Obesity, MorbidEarly Phase 1NCT03105661
Use of Impedance Cardiography to Decrease the Risk of Pre-eclampsia in Obese Patients
A Early Phase 1 study testing Labetalol Hydrochloride 200 mg, NIFEdipine 60 mg and Atenolol 25 mg in people with Obesity, Morbid and Preeclampsia, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Obesity, Morbid, Preeclampsia
- What is being tested?
- Labetalol Hydrochloride 200 mg, NIFEdipine 60 mg and Atenolol 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2017to 4 Mar 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients 18-51 years old,
- Less than 20 weeks gestation with Morbid Obesity (BMI >/= 40)
- Not on antihypertensive medications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Craig V. Towers, MD, 865-305-8888, ctowers@utmck.edu
Mary Ellen McNeal, BSN, RN, 865-305-8888 ext. 3275, mmcneal@utmck.edu
About this study
Official title: Use of Impedance Cardiography to Decrease the Risk of Preeclampsia in Obese Patients
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.
Read the 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.
- Conditions
- Obesity, Morbid, Preeclampsia
- Being tested
- Labetalol Hydrochloride 200 mg, NIFEdipine 60 mg, Atenolol 25 mg
- Medical subject headings
- Obesity, Morbid, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labetalol Hydrochloride 200 mgDrug
Also called Trandate
Anti-hypertensive prescribed for increased cardiac output as determined by Impedance Cardiography
NIFEdipine 60 mgDrug
Also called Procardia
Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by Impedance Cardiography
Atenolol 25 mgDrug
Also called Tenormin
Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | Patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years.
Labetalol Hydrochloride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily Receives: Drug: Labetalol Hydrochloride 200 mg; Drug: NIFEdipine 60 mg; Drug: Atenolol 25 mg |
| Non-treatment Arm | No intervention | Patients who are randomized to the non-treatment arm will not receive antihypertensive medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of preeclampsia in morbidly obese pregnant women
Rates of preeclampsia in morbidly obese pregnant women
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start4 Apr 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion4 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to treatment or non treatment group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Ellen McNeal, University of Tennessee Graduate School of Medicine
- Investigators
- Craig V. Towers, MD, Principal investigator, University of Tennessee Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105661
- Sponsor's protocol ID
- 4226
- Status last verified
- Feb 2019
- First submitted
- 4 Apr 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Impedance Cardiography to Decrease the Risk of Preeclampsia in Obese Patients
- ClinicalTrials.gov ID
- NCT03105661
- Acronym / sponsor ID
- 4226
- Conditions
- Obesity, Morbid, Preeclampsia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 4 Mar 2020 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to treatment or non treatment group
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Drug: Labetalol Hydrochloride 200 mg, Drug: NIFEdipine 60 mg, Drug: Atenolol 25 mgPatients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years. Labetalol Hydrochloride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily |
| Non-treatment Arm | No intervention | –Patients who are randomized to the non-treatment arm will not receive antihypertensive medications. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant patients 18-51 years old,
- Less than 20 weeks gestation with Morbid Obesity (BMI >/= 40)
- Not on antihypertensive medications
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labetalol Hydrochloride 200 mgAlso: TrandateAnti-hypertensive prescribed for increased cardiac output as determined by Impedance Cardiography | Drug | Treatment Arm |
| NIFEdipine 60 mgAlso: ProcardiaAnti-hypertensive medication prescribed for increased systemic vascular resistance as determined by Impedance Cardiography | Drug | Treatment Arm |
| Atenolol 25 mgAlso: TenorminAnti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater | Drug | Treatment Arm |
Primary outcome
Rates of preeclampsia in morbidly obese pregnant women
Time frame: 2 years
Rates of preeclampsia in morbidly obese pregnant women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig V. Towers, MD principal investigator
University of Tennessee Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Labetalol Hydrochloride 200 mg, NIFEdipine 60 mg and Atenolol 25 mg in people with Obesity, Morbid and Preeclampsia, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig V. Towers, MD (865-305-8888, ctowers@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of preeclampsia in morbidly obese pregnant women (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.