PregnancyNCT02793505
Safety of Metformin in Pregnancy
An observational study of Pregnancy and Pregestational Diabetes, run by Centre Hospitalier Universitaire Vaudois.
Trial summary
This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Pregestational Diabetes, Polycystic Ovary Syndrom
- What is being tested?
- metformin and any drug not known as a major teratogen or major fetotoxicant
- How many people
- 950 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Nov 2015
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient from the European Network of Teratology Information Services (ENTIS) Cohort. This cohort is composed with patients, seeking counseling on the safety and risks regarding medication exposures in the reproductive age by themselves or through their healthcare provider. Each center gathers structured information on the exposure (medication, time of exposure, dose), maternal demographics, as well as medical and obstetric histories is collected prospectively. After the estimated date of birth, follow-up information on pregnancy outcome, gestational age at delivery, birth weight, congenital anomalies and neonatal complications is gathered through structured telephone interviews and/or mailed questionnaires sent to the mothers or their healthcare providers.
Who may be able to join
- Exposed group: exposed to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).
- Reference group: at no time during pregnancy were exposed to metformin, insulin or any other hypoglycaemic agent.
Who cannot join
- exposed to any of the following known major teratogen or major fetotoxicant: acitretin, isotretinoin, mycophenolate, thalidomide, valproic acid, angiotensin-II receptor blockers (only when used in 2nd or 3rd trimester), ACE inhibitors (only when used in 2nd or 3rd trimester), or (b) following treatment indications coded: malignancies (MedDRA code: malignant or unspecified tumors (SMQ 20000091), ICD-10: C00-D09)) or malignancy related conditions (MedDRA: SMQ 20000092), ICD-10: C00-D09).
- lost to follow-up
About this study
Official title: Pregnancy Outcome Following Maternal Exposure to Metformin: a Collaborative ENTIS Study
This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes.
- Conditions
- Pregnancy, Pregestational Diabetes, Polycystic Ovary Syndrom
- Being tested
- metformin, any drug not known as a major teratogen or major fetotoxicant
- Keywords
- metformin, pregnancy outcomes, birth defects, spontaneous abortion, pharmacoepidemiology
- Medical subject headings
- Congenital Abnormalities, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
This is not an intervention but an observed exposure.
any drug not known as a major teratogen or major fetotoxicantDrug
This is not an intervention but an observed exposure.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant patient exposed to metformin | Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)). Receives: Drug: metformin | |
| Reference group | Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to any drug not known as a major teratogen or fetotoxicant and different than metformin, insulin or any other hypoglycaemic agent. Receives: Drug: any drug not known as a major teratogen or major fetotoxicant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major birth defects
Measured: within two weeks after birth or at histopathological exam in case of late spontaneous abortion or stillbirth occuring in pregnancy
Spontaneous abortion
Measured: until 20 weeks of pregnancy
Secondary outcomes (3)
Minor birth defects
Measured: within two weeks after birth
Preterm birth
Measured: after 24 weeks of pregnancy
Pregnancy complications
Measured: after 12 weeks of pregnancy until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJan 2014
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Panchaud, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793505
- Sponsor's protocol ID
- STIS-05
- Status last verified
- Jun 2016
- First submitted
- 25 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcome Following Maternal Exposure to Metformin: a Collaborative ENTIS Study
- ClinicalTrials.gov ID
- NCT02793505
- Acronym / sponsor ID
- STIS-05
- Conditions
- Pregnancy, Pregestational Diabetes, Polycystic Ovary Syndrom
- Keywords
- metformin, pregnancy outcomes, birth defects, spontaneous abortion, pharmacoepidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- First posted
- 8 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.
This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant patient exposed to metformin | – | Drug: metforminPregnant women seeking counseling by themselves or through their healthcare provider for exposure to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)). |
| Reference group | – | Drug: any drug not known as a major teratogen or major fetotoxicantPregnant women seeking counseling by themselves or through their healthcare provider for exposure to any drug not known as a major teratogen or fetotoxicant and different than metformin, insulin or any other hypoglycaemic agent. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient from the European Network of Teratology Information Services (ENTIS) Cohort. This cohort is composed with patients, seeking counseling on the safety and risks regarding medication exposures in the reproductive age by themselves or through their healthcare provider. Each center gathers structured information on the exposure (medication, time of exposure, dose), maternal demographics, as well as medical and obstetric histories is collected prospectively. After the estimated date of birth, follow-up information on pregnancy outcome, gestational age at delivery, birth weight, congenital anomalies and neonatal complications is gathered through structured telephone interviews and/or mailed questionnaires sent to the mothers or their healthcare providers.
Key inclusion criteria (2 listed)
- Exposed group: exposed to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).
- Reference group: at no time during pregnancy were exposed to metformin, insulin or any other hypoglycaemic agent.
Key exclusion criteria (2 listed)
- exposed to any of the following known major teratogen or major fetotoxicant: acitretin, isotretinoin, mycophenolate, thalidomide, valproic acid, angiotensin-II receptor blockers (only when used in 2nd or 3rd trimester), ACE inhibitors (only when used in 2nd or 3rd trimester), or (b) following treatment indications coded: malignancies (MedDRA code: malignant or unspecified tumors (SMQ 20000091), ICD-10: C00-D09)) or malignancy related conditions (MedDRA: SMQ 20000092), ICD-10: C00-D09).
- lost to follow-up
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 |
|---|---|---|
| metforminThis is not an intervention but an observed exposure. | Drug | Pregnant patient exposed to metformin |
| any drug not known as a major teratogen or major fetotoxicantThis is not an intervention but an observed exposure. | Drug | Reference group |
Primary outcome
Major birth defects
Time frame: within two weeks after birth or at histopathological exam in case of late spontaneous abortion or stillbirth occuring in pregnancy
Spontaneous abortion
Time frame: until 20 weeks of pregnancy
3 secondary outcomes
Minor birth defects
Time frame: within two weeks after birth
Preterm birth
Time frame: after 24 weeks of pregnancy
Pregnancy complications
Time frame: after 12 weeks of pregnancy until delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Pregestational Diabetes, run by Centre Hospitalier Universitaire Vaudois.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major birth defects (time frame: within two weeks after birth or at histopathological exam in case of late spontaneous abortion or stillbirth occuring in pregnancy). The study lists 2 primary outcomes in all. 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 8 Jun 2016.