High Risk PregnancyNCT07717619
Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal
A study testing High Risk Pregnancy Bundle in people with High Risk Pregnancy, run by University of California, San Francisco at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk Pregnancy
- What is being tested?
- High Risk Pregnancy Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNepal
- Study dates
- 1 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all pregnant women above who are receiving antenatal care at Melamchi Primary Health Care Center
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal1 site
Melamchi Primary Health Care Center
Melamchi, Bagmati
Umang Raut (Medical Superintendent), +977 9860923221, melamchiphc@gmail.com
About this study
Official title: 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
- Conditions
- High Risk Pregnancy
- Being tested
- High Risk Pregnancy Bundle
- Keywords
- high risk pregnancy, low and middle income countries, teleheatlh, pregnancy checklist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Risk Pregnancy BundleOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Usual prenatal care, including on-site consultation and visits from health facility staff |
| High Risk Pregnancy (HRP) Bundle Intervention Arm | Active comparator | 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 Receives: Other: High Risk Pregnancy Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 60 days postpartum
Secondary outcomes (11)
Neonatal death
Number of neonatal deaths, defined as death of a liveborn infant within the first 28 days of life
Measured: 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
Measured: At 5 minutes after birth
Neonatal Intensive Care Unit Admission
Number of infants admitted to a neonatal intensive care unit
Measured: Up to 30 days after birth
Need for Mechanical Ventilation
Number of infants requiring mechanical ventilation
Measured: up to 30 days after birth
Neonatal Respiratory Distress Syndrome
Number of infants diagnosed with respiratory distress syndrome
Measured: Up to 30 days after birth
Neonatal Hypoglycemia
Number of infants with hypoglycemia, defined as less than 45 mg/dl
Measured: Up to 48 hours after birth
Low Birth Weight
Number of infants with birth weight less than 2500 grams
Measured: At birth
Composite Adverse Neonatal Outcome
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
Measured: up to 30 days after birth
Antenatal Risk Screening Rate
Proportion of pregnant women enrolled in the study who undergo antenatal risk screening using the Antenatal Risk-Score Checklist
Measured: Up to 24 months
Referral Rate
Percentage of pregnant women referred to higher levels of care based on risks identified through antenatal risk screening
Measured: Up to 24 months
Telehealth Consultation Utilization Rate
Proportion of pregnant women in the High Risk Pregnancy Bundle Intervention Arm who utilize at least 80% of their recommended telehealth consultations
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anju Ranjit, MD MPH, Principal investigator, University of California, San FranciscoArchana Shrestha, Principal investigator, Kathmandu University School of Medicine/Dhulikhel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717619
- Sponsor's protocol ID
- 26-46873
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating an Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal
- ClinicalTrials.gov ID
- NCT07717619
- Acronym / sponsor ID
- 26-46873
- Conditions
- High Risk Pregnancy
- Keywords
- high risk pregnancy, low and middle income countries, teleheatlh, pregnancy checklist
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Usual prenatal care, including on-site consultation and visits from health facility staff |
| High Risk Pregnancy (HRP) Bundle Intervention Arm | Active comparator | Other: High Risk Pregnancy BundleThe 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 |
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all pregnant women above who are receiving antenatal care at Melamchi Primary Health Care Center
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Risk Pregnancy BundleThe 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 | Other | High Risk Pregnancy (HRP) Bundle Intervention Arm |
Primary outcome
Maternal Near Miss
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)
11 secondary outcomes
Neonatal death
Time frame: Up to 28 days after birth
Low Apgar Score at 5 Minutes
Time frame: At 5 minutes after birth
Neonatal Intensive Care Unit Admission
Time frame: Up to 30 days after birth
Need for Mechanical Ventilation
Time frame: up to 30 days after birth
Neonatal Respiratory Distress Syndrome
Time frame: Up to 30 days after birth
Neonatal Hypoglycemia
Time frame: Up to 48 hours after birth
Low Birth Weight
Time frame: At birth
Composite Adverse Neonatal Outcome
Time frame: up to 30 days after birth
Antenatal Risk Screening Rate
Time frame: Up to 24 months
Referral Rate
Time frame: Up to 24 months
Telehealth Consultation Utilization Rate
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anju Ranjit, MD MPH principal investigator
University of California, San Francisco
Archana Shrestha principal investigator
Kathmandu University School of Medicine/Dhulikhel Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Risk Pregnancy Bundle in people with High Risk Pregnancy, run by University of California, San Francisco at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anju Ranjit, MD MPH (4153533400, anju.ranjit@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Near Miss (time frame: up to 60 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.