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The study has closed due to difficulty in enrollment.
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) |
|
| Non-treatment Group | No Intervention | Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine | Drug | Standard of care for treatment of elevated blood pressure during pregnancy |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ICG directed treatment | Compare cardiac output | through study completion, an average of 1 year |
| ICG directed treatment | mean arterial pressure |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marshall Obstetrics and Gynecology | Huntington | West Virginia | 25701 | United States |
Undecided
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| D007741 | Labetalol |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Labetalol | Drug | Standard of care for treatment of elevated blood pressure during pregnancy |
|
| 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 |
| 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 |
| D000091642 | Urogenital Diseases |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |