Oral Nifedipine Versus Oral Labetalol



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 100
Updated:12/15/2017
Start Date:June 2014
End Date:May 2016

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Comparison of Oral Nifedipine to Oral Labetolol for the Management of Severe Postpartum Hypertension

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.

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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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mi
from
Los Angeles, CA
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