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OpenTrials
Completed

NCT Number: NCT00744965

Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.

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Key information

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information
  • An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl
  • Gestational age of less than or equal to 28 weeks and 0 days at the time of consent/randomization
  • Singleton gestation

Exclusion criteria

  • Established pregestational diabetes
  • Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation. Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still be considered for this study if they present again for glucose tolerance testing between 24 and 27 weeks.
  • Multiple gestations
  • Known major fetal anomaly or fetal demise
  • Any renal disease with serum creatinine of >1.0
  • Known liver disease such as hepatitis
  • Maternal or fetal conditions likely to require imminent or very preterm delivery such as preeclampsia, preterm premature rupture of the membranes, preterm labor, and intrauterine fetal growth restriction
  • Known hypersensitivity or allergic reaction to Glyburide

Treatment and study plan

Glyburide

Drug

Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.

Placebo

Drug

Sham dose adjustments of the placebo will be made.

Primary outcomes

  1. Mean Fetal Weight at Birth

    Time frame: Immediately after delivery of fetus

Secondary outcomes

  1. Number of Participants With Large for Gestational Age Infants

    Time frame: After delivery

    Birth weight exceeding the 90th percentile for the gestational age at delivery.

  2. Macrosomia

    Time frame: After delivery

    birth weight 4,000 g or greater

  3. Neonatal Intensive Care Unit Admissions

    Time frame: Until hospital discharge

  4. Rate of Cesarean Delivery

    Time frame: After delivery

  5. Diagnosis of Pregnancy-induced Hypertension

    Time frame: until hospital discharge

  6. Shoulder Dystocia

    Time frame: at delivery

  7. Need for Insulin Treatment

    Time frame: after delivery

  8. 3rd or 4th Degree Perineal Laceration

    Time frame: at delivery

  9. Chorioamnionitis

    Time frame: intrapartum

    Maternal fever >=38.0°C

  10. Need for Insulin Therapy

    Time frame: throughout pregnancy and delivery

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Important dates

Study start
2008
Primary completion
2013
Study completion
2016
First posted
Sep 1, 2008
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.