Metformin for Prevention Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome

NCT02802215 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-06-16

No results posted yet for this study

Summary

Randomized, placebo controlled clinical trial that evaluate the role of taking metformin therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the development of gestational diabetes(GDM) and improving pregnancy outcomes.

Conditions

  • Polycystic Ovary Syndrome
  • Diabetes, Gestational

Interventions

DRUG

metformin

Metformin group will receive 1500 mg of metformin per day orally ( 500 mg every 8hrs in the middle of meal) starting from 12th week of gestation till delivery.

DRUG

placebo (folic acid )

500 micro gram of folic acid every 8 hrs

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ahmed E elbohoty, MD · Ain Shams University

  • Reda k Mokhtar, MD · Ain Shams University

  • mai R ibrahim, MBBCH · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-08-31
Completion
2016-09-30

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02802215 on ClinicalTrials.gov