Impedance Cardiography to Decrease the Risk of Preeclampsia | NCT03245970

Studies
Impedance Cardiography to Decrease the Risk of Preeclampsia

NCT03245970

Sponsor

University of Tennessee Medical Center

Status

Withdrawn

Last Update Posted

Aug 5, 2020Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Chronic Hypertension Complicating Pregnancy (Diagnosis)
Preeclampsia

Interventions

Labetalol Hydrocholoride 200 mg orally every 12 hours
Nifedipine 60 mg orally daily
Atenolol 25 mg daily

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator retired. Other investigators did not want to continue study.

Expanded Access Info

Start Date

Apr 24, 2017Actual

Primary Completion Date

Feb 29, 2020Actual

Completion Date

Feb 29, 2020Actual

First Submitted Date

Aug 8, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2020

Last Update Posted Date

Aug 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine if the use of impedance cardiography can identify appropriate medications for use in treating chronic hypertensive patients to decrease the risk of preeclampsia.

Detailed Description

Impedance cardiography helps determine whether vasoconstriction or an elevated cardiac output is occurring. The test is easy to perform and non invasive. The treatment for an elevated cardiac output in pregnancy is a beta-blocker while a vasodilator is used for vasoconstriction. If a beta-blocker is given to someone that vasoconstricted, this might make the cardiovascular parameters worse, leading to no improvement in future pregnancy issues. Likewise, if a vasoconstricting drug is given to someone with an elevated cardiac output, it could potentially make the cardiovascular parameters worse.

All centers in the United States that choose to prescribe an antihypertensive medication for use in pregnancy do so by trial and error, whereas impedance cardiography can help the clinician choose the best medication from the start. Many pregnant patient patients have chronic hypertension and this population is at increased risk for superimposed preeclampsia and other pregnancy complications. The current recommendation for pregnancy is to NOT treat mild hypertension because studies have not shown any benefit. These studies, have also not shown any harm. Prior studies that have shown no benefit to treatment of mild hypertension in pregnancy may be hampered by choosing the wrong antihypertensive medication, thereby not improving the rate of superimposed preeclampsia and other pregnancy related complications.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Arm	Active Comparator	Treatment arm patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years. Intervention: Labetalol Hydrocholoride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily	Drug: Labetalol Hydrocholoride 200 mg orally every 12 hours Drug: Nifedipine 60 mg orally daily Drug: Atenolol 25 mg daily
Non Treatment	No Intervention	Non treatment Arm patients who are randomized to the non-treatment arm will not receive antihypertensive medications.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Labetalol Hydrocholoride 200 mg orally every 12 hours	Drug	Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography	Treatment Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rates of preeclampsia in chronically hypertensive pregnant women	Rates of preeclampsia in chronically hypertensive pregnant women	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant patients 18-51 years old Less than 20 weeks gestation with mild chronic hypertension - Not on antihypertensive medications

Exclusion Criteria:

Patients with an allergy to antihypertensive medication or contraindication for their usage such as certain cardiac or neurologic disorder during pregnancy Patients who have a blood pressure 140/90 or greater -

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

51 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kimberly Fortner, MD	University of Tennessee Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HIgh Risk Obstetrical Consultants		Knoxville	Tennessee	37920	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007741	Labetalol
D009543	Nifedipine
D001262	Atenolol

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided