Volume 10, Issue 3 (2025)
SJMR 2025, 10(3): 113-123 |
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Saremi A, Nateghi M R, Sanaye Naderi M, Mohammadian H, Karamnia Far M, Giti S. The Evaluation of Effectiveness of the Sarem Protocol Compared to the National Standard in the Management of Gestational Diabetes and Maternal–Neonatal Outcomes: A Single-Blind Clinical Trial. SJMR 2025; 10 (3) : 2
URL: http://saremjrm.com/article-1-373-en.html
URL: http://saremjrm.com/article-1-373-en.html
AboTaleb Saremi *1 
, Mohammad Reza Nateghi2 , Maryam Sanaye Naderi2 , Hadis Mohammadian2 , Mojhgan Karamnia Far3 , Sima Giti3
, Mohammad Reza Nateghi2 , Maryam Sanaye Naderi2 , Hadis Mohammadian2 , Mojhgan Karamnia Far3 , Sima Giti3
1- - Sarem Gynecology, Obstetrics and Infertility Research Center, Sarem Women’s Hospital, Iran University of Medical Sciences, Tehran, Iran. & Sarem Cell Research Center (SCRC), Sarem Women’s Hospital, Tehran, Iran.
2- Sarem Gynecology, Obstetrics and Infertility Research Center, Sarem Women’s Hospital, Iran University of Medical Sciences, Tehran, Iran. & Sarem Cell Research Center (SCRC), Sarem Women’s Hospital, Tehran, Iran.
3- Sarem Gynecology, Obstetrics and Infertility Research Center, Sarem Women’s Hospital, Iran University of Medical Sciences, Tehran, Iran.
2- Sarem Gynecology, Obstetrics and Infertility Research Center, Sarem Women’s Hospital, Iran University of Medical Sciences, Tehran, Iran. & Sarem Cell Research Center (SCRC), Sarem Women’s Hospital, Tehran, Iran.
3- Sarem Gynecology, Obstetrics and Infertility Research Center, Sarem Women’s Hospital, Iran University of Medical Sciences, Tehran, Iran.
Abstract: (15 Views)
Background: Gestational diabetes mellitus (GDM) is one of the most common metabolic disorders during pregnancy and is associated with adverse maternal and neonatal outcomes. The selection of an appropriate protocol for blood glucose monitoring and control plays a key role in minimizing these complications. The present study aimed to compare the effectiveness of the Sarem protocol with the national standard protocol in the management of GDM.
Methods: This single-blind clinical trial was conducted on 52 pregnant women diagnosed with GDM during the second or third trimester. Participants were randomly assigned into two equal groups: 26 managed by the Sarem protocol and 26 by the national standard protocol. In the standard protocol, glucose monitoring was performed at fasting and two hours after each main meal, while in the Sarem protocol, glucose levels were measured at fasting, two hours before breakfast, two hours before lunch, and at 10 p.m. The primary outcomes included insulin requirements, glycemic control, and maternal and neonatal outcomes. Data were analyzed using independent t-test and chi-square test, with a significance level of P<0.05.
Results: There were no significant differences in baseline characteristics, including maternal age, BMI, and HbA1C, confirming group homogeneity. Insulin consumption was significantly lower in the Sarem group compared to the standard group (regular insulin: 1.81 ± 2.29 vs. 7.77 ± 4.36 IU; NPH: 0.50 ± 1.24 vs. 11.81 ± 7.84 IU; P=0.001). Fasting and daily blood glucose levels were significantly lower in the Sarem group (P=0.045 to P=0.001). Neonatal birth weight was higher in the standard group (3516.15 ± 469.79 g vs. 3137.50 ± 435.92 g; P=0.004), but macrosomia occurred only in the standard group (23.1% vs. 0%; P=0.009). Preterm delivery was observed only in the standard group (19.2% vs. 0%; P=0.019). Apgar scores at 1 and 5 minutes were significantly higher in the Sarem group (P=0.011 and P=0.022, respectively). Moreover, no cases of LGA were reported in the Sarem group compared with 26.9% in the standard group (P=0.008).
Conclusion: The Sarem protocol demonstrated superiority over the national standard by significantly reducing insulin requirements, improving glycemic control, and yielding more favorable neonatal outcomes, including reduced preterm birth, higher Apgar scores, and elimination of macrosomia and LGA. These findings suggest that revising glucose monitoring schedules in accordance with pregnancy physiology may provide a more effective strategy for managing GDM. Nevertheless, the occurrence of a few SGA cases in the Sarem group indicates the need for balanced and individualized glycemic targets. Larger, multicenter randomized trials are required to confirm these results.
Methods: This single-blind clinical trial was conducted on 52 pregnant women diagnosed with GDM during the second or third trimester. Participants were randomly assigned into two equal groups: 26 managed by the Sarem protocol and 26 by the national standard protocol. In the standard protocol, glucose monitoring was performed at fasting and two hours after each main meal, while in the Sarem protocol, glucose levels were measured at fasting, two hours before breakfast, two hours before lunch, and at 10 p.m. The primary outcomes included insulin requirements, glycemic control, and maternal and neonatal outcomes. Data were analyzed using independent t-test and chi-square test, with a significance level of P<0.05.
Results: There were no significant differences in baseline characteristics, including maternal age, BMI, and HbA1C, confirming group homogeneity. Insulin consumption was significantly lower in the Sarem group compared to the standard group (regular insulin: 1.81 ± 2.29 vs. 7.77 ± 4.36 IU; NPH: 0.50 ± 1.24 vs. 11.81 ± 7.84 IU; P=0.001). Fasting and daily blood glucose levels were significantly lower in the Sarem group (P=0.045 to P=0.001). Neonatal birth weight was higher in the standard group (3516.15 ± 469.79 g vs. 3137.50 ± 435.92 g; P=0.004), but macrosomia occurred only in the standard group (23.1% vs. 0%; P=0.009). Preterm delivery was observed only in the standard group (19.2% vs. 0%; P=0.019). Apgar scores at 1 and 5 minutes were significantly higher in the Sarem group (P=0.011 and P=0.022, respectively). Moreover, no cases of LGA were reported in the Sarem group compared with 26.9% in the standard group (P=0.008).
Conclusion: The Sarem protocol demonstrated superiority over the national standard by significantly reducing insulin requirements, improving glycemic control, and yielding more favorable neonatal outcomes, including reduced preterm birth, higher Apgar scores, and elimination of macrosomia and LGA. These findings suggest that revising glucose monitoring schedules in accordance with pregnancy physiology may provide a more effective strategy for managing GDM. Nevertheless, the occurrence of a few SGA cases in the Sarem group indicates the need for balanced and individualized glycemic targets. Larger, multicenter randomized trials are required to confirm these results.
Article number: 2
Article Type: Original Research |
Subject:
Pregnancy Care
Received: 2025/09/16 | Accepted: 2025/09/22 | Published: 2025/09/25
Received: 2025/09/16 | Accepted: 2025/09/22 | Published: 2025/09/25
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