A Comparative Study of Maternal, Fetal and Neonatal Outcomes in Pregnancy with Diabetes Treated with Human Regular Insulin and Rapid Acting Insulin Analogs

Abstract

Introduction: Diabetes in pregnancy poses significant risks to both maternal and fetal health, necessitating careful management to optimize outcomes. Traditional management often involves the use of Human Regular Insulin (HRI), while Rapid-Acting Insulin Analogs (RAIA) have emerged as an alternative. This study aims to compare maternal, fetal, and neonatal outcomes in pregnancies managed with HRI versus RAIA.

Aims: The primary aim is to evaluate the efficacy and safety of HRI and RAIA in managing diabetes during pregnancy. Secondary aims include assessing the incidence of adverse maternal and neonatal outcomes, such as preterm birth, macrosomia, and neonatal hypoglycemia.

Materials and Methods: Our study was a single center randomized control trial conducted in the department of Obstetrics & Gynecology of Ramakrishna Mission Seva Pratishthan (RKMSP), Vivekananda Institute of Medical sciences (VIMS). After obtaining necessary approval from the ‘Institutional Ethical Committee’ and written informed consent from the participants.134 patients were included in this study

Results: We showed that During the 1st trimester, FBS values were 116.86 ± 9.81, 111.83 ± 5.95, and 122 ± 8.64 mg/dl in the I.Asp, I.Lisp and RHI group respectively ( p = 0.201, not significant). FBS during the 2nd trimester were 99.50 ± 4.28, 95.67 ± 1.51, and 102.20 ± 5.59 mg/dl in the I.Asp, I.Lisp, and RHI group respectively ( p = 0.050, not significant). 3rd trimester FBS values were 91.86 ± 4.41,89.67 ± 2.34 and 94.00 ± 2.83 mg/dl in the I.Asp, I.Lisp and RHI group respectively ( p = 0.185, not significant).

Conclusion: The findings suggest that RAIA may offer comparable, if not superior, control of maternal blood glucose with potentially fewer complications compared to HRI. However, further research, including randomized controlled trials, is necessary to confirm these findings and establish definitive clinical guidelines.