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

Polycystic Ovary Syndrome Clinical Trial

— MGDPCOS  

Official title:

Metformin for Prevention of Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome: Randomized Controlled Trial (RCT )

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02802215
• Other study ID #: MGDPCOS
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 7, 2016
• Last updated: June 15, 2016
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: December 2015
• Source: Ain Shams University
• Contact: Ahmed E elbohoty, MD
• Email: elbohoty79[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• placebo (folic acid )
500 micro gram of folic acid every 8 hrs

Locations

Country	Name	City	State
Egypt	Ain Shams maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with gestational diabetes by measuring plasma glucose levels ( mg / dl ).	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).	24th -28th week gestation	Yes
Secondary	Fetal adverse effects	Recorded in Case Record Form	from 12th week gestation till delivery	Yes
Secondary	Maternal adverse effects	Recorded in Case Record Form	from 12th week gestation till delivery	Yes