Azelia Brown, Mercer University College of Pharmacy
Gestational diabetes mellitus (GDM) is glucose intolerance beginning during pregnancy that is associated with an increased risk of complications including shoulder dystocia, fetal macrosomia, and morbidity.  Induction of labor in the 38th or 39th week has been associated with reduced risk of complications but an increased risk of cesarean section (C-section) in nulliparous women. It was expressed that the timing and mode of delivery that is best for this patient population is still unclear. Current guideline recommendations for GDM labor management have been based on low quality evidence and, reportedly, there is no consensus on the best clinical management for these patients. 
|Immediate delivery or expectant management in gestational diabetes at term: the GINEXMAL randomized controlled trial |
|Design||Randomized, controlled, open label, intention-to-treat; N= 425|
|Objective||To evaluate maternal and perinatal outcomes after induction of labor versus expectant management in pregnant women with gestational diabetes at term|
|Study Groups||Induction group (n= 214); expectant group (n= 211)|
|Methods||Participants with a diagnosis of GDM were enrolled in the study at 38 and 39 weeks of pregnancy and assigned to either the induction or expectant group. The International Association of Diabetes and Pregnancy Study Groups criteria (IADPSGC) and the Hyperglycemia and Adverse Pregnancy Outcomes study was used to diagnose gestational diabetes.
Participants in the induction group were admitted to the maternity unit and labor was induced. Participants in the expectant group were managed conservatively. Fetal heart rate and biophysical profile was monitored twice weekly until 41 weeks when induction was offered. Data from a patient questionnaire was collected. Well-controlled mean blood glucose was defined as 95 mg/dL or less.
|Primary Outcome Measure||Incidence of caesarean section|
|Secondary Outcome Measures||Maternal and neonatal outcomes|
|Adverse Events||Common Adverse Events: N/A|
|Serious Adverse Events: N/A|
|Percentage that Discontinued due to Adverse Events: N/A|
|Study Author Conclusions||In low-risk populations, there was no difference in the birth outcomes of patients with GDM.|
For many pregnant patients with GDM, inducing labor and reducing the risks to their fetus is ideal, but the associated risk of cesarean section is undesirable. If the risk of cesarean section is not increased with induced labor, expectant mothers can more comfortably make decisions sole on the benefit to their baby and not the added complications of an invasive cesarean section. However, these results may not be applicable to patients with pre-existing diabetes, obesity, or other comorbidities since the since the study population was low-risk and relatively healthy. The study was not adequately powered and the women in the induction group required more insulin and glyburide which may indicate a different severity of disease. These factors may affect the applicability of these results.
- Nesbitt TS, Gilber t WM, Herrchen B. Shoulder dystocia and associated risk factors with macrosomic infants born in California. Am J Obstet Gynecol 1998;179:476–80.
- Macer JA, Macer CL, Chan LS. Elective induction versus spontaneous labor: a retrospective study of complications and outcome. Am J Obstet Gynecol 1992;166:1690–7.
- Alberico S, Erenbourg A, Hod M, et al. Immediate delivery or expectant management in gestational diabetes at term: the GINEXMAL randomised controlled trial. BJOG. 2017;124(4):669-677.