Safety of Metformin in Pregnancy

NCT02793505 | Completed

• 1 other identifier: STIS-05
• Study Type: observational
• Target: 950
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy; Pregestational Diabetes; Polycystic Ovary Syndrom

Keywords

metformin; pregnancy outcomes; birth defects; spontaneous abortion; pharmacoepidemiology

Outcome Measures

Primary Outcomes (2)

• Major birth defects

  within two weeks after birth or at histopathological exam in case of late spontaneous abortion or stillbirth occuring in pregnancy

• Spontaneous abortion

  until 20 weeks of pregnancy

Secondary Outcomes (3)

• Minor birth defects

  within two weeks after birth

• Preterm birth

  after 24 weeks of pregnancy

• Pregnancy complications

  after 12 weeks of pregnancy until delivery

Study Arms (2)

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)).

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.

Drug: any drug not known as a major teratogen or major fetotoxicant

Interventions

metformin DRUG

This is not an intervention but an observed exposure.

Pregnant patient exposed to metformin

any drug not known as a major teratogen or major fetotoxicant DRUG

This is not an intervention but an observed exposure.

Reference group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

MeSH Terms

Conditions

Congenital Abnormalities; Abortion, Spontaneous

Interventions

Metformin

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior research associate

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 8, 2016
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Last Updated: June 8, 2016

Record last verified: 2016-06