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Use of Impedance Cardiography to Decrease the Risk of Pre-eclampsia in Obese Patients

Use of Impedance Cardiography to Decrease the Risk of Preeclampsia in Obese Patients

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03105661
Enrollment
400
Registered
2017-04-10
Start date
2017-04-04
Completion date
2020-03-04
Last updated
2019-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid, Preeclampsia

Brief summary

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

Detailed description

Research Protocol Use of Impedance Cardiography to decrease the risk of preeclampsia in obese patients Background: Obesity is epidemic in the United States and this is leading to an increase in the number of pregnant patients with obesity. Obesity, especially morbid obesity (BMI \>/= 40), increases the risk of developing preeclampsia when compared to the non-obese population. Impedance Cardiography has never been used to evaluate this patient population to see if they have abnormal cardiac output and/or abnormal peripheral resistance. If identified, low dose medical treatment can be done to normalize these patterns early on to see if this treatment modality decreases the development of preeclampsia and other pregnancy complications. Specific Aims: The primary aim of this study is to determine if the use of Impedance Cardiography can help identify the appropriate medicine for use in treating morbidly obese patients that have abnormal testing results, to see if by normalizing impedance cardiography testing parameters results in a decrease in the incidence of preeclampsia in general and other pregnancy complications. Enrollment: All pregnant patients, 18-51 years old, less than 20 weeks pregnant, with a BMI \>/= 40 will undergo impedance cardiography and if the results are abnormal, will be provided informed consent to participate. If consent is given, and blood pressure is \< 140/90,they will be eligible for enrollment. Randomization: All patients who meet criteria will undergo impedance cardiography. Those with abnormal results will be randomized as the whether they will be treated or not. Randomization will require they blindly pull a paper labelled yes or no from a container. Those who select yes will be randomized to the treatment arm and will be prescribed antihypertensive medications commonly used in obstetrics for hypertension (labetalol, nifedipine, atenolol) Those who select no will not receive medication. Study Procedure: All pregnant patients that meet study criteria and have abnormal Impedance Cardiography testing will be asked to participate, consented and randomized to the treatment or non treatment arm. The treatment group will receive antihypertensive medications as listed above and undergo monthly cardiography testing after beginning treatment with medication adjustments until normal test results are obtained. The non treatment group will undergo repeat cardiography testing 8 weeks after the first test to compare results. All enrolled patients will be followed with regular prenatal care for their prospective conditions and followed closely for the development of high or low blood pressure and preeclampsia. Adverse events: Adverse events related to this study are minimal because the test is non invasive and complications for Impedance Cardiology are non existent. In addition, the drugs used to treat hypertension have been used in obstetrics for over 30 years with good results and minimal problems.

Interventions

DRUGLabetalol Hydrochloride 200 mg

Anti-hypertensive prescribed for increased cardiac output as determined by Impedance Cardiography

DRUGNIFEdipine 60 mg

Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by Impedance Cardiography

Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater

Sponsors

University of Tennessee Graduate School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Randomization to treatment or non treatment group

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No

Inclusion criteria

* Pregnant patients 18-51 years old, * Less than 20 weeks gestation with Morbid Obesity (BMI \>/= 40) * 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

Design outcomes

Primary

MeasureTime frameDescription
Rates of preeclampsia in morbidly obese pregnant women2 yearsRates of preeclampsia in morbidly obese pregnant women

Countries

United States

Contacts

Primary ContactCraig V. Towers, MD
ctowers@utmck.edu865-305-8888
Backup ContactMary Ellen McNeal, BSN, RN
mmcneal@utmck.edu865-305-8888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026