Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols

NCT ID: NCT02933593

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators plan to monitor the central blood pressure in women with severely elevated blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3 different options for blood pressure control, however no one has studied how these medications affect the central pressures, only peripheral blood pressure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Women will be screened as they come in through the Women's Evaluation Unit or as transfers from outside hospitals to Labor \& Delivery or the Perinatal Special Care Unit (PSCU). All women with severe hypertension (defined as 160/110 or above for 15 minutes or more) will be screened for inclusion and asked to participate in the study. If the woman agrees to participate she will be randomized to one of three groups with the following protocol:

Labetalol Administer 20mg IV labetalol Repeat BP in 10 minutes, if still severe administer 40mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 80mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, if still elevated consider ICU consult Hydralazine Administer 5mg IV hydralazine Repeat BP in 20 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, still elevated administer labetalol 20mg IV Repeat BP in 10 minutes, still elevated administer labetalol 40mg IV and consider ICU consult Nifedipine Administer procardia 10mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer labetalol 40mg IV and consider ICU consult

Administration of medication will be determined by the routine sphygmomanometer blood pressure as that is what the guidelines are based upon.

Women will then have their central arterial pressure and their carotid waveform assessed before administration of medication. The central pressure will be assessed every 5 minutes and carotid waveforms every 10 minutes until blood pressures are \<160/110 for 20 minutes.

Administration of the above medications is standard of care. Randomization to different medications, measuring the central pressure and the carotid waveform is part of the study.

Once the patient's BP stays below 160/110 for 20 minutes their participation in the study will end.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

labetalol

labetalol

Group Type ACTIVE_COMPARATOR

Labetalol

Intervention Type DRUG

To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.

hydralazine

Hydralazine

Group Type ACTIVE_COMPARATOR

Hydralazine

Intervention Type DRUG

To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.

nifedipine

nifedipine

Group Type ACTIVE_COMPARATOR

nifedipine

Intervention Type DRUG

To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Labetalol

To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.

Intervention Type DRUG

Hydralazine

To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.

Intervention Type DRUG

nifedipine

To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Trandate® Apresoline Procardia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnant women
* Singleton pregnancy
* Severe hypertension as defined by a blood pressure of 160/110 with plans to treat

Exclusion Criteria

* Multiple pregnancy
* Blood pressures \< 160/110, or those whose blood pressures do not require medication for control
* Irregular heart rhythms or arrhythmias
* Peripheral arterial disease, leg artery disease
* Reynaud's phenomena
* Intense cold/hypothermia
* If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
* Known sensitivity to labetalol, nifedipine, or hydralazine
* Severe tachycardia (\>120)
* Greater than 1st degree heart block
* Severe asthma
* Congestive heart failure or heart disease
* Lupus
* Inability to adequately monitor BP
* Inability to monitor fetus (if 23 weeks or above)
* Magnesium started prior to initiation of study
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Louis University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jennifer Goldkamp, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer Goldkamp, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

27295

Identifier Type: -

Identifier Source: org_study_id