Treatment of Elevated Blood Pressures in Early Pregnancy

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

Detailed Description
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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).

Official Title
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Treatment of Elevated Blood Pressures in Early Pregnancy

Conditions
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Elevated Blood Pressure, Pregnancy Induced Hypertension

Intervention / Treatment
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* Drug: Nifedipine
* Drug: Labetalol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) | Drug: Nifedipine<br>* Standard of care for treatment of elevated blood pressure during pregnancy<br>Drug: Labetalol<br>* Standard of care for treatment of elevated blood pressure during pregnancy<br>|
| No Intervention: Non-treatment Group<br>Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic | |

What is the study measuring?
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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 |