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

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ClinicalTrials.gov Identifier: NCT02802215
Recruitment Status : Unknown
Verified December 2015 by Ahmed Elsayed Hassan Elbohoty, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Elsayed Hassan Elbohoty, Ain Shams University

Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Diabetes, Gestational Drug: metformin Drug: placebo (folic acid ) Phase 2 Phase 3

Detailed Description:

The study will include a total of 80 pregnant women who fulfill the inclusion and exclusion criteria. Participants will be distributed into two groups :

Group A: Active one (40 women) will receive metformin in a dose of 1500mg per day (500mg every 8hrs in the middle of meal), starting from 12th week of gestation till delivery.

Group B: control group (40 women) will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet.

80 opaque envelope will be numbered serially from 1-80, in each envelope paper containing the group to which the participants will be allocated according to randomization table .The envelopes will be put in one box and when the first patient arrives the first envelope will be open and the patient will be allocated according to the paper inside.

Detection of glucose intolerance will be done using oral glucose tolerance test (OGTT), which based on 75 gm to exclude any case of pre-gestational DM. BMI and blood pressure will be also assessed for all cases at entry of the study.

Follow up of all cases in antenatal care clinic, with clinical assessment including weight gain, blood pressure, urine examination for proteinuria and fetal well being tests.

Detection of development of GDM or even glucose intolerance will be by using (OGTT), which based on 75 gm glucose between 24th-28th wk and also can be repeated between 32th- 34th wk of pregnancy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Metformin for Prevention of Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome: Randomized Controlled Trial (RCT )
Study Start Date : January 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016


Arm Intervention/treatment
Active Comparator: Metformin group
40 women will receive metformin in dose of 1500 mg per day orally (500 mg every 8 hrs in the middle of meal) starting from 12th week of gestation till delivery.
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.
Other Name: cidophage

Placebo Comparator: control group
40 women will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet.
Drug: placebo (folic acid )
500 micro gram of folic acid every 8 hrs
Other Name: folicap




Primary Outcome Measures :
  1. Number of participants with gestational diabetes by measuring plasma glucose levels ( mg / dl ). [ Time Frame: 24th -28th week gestation ]
    Diagnosis of GDM when these values are met or exceed fasting plasma glucose level (92 mg/dl).1hr level is (180 mg/dl) and 2hrs level is (153 mg/dl).


Secondary Outcome Measures :
  1. Fetal adverse effects [ Time Frame: from 12th week gestation till delivery ]
    Recorded in Case Record Form

  2. Maternal adverse effects [ Time Frame: from 12th week gestation till delivery ]
    Recorded in Case Record Form



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women had confirmed diagnosis of PCOS before pregnancy according to revised 2003 Rotterdam criteria.
  • Age more than 20 and more than 40 years.
  • BMI ranging from (25_35 )
  • Written and signed informed consent is given from the patient to participate in the study.

Exclusion Criteria:

  • Women with pre-gestational diabetes mellitus confirmed by 2hrs OGTT.
  • Patients who take metformin in the first 12 wk of pregnancy.
  • Patients who are unwilling to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802215


Contacts
Contact: Ahmed E elbohoty, MD elbohoty79@yahoo.com

Locations
Egypt
Ain Shams maternity hospital Recruiting
Cairo, Egypt
Principal Investigator: Ahmed E Elbohoty, Ph.D.         
Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: Ahmed E elbohoty, MD Ain Shams University
Principal Investigator: Reda k Mokhtar, MD Ain Shams University
Principal Investigator: mai R ibrahim, MBBCH Ain Shams University

Responsible Party: Ahmed Elsayed Hassan Elbohoty, Assistant professor of Obstetric and Gynecology Faculty of medicine Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT02802215     History of Changes
Other Study ID Numbers: MGDPCOS
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Ahmed Elsayed Hassan Elbohoty, Ain Shams University:
Diabetes Mellitus
Pregnancy

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Pregnancy Complications
Metformin
Folic Acid
Vitamin B Complex
Hypoglycemic Agents
Physiological Effects of Drugs
Hematinics
Vitamins
Micronutrients
Growth Substances