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

• Sponsor: Ain Shams University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02802215
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 10

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2016
• Anticipated Study Completion Date: Sep 1, 2016

Arms and Interventions

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 Names: 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 Names: folicap

Outcome Measures

Primary Outcome Measures

1. Number of participants with gestational diabetes by measuring plasma glucose levels ( mg / dl ). [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 [from 12th week gestation till delivery]

   Recorded in Case Record Form

2. Maternal adverse effects [from 12th week gestation till delivery]

   Recorded in Case Record Form

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams maternity hospital	Cairo		Egypt

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: MGDPCOS
• First Posted: Jun 16, 2016
• Last Update Posted: Jun 16, 2016
• Last Verified: Dec 1, 2015

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Ahmed Elsayed Hassan Elbohoty, Assistant professor of Obstetric and Gynecology Faculty of medicine Ain Shams University, Ain Shams University: Diabetes Mellitus; Pregnancy
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Diabetes, Gestational; Diabetes Mellitus; Syndrome; Folic Acid; Metformin

Study Results

No Results Posted as of Jun 16, 2016