Back to resultsTreatment of Elevated Blood Pressures in Early Pregnancy
Primary Purpose
Elevated Blood Pressure, Pregnancy Induced Hypertension
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nifedipine
Labetalol
Sponsored by
About this trial
This is an interventional treatment trial for Elevated Blood Pressure
Eligibility 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
Sites / Locations
- Marshall Obstetrics and GynecologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Treatment Group
Non-treatment Group
Arm Description
Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic
Outcomes
Primary Outcome Measures
Treatment of elevated blood pressures
Patient age
Treatment of elevated blood pressures
BMI
Treatment of elevated blood pressures
delivery weeks
Treatment of elevated blood pressures
systemic vascular resistance
Treatment of elevated blood pressures
heart rate
Treatment of elevated blood pressures
blood pressure
Treatment of elevated blood pressures
gravidity
Treatment of elevated blood pressures
parity
Treatment of elevated blood pressures
abortions
Treatment of elevated blood pressures
gestational hypertension
Treatment of elevated blood pressures
inhouse days
Treatment of elevated blood pressures
preeclampsia
Treatment of elevated blood pressures
birth weight percentile
Treatment of elevated blood pressures
Apgar 1 min
Treatment of elevated blood pressures
Apgar 5 min
Treatment of elevated blood pressures
NICU days
Secondary Outcome Measures
ICG directed treatment
Compare cardiac output
ICG directed treatment
mean arterial pressure
ICG directed treatment
systemic vascular resistance among groups treated with nifedipine, labetalol, and the control group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05955040
Brief Title
Treatment of Elevated Blood Pressures in Early Pregnancy
Official Title
Treatment of Elevated Blood Pressures in Early Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshall University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elevated Blood Pressure, Pregnancy Induced Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
Arm Title
Non-treatment Group
Arm Type
No Intervention
Arm Description
Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
Standard of care for treatment of elevated blood pressure during pregnancy
Intervention Type
Drug
Intervention Name(s)
Labetalol
Intervention Description
Standard of care for treatment of elevated blood pressure during pregnancy
Primary Outcome Measure Information:
Title
Treatment of elevated blood pressures
Description
Patient age
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
BMI
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
delivery weeks
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
systemic vascular resistance
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
heart rate
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
blood pressure
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
gravidity
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
parity
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
abortions
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
gestational hypertension
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
inhouse days
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
preeclampsia
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
birth weight percentile
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
Apgar 1 min
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
Apgar 5 min
Time Frame
through study completion, an average of 1 year
Title
Treatment of elevated blood pressures
Description
NICU days
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
ICG directed treatment
Description
Compare cardiac output
Time Frame
through study completion, an average of 1 year
Title
ICG directed treatment
Description
mean arterial pressure
Time Frame
through study completion, an average of 1 year
Title
ICG directed treatment
Description
systemic vascular resistance among groups treated with nifedipine, labetalol, and the control group
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse Cottrell, MD
Phone
304-691-1400
Email
cottrellje@marshall.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Morgan Ruley
Phone
304-691-1458
Email
kelley115@marshall.edu
Facility Information:
Facility Name
Marshall Obstetrics and Gynecology
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse Cottrell, MD
Phone
304-691-1400
Email
cottrellj@marshall.edu
First Name & Middle Initial & Last Name & Degree
Morgan Ruley, MS
Phone
304-691-1458
Email
kelley115@marshall.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided
Learn more about this trial
Treatment of Elevated Blood Pressures in Early Pregnancy
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