Treatment of Elevated Blood Pressures in Early Pregnancy

Marshall University

Status and phase: Terminated; Phase 2

Conditions: Pregnancy Induced Hypertension; Elevated Blood Pressure

Treatments: Drug: Nifedipine; Drug: Labetalol

Study type: Interventional

Funder types: Other

Identifiers

NCT05955040

1889318

Details and patient eligibility

About

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

Full 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).

Enrollment: 2 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2 participants in 2 patient groups

Treatment Group

Active Comparator group

Description:

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

Treatment:

Drug: Labetalol

Drug: Nifedipine

Non-treatment Group

No Intervention group

Description:

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