An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry

Novo Nordisk A/S2,446 enrolled

Overview

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

Study Type

OBSERVATIONAL

Enrollment

2,446

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Patients will be treated according to routine clinical practice at the discretion of the treating physician

other injectable antidiabetic treatment regimensDRUG

Patients will be treated according to routine clinical practice at the discretion of the treating physician

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: - Informed consent obtained before any data collection - Woman with a positive pregnancy test - Diabetes mellitus type 1 or 2, diagnosed prior to conception - Currently treated with Levemir® or other injectable antidiabetic treatment(s) - Unchanged basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception Exclusion Criteria: - Women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study

Locations (93)

Outcomes

Primary Outcomes

Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death

Time frame: Assessed up to 4 weeks after delivery

Secondary Outcomes

Incidence of major hypoglycaemia

Time frame: During pregnancy

Proportion of pregnancies complicated by pre-eclampsia

Time frame: During pregnancy

Proportion of pregnancies resulting in perinatal death

Time frame: Assessed 1 week after delivery

Proportion of pregnancies resulting in neonatal death

Time frame: Assessed 4 weeks after delivery

Proportion of pregnancies resulting in spontaneous abortion

Time frame: Assessed at pregnancy termination

Proportion of pregnancies resulting in pre-term delivery

Time frame: Assessed at delivery

Height

Time frame: At the age of 1 year

Weight

Time frame: At the age of 1 year

Proportion with changes (progression/regression) of major congenital malformations

Time frame: At the age of 1 year

Data from ClinicalTrials.gov

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