Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal

Keywords

• high risk pregnancy
• low and middle income countries
• teleheatlh
• pregnancy checklist

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Study arms

• No intervention
  Standard of Care

  Usual prenatal care, including on-site consultation and visits from health facility staff

• Active comparator
  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

  Other: High Risk Pregnancy Bundle

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

Primary outcomes

1. 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)

   Time frame: up to 60 days postpartum

Secondary outcomes

1. Neonatal death

   Number of neonatal deaths, defined as death of a liveborn infant within the first 28 days of life

   Time frame: Up to 28 days after birth

2. Low Apgar Score at 5 Minutes

   Number of infants with an Apgar score less than 7 at 5 minutes after birth

   Time frame: At 5 minutes after birth

3. Neonatal Intensive Care Unit Admission

   Number of infants admitted to a neonatal intensive care unit

   Time frame: Up to 30 days after birth

4. Need for Mechanical Ventilation

   Number of infants requiring mechanical ventilation

   Time frame: up to 30 days after birth

5. Neonatal Respiratory Distress Syndrome

   Number of infants diagnosed with respiratory distress syndrome

   Time frame: Up to 30 days after birth

6. Neonatal Hypoglycemia

   Number of infants with hypoglycemia, defined as less than 45 mg/dl

   Time frame: Up to 48 hours after birth

7. Low Birth Weight

   Number of infants with birth weight less than 2500 grams

   Time frame: At birth

8. 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

   Time frame: up to 30 days after birth

9. Antenatal Risk Screening Rate

   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

10. Referral Rate

    Percentage of pregnant women referred to higher levels of care based on risks identified through antenatal risk screening

    Time frame: Up to 24 months

11. 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

    Time frame: Up to 24 months

Other outcomes

1. Acceptability of Intervention Measure (AIM) Score

   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

2. Intervention Appropriateness Measure (IAM) Score

   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

3. Feasibility of Intervention Measure (FIM) Score

   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.

   Time frame: Up to 24 months

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: 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.

Access criteria: 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.