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

Time frame

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

Time frame

At 5 minutes after birth

Neonatal Intensive Care Unit Admission

Number of infants admitted to a neonatal intensive care unit

Time frame

Up to 30 days after birth

Need for Mechanical Ventilation

Number of infants requiring mechanical ventilation

Time frame

up to 30 days after birth

Other outcomes

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.

Time frame

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.

Time frame

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.

Time frame

Up to 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: