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Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal

15. juli 2026 opdateret af: 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:

  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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Nepal
    • Bagmati
      • Melamchi, Bagmati, Nepal
        • Melamchi Primary Health Care Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Efterforskere

  • Ledende efterforsker: Anju Ranjit, MD MPH, University of California, San Francisco
  • Ledende efterforsker: Archana Shrestha, Kathmandu University School of Medicine/Dhulikhel Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

31. juli 2027

Studieafslutning (Anslået)

31. juli 2028

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 26-46873

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Høj risiko graviditet

Kliniske forsøg med High Risk Pregnancy Bundle

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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