Elevated Blood PressurePhase 2NCT05955040
Treatment of Elevated Blood Pressures in Early Pregnancy
A Phase 2 study testing Nifedipine and Labetalol in people with Elevated Blood Pressure and Pregnancy Induced Hypertension, run by Marshall University at 1 site in United States.
Trial summary
This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elevated Blood Pressure, Pregnancy Induced Hypertension
- What is being tested?
- Nifedipine and Labetalol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to 6 May 2024
- Phase
- Phase 2
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting for obstetric care at Marshall University (Huntington office and Teays Valley office) between 12 and 16 weeks gestation with a systolic blood pressure of 120 or greater OR a diastolic blood pressure of 80 or greater. Eligibility for this study will be have blood pressures between 120-139 systolic and 80-89 diastolic. Randomization to control, labetalol, or nifedipine will be performed after patient consent.
Who cannot join
- Patients already be on medication for hypertension.
- Patients with the diagnosis of chronic hypertension
- Patients with a BP of 140 or greater systolic OR 90 or greater diastolic (this meets criteria for chronic hypertension in pregnancy).
- Patients actively using any illicit substance or have history of substance use disorder.
- Patients who are actively consuming alcohol during pregnancy.
- Patients with Type I or Type II Diabetes Mellitus.
- Patients with end stage renal disease.
- Patients less then 12 weeks gestation or greater than 16 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshall Obstetrics and Gynecology
Huntington, West Virginia, 25701
About this study
This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.
Read the detailed description
Patients will be randomized to treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment. After randomization to treatment, patient's will be treated with either nifedipine or labetalol (both medications that are standard of care for treatment of elevated blood pressure during pregnancy).
The purpose of this study is two-fold: 1) Determine if treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment improves maternal and fetal outcomes and 2) determine if ICG directed treatment is optimal as ICG will not be used to determine treatment medication (this will be done by secondary analysis after conclusion of the study).
- Being tested
- Nifedipine, Labetalol
- Medical subject headings
- Hypertension, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NifedipineDrug
Standard of care for treatment of elevated blood pressure during pregnancy
LabetalolDrug
Standard of care for treatment of elevated blood pressure during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) Receives: Drug: Nifedipine; Drug: Labetalol |
| Non-treatment Group | No intervention | Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of elevated blood pressures
Patient age
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
BMI
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
delivery weeks
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
systemic vascular resistance
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
heart rate
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
blood pressure
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
gravidity
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
parity
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
abortions
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
gestational hypertension
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
inhouse days
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
preeclampsia
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
birth weight percentile
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
Apgar 1 min
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
Apgar 5 min
Measured: through study completion, an average of 1 year
Treatment of elevated blood pressures
NICU days
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
ICG directed treatment
Compare cardiac output
Measured: through study completion, an average of 1 year
ICG directed treatment
mean arterial pressure
Measured: through study completion, an average of 1 year
ICG directed treatment
systemic vascular resistance among groups treated with nifedipine, labetalol, and the control group
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start11 Jul 2023
- Primary completion6 May 2024
- Study completion6 May 2024
Why it stopped: The study has closed due to difficulty in enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cottrell, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955040
- Sponsor's protocol ID
- 1889318
- Status last verified
- Nov 2024
- First submitted
- 1 Jun 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Elevated Blood Pressures in Early Pregnancy
- ClinicalTrials.gov ID
- NCT05955040
- Acronym / sponsor ID
- 1889318
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has closed due to difficulty in enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 20 Jul 2023 (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.
This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.
Detailed description
Patients will be randomized to treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment. After randomization to treatment, patient's will be treated with either nifedipine or labetalol (both medications that are standard of care for treatment of elevated blood pressure during pregnancy).
The purpose of this study is two-fold: 1) Determine if treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment improves maternal and fetal outcomes and 2) determine if ICG directed treatment is optimal as ICG will not be used to determine treatment medication (this will be done by secondary analysis after conclusion of the study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: Nifedipine, Drug: LabetalolTreatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) |
| Non-treatment Group | No intervention | –Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients presenting for obstetric care at Marshall University (Huntington office and Teays Valley office) between 12 and 16 weeks gestation with a systolic blood pressure of 120 or greater OR a diastolic blood pressure of 80 or greater. Eligibility for this study will be have blood pressures between 120-139 systolic and 80-89 diastolic. Randomization to control, labetalol, or nifedipine will be performed after patient consent.
Key exclusion criteria (8 listed)
- Patients already be on medication for hypertension.
- Patients with the diagnosis of chronic hypertension
- Patients with a BP of 140 or greater systolic OR 90 or greater diastolic (this meets criteria for chronic hypertension in pregnancy).
- Patients actively using any illicit substance or have history of substance use disorder.
- Patients who are actively consuming alcohol during pregnancy.
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 |
|---|---|---|
| NifedipineStandard of care for treatment of elevated blood pressure during pregnancy | Drug | Treatment Group |
| LabetalolStandard of care for treatment of elevated blood pressure during pregnancy | Drug | Treatment Group |
Primary outcome
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
Patient age
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
BMI
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
delivery weeks
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
systemic vascular resistance
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
heart rate
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
blood pressure
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
gravidity
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
parity
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
abortions
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
gestational hypertension
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
inhouse days
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
preeclampsia
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
birth weight percentile
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
Apgar 1 min
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
Apgar 5 min
Treatment of elevated blood pressures
Time frame: through study completion, an average of 1 year
NICU days
3 secondary outcomes
ICG directed treatment
Time frame: through study completion, an average of 1 year
ICG directed treatment
Time frame: through study completion, an average of 1 year
ICG directed treatment
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: The study has closed due to difficulty in enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided. Undecided
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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 2 study testing Nifedipine and Labetalol in people with Elevated Blood Pressure and Pregnancy Induced Hypertension, run by Marshall University 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 1 inclusion and 8 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 21 Nov 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: The study has closed due to difficulty in 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?
Treatment of elevated blood pressures (time frame: through study completion, an average of 1 year). The study lists 16 primary outcomes in all. 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 21 Nov 2024.