Response to Anti-hypertensives in Pregnant and Postpartum Patients

NCT03506724 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GCO 17-0257Maimonides IRB 2018-02-17
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypertension in Pregnancy; Preeclampsia

Keywords

Hypertension, Pregnancy-induced; Pregnancy Induced Hypertension; Gestational Hypertension; Transient Hypertension, Pregnancy; Pharmacogenetics

Outcome Measures

Primary Outcomes (2)

• Time to Achieve Non Severe Range Blood Pressure

  Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received.

  Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour

• Number of Participants to Achieve Non Severe Range Blood Pressure

  Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received.

  up to 1 hour

Secondary Outcomes (2)

• Frequency of Genetic Variants of Genes

  up to 1 year

• Number of Participants With Medication Side Effects

  assessed 10 minutes to 1 hour after medication is given

Study Arms (2)

Oral nifedipine

OTHER

Oral medication 10mg and 20mg

Drug: Nifedipine

Intravenous labetalol

OTHER

intravenous medication 20mg, 40mg, 80 mg

Drug: Labetalol

Interventions

Nifedipine DRUG

Nifedipine 10mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given and institution specific protocol will be performed.

Oral nifedipine

Labetalol DRUG

Labetalol 20mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication will be chosen based on institution specific protocol.

Intravenous labetalol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Mount Sinai Hospital, New York: collaborator
• Maimonides Medical Center: collaborator

Study Sites (2)

Maimonides Hospital

Brooklyn, New York, 11219, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Interventions

Nifedipine; Labetalol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Limitations and Caveats

Small sample size and the study was not double blind

Results Point of Contact

• Title: Dr. Dyese Taylor
• Organization: Icahn School of Medicine at Mount Sinai

Dyesetaylor@gmail.com

973-926-5508

Study Officials

• Lois Brustman, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Howard Minkoff, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Poroshat Shekarloo, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients who present to the hospitals in this study will be randomized to receive IV labetalol or oral nifedipine when presenting with persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic. These anti-hypertensives are first line therapy for management of severe range blood pressures by the American Congress of Obstetricians and Gynecologists.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 24, 2018
• Study Start: September 11, 2017
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: May 24, 2021
• Results First Posted: May 24, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)