Status:

UNKNOWN

Probiotics (Lactobacillus Rhamnosus) in Reducing Glucose Intolerance During and After Pregnancy

Lead Sponsor:

Aga Khan University

Conditions:

Glucose Intolerance

Pregnancy

Eligibility:

FEMALE

18-45 years

Phase:

PHASE3

Brief Summary

Introduction: The overall aim of the study is to assess the efficacy of Lactobacillus Rhamnosus in reducing glucose intolerance during and after pregnancy. A second objective of the study is to determ...

Eligibility Criteria

Inclusion

  • High risk pregnancy ( presence of more than or equal to 1 of the following)
  • Maternal age greater than or equal to 35
  • Family history of diabetes among 1st degree relative defined as parents, siblings and children
  • Overweight (BMI greater than 23) Women visiting the antenatal clinics during 12-14 weeks of gestation Women with Singleton pregnancy Women whose delivery is planned at the study hospital

Exclusion

  • History of GDM ( since in our setting the women are not usually screen for pre- gestational diabetes therefore it is difficult to differentiate between GDM and pre gestational diabetes)
  • Known Diabetes mellitus
  • Known chronic diseases ( hypothyroidism ,cardiac, renal, rheumatoid arthritis, carcinoma)
  • Women maintained on medications such as: corticosteroids, Azathioprin, antiepileptic epileptic drugs.
  • Known Poly Cystic Ovarian Syndrome
  • Non-residents of Karachi

Key Trial Info

Start Date :

October 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2013

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT01436448

Start Date

October 1 2011

End Date

May 1 2013

Last Update

September 20 2011

Active Locations (1)

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Aga Khan Hospital for Garden

Karachi, Sindh, Pakistan, 74800