Preeclampsia With Severe FeaturesPhase 4ALERTNCT03872336
Acute Labetalol Use in Preeclampsia
A Phase 4 study testing Experimental labetalol dose in people with Preeclampsia With Severe Features, run by Albany Medical College at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia With Severe Features
- What is being tested?
- Experimental labetalol dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to 20 Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 30
- Age ≥ 18 years
- Gestational age ≥ 24 weeks
- Singleton gestation
- One sustained severe range blood pressure at Albany Medical Center
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albany Medical Center Obstetrics and Gynecology
Albany, New York, 12208
About this study
Official title: Acute Labetalol Use in Preeclampsia Randomized Trial
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.
Read the detailed description
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.
- Conditions
- Preeclampsia With Severe Features
- Being tested
- Experimental labetalol dose, Current standard of care
- Keywords
- Hypertension, Labetalol, Obesity
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental labetalol doseDrug
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.
Current standard of careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental labetalol dose | Experimental | Subjects receive 40mg, 60mg 80mg in succession after each severe BP Receives: Drug: Experimental labetalol dose |
| Current standard of care | Active comparator | Subjects receive 20mg, 40mg 80mg in succession after each severe BP Receives: Other: Current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to blood pressure control
The length of time the subject continued to have non-severe range blood pressure following administration of labetolol.
Measured: 4 hours after last labetalol dosing
Secondary outcomes (3)
Differences in racial response
The difference in time for blood pressure control amongst racial groups
Measured: 4 hours after last labetalol dosing
Maternal adverse events
Anticipated and unanticipated maternal events including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
Measured: within 3 months of delivery
Neonatal adverse events
complications experienced by the neonate including PGAR score < 5, need for respiratory support, blood glucose, death
Measured: within 28 days of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start18 Feb 2019
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preeclampsia With Severe FeaturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872336
- Sponsor's protocol ID
- 5254
- Acronym
- ALERT
- Status last verified
- Jul 2020
- First submitted
- 11 Mar 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25611642
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Labetalol Use in Preeclampsia Randomized Trial
- ClinicalTrials.gov ID
- NCT03872336
- Acronym / sponsor ID
- ALERT / 5254
- Conditions
- Preeclampsia With Severe Features
- Keywords
- Hypertension, Labetalol, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental labetalol dose | Experimental | Drug: Experimental labetalol doseSubjects receive 40mg, 60mg 80mg in succession after each severe BP |
| Current standard of care | Active comparator | Other: Current standard of careSubjects receive 20mg, 40mg 80mg in succession after each severe BP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI ≥ 30
- Age ≥ 18 years
- Gestational age ≥ 24 weeks
- Singleton gestation
- One sustained severe range blood pressure at Albany Medical Center
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental labetalol doseSubjects 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. | Drug | Experimental labetalol dose |
| Current standard of careSubjects 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. | Other | Current standard of care |
Primary outcome
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.
3 secondary outcomes
Differences in racial response
Time frame: 4 hours after last labetalol dosing
Maternal adverse events
Time frame: within 3 months of delivery
Neonatal adverse events
Time frame: within 28 days of delivery
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Results publication: PubMed 25611642Committee 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.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia With Severe Features
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Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
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Blood Pressure Goal in Preterm Preeclampsia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental labetalol dose in people with Preeclampsia With Severe Features, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to blood pressure control (time frame: 4 hours after last labetalol dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.