Study Stopped
The study has closed due to difficulty in enrollment.
Treatment of Elevated Blood Pressures in Early Pregnancy
1 other identifier
interventional
2
1 country
1
Brief Summary
This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2023
CompletedStudy Start
First participant enrolled
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2024
CompletedNovember 21, 2024
November 1, 2024
10 months
June 1, 2023
November 19, 2024
Conditions
Outcome Measures
Primary Outcomes (16)
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 Outcomes (3)
ICG directed treatment
through study completion, an average of 1 year
ICG directed treatment
through study completion, an average of 1 year
ICG directed treatment
through study completion, an average of 1 year
Study Arms (2)
Treatment Group
ACTIVE COMPARATORTreatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
Non-treatment Group
NO INTERVENTIONNon-treatment of blood pressures between 120-139 systolic and 80-89 diastolic
Interventions
Standard of care for treatment of elevated blood pressure during pregnancy
Standard of care for treatment of elevated blood pressure during pregnancy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marshall Obstetrics and Gynecology
Huntington, West Virginia, 25701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Maternal Fetal Medicine
Study Record Dates
First Submitted
June 1, 2023
First Posted
July 20, 2023
Study Start
July 11, 2023
Primary Completion
May 6, 2024
Study Completion
May 6, 2024
Last Updated
November 21, 2024
Record last verified: 2024-11