Abstract
Author(s): Dina Omar Alsunaidi*, Ashraf Sobhi Khalil Abolouz, Mohamed Shabaan Mahmoud, Ahmed Hussein Mohamed Abdel Aal
Background/Aim: Gestational Diabetes Mellitus (GDM) is a common pregnancy complication associated with significant adverse maternal and neonatal outcomes. Probiotic supplementation has emerged as a potential preventive strategy through modulation of gut microbiota and improvement of metabolic parameters. Objective: To evaluate the role of daily probiotic supplementation with Lactobacillus acidophilus and Bifidobacterium animalis subsp. lactis in preventing GDM among high-risk pregnant women. Methods: This single-arm interventional study enrolled 60 high-risk pregnant women (14-16 weeks? gestation) attending October 6th University Hospital, Egypt. Inclusion criteria included at least one GDM risk factor: previous GDM, previous macrosomia (birth weight ?4000g), pre-pregnancy BMI ?30 kg/m, PCOS, or first-degree family history of diabetes. Participants received daily probiotics (Linex Adult Probio-tec AB Blend 64, minimum 110? CFU) from 14-16 weeks until the 24-28-week Oral Glucose Tolerance Test (OGTT). The primary outcome was GDM incidence by IADPSG criteria (fasting ?92 mg/dL, 1-hour ?180 mg/dL, or 2-hour ?153 mg/dL). Secondary outcomes included OGTT values, change in fasting glucose from baseline, maternal weight gain, adherence, and maternal-neonatal outcomes. Statistical analysis was performed using IBM SPSS version 28. Results: Mean age was 28.7 years, mean BMI 30.0 kg/m (55% obese). Mean baseline fasting glucose was 97.1 mg/dL. GDM incidence was 65.0% (39/60). Among GDM cases, 30.8% had isolated 1-hour hyperglycemia, 20.5% isolated fasting hyperglycemia, and 35.9% met multiple criteria. Adherence was excellent (84.8%), with no participant below 70%. Fasting glucose remained stable (baseline 97.1 vs. OGTT 98.2 mg/dL, p=0.498). Women with GDM had significantly higher OGTT values at all-time points (p<0.001). Mean weight gain was 11.7 kg over 10-14 weeks, exceeding IOM recommendations. Mean gestational age at delivery was 38.4 weeks, with preterm birth rate 5.0% and post term birth rate 13.3%. Cesarean section rate was 81.6% (33.3% elective, 48.3% emergency). Neonatal outcomes showed mean birth weight 3483g, macrosomia 16.7%, neonatal hypoglycemia 50.0%, and NICU admission 23.3%. Apgar scores were favorable (7.4 at 1-min, 9.0 at 5-min). Maternal complications included hypertensive disorders (38.3%) and postpartum hemorrhage (11.3%). Subgroup analysis showed highest GDM risk in obese women (72.7%) and those with multiple risk factors. Women with excellent adherence (?90%) had lower GDM incidence (59.1%) than those with moderate adherence (73.7%). Weak non-significant negative correlations were found between adherence and OGTT values (r = -0.15 to -0.22). Conclusion: GDM incidence in this high-risk cohort receiving probiotics was 65%. Excellent adherence confirms intervention feasibility. Suggests a possible trend, although no statistically significant association was observed. High rates of adverse outcomes underscore the urgent need for effective preventive strategies in this vulnerable population.