Severe Postpartum Hypertension
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGLabetalol
Titrate up for blood pressure control
DRUGNifedipine
Titrate up to achieve blood pressure control
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years with the abililty to give informed consent * Intrauterine pregnancy ≥ 32 weeks * Postpartum * Persistent postpartum blood pressures ≥ 160/105 on two or more occasions * Primary obstetrician amenable to starting either study medication in the postpartum period
Exclusion criteria
* Use of other oral antihypertensives concomitantly * Known AV heart block * HR \<60 or \>120 * Absolute contraindication to nifedipine or labetolol such as allergy * Significant renal disease (Cr \>1.5 mg/dL) * Heart failure * Moderate persistent or severe asthma * Preexisting diagnosis of chronic hypertension with medical treatment before delivery * Chronic hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication | 24 hours | Primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Length of Hospital Stay in Days | 0-10 days | Secondary outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Labetalol Labetalol 200mg PO BID starting dose
Labetalol: Titrate up for blood pressure control | 25 |
| Nifedipine Nifedpine XL starting at dose 30mg PO daily
Nifedipine: Titrate up to achieve blood pressure control | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Labetalol | Nifedipine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 7.4 | 33.3 years STANDARD_DEVIATION 6.4 | 33.7 years STANDARD_DEVIATION 6.9 |
| Body Mass Index | 30.3 kg/m^2 STANDARD_DEVIATION 4.1 | 33.0 kg/m^2 STANDARD_DEVIATION 7.8 | 31.7 kg/m^2 STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 9 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 16 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication
Primary outcome
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Labetalol | Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication | 37.6 hours | Standard Deviation 32.5 |
| Nifedipine | Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication | 38.2 hours | Standard Deviation 27.6 |
Secondary
Total Length of Hospital Stay in Days
Secondary outcome
Time frame: 0-10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Labetalol | Total Length of Hospital Stay in Days | 4.0 days | Standard Deviation 1.5 |
| Nifedipine | Total Length of Hospital Stay in Days | 4.3 days | Standard Deviation 2.3 |