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Randomized Controlled Trial
. 2022 Dec;10(6):e002915.
doi: 10.1136/bmjdrc-2022-002915.

Flexible treatment of gestational diabetes mellitus adjusted according to intrauterine fetal growth versus treatment according to strict maternal glycemic parameters: a randomized clinical trial

Affiliations
Randomized Controlled Trial

Flexible treatment of gestational diabetes mellitus adjusted according to intrauterine fetal growth versus treatment according to strict maternal glycemic parameters: a randomized clinical trial

Manuela Fernández-López et al. BMJ Open Diabetes Res Care. 2022 Dec.

Abstract

Introduction: To compare the conventional treatment of gestational diabetes mellitus (GDM) with flexible treatment according to the measurement of fetal abdominal circumference (AC) in daily clinical practice.

Research design and methods: Two hundred and sixty pregnant women diagnosed with GDM before week 34 were randomly placed in two groups: a control group, treated according to maternal capillary glycemia, and an experimental group, treated according to ultrasound parameters of fetal growth. The glycemic targets in the control group were blood glucose levels when fasting and 1 hour postprandial (<95/140 mg/dL). In the experimental group, glycemic targets depended on the percentile (p) of fetal AC: if AC p <75th, then blood glucose targets when fasting and at 1 hour postprandial were <120/180 mg/dL; and if AC p ≥75th, then the glycemic targets were <80/120 mg/dL. The follow-up of both groups was scheduled according to the GDM protocol of our diabetes and gestation unit.

Results: The study was completed by 246 pregnant women, 125 in the control group and 121 in the experimental group. In the experimental group, insulin treatment and neonatal hypoglycemia were significantly lower (p=0.018 and p 0.035, respectively). No differences were observed in large and small infants according to gestational age. However, macrosomic infants were less frequent in the experimental group, although this difference did not reach statistical significance. In terms of gestation complications, the type of delivery and its complications and the rest of the neonatal complications analyzed, no significant differences were observed.

Conclusions: The treatment of flexible GDM according to the measurement of fetal AC is safe for the mother and the fetus and almost halves the number of pregnant women who require insulin treatment, without increasing the number of ultrasound checks or medical visits.

Keywords: Birth Weight; Gestational Diabetes Mellitus; Insulin; Ultrasonography.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Cross analysis. Group A: no insulin in both groups (AC p<75+fasting capillary glycemia/glycemia 1 hour postprandial <95/140 mg/dL and AC p≥75+fasting capillary glycemia/glycemia 1 hour postprandial <80/120 mg/dL). Group B: insulin only in MC group (AC p<75+fasting capillary glycemia/glycemia 1 hour postprandial ≥95/140 but<120/180 mg/dL). Group C: insulin only in FC group (AC p≥75+fasting capillary glycemia/glycemia 1 hour postprandial ≥80/120 but <95/140 mg/dL). Group D: insulin in both groups (AC p≥75+fasting capillary glycemia/glycemia 1 hour postprandial ≥95/140 mg/dL and AC p<75+fasting capillary glycemia/glycemia 1 hour postprandial ≥120/180 mg/dL). *P=0.025. FC, fetal criteria; LGA, MC, maternal criteria; SGA, small for gestational age.

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