High Risk Pregnancy
Conditions
Keywords
high risk pregnancy, low and middle income countries, teleheatlh, pregnancy checklist
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. 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
OTHERHigh 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
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
0 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Near Miss | 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
| Measure | Time frame | Description |
|---|---|---|
| Neonatal death | Up to 28 days after birth | Number of neonatal deaths, defined as death of a liveborn infant within the first 28 days of life |
| Low Apgar Score at 5 Minutes | At 5 minutes after birth | Number of infants with an Apgar score less than 7 at 5 minutes after birth |
| Neonatal Intensive Care Unit Admission | Up to 30 days after birth | Number of infants admitted to a neonatal intensive care unit |
| Need for Mechanical Ventilation | up to 30 days after birth | Number of infants requiring mechanical ventilation |
| Neonatal Respiratory Distress Syndrome | Up to 30 days after birth | Number of infants diagnosed with respiratory distress syndrome |
| Neonatal Hypoglycemia | Up to 48 hours after birth | Number of infants with hypoglycemia, defined as less than 45 mg/dl |
| Low Birth Weight | At birth | Number of infants with birth weight less than 2500 grams |
| Composite Adverse Neonatal Outcome | 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 |
| Antenatal Risk Screening Rate | Up to 24 months | Proportion of pregnant women enrolled in the study who undergo antenatal risk screening using the Antenatal Risk-Score Checklist |
| Referral Rate | Up to 24 months | Percentage of pregnant women referred to higher levels of care based on risks identified through antenatal risk screening |
| Telehealth Consultation Utilization Rate | 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 |
Countries
Nepal
Contacts
CONTACTAnju Ranjit, MD MPH
CONTACTArchana Shrestha, PhD
PRINCIPAL_INVESTIGATORAnju Ranjit, MD MPH
University of California, San Francisco
PRINCIPAL_INVESTIGATORArchana Shrestha
Kathmandu University School of Medicine/Dhulikhel Hospital
Outcome results
None listed