Phase 4
N=109
Response to Anti-hypertensives in Pregnant and Postpartum Patients
Hypertension in Pregnancy · Preeclampsia
Bottom Line
View on ClinicalTrials.gov: NCT03506724 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Time to Achieve Non Severe Range Blood Pressure — 10; 20 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nifedipine (Drug); Labetalol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Achieve Non Severe Range Blood Pressure |
10; 20 | — |
| PRIMARY Number of Participants to Achieve Non Severe Range Blood Pressure |
33; 31; 18; 22 | — |
| SECONDARY Frequency of Genetic Variants of Genes |
— | — |
| SECONDARY Number of Participants With Medication Side Effects |
6; 10; 3; 7; 2; 3 | — |
Summary
In this study, the investigators will evaluate the blood pressure response to nifedipine and labetalol in pregnant and postpartum patients, who present with hypertensive disease in pregnancy with severe range blood pressure defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG). In addition at the Mount Sinai West site, the investigators will also analyze the ADRB1 and similar genes involved in beta blockade, genes involved in calcium channel blockade and other genes implicated in blood pressure response among pregnant and postpartum patients receiving labetalol and nifedipine. This analysis will be used to determine if a pharmacogenetic association exists between variant alleles in these receptors in the pregnant and postpartum population.
Eligibility Criteria
Inclusion Criteria
- pregnant patients from 20 weeks to up to 6 weeks postpartum
- between the ages of 18-55.
- persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic.
Exclusion Criteria
- multiple gestation
- patients with non-reassuring fetal heart rate (category 3)
- patients with abruptio placenta
- patients with renal impairment
- history of heart failure
- history of cardiac arrhythmia
- use of anti-hypertensive medications in the past 24 hours
- patients with allergies or medical contraindications to labetalol or nifedipine.
Data sourced from ClinicalTrials.gov (NCT03506724). 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.