Clinical trial NCT02793505: Safety of Metformin in Pregnancy
Official title: Pregnancy Outcome Following Maternal Exposure to Metformin: a Collaborative ENTIS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Pregestational Diabetes
Polycystic Ovary Syndrom
Keywords: metformin
pregnancy outcomes
birth defects
spontaneous abortion
pharmacoepidemiology
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 950
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Major birth defects
timeFrame: within two weeks after birth or at histopathological exam in case of late spontaneous abortion or stillbirth occuring in pregnancy
measure: Spontaneous abortion
timeFrame: until 20 weeks of pregnancy
Secondary outcomes:
measure: Minor birth defects
timeFrame: within two weeks after birth
measure: Preterm birth
timeFrame: after 24 weeks of pregnancy
measure: Pregnancy complications
timeFrame: after 12 weeks of pregnancy until delivery
Other outcomes:
Locations:
Study officials:
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