Effect of probiotic supplementation on blood glucose of gestational diabetic mellitus (GDM) mothers
Not Applicable
- Conditions
- Health Condition 1: O992- Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2018/08/015432
- Lead Sponsor
- Sri Ramachandra University Founder Chancellor Shri NPVRamasamy Udayar Research Fellowship
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Pregnant GDM mothers with/who:
1. singleton pregnancy.
2. primi and multi gravidae.
3. normal ultrasound scan of the fetus at gestational age 12-14 weeks.
4. oral glucose tolerance test confirming the diagnosis of GDM as per the respective OG consultants.
Exclusion Criteria
Pregnant GDM mothers with/who:
•gestational age > 28 weeks gestation at the time of recruitment for the study
•pre-gestational diabetes
•consumemedications influencing insulin resistance (glucocorticoids and immunosuppressants)
•had taken any form of probiotic supplemented foods or medications < 1 month before the inclusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the effect of maternal-probiotic supplementation in glycaemic control among pregnant women with GDM by: <br/ ><br>i.Biochemical measures: Blood glucose levels(self-monitored by using Glucometer &Fasting blood glucose, post prandial blood glucose), andurine analysis for pus cells. <br/ ><br>Timepoint: 7months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 2.To assess the effect of maternal-probiotic supplementation on maternal and neonatal parameters: <br/ ><br>i.Clinical variables: <br/ ><br>a)Maternal: weight, mode of delivery, preterm delivery, perineal tear, and co-morbidities like PIH, hydramnios and vaginal infections. <br/ ><br> <br/ ><br>ii.Clinical variables: <br/ ><br>a)Neonatal: birth weight, congenital malformations, birth injuries, shoulder dystocia, hypoglycemia, admission to neonatal intensive care. <br/ ><br>Timepoint: 7 months