A Phase 2 interventional study of Nifedipine and Labetalol in Elevated Blood Pressure and Pregnancy Induced Hypertension, sponsored by Marshall University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Marshall University · Phase 2, Interventional, and Treatment
This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.
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).
240 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 66 are open to participants now.
This study's enrollment of 2 is below the median of 144 across 163 interventional studies indexed under Hypertension, Pregnancy-Induced.
Browse Hypertension, Pregnancy-Induced studies →Marshall University is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
Drug: Nifedipine · Drug: Labetalol
Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic
Standard of care for treatment of elevated blood pressure during pregnancy
Standard of care for treatment of elevated blood pressure during pregnancy
Treatment of elevated blood pressures
Patient age
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
BMI
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
delivery weeks
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
systemic vascular resistance
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
heart rate
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
blood pressure
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
gravidity
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
parity
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
abortions
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
gestational hypertension
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
inhouse days
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
preeclampsia
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
birth weight percentile
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
Apgar 1 min
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
Apgar 5 min
Time frame: through study completion, an average of 1 year
Treatment of elevated blood pressures
NICU days
Time frame: through study completion, an average of 1 year
ICG directed treatment
Compare cardiac output
Time frame: through study completion, an average of 1 year
ICG directed treatment
mean arterial pressure
Time frame: through study completion, an average of 1 year
ICG directed treatment
systemic vascular resistance among groups treated with nifedipine, labetalol, and the control group
Time frame: through study completion, an average of 1 year
Plan to share: Undecided — Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Hypertension, Pregnancy-Induced→
Marshall University