Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal
15. juli 2026 oppdatert av: University of California, San Francisco
Implementing and Evaluating an 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:
- To estimate the burden of HRPs using the existing Antenatal Risk-Score Checklist in rural Nepal
- Assess acceptability, feasibility, preliminary effectiveness, and implementation outcomes of the HRP bundle at the primary healthcare in Nepal
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Archana Shrestha, PhD
- Telefonnummer: +9779801002245
- E-post: archana@kusms.edu.np
Studer Kontakt Backup
- Navn: Anju Ranjit, MD MPH
- Telefonnummer: 4153533400
- E-post: anju.ranjit@ucsf.edu
Studiesteder
-
-
Bagmati
-
Melamchi, Bagmati, Nepal
- Melamchi Primary Health Care Center
-
Ta kontakt med:
- Umang Raut (Medical Superintendent)
- Telefonnummer: +977 9860923221
- E-post: melamchiphc@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Standard of Care
Usual prenatal care, including on-site consultation and visits from health facility staff
|
|
|
Aktiv komparator: High Risk Pregnancy (HRP) Bundle Intervention Arm
The intervention arm 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
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maternal Near Miss
Tidsramme: 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)
|
up to 60 days postpartum
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neonatal death
Tidsramme: Up to 28 days after birth
|
Number of neonatal deaths, defined as death of a liveborn infant within the first 28 days of life
|
Up to 28 days after birth
|
|
Low Apgar Score at 5 Minutes
Tidsramme: At 5 minutes after birth
|
Number of infants with an Apgar score less than 7 at 5 minutes after birth
|
At 5 minutes after birth
|
|
Neonatal Intensive Care Unit Admission
Tidsramme: Up to 30 days after birth
|
Number of infants admitted to a neonatal intensive care unit
|
Up to 30 days after birth
|
|
Need for Mechanical Ventilation
Tidsramme: up to 30 days after birth
|
Number of infants requiring mechanical ventilation
|
up to 30 days after birth
|
|
Neonatal Respiratory Distress Syndrome
Tidsramme: Up to 30 days after birth
|
Number of infants diagnosed with respiratory distress syndrome
|
Up to 30 days after birth
|
|
Neonatal Hypoglycemia
Tidsramme: Up to 48 hours after birth
|
Number of infants with hypoglycemia, defined as less than 45 mg/dl
|
Up to 48 hours after birth
|
|
Low Birth Weight
Tidsramme: At birth
|
Number of infants with birth weight less than 2500 grams
|
At birth
|
|
Composite Adverse Neonatal Outcome
Tidsramme: 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
|
up to 30 days after birth
|
|
Antenatal Risk Screening Rate
Tidsramme: Up to 24 months
|
Proportion of pregnant women enrolled in the study who undergo antenatal risk screening using the Antenatal Risk-Score Checklist
|
Up to 24 months
|
|
Referral Rate
Tidsramme: Up to 24 months
|
Percentage of pregnant women referred to higher levels of care based on risks identified through antenatal risk screening
|
Up to 24 months
|
|
Telehealth Consultation Utilization Rate
Tidsramme: 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
|
Up to 24 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptability of Intervention Measure (AIM) Score
Tidsramme: 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.
|
up to 24 months
|
|
Intervention Appropriateness Measure (IAM) Score
Tidsramme: 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.
|
Up to 24 months
|
|
Feasibility of Intervention Measure (FIM) Score
Tidsramme: 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.
|
Up to 24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Anju Ranjit, MD MPH, University of California, San Francisco
- Hovedetterforsker: Archana Shrestha, Kathmandu University School of Medicine/Dhulikhel Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
31. juli 2027
Studiet fullført (Antatt)
31. juli 2028
Datoer for studieregistrering
Først innsendt
25. juni 2026
Først innsendt som oppfylte QC-kriteriene
15. juli 2026
Først lagt ut (Faktiske)
21. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 26-46873
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data will be shared, including quantitative survey data on primary outcomes (maternal near-miss) and secondary outcomes (maternal mortality, composite neonatal outcomes, stillbirth rate, preterm delivery, implementation outcomes), socio-demographic and reproductive health data, and chronic health condition data.
Qualitative data (de-identified transcripts) from focus group discussions and in-depth interviews on implementation barriers and facilitators will also be shared.
Process tracking data (service utilization records, monthly reports) may be shared in aggregate form.
Personally identifiable information will be removed prior to sharing.
Data will be shared in standard formats (e.g., Stata) in accordance with ICPSR standards, accompanied by a codebook and questionnaire to support interpretation.
IPD-delingstidsramme
Individual participant data and supporting information will be available beginning at the time of publication of the associated study results.
Data will remain available indefinitely upon request following publication, with no specified end date.
Tilgangskriterier for IPD-deling
De-identified data will be accessible to qualified researchers and program implementers who submit a formal data request and agree to comply with applicable ethical guidelines and data use terms.
Requestors will have access to de-identified quantitative datasets, qualitative transcripts, and associated metadata (questionnaire, codebook).
Potentially identifying variables will be classified under restricted access and made available only through a secure virtual data enclave (e.g., DSDR/ICPSR) for approved researchers.
Data will be archived on a secure server at Dhulikhel Hospital-Kathmandu University Hospital, with a backup at UCSF.
Requests will be reviewed by the study's Principal Investigators or designated project coordinator.
A Certificate of Confidentiality will safeguard participant information throughout the access process.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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