Tele-ANC for high-risk pregnancies versus standard clinic-based follow-up: A non-inferiority randomized trial

Abstract

Background: High-risk pregnancies need better antenatal care (ANC). Telemedicine-based ANC (Tele-ANC) has come up as a way to improve access and continuity of care. However, there is limited evidence comparing its effectiveness to standard clinic-based ANC in Indian high-risk populations. Objective: To see if Tele-ANC is not worse than standard clinic-based follow-up in maternal and perinatal outcomes among high-risk pregnant women. Methods: A one-year non-inferiority randomized controlled trial took place at Gouri Devi Institute of Medical Science, Durgapur. We randomized 200 high-risk pregnant women to Tele-ANC (n=100) or standard clinic-based ANC (n=100). Tele-ANC included scheduled video consultations, remote monitoring of blood pressure and fetal movements, and hotline support. The main outcome was a composite of adverse maternal outcomes (preeclampsia progression, ICU admission, uncontrolled hypertension, severe anemia). Secondary outcomes included perinatal outcomes, number of unscheduled visits, patient satisfaction, and compliance. We set a non-inferiority margin of 10%. Results: A composite adverse maternal outcome occurred in 14% of Tele-ANC participants compared to 16% in the standard ANC group (risk difference -2%, 95% CI -8.1 to +4.1), which met the non-inferiority criterion. Perinatal outcomes (preterm birth, NICU admission, birth weight) were similar. Tele-ANC significantly reduced total physical visits and increased patient satisfaction. Conclusion: Tele-ANC is not worse than standard clinic-based ANC for high-risk pregnancies. It also helps reduce clinic burden and improve patient satisfaction. We can safely add Telemedicine-supported ANC into high-risk pregnancy management protocols in resource-limited settings.