Treatment of Elevated Blood Pressures in Early Pregnancy

Elevated Blood Pressure Clinical Trial

Official title:

Treatment of Elevated Blood Pressures in Early Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955040
• Other study ID #: 1889318
• Status: Recruiting
• Phase: Phase 2
• Start date: July 11, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Marshall University
• Contact: Jesse Cottrell, MD
• Phone: 304-691-1400
• Email: cottrellje[@]marshall.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Hypertension
• Hypertension, Pregnancy-Induced
• Pregnancy Induced Hypertension

Intervention

Drug:
• Nifedipine
Standard of care for treatment of elevated blood pressure during pregnancy
• Labetalol
Standard of care for treatment of elevated blood pressure during pregnancy

Locations

Country	Name	City	State
United States	Marshall Obstetrics and Gynecology	Huntington	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Marshall University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment of elevated blood pressures	Patient age	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	BMI	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	delivery weeks	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	systemic vascular resistance	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	heart rate	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	blood pressure	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	gravidity	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	parity	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	abortions	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	gestational hypertension	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	inhouse days	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	preeclampsia	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	birth weight percentile	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	Apgar 1 min	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	Apgar 5 min	through study completion, an average of 1 year
Primary	Treatment of elevated blood pressures	NICU days	through study completion, an average of 1 year
Secondary	ICG directed treatment	Compare cardiac output	through study completion, an average of 1 year
Secondary	ICG directed treatment	mean arterial pressure	through study completion, an average of 1 year
Secondary	ICG directed treatment	systemic vascular resistance among groups treated with nifedipine, labetalol, and the control group	through study completion, an average of 1 year