Melamchi Primary Health Care Center
Melamchi, Bagmati, Nepal
NCT Number: NCT07717619
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
Trial opening soon.
Get Notified0 year and older
Female
Interventional
Not applicable
Melamchi, Bagmati, Nepal
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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)
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
Time frame: At 5 minutes after birth
Number of infants with an Apgar score less than 7 at 5 minutes after birth
Time frame: Up to 30 days after birth
Number of infants admitted to a neonatal intensive care unit
Time frame: up to 30 days after birth
Number of infants requiring mechanical ventilation
Time frame: Up to 30 days after birth
Number of infants diagnosed with respiratory distress syndrome
Time frame: Up to 48 hours after birth
Number of infants with hypoglycemia, defined as less than 45 mg/dl
Time frame: At birth
Number of infants with birth weight less than 2500 grams
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
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
Time frame: Up to 24 months
Percentage of pregnant women referred to higher levels of care based on risks identified through antenatal risk screening
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
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Anju Ranjit, MD MPH
CONTACT
Archana Shrestha, PhD
CONTACT
University of California, San Francisco
Other
Implementing and Evaluating an Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal
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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.
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