Metformin for Prevention Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome (MGDPCOS)
|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
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Diabetes, Gestational||Drug: metformin Drug: placebo (folic acid )||Phase 2 Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|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|
U.S. FDA Resources
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.
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
- 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).
- Fetal adverse effects [ Time Frame: from 12th week gestation till delivery ]Recorded in Case Record Form
- Maternal adverse effects [ Time Frame: from 12th week gestation till delivery ]Recorded in Case Record Form
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802215
|Contact: Ahmed E elbohoty, MDfirstname.lastname@example.org|
|Ain Shams maternity hospital||Recruiting|
|Principal Investigator: Ahmed E Elbohoty, Ph.D.|
|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|