Clinical trial NCT05955040: Treatment of Elevated Blood Pressures in Early Pregnancy
Official title: Treatment of Elevated Blood Pressures in Early Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Elevated Blood Pressure
Pregnancy Induced Hypertension
Lead sponsor: Marshall University
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
measure: Treatment of elevated blood pressures
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: ICG directed treatment
timeFrame: through study completion, an average of 1 year
measure: ICG directed treatment
timeFrame: through study completion, an average of 1 year
measure: ICG directed treatment
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Marshall Obstetrics and Gynecology
state: West Virginia
Study officials:
References: