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Slow enrollment
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The purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's body-mass index, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.
The investigators seek to asses the effect of obesity (BMI>30) on severe hypertension control in patients with preeclampsia with severe features. The investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the American College of Obstetricians and Gynecologists in 2015.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental labetalol dose | Experimental | Subjects receive 40mg, 60mg 80mg in succession after each severe BP |
|
| Current standard of care | Active Comparator | Subjects receive 20mg, 40mg 80mg in succession after each severe BP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental labetalol dose | Drug | Subjects who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive the experimental dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to blood pressure control | The length of time the subject continued to have non-severe range blood pressure following administration of labetolol. | 4 hours after last labetalol dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in racial response | The difference in time for blood pressure control amongst racial groups | 4 hours after last labetalol dosing |
| Maternal adverse events | Anticipated and unanticipated maternal events including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center Obstetrics and Gynecology | Albany | New York | 12208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25611642 | Result | Committee Opinion No. 623: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2015 Feb;125(2):521-525. doi: 10.1097/01.AOG.0000460762.59152.d7. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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The principle investigator and outcomes assessor are masked to group assignment.
|
| Current standard of care | Other | Subjects who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive the standard dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose. |
|
| within 3 months of delivery |
| Neonatal adverse events | complications experienced by the neonate including PGAR score < 5, need for respiratory support, blood glucose, death | within 28 days of delivery |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |