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This study's aim is to determine whether oral extended release nifedipine is superior to oral labetolol for the management of postpartum severe hypertension, specifically time to achieve goal blood pressure, and shortening hospital stay. Our hypothesis is that oral extended release nifedipine is superior to oral labetolol for achieving goal blood pressure in the postpartum period.
Hypertension complicating pregnancy is common and, when uncontrolled, can have devastating consequences. While the true incidence of postpartum hypertension is unknown, blood pressure (BP) is known to initially decrease 48 hours following delivery then peak on postpartum days 3-6, likely 45 from the mobilization of interstitial fluids following parturition.
The American College of Obstetricians and Gynecologists (ACOG) recommends medical treatment of persistent postpartum hypertension, defined as systolic BP (SBP) ≥150 mmHg or diastolic BP (DBP) ≥100 mmHg, on two or more occasions 4-6 hours apart. Prior studies compared intravenous medications to intramuscular and immediate-release oral 50 medications in the treatment of postpartum hypertension. However, oral labetalol and oral extended release nifedipine are the most commonly used medications for post- partum hypertension, and their efficacy has not been directly compared.
Our aim was to determine whether oral labetalol is associated with a shorter time to BP control compared to oral extended release nifedipine for management of persistent 55 postpartum hypertension. Our primary outcome was time to sustained BP control defined as the absence of severe hypertension (SBP ≥160 mmHg or DBP ≥105 mmHg) for at least 12 hours. Secondary outcomes included postpartum length of stay, need for increased dosing, need for additional oral antihypertensive agents, and patient-reported side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Labetalol | Other | Labetalol 200mg PO BID starting dose |
|
| Nifedipine | Other | Nifedpine XL starting at dose 30mg PO daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labetalol | Drug | Titrate up for blood pressure control |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication | Primary outcome | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Length of Hospital Stay in Days | Secondary outcome | 0-10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Kilpatrick | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27786578 | Derived | Sharma KJ, Greene N, Kilpatrick SJ. Oral labetalol compared to oral nifedipine for postpartum hypertension: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):44-47. doi: 10.1080/10641955.2016.1231317. Epub 2016 Oct 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Labetalol | Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control |
| FG001 | Nifedipine | Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Labetalol | Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control |
| BG001 | Nifedipine | Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication | Primary outcome | Posted | Mean | Standard Deviation | hours | 24 hours |
|
|
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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 | Labetalol | Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Sharma | Central Coast Perinatology | 8058980258 | katy.jones@gmail.com |
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| ID | Term |
|---|---|
| D007741 | Labetalol |
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Nifedipine | Drug | Titrate up to achieve blood pressure control |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
| Secondary | Total Length of Hospital Stay in Days | Secondary outcome | Posted | Mean | Standard Deviation | days | 0-10 days |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Nifedipine | Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control | 0 | 25 | 0 | 25 |
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| D012457 |
| Salicylamides |
| D000577 | Amides |
| D000588 | Amines |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |