Treatment of Elevated Blood Pressures in Early Pregnancy

Phase 2

Terminated

• Conditions: Elevated Blood Pressure; Pregnancy Induced Hypertension
• Interventions: Drug: Nifedipine; Drug: Labetalol

• Registration Number: NCT05955040
• Lead Sponsor: Marshall University

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).

Study Timeline

• Study First Submitted: 2023-06-01
• Study Start: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-20
• Primary Completion: 2024-05-06
• Study Completion: 2024-05-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Nifedipine	Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
Treatment Group	Labetalol	Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)

Primary Outcome Measures

Name	Time	Method
Treatment of elevated blood pressures	through study completion, an average of 1 year	NICU days

Secondary Outcome Measures

Name	Time	Method
ICG directed treatment	through study completion, an average of 1 year	systemic vascular resistance among groups treated with nifedipine, labetalol, and the control group

Trial Locations

Locations (1)

Marshall Obstetrics and Gynecology; 🇺🇸 Huntington, West Virginia, United States