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Treatment of Impaired Glucose Tolerance in Pregnancy

NCT00625781 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Impaired Glucose Tolerance
  • Fetal Macrosomia

Interventions

DRUG

Insulin aspart and Insulin human (isophane)

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

Sponsors & Collaborators

  • Uppsala-Örebro Regional Research Council

    collaborator OTHER

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Ulf Hanson, Consultant · Uppsala Academic Hospital , Sweden

  • Ingrid Östlund, MD · Region Örebro County

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-06-30
Completion
2013-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00625781 on ClinicalTrials.gov