Hypertensive Emergency, Postpartum Preeclampsia, Postpartum Pregnancy-Induced Hypertension, Pregnancy-Induced Hypertension in Postpartum
Conditions
Keywords
Hypertension, Hypertensive Emergency, Postpartum, Preeclampsia
Brief summary
The purpose of this study is to assess which blood pressure medication (intravenous labetalol or oral nifedipine) works better in treating severely elevated blood pressure in women who have just delivered a baby.
Detailed description
Hypertensive emergencies cause significant maternal morbidity and mortality in the postpartum period. In order to reduced these risks, the recommendation is to treat women with severe range blood pressure with either intravenous labetalol or oral nifedipine; it is unclear which medication is superior. The objective of this study is to prospectively enroll women who have hypertensive emergencies in the postpartum period; women will be randomized in a 1:1 fashion and treated with one of the two antihypertensives to see which one works better.
Interventions
DRUGLabetalol
Intravenous labetalol, a short acting ant-hypertensive
DRUGNifedipine
Oral nifedipine, a short acting ant-hypertensive
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients admitted to labor and delivery (L\&D) with blood pressure (BP) in severe range, defined as a systolic ≥160 mm Hg and/or diastolic ≥110 mm Hg * Postpartum, immediately to 6 weeks postpartum * With a prior diagnosis of chronic hypertension (not on medication) or hypertensive disorder of pregnancy
Exclusion criteria
* They may not have previously had exposure to either study medication within the previous 24-hour period. * Patients with a known atrial-ventricular heart block or moderate to severe bronchial asthma will be excluded, or other contraindication to receiving either study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Initial Blood Pressure Control (Minutes) | Up to 48 hours | The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of \<160 mmHg systolic and \<110 mmHg diastolic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Recurrence of Severe Blood Pressure | Up to 48 hours | The number of times a patient has recurrence of severe hypertensive necessitating treatment with an antihypertensive. |
| Total Number of Participants Who Need for Second Antihypertensive Agent | Up to 48 hours | The need to use a second (alternative) antihypertensive medication. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWhitney A. Booker, MD
Columbia University
Participant flow
Pre-assignment details
0 participants crossed over to receive the other intervention
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
None listed