Hypertension, Pregnancy InducedPhase 3NCT01538875
Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy
A Phase 3 study testing Hydralazine and Labetalol in people with Hypertension, Pregnancy Induced, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure > 110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with severe and even deadly consequences. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypertension, Pregnancy Induced
- What is being tested?
- Hydralazine and Labetalol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 sitePanama
- Study dates
- Jul 2012to May 2013
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age > 24 weeks.
- Hypertensive Crisis (systolic pressure > 160 mmHg / diastolic pressure < 110mmHg).
Who cannot join
- Known allergy to hydralazine.
- Known allergy to labetalol.
- Severe Bradycardia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.
Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure > 110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with severe and even deadly consequences. The management in this population had been studied, but no consensus has been reached with regards to which treatment is better. Our study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive crisis.
- Conditions
- Hypertension, Pregnancy Induced
- Being tested
- Hydralazine, Labetalol
- Keywords
- Hypertension, pregnancy induced, Hydralazine, Labetalol
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydralazineDrug
Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes until high blood pressure is controlled (Maximum number of doses: 3).
LabetalolDrug
Patients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total).
| Study group | Role | What they receive |
|---|---|---|
| Hydralazine | Experimental | Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3). Receives: Drug: Hydralazine |
| Labetalol | Active comparator | Patients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total). Receives: Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of Hypertensive Crisis
Number of patients with hypertensive crisis in which the blood pressure is controlled with the use of the assigned drug, without requiring additional medications.
Measured: 10 months
Secondary outcomes (2)
Adverse reactions
Number of patients in each group that reported an adverse reaction to the drug assigned.
Measured: 10 months
Number of doses
Number of doses of the assigned drug required to lower blood pressure, without requiring additional medication.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Pregnancy InducedStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538875
- Sponsor's protocol ID
- MHST2012-06
- Status last verified
- May 2013
- First submitted
- 18 Feb 2012
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01538875
- Acronym / sponsor ID
- MHST2012-06
- Conditions
- Hypertension, Pregnancy Induced
- Keywords
- Hypertension, pregnancy induced, Hydralazine, Labetalol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Feb 2012 (estimated)
- 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.
Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure > 110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with severe and even deadly consequences. The management in this population had been studied, but no consensus has been reached with regards to which treatment is better. Our study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive crisis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydralazine | Experimental | Drug: HydralazinePatients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3). |
| Labetalol | Active comparator | Drug: LabetalolPatients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gestational age > 24 weeks.
- Hypertensive Crisis (systolic pressure > 160 mmHg / diastolic pressure < 110mmHg).
Key exclusion criteria (3 listed)
- Known allergy to hydralazine.
- Known allergy to labetalol.
- Severe Bradycardia
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 |
|---|---|---|
| HydralazinePatients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes until high blood pressure is controlled (Maximum number of doses: 3). | Drug | Hydralazine |
| LabetalolPatients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total). | Drug | Labetalol |
Primary outcome
Control of Hypertensive Crisis
Time frame: 10 months
Number of patients with hypertensive crisis in which the blood pressure is controlled with the use of the assigned drug, without requiring additional medications.
2 secondary outcomes
Adverse reactions
Time frame: 10 months
Number of doses
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
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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 3 study testing Hydralazine and Labetalol in people with Hypertension, Pregnancy Induced, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 17 May 2013. 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 Panama. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Control of Hypertensive Crisis (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2013.