N/A
N=50
Oral Nifedipine Versus Oral Labetalol
Severe Postpartum Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02168309 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication — 37.6; 38.2 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Labetalol (Drug); Nifedipine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication |
37.6; 38.2 | — |
| SECONDARY Total Length of Hospital Stay in Days |
4.0; 4.3 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02168309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.