HypertensionNCT02933593
Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols
A study testing Labetalol, Hydralazine and nifedipine in people with Hypertension, run by St. Louis University.
Trial summary
The investigators plan to monitor the central blood pressure in women with severely elevated blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3 different options for blood pressure control, however no one has studied how these medications affect the central pressures, only… Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Labetalol, Hydralazine and nifedipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jan 2017
- Phase
- Interventional
- 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 14 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women
- Singleton pregnancy
- Severe hypertension as defined by a blood pressure of 160/110 with plans to treat
Who cannot join
- Multiple pregnancy
- Blood pressures < 160/110, or those whose blood pressures do not require medication for control
- Irregular heart rhythms or arrhythmias
- Peripheral arterial disease, leg artery disease
- Reynaud's phenomena
- Intense cold/hypothermia
Show all 16Show fewer
- If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
- Known sensitivity to labetalol, nifedipine, or hydralazine
- Severe tachycardia (>120)
- Greater than 1st degree heart block
- Severe asthma
- Congestive heart failure or heart disease
- Lupus
- Inability to adequately monitor BP
- Inability to monitor fetus (if 23 weeks or above)
- Magnesium started prior to initiation of study
About this study
The investigators plan to monitor the central blood pressure in women with severely elevated blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3 different options for blood pressure control, however no one has studied how these medications affect the central pressures, only peripheral blood pressure.
Read the detailed description
Women will be screened as they come in through the Women's Evaluation Unit or as transfers from outside hospitals to Labor \& Delivery or the Perinatal Special Care Unit (PSCU). All women with severe hypertension (defined as 160/110 or above for 15 minutes or more) will be screened for inclusion and asked to participate in the study. If the woman agrees to participate she will be randomized to one of three groups with the following protocol:
Labetalol Administer 20mg IV labetalol Repeat BP in 10 minutes, if still severe administer 40mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 80mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, if still elevated consider ICU consult Hydralazine Administer 5mg IV hydralazine Repeat BP in 20 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, still elevated administer labetalol 20mg IV Repeat BP in 10 minutes, still elevated administer labetalol 40mg IV and consider ICU consult Nifedipine Administer procardia 10mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer labetalol 40mg IV and consider ICU consult
Administration of medication will be determined by the routine sphygmomanometer blood pressure as that is what the guidelines are based upon.
Women will then have their central arterial pressure and their carotid waveform assessed before administration of medication. The central pressure will be assessed every 5 minutes and carotid waveforms every 10 minutes until blood pressures are <160/110 for 20 minutes.
Administration of the above medications is standard of care. Randomization to different medications, measuring the central pressure and the carotid waveform is part of the study.
Once the patient's BP stays below 160/110 for 20 minutes their participation in the study will end.
- Conditions
- Hypertension
- Being tested
- Labetalol, Hydralazine, nifedipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
Also called Trandate®
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
HydralazineDrug
Also called Apresoline
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
nifedipineDrug
Also called Procardia
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
| Study group | Role | What they receive |
|---|---|---|
| labetalol | Active comparator | labetalol Receives: Drug: Labetalol |
| hydralazine | Active comparator | Hydralazine Receives: Drug: Hydralazine |
| nifedipine | Active comparator | nifedipine Receives: Drug: nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication recommended by ACOG for severe hypertension
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously
Measured: 20min from time of first normal blood pressure after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: PI withdrew the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Goldkamp, MD, St. Louis University
- Investigators
- Jennifer Goldkamp, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933593
- Sponsor's protocol ID
- 27295
- Status last verified
- Nov 2017
- First submitted
- 22 Aug 2016
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols
- ClinicalTrials.gov ID
- NCT02933593
- Acronym / sponsor ID
- 27295
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI withdrew the protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 Oct 2016 (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.
The investigators plan to monitor the central blood pressure in women with severely elevated blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3 different options for blood pressure control, however no one has studied how these medications affect the central pressures, only peripheral blood pressure.
Detailed description
Women will be screened as they come in through the Women's Evaluation Unit or as transfers from outside hospitals to Labor \& Delivery or the Perinatal Special Care Unit (PSCU). All women with severe hypertension (defined as 160/110 or above for 15 minutes or more) will be screened for inclusion and asked to participate in the study. If the woman agrees to participate she will be randomized to one of three groups with the following protocol:
Labetalol Administer 20mg IV labetalol Repeat BP in 10 minutes, if still severe administer 40mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 80mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, if still elevated consider ICU consult Hydralazine Administer 5mg IV hydralazine Repeat BP in 20 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, still elevated administer labetalol 20mg IV Repeat BP in 10 minutes, still elevated administer labetalol 40mg IV and consider ICU consult Nifedipine Administer procardia 10mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer labetalol 40mg IV and consider ICU consult
Administration of medication will be determined by the routine sphygmomanometer blood pressure as that is what the guidelines are based upon.
Women will then have their central arterial pressure and their carotid waveform assessed before administration of medication. The central pressure will be assessed every 5 minutes and carotid waveforms every 10 minutes until blood pressures are <160/110 for 20 minutes.
Administration of the above medications is standard of care. Randomization to different medications, measuring the central pressure and the carotid waveform is part of the study.
Once the patient's BP stays below 160/110 for 20 minutes their participation in the study will end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| labetalol | Active comparator | Drug: Labetalollabetalol |
| hydralazine | Active comparator | Drug: HydralazineHydralazine |
| nifedipine | Active comparator | Drug: nifedipinenifedipine |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant women
- Singleton pregnancy
- Severe hypertension as defined by a blood pressure of 160/110 with plans to treat
Key exclusion criteria (16 listed)
- Multiple pregnancy
- Blood pressures < 160/110, or those whose blood pressures do not require medication for control
- Irregular heart rhythms or arrhythmias
- Peripheral arterial disease, leg artery disease
- Reynaud's phenomena
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 |
|---|---|---|
| LabetalolAlso: Trandate®To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously. | Drug | labetalol |
| HydralazineAlso: ApresolineTo determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously. | Drug | hydralazine |
| nifedipineAlso: ProcardiaTo determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously. | Drug | nifedipine |
Primary outcome
medication recommended by ACOG for severe hypertension
Time frame: 20min from time of first normal blood pressure after intervention
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Jennifer Goldkamp, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
A study testing Labetalol, Hydralazine and nifedipine in people with Hypertension, run by St. Louis University.
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 3 inclusion and 16 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: withdrawn, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
medication recommended by ACOG for severe hypertension (time frame: 20min from time of first normal blood pressure after intervention). 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 13 Nov 2017; AzTrials last refreshed its copy on 31 Oct 2026.