A Randomized Controlled Trial Using Glycemic Plus Fetal Ultrasound Parameters Versus Glycemic Parameters to Determine Insulin Therapy in Gestational Diabetes With Fasting Hyperglycemia
- Siri L. Kjos, MD1,
- Ute Schaefer-Graf, MD12,
- Smeeta Sardesi, MD3,
- Ruth K. Peters, DSC4,
- Ann Buley, MS4,
- Anny H. Xiang, PHD4,
- James D. Bryne, MD15,
- Cher Sutherland, RN, CDE1,
- Martin N. Montoro, MD1 and
- Thomas A. Buchanan, MD16
- 1Department of Obstetrics and Gynecology, University of Southern California Keck School of Medicine, Los Angeles, California
- 2Department of Obstetrics, Charité, Virchow-Klinikum, Humboldt University, Berlin, Germany
- 3Department of Pediatrics, University of Southern California Keck School of Medicine, Los Angeles, California
- 4Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California
- 5Good Samaritan Hospital, San Jose, California
- 6Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California
Abstract
OBJECTIVE—To compare management based on maternal glycemic criteria with management based on relaxed glycemic criteria and fetal abdominal circumference (AC) measurements in order to select patients for insulin treatment of gestational diabetes mellitus (GDM) with fasting hyperglycemia.
RESEARCH DESIGN AND METHODS—In a pilot study, 98 women with fasting plasma glucose (FPG) concentrations of 105–120 mg/dl were randomized. The standard group received insulin treatment. The experimental group received insulin if the AC, measured monthly, was ≥70th percentile and/or if any venous FPG measurement was >120 mg/dl. Power was projected to detect a 250-g difference in birth weights.
RESULTS—Gestational ages, maternal glycemia, and AC percentiles were similar at randomization. After initiation of protocol, venous FPG (P = 0.003) and capillary blood glucose levels (P = 0.049) were significantly lower in the standard group. Birth weights (3,271 ± 458 vs. 3,369 ± 461 g), frequencies of birth weights >90th percentile (6.3 vs 8.3%), and neonatal morbidity (25 vs. 25%) did not differ significantly between the standard and experimental groups, respectively. The cesarean delivery rate was significantly lower (14.6 vs. 33.3%, P = 0.03) in the standard group; this difference was not explained by birth weights. In the experimental group, infants of women who did not receive insulin had lower birth weights than infants of mothers treated with insulin (3,180 ± 425 vs. 3,482 ± 451 g, P = 0.03).
CONCLUSIONS—In women with GDM and fasting hyperglycemia, glucose plus fetal AC measurements identified pregnancies at low risk for macrosomia and resulted in the avoidance of insulin therapy in 38% of patients without increasing rates of neonatal morbidity.
- AC, abdominal circumference
- FPG, fasting plasma glucose
- FSG, fasting serum glucose
- GDM, gestational diabetes mellitus
- LGA, large for gestational age
- SGA, small for gestational age
- VBAC, vaginal birth after cesarean
Footnotes
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Address correspondence and reprint requests to Siri L. Kjos, MD, 1240 North Mission Rd., Rm. L1017, Los Angeles, CA 90033. E-mail: skjos{at}hsc.usc.edu.
Received for publication 16 February 2001 and accepted in revised form 27 July 2001.
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