Gestational Changes in Hemodynamics and Respiratory Mechanics in Association With Pre-Eclampsia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This study focuses on elucidating the changes of hemodynamics assessed by USCOM and respiratory mechanics assessed by impedance oscillometry (IOS) over the course of pregnancy and the postpartum period. Additionally, to understand how these changes over the course of gestation relate to the development of preeclampsia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant patient
Aged 18-50 years old
Planning to deliver in Mount Sinai Health System
Disqualifiers
Multiple gestation (i.e., twins)
Known fetal anomalies or genetic abnormalities
Trial population
Patients attending prenatal visits at Mount Sinai will be screened for eligibility by study staff.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Observational Group
Trial outcomes
Primary outcomes
1
Stroke Volume
The volume of blood pumped out of the left ventricle of the heart with each heartbeat.
Time frame
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum2
Cardiac Output
The total volume of blood pumped out of the heart and into the rest of the body with each heartbeat.
Time frame
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum3
Systemic Vascular Resistance
The level of force (or resistance) against which the heart must work to pump blood into the circulatory system.
Time frame
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum4
Cardiac Index
A measure of the pumping capacity of the heart, calculated by dividing one's cardiac output by their body surface area.
Time frame
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks PostpartumSecondary outcomes
1
Number of Gestational Hypertension
A state of high blood pressure triggered by the physiological changes specific to pregnancy.
Time frame
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum2
Number of Preeclampsia
A pregnancy-related complication characterized by high blood pressure and systemic organ dysfunction that can be life-threatening.
Time frame
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum3
Number of Fetal Growth Restriction
A complication where the fetus is growing much less than expected for the gestational age of the pregnancy (i.e., estimated fetal weight and/or fetal abdominal circumstance less than the 10th percentile).
Time frame
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum4
Number of Spontaneous Preterm Birth
The spontaneous (labor not induced) delivery of a pregnancy before 37.0 weeks of gestation.
Time frame
1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks PostpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: