Oral Nifedipine Versus Oral Labetalol

Cedars-Sinai Medical Center

Status

Completed

Conditions

Severe Postpartum Hypertension

Treatments

Drug: Labetalol

Drug: Nifedipine

Study type

Interventional

Funder types

Other

Identifiers

NCT02168309

Pro34034

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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