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| ID | Type | Description | Link |
|---|---|---|---|
| Maimonides IRB 2018-02-17 | Other Identifier | Maimonides IRB/Research Committee |
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| Name | Class |
|---|---|
| Mount Sinai Hospital, New York | OTHER |
| Maimonides Medical Center | OTHER |
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In this study, the investigators will evaluate the blood pressure response to nifedipine and labetalol in pregnant and postpartum patients, who present with hypertensive disease in pregnancy with severe range blood pressure defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG). In addition at the Mount Sinai West site, the investigators will also analyze the ADRB1 and similar genes involved in beta blockade, genes involved in calcium channel blockade and other genes implicated in blood pressure response among pregnant and postpartum patients receiving labetalol and nifedipine. This analysis will be used to determine if a pharmacogenetic association exists between variant alleles in these receptors in the pregnant and postpartum population.
Hypertensive disease in pregnancy is a major cause of maternal morbidity and mortality. This condition is responsible for about 12% of the maternal deaths in the United States.
Currently, if pregnant patients present with severe hypertension they are either given IV labetalol, IV hydralazine of nifedipine based on individual provider preference. There are few studies in the literature comparing oral nifedipine and IV labetalol with mixed data showing either they are equally effective or a faster time to achieving target blood pressure for patients who received nifedipine.
In this study, the investigators will evaluate if there is a difference in time to achieve goal blood pressure in pregnant and postpartum patients who are treated with nifedipine and labetalol for severe range blood pressures defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral nifedipine | Other | Oral medication 10mg and 20mg |
|
| Intravenous labetalol | Other | intravenous medication 20mg, 40mg, 80 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine | Drug | Nifedipine 10mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given and institution specific protocol will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Non Severe Range Blood Pressure | Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received. | Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour |
| Number of Participants to Achieve Non Severe Range Blood Pressure | Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received. | up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Genetic Variants of Genes | the frequency of variant alleles in different receptors involved in the response to labetalol and nifedipine administration in the pregnant and postpartum population. | up to 1 year |
| Number of Participants With Medication Side Effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lois Brustman, MD | Icahn School of Medicine at Mount Sinai | Study Director |
| Howard Minkoff, MD | Icahn School of Medicine at Mount Sinai | Study Director |
| Poroshat Shekarloo, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Hospital | Brooklyn | New York | 11219 | United States | ||
| Mount Sinai West |
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This trial was conducted at two urban academic institutions with participants enrolled from September 2017 to April 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Nifedipine | Oral medication 10mg and 20mg Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed. |
| FG001 | Intravenous Labetalol | Intravenous medication 20mg, 40mg, 80 mg Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Labetalol | intravenous medication 20mg, 40mg, 80 mg Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Achieve Non Severe Range Blood Pressure | Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received. | Posted | Median | Inter-Quartile Range | minutes | Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour |
|
1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Labetalol | intravenous medication 20mg, 40mg, 80 mg Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| symptomatic hypotenstion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
Small sample size and the study was not double blind
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dyese Taylor | Icahn School of Medicine at Mount Sinai | 973-926-5508 | Dyesetaylor@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2017 | Apr 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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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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Patients who present to the hospitals in this study will be randomized to receive IV labetalol or oral nifedipine when presenting with persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic. These anti-hypertensives are first line therapy for management of severe range blood pressures by the American Congress of Obstetricians and Gynecologists.
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|
| Labetalol | Drug | Labetalol 20mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication will be chosen based on institution specific protocol. |
|
Number of participants with side effect profile to assess the rate of side effects from IV labetalol and oral nifedipine |
| assessed 10 minutes to 1 hour after medication is given |
| New York |
| New York |
| 10019 |
| United States |
| BG001 | Oral Nifedipine | Oral medication 10mg and 20mg Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Gestational age | Data for participants pregnant at baseline | Median | Inter-Quartile Range | weeks |
|
| Number of participants who are Post-partum | Count of Participants | Participants |
|
| Number of Participants with Chronic Hypertension (CHTN) | Count of Participants | Participants |
|
| Number of Participants with Gestational Hypertension (GHTN) | Count of Participants | Participants |
|
| Number of Participants with Diabete Mellitus Type I or II | Count of Participants | Participants |
|
| Family History of HTN | Count of Participants | Participants |
|
| History of Smoking | Count of Participants | Participants |
|
| Pre-medication, Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Pre-medication, DiastolicBlood Pressure | Mean | Standard Deviation | mmHg |
|
| OG001 |
| Oral Nifedipine |
Oral medication 10mg and 20mg Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed. |
|
|
| Primary | Number of Participants to Achieve Non Severe Range Blood Pressure | Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received. | participants by ethnicity | Posted | Count of Participants | Participants | up to 1 hour |
|
|
|
| Secondary | Frequency of Genetic Variants of Genes | the frequency of variant alleles in different receptors involved in the response to labetalol and nifedipine administration in the pregnant and postpartum population. | data not collected | Posted | up to 1 year |
|
|
| Secondary | Number of Participants With Medication Side Effects | Number of participants with side effect profile to assess the rate of side effects from IV labetalol and oral nifedipine | Posted | Count of Participants | Participants | assessed 10 minutes to 1 hour after medication is given |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Oral Nifedipine | Oral medication 10mg and 20mg Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed. | 0 | 54 | 0 | 54 | 1 | 54 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |
| Black |
|
|
| Vomiting |
|
| Dizziness |
|
| Flushing |
|
| Any of the above |
|