NCT05955040

Treatment of Elevated Blood Pressures in Early Pregnancy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Marshall University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Elevated Blood Pressure
• Pregnancy Induced Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-11
• Primary completion: 2024-05-06
• Completion: 2024-05-06
• First posted: 2023-07-20
• Last updated: 2024-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study