Treatment of Impaired Glucose Tolerance in Pregnancy

Region Örebro County72 enrolled

Overview

The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g OGTT with a fasting P-gluc \<7.0 mmol/l and 2 h P-gluc \>10.0 and \<12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. There will be a focus on treatment according to specific goals and separate follow-up regimes for the children and women post partum.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Impaired Glucose Tolerance Fetal Macrosomia

Interventions

Insulin aspart and Insulin human (isophane)DRUG

Insulin treatment if fasting p-glucose \>5.0 mmol/l or post meal value \>6.5 mmol/l according to study protocol.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women with 75g OGTT result : fasting capillary plasma \<=7.0 mmol/l and/or 2 h value \>= 12.2 mmol/l Exclusion Criteria: * Multiple pregnancy * Pregestational Diabetes

Locations (1)

University Hospital Örebro

Örebro, Sweden

Outcomes

Primary Outcomes

Perinatal morbidity and intrauterine growth

Time frame: 1 year post partum

Secondary Outcomes

Children´s future health

Time frame: 5 years

Data from ClinicalTrials.gov

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