Acute Labetalol Use in Preeclampsia (ALERT)
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ClinicalTrials.gov Identifier: NCT03872336 |
Recruitment Status :
Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
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Condition or disease | Intervention/treatment | Phase |
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Preeclampsia With Severe Features | Drug: Experimental labetalol dose Other: Current standard of care | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 166 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Masking Description: | The principle investigator and outcomes assessor are masked to group assignment. |
Primary Purpose: | Treatment |
Official Title: | Acute Labetalol Use in Preeclampsia Randomized Trial |
Actual Study Start Date : | February 18, 2019 |
Estimated Primary Completion Date : | March 1, 2021 |
Estimated Study Completion Date : | July 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental labetalol dose
Subjects receive 40mg, 60mg 80mg in succession after each severe BP
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Drug: Experimental labetalol dose
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. |
Active Comparator: Current standard of care
Subjects receive 20mg, 40mg 80mg in succession after each severe BP
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Other: Current standard of care
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. |
- Time to blood pressure control [ Time Frame: 4 hours after last labetalol dosing ]The length of time the subject continued to have non-severe range blood pressure following administration of labetolol.
- Differences in racial response [ Time Frame: 4 hours after last labetalol dosing ]The difference in time for blood pressure control amongst racial groups
- Maternal adverse events [ Time Frame: within 3 months of delivery ]Anticipated and unanticipated maternal events including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
- Neonatal adverse events [ Time Frame: within 28 days of delivery ]complications experienced by the neonate including PGAR score < 5, need for respiratory support, blood glucose, death

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- BMI ≥ 30
- Age ≥ 18 years
- Gestational age ≥ 24 weeks
- Singleton gestation
- One sustained severe range blood pressure at Albany Medical Center
Exclusion Criteria:
- Known allergic reaction to labetlol
- Persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month)
- Obstructive airway disease
- Bradycardia < 70 beats/min
- Heart block > 1st degree or history of heart failure

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872336
Contact: Asha Rijhsinghani | 518.262.4942 | rijhsia@amc.edu | |
Contact: Yiwen Cui | 832.788.8154 | cuiy@amc.edu |
United States, New York | |
Albany Medical Center Obstetrics and Gynecology | Recruiting |
Albany, New York, United States, 12208 | |
Contact: OBGYN Research Director, MD 518-262-4942 obgynresearch@amc.edu |
Publications of Results:
Responsible Party: | Albany Medical College |
ClinicalTrials.gov Identifier: | NCT03872336 History of Changes |
Other Study ID Numbers: |
5254 |
First Posted: | March 13, 2019 Key Record Dates |
Last Update Posted: | March 13, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension Labetalol Obesity |
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Labetalol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antihypertensive Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |