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

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.

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