HypertensionNCT02912910
Changes in Central Arterial Pressure When Comparing Nifedipine/Labetalol for Routine Hypertension Control in Pregnancy
An observational study of Hypertension, run by St. Louis University.
Trial summary
To study central blood pressure changes caused by commonly used high blood pressure medications in pregnancy. 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?
- Nifedipine and Labetalol
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2017
- Phase
- Observational
- 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
Study population: Women in our clinics in addition to admitted to our antepartum units will be screened for inclusion criteria.
Who may be able to join
- Singleton pregnancy
- Women with hypertensive disease in pregnancy who are currently being treated with nifedipine xl or labetalol
Who cannot join
- Multiple pregnancy
- Currently on multiple anti-hypertension medications
- Narcotic use
- Irregular heart rhythms or arrhythmias
- Peripheral arterial disease, leg artery disease
- Reynaud's phenomena
Show all 16Show fewer
- Intense cold/hypothermia
- If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
- Known sensitivity to labetalol or nifedipine
- Severe tachycardia (>120)
- Greater than 1st degree heart block
- Severe asthma
- Congestive heart failure or heart disease
- Lupus
- Inability to adequately monitor BP
- Currently receiving magnesium sulfate
About this study
Official title: Changes in Central Arterial Pressure When Comparing Nifedipine and Labetalol for Routine Hypertension Control in Pregnancy
To study central blood pressure changes caused by commonly used high blood pressure medications in pregnancy.
Read the detailed description
Central blood pressures in addition to pulse wave velocity will be attained prior to medication, and then every 30 minutes for 4 hours (total of 9 readings). Sphygmomanometer readings will be completed at the same time (total readings 9). These readings are all related to the study.
Nursing will have the opportunity to to record the routine sphygmomanometer readings for their routine vitals if they chose to do so.
Their participation will be complete after the 4 hour assessment is complete.
- Conditions
- Hypertension
- Being tested
- Nifedipine, Labetalol
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NifedipineOther
patients will be assigned to antihypertensive medications by their physicians in the course of their routine care
LabetalolOther
patients will be assigned to antihypertensive medications by their physicians in the course of their routine care
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | patients will be assigned to antihypertensive medications by their physicians in the course of their routine care Receives: Other: Nifedipine | |
| Labetalol | patients will be assigned to antihypertensive medications by their physicians in the course of their routine care Receives: Other: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
central blood pressure changes
Measured: every 30 min for 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2016 (estimated)
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: PI withdrew 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- 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, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912910
- Sponsor's protocol ID
- 27464
- Status last verified
- Nov 2017
- First submitted
- 12 Sep 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 Nifedipine and Labetalol for Routine Hypertension Control in Pregnancy
- ClinicalTrials.gov ID
- NCT02912910
- Acronym / sponsor ID
- 27464
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI withdrew protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Sep 2016 (estimated)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Sep 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.
To study central blood pressure changes caused by commonly used high blood pressure medications in pregnancy.
Detailed description
Central blood pressures in addition to pulse wave velocity will be attained prior to medication, and then every 30 minutes for 4 hours (total of 9 readings). Sphygmomanometer readings will be completed at the same time (total readings 9). These readings are all related to the study.
Nursing will have the opportunity to to record the routine sphygmomanometer readings for their routine vitals if they chose to do so.
Their participation will be complete after the 4 hour assessment is complete.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | – | Other: Nifedipinepatients will be assigned to antihypertensive medications by their physicians in the course of their routine care |
| Labetalol | – | Other: Labetalolpatients will be assigned to antihypertensive medications by their physicians in the course of their routine care |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women in our clinics in addition to admitted to our antepartum units will be screened for inclusion criteria.
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Women with hypertensive disease in pregnancy who are currently being treated with nifedipine xl or labetalol
Key exclusion criteria (16 listed)
- Multiple pregnancy
- Currently on multiple anti-hypertension medications
- Narcotic use
- Irregular heart rhythms or arrhythmias
- Peripheral arterial disease, leg artery disease
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 |
|---|---|---|
| Nifedipinepatients will be assigned to antihypertensive medications by their physicians in the course of their routine care | Other | Nifedipine |
| Labetalolpatients will be assigned to antihypertensive medications by their physicians in the course of their routine care | Other | Labetalol |
Primary outcome
central blood pressure changes
Time frame: every 30 min for 4 hours
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 principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 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?
central blood pressure changes (time frame: every 30 min for 4 hours). 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.