Helena E Fadl1, Susanne Gärdefors1, Ragnhild Hjertberg2, Eva Nord3, Bengt Persson4, Erik Schwarcz5, Jan Åman6, Ingrid K Östlund1, Ulf S B Hanson1,7. 1. Department of Obstetrics and Gynecology, School of Health and Medical Sciences, Örebro University, Örebro, Sweden. 2. UltraGyn Clinic, Stockholm, Sweden. 3. Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden. 4. Karolinska Institute, Stockholm, Sweden. 5. Department of Internal Medicine, School of Health and Medical Sciences, Örebro University, Örebro, Sweden. 6. Department of Pediatrics, School of Health and Medical Sciences, Örebro University, Örebro, Sweden. 7. Department of Children's and Women's Health, Uppsala University, Uppsala, Sweden.
Abstract
INTRODUCTION: A randomized multicenter study was conducted in the Stockholm-Örebro areas in Sweden to evaluate how treatment aiming at normoglycemia affects fetal growth, pregnancy and neonatal outcome in pregnant women with severe hyperglycemia. MATERIAL AND METHODS:Pregnant women with hyperglycemia defined as fasting capillary plasma glucose <7.0 mmol/L and a two-hour plasma glucose value ≥10.0 and <12.2 mmol/L following a 75-g oral glucose tolerance test (OGTT) diagnosed before 34 weeks of gestation were randomized to treatment (n = 33) or controls (n = 36). Women assigned to the control group were blinded for the OGTT results and received routine care. The therapeutic goal was fasting plasma glucose 4-5 mmol/L, and <6.5 mmol/L after a meal. Primary outcomes were size at birth and number of large-for-gestational age (>90th percentile) neonates. Secondary outcomes were pregnancy complications, neonatal morbidity and glycemic control. RESULTS: The planned number of participating women was not reached. There was a significantly reduced rate of large-for-gestational age neonates, 21 vs. 47%, P < 0.05. Group differences in pregnancy complications and neonatal morbidity were not detected because of limited statistical power. In total, 66.7% of the women in the intervention group received insulin. Of all measured plasma glucose values, 64.1% were in the target range, 7.2% in the hypoglycemic range and 28.7% above target values. There were no cases of severe hypoglycemia. CONCLUSIONS: Aiming for normalized glycemia in a pregnancy complicated by severe hyperglycemia reduces fetal growth but is associated with an increased rate of mild hypoglycemia.
RCT Entities:
INTRODUCTION: A randomized multicenter study was conducted in the Stockholm-Örebro areas in Sweden to evaluate how treatment aiming at normoglycemia affects fetal growth, pregnancy and neonatal outcome in pregnant women with severe hyperglycemia. MATERIAL AND METHODS: Pregnant women with hyperglycemia defined as fasting capillary plasma glucose <7.0 mmol/L and a two-hour plasma glucose value ≥10.0 and <12.2 mmol/L following a 75-g oral glucose tolerance test (OGTT) diagnosed before 34 weeks of gestation were randomized to treatment (n = 33) or controls (n = 36). Women assigned to the control group were blinded for the OGTT results and received routine care. The therapeutic goal was fasting plasma glucose 4-5 mmol/L, and <6.5 mmol/L after a meal. Primary outcomes were size at birth and number of large-for-gestational age (>90th percentile) neonates. Secondary outcomes were pregnancy complications, neonatal morbidity and glycemic control. RESULTS: The planned number of participating women was not reached. There was a significantly reduced rate of large-for-gestational age neonates, 21 vs. 47%, P < 0.05. Group differences in pregnancy complications and neonatal morbidity were not detected because of limited statistical power. In total, 66.7% of the women in the intervention group received insulin. Of all measured plasma glucose values, 64.1% were in the target range, 7.2% in the hypoglycemic range and 28.7% above target values. There were no cases of severe hypoglycemia. CONCLUSIONS: Aiming for normalized glycemia in a pregnancy complicated by severe hyperglycemia reduces fetal growth but is associated with an increased rate of mild hypoglycemia.
Authors: Julie Brown; Nisreen A Alwan; Jane West; Stephen Brown; Christopher Jd McKinlay; Diane Farrar; Caroline A Crowther Journal: Cochrane Database Syst Rev Date: 2017-05-04
Authors: L Guillemette; A Durksen; R Rabbani; R Zarychanski; A M Abou-Setta; T A Duhamel; J M McGavock; B Wicklow Journal: Int J Obes (Lond) Date: 2017-03-13 Impact factor: 5.095
Authors: Diane Farrar; Mark Simmonds; Maria Bryant; Trevor A Sheldon; Derek Tuffnell; Su Golder; Debbie A Lawlor Journal: BMJ Open Date: 2017-06-24 Impact factor: 2.692
Authors: Helena Fadl; Maryam Saeedi; Scott Montgomery; Anders Magnuson; Erik Schwarcz; Kerstin Berntorp; Verena Sengpiel; Elisabeth Storck-Lindholm; Helena Strevens; Anna-Karin Wikström; Sophia Brismar-Wendel; Martina Persson; Stefan Jansson; Fredrik Ahlsson; Carina Ursing; Linda Ryen; Kerstin Petersson; Ulla-Britt Wennerholm; Karin Hildén; David Simmons Journal: BMC Pregnancy Childbirth Date: 2019-11-01 Impact factor: 3.007