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Treatment of Elevated Blood Pressures in Early Pregnancy

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ClinicalTrials.gov Identifier: NCT05955040
Recruitment Status : Recruiting
First Posted : July 20, 2023
Last Update Posted : October 19, 2023
Sponsor:
Information provided by (Responsible Party):
Jesse Cottrell, Marshall University

Study Description
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Brief Summary:
This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.

Condition or disease Intervention/treatment Phase
Elevated Blood Pressure Pregnancy Induced Hypertension Drug: Nifedipine Drug: Labetalol Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Elevated Blood Pressures in Early Pregnancy
Actual Study Start Date : July 11, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment Group
Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
 Drug: Nifedipine
Standard of care for treatment of elevated blood pressure during pregnancy

Drug: Labetalol
Standard of care for treatment of elevated blood pressure during pregnancy
No Intervention: Non-treatment Group
Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic


Outcome Measures
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Primary Outcome Measures :
  1. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    Patient age

  2. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    BMI

  3. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    delivery weeks

  4. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    systemic vascular resistance

  5. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    heart rate

  6. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    blood pressure

  7. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    gravidity

  8. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    parity

  9. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    abortions

  10. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    gestational hypertension

  11. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    inhouse days

  12. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    preeclampsia

  13. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    birth weight percentile

  14. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    Apgar 1 min

  15. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    Apgar 5 min

  16. Treatment of elevated blood pressures [ Time Frame: through study completion, an average of 1 year ]
    NICU days


Secondary Outcome Measures :
  1. ICG directed treatment [ Time Frame: through study completion, an average of 1 year ]
    Compare cardiac output

  2. ICG directed treatment [ Time Frame: through study completion, an average of 1 year ]
    mean arterial pressure

  3. ICG directed treatment [ Time Frame: through study completion, an average of 1 year ]
    systemic vascular resistance among groups treated with nifedipine, labetalol, and the control group


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05955040


Contacts
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Contact: Jesse Cottrell, MD 304-691-1400 cottrellje@marshall.edu
Contact: Morgan Ruley 304-691-1458 kelley115@marshall.edu

Locations
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United States, West Virginia
Marshall Obstetrics and Gynecology Recruiting
Huntington, West Virginia, United States, 25701
Contact: Jesse Cottrell, MD    304-691-1400    cottrellj@marshall.edu   
Contact: Morgan Ruley, MS    304-691-1458    kelley115@marshall.edu   
Sponsors and Collaborators
Marshall University
More Information
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Responsible Party: Jesse Cottrell, Assistant Professor of Maternal Fetal Medicine, Marshall University
ClinicalTrials.gov Identifier: NCT05955040    
Other Study ID Numbers: 1889318
First Posted: July 20, 2023    Key Record Dates
Last Update Posted: October 19, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Labetalol
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
 Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists