Treatment of Elevated Blood Pressures in Early Pregnancy

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

Study Overview

• Status: Recruiting
• Conditions: Elevated Blood Pressure; Pregnancy Induced Hypertension
• Intervention / Treatment: Drug: Nifedipine; Drug: Labetalol

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 Type: Interventional
• Enrollment (Estimated): 234
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jesse Cottrell, MD; Phone Number: 304-691-1400; Email: cottrellje@marshall.edu
• Study Contact Backup: Name: Morgan Ruley; Phone Number: 304-691-1458; Email: kelley115@marshall.edu

Study Locations

• United States
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Recruiting
      • Marshall Obstetrics and Gynecology
      • Contact: Jesse Cottrell, MD; Phone Number: 304-691-1400; Email: cottrellj@marshall.edu
      • Contact: Morgan Ruley, MS; Phone Number: 304-691-1458; Email: kelley115@marshall.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group; Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)	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
No Intervention: Non-treatment Group; Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment of elevated blood pressures	Patient age	through study completion, an average of 1 year
Treatment of elevated blood pressures	BMI	through study completion, an average of 1 year
Treatment of elevated blood pressures	delivery weeks	through study completion, an average of 1 year
Treatment of elevated blood pressures	systemic vascular resistance	through study completion, an average of 1 year
Treatment of elevated blood pressures	heart rate	through study completion, an average of 1 year
Treatment of elevated blood pressures	blood pressure	through study completion, an average of 1 year
Treatment of elevated blood pressures	gravidity	through study completion, an average of 1 year
Treatment of elevated blood pressures	parity	through study completion, an average of 1 year
Treatment of elevated blood pressures	abortions	through study completion, an average of 1 year
Treatment of elevated blood pressures	gestational hypertension	through study completion, an average of 1 year
Treatment of elevated blood pressures	inhouse days	through study completion, an average of 1 year
Treatment of elevated blood pressures	preeclampsia	through study completion, an average of 1 year
Treatment of elevated blood pressures	birth weight percentile	through study completion, an average of 1 year
Treatment of elevated blood pressures	Apgar 1 min	through study completion, an average of 1 year
Treatment of elevated blood pressures	Apgar 5 min	through study completion, an average of 1 year
Treatment of elevated blood pressures	NICU days	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICG directed treatment	Compare cardiac output	through study completion, an average of 1 year
ICG directed treatment	mean arterial pressure	through study completion, an average of 1 year
ICG directed treatment	systemic vascular resistance among groups treated with nifedipine, labetalol, and the control group	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Marshall University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Hypertension, Pregnancy-Induced; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Sympathomimetics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Nifedipine; Labetalol
• Other Study ID Numbers: 1889318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No