Trial · NCT00744965
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
NCT00744965, Phase 4, Completed, University of Texas Southwestern Medical Center; results first posted 2020-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo. Trials, record NCT00744965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00744965
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
- NCT number
- NCT00744965
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 395 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Mild Gestational Diabetes
- Interventions
- Glyburide, Placebo
- First posted
- 2008-09-01
- Last updated
- 2020-03-12
- Results first posted
- 2020-03-12
- Limitations and caveats
- Sample size of 395 limits our ability to analyze the effect of Glyburide on uncommon pregnancy outcomes. The study was underpowered for outcomes other than birth weight difference.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Fetal Weight at Birth | Immediately after delivery of fetus | |
| Secondary | Number of Participants With Large for Gestational Age Infants | After delivery | Birth weight exceeding the 90th percentile for the gestational age at delivery. |
| Secondary | Macrosomia | After delivery | birth weight 4,000 g or greater |
| Secondary | Neonatal Intensive Care Unit Admissions | Until hospital discharge | |
| Secondary | Rate of Cesarean Delivery | After delivery | |
| Secondary | Diagnosis of Pregnancy-induced Hypertension | until hospital discharge | |
| Secondary | Shoulder Dystocia | at delivery | |
| Secondary | Need for Insulin Treatment | after delivery | |
| Secondary | 3rd or 4th Degree Perineal Laceration | at delivery | |
| Secondary | Chorioamnionitis | intrapartum | Maternal fever \>=38.0°C |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Fetal Weight at Birth | Immediately after delivery of fetus | grams | MEAN | |
| SECONDARY | Number of Participants With Large for Gestational Age Infants | After delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Macrosomia | After delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Neonatal Intensive Care Unit Admissions | Until hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Cesarean Delivery | After delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Diagnosis of Pregnancy-induced Hypertension | until hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Shoulder Dystocia | at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Need for Insulin Treatment | after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 3rd or 4th Degree Perineal Laceration | at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Chorioamnionitis | intrapartum | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Fetal Weight at Birth | Placebo | 3355 | Standard Deviation 521 | grams | |
| Mean Fetal Weight at Birth | Glyburide | 3322 | Standard Deviation 481 | grams | |
| Number of Participants With Large for Gestational Age Infants | Placebo | 22 | Participants | ||
| Number of Participants With Large for Gestational Age Infants | Glyburide | 20 | Participants | ||
| Macrosomia | Placebo | 18 | Participants | ||
| Macrosomia | Glyburide | 13 | Participants | ||
| Neonatal Intensive Care Unit Admissions | Placebo | 11 | Participants | ||
| Neonatal Intensive Care Unit Admissions | Glyburide | 13 | Participants | ||
| Rate of Cesarean Delivery | Placebo | 67 | Participants | ||
| Rate of Cesarean Delivery | Glyburide | 70 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 197 | |
| Overall Study | STARTED | Glyburide | 198 | |
| Overall Study | COMPLETED | Placebo | 186 | |
| Overall Study | COMPLETED | Glyburide | 189 | |
| Overall Study | NOT COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Glyburide | 9 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | facial swelling | Endocrine disorders | Placebo | 0 | 186 | 0 |
| serious | facial swelling | Endocrine disorders | Glyburide | 1 | 189 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 186 |
| Total, all-cause mortality | Glyburide | 0 | 189 |
| Total, other adverse events | Placebo | 0 | 186 |
| Total, other adverse events | Glyburide | 0 | 189 |
| Total, serious adverse events | Placebo | 0 | 186 |
| Total, serious adverse events | Glyburide | 1 | 189 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26241419 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Glyburide vs Placebo: Diagnosis of Pregnancy-induced Hypertension | Trial comparisons |
| Glyburide vs Placebo: 3rd or 4th Degree Perineal Laceration | Trial comparisons |
| Glyburide vs Placebo: Shoulder Dystocia | Trial comparisons |
| Glyburide vs Placebo: Macrosomia | Trial comparisons |
| Glyburide vs Placebo: Need for Insulin Treatment | Trial comparisons |
| Glyburide vs Placebo: Need for Insulin Therapy | Trial comparisons |
| Glyburide vs Placebo: Rate of Cesarean Delivery | Trial comparisons |
| Glyburide vs Placebo: deaths from any cause | Trial comparisons |
| Glyburide vs Placebo: Number of Participants With Large for Gestational Age Infants | Trial comparisons |
| Glyburide vs Placebo: Chorioamnionitis | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00744965
GET https://conductscience.org/api/trials/v1/NCT00744965/results?page=2