Treatment of Elevated Blood Pressures in Early Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-11

Study Completion Date

2024-05-06

Brief Summary

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

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Detailed Description

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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).

Conditions

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Elevated Blood Pressure Pregnancy Induced Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

Standard of care for treatment of elevated blood pressure during pregnancy

Labetalol

Intervention Type DRUG

Standard of care for treatment of elevated blood pressure during pregnancy

Non-treatment Group

Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nifedipine

Standard of care for treatment of elevated blood pressure during pregnancy

Intervention Type DRUG

Labetalol

Standard of care for treatment of elevated blood pressure during pregnancy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes