CTRI/2018/08/015432.

Study name	Effect of probiotic supplementation on blood glucose of gestational diabetic mellitus (GDM) mothers
Methods	Double‐blind randomised trial.
Participants	Pregnant women, primigravidae with a singleton pregnancy, with a normal fetal scan, at 12‐14 weeks' gestation, with an OGTT confirming GDM as per respective O&G consultants. Exclusion: pregnant GDM mothers with gestational age > 28 weeks, pre‐GDM, medications that influence insulin resistance (glucocorticoids, immunosuppressants), taking any form of probiotics < 1 month before recruitment.
Interventions	Receive 1 probiotic capsule a day that contains recommended strains of bacteria from the onset of GDM Routine care without probiotics receive counselling session on diet and physical activity interventions for pregnant women with GDM. Trained dietitians would give the counselling sessions on modified diet with portions and size; printed educational materials that included common diet guidelines and physical activity information on GDM. In the postnatal period, they will receive session on importance of compliance of lifestyle modifications such as diet and physical activity after delivery.
Outcomes	Primary outcomes: blood glucose levels (fasting and postprandial), urine analysis for pus cells. Secondary outcomes: maternal: mode of delivery, preterm delivery, perineal tear, pregnancy‐induced hypertension, hydramnios, vaginal infections. Neonatal/infant: birthweight, congenital malformations, birth injuries, shoulder dystocia, hypoglycaemia, NICU admissions.
Starting date
Contact information
Notes	Title: The effect of maternal probiotic supplementation on glycaemic control and pregnancy outcomes among GDM. Total sample size: 202. CTRI/2018/08/015432. Kavitha Ramanathan: Study not yet recruiting. Locality Chennai, India.