Polycystic Ovary SyndromePhase 2/3MGDPCOSNCT02802215
Metformin for Prevention Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome
A Phase 2/3 study testing metformin in people with Polycystic Ovary Syndrome and Diabetes, Gestational, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Diabetes, Gestational
- What is being tested?
- metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Sep 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ahmed E elbohoty, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams maternity hospital
Cairo
Ahmed E Elbohoty, Ph.D.
About this study
Official title: Metformin for Prevention of Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome: Randomized Controlled Trial (RCT )
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome, Diabetes, Gestational
- Being tested
- metformin, placebo (folic acid )
- Keywords
- Diabetes Mellitus, Pregnancy
- Medical subject headings
- Polycystic Ovary Syndrome, Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
Also called cidophage
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 )Drug
Also called folicap
500 micro gram of folic acid every 8 hrs
| Study group | Role | What they receive |
|---|---|---|
| Metformin group | Active comparator | 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. Receives: Drug: metformin |
| control group | Placebo comparator | 40 women will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet. Receives: Drug: placebo (folic acid ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24th -28th week gestation
Secondary outcomes (2)
Fetal adverse effects
Recorded in Case Record Form
Measured: from 12th week gestation till delivery
Maternal adverse effects
Recorded in Case Record Form
Measured: from 12th week gestation till delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Hassan Elbohoty, Ain Shams University
- Investigators
- Ahmed E elbohoty, MD, Principal investigator, Ain Shams UniversityReda k Mokhtar, MD, Principal investigator, Ain Shams Universitymai R ibrahim, MBBCH, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802215
- Sponsor's protocol ID
- MGDPCOS
- Acronym
- MGDPCOS
- Status last verified
- Dec 2015
- First submitted
- 7 May 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin for Prevention of Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome: Randomized Controlled Trial (RCT )
- ClinicalTrials.gov ID
- NCT02802215
- Acronym / sponsor ID
- MGDPCOS / MGDPCOS
- Conditions
- Polycystic Ovary Syndrome, Diabetes, Gestational
- Keywords
- Diabetes Mellitus, Pregnancy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin group | Active comparator | Drug: metformin40 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. |
| control group | Placebo comparator | Drug: placebo (folic acid )40 women will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metforminAlso: cidophageMetformin 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 | Metformin group |
| placebo (folic acid )Also: folicap500 micro gram of folic acid every 8 hrs | Drug | control group |
Primary outcome
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).
2 secondary outcomes
Fetal adverse effects
Time frame: from 12th week gestation till delivery
Maternal adverse effects
Time frame: from 12th week gestation till delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed E elbohoty, MD contact
Ahmed E elbohoty, MD principal investigator
Ain Shams University
Reda k Mokhtar, MD principal investigator
Ain Shams University
mai R ibrahim, MBBCH principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing metformin in people with Polycystic Ovary Syndrome and Diabetes, Gestational, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed E elbohoty, MD (elbohoty79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with gestational diabetes by measuring plasma glucose levels ( mg / dl ). (time frame: 24th -28th week gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.