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Effect of probiotic supplementation on blood glucose of gestational diabetic mellitus (GDM) mothers

EFFECT OF MATERNAL PROBIOTIC- SUPPLEMENTATION ON GLYCAEMIC CONTROL AND PREGNANCY OUTCOMES AMONG GESTATIONAL DIABETES MELLITUS (GDM) - GDM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015432
Enrollment
202
Registered
2018-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O992- Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Group I - Probiotic Supplementation: receive routine care with probiotic supplementation. This group of mothers will receive one probiotic capsule a day that contains recommended strain

Sponsors

Sri Ramachandra University Founder Chancellor Shri NPVRamasamy Udayar Research Fellowship
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. To assess the effect of maternal-probiotic supplementation in glycaemic control among pregnant women with GDM by: i.Biochemical measures: Blood glucose levels(self-monitored by using Glucometer &Fasting blood glucose, post prandial blood glucose), andurine analysis for pus cells. Timepoint: 7months—

Secondary

MeasureTime frame
2. To assess the effect of maternal-probiotic supplementation on maternal and neonatal parameters: i. Clinical variables: a) Maternal: weight, mode of delivery, preterm delivery, perineal tear, and co-morbidities like PIH, hydramnios and vaginal infections. ii. Clinical variables: a) Neonatal: birth weight, congenital malformations, birth injuries, shoulder dystocia, hypoglycemia, admission to neonatal intensive care. Timepoint: 7 months—

Countries

India

Contacts

Public ContactKavitha Ramanathan

Sri Ramachandra Medical College and Research Institute

sjnalini@sriramachandra.edu.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026