Safety of Metformin in Pregnancy

Pregnancy Clinical Trial

Official title:

Pregnancy Outcome Following Maternal Exposure to Metformin: a Collaborative ENTIS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793505
• Other study ID #: STIS-05
• Status: Completed
• Phase: N/A
• First received: May 25, 2016
• Last updated: June 2, 2016
• Start date: January 2014

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 950
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Polycystic Ovary Syndrom
• Polycystic Ovary Syndrome
• Pregestational Diabetes
• Pregnancy

Intervention

Drug:
• metformin
This is not an intervention but an observed exposure.
• any drug not known as a major teratogen or major fetotoxicant
This is not an intervention but an observed exposure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major birth defects		within two weeks after birth or at histopathological exam in case of late spontaneous abortion or stillbirth occuring in pregnancy	Yes
Primary	Spontaneous abortion		until 20 weeks of pregnancy	Yes
Secondary	Minor birth defects		within two weeks after birth	Yes
Secondary	Preterm birth		after 24 weeks of pregnancy	Yes
Secondary	Pregnancy complications		after 12 weeks of pregnancy until delivery	Yes