A randomized controlled trial comparing two antenatal care regimes in the management of mild to moderate gestational diabetes in a low-middle income country

Abstract

ABSTRACT Context: The prevalence of gestational diabetes mellitus (GDM) in the Indian subcontinent has increased exponentially, especially after new diagnostic criteria. Identifying women who need close monitoring is a challenge. Ultrasound has been used to guide therapy but its use in the management of GDM has been used indiscriminately due to paucity of information. The use of ultrasound to guide the number of antenatal visits for adequate glycemic control has not been researched adequately. There is also a need to contrive antenatal care strategies that can obtain optimal neonatal outcomes without burdening the health system in low-middle income countries (LMIC). Aims: Our study was to compare pragmatic standard management of GDM with an ultrasound-guided regime (USGR) to prevent neonatal complications to ensure optimal care. Settings and Designs: A randomized controlled trial was done in a tertiary hospital between May 2019 and September 2021 in South India. Methods and Materials: Five hundred and eighty-eight women were randomized to a standard regime or USGR. Statistical Analysis: χ2 and t-test were used to compare outcomes. Results: Maternal and neonatal outcomes between standard and ultrasound USGR showed no significant difference in outcomes. Fetuses in USGR with AC ≥ 70th centile had macrosomia (3.59% vs 26.67%, P < 0.001), increased severity of diabetes (2.97% vs 16.67%, P < 0.001), 3rd- and 4th-degree perineal tear (2.95% vs 27.27%, P < 0.001). The increased number of visits did not decrease adverse outcomes. Conclusion: This small well-designed study did not show any advantage with USGR as compared to the pragmatic simple standard regime, in the treatment of women with GDM.