Post Partum, Pre-eclampsia, Pregnancy
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant patient * Aged 18-50 years old * Planning to deliver in Mount Sinai Health System
Exclusion criteria
* Multiple gestation (i.e., twins) * Known fetal anomalies or genetic abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Volume | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | The volume of blood pumped out of the left ventricle of the heart with each heartbeat. |
| Cardiac Output | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | The total volume of blood pumped out of the heart and into the rest of the body with each heartbeat. |
| Systemic Vascular Resistance | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | The level of force (or resistance) against which the heart must work to pump blood into the circulatory system. |
| Cardiac Index | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | A measure of the pumping capacity of the heart, calculated by dividing one's cardiac output by their body surface area. |
| R5 | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | A respiratory measure of the resistance across all airways, both large and small, using 5Hz soundwaves. |
| R20 | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | A respiratory measure of the resistance across central/large airways only, using 20Hz soundwaves. |
| X5 | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | A respiratory measure of the elasticity of airways using 5Hz soundwaves to calculate the difference in energy to and from lung tissue. |
| Fres | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | This denotes the Resonant Frequency, which measures the frequency of soundwaves required to balance the internal forces of the lung tissue with its external capacity. |
| AX | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | Called the Area of Reactance, this is the measure of the area under the curve from the lowest measured frequency to the Resonant Frequency, and reflects the dysfunction of small airways. |
| R5-R20 | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | A measure isolating the resistance of small airways, subtracting the R20 value from the R5 value to calculate the difference. Greater levels of this value correspond to greater small airway resistance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Gestational Hypertension | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | A state of high blood pressure triggered by the physiological changes specific to pregnancy. |
| Number of Preeclampsia | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | A pregnancy-related complication characterized by high blood pressure and systemic organ dysfunction that can be life-threatening. |
| Number of Fetal Growth Restriction | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | 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). |
| Number of Spontaneous Preterm Birth | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | The spontaneous (labor not induced) delivery of a pregnancy before 37.0 weeks of gestation. |
| Number of Placental Abruption | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | A serious complication where the placenta detaches from the inside of the uterus prior to the delivery of the baby. |
| Number of Intensive Care Unit (ICU) Admission | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | Admission to the Intensive Care Unit (ICU) wherein a greater level of clinical surveillance and intervention is administered for higher severity cases. |
| Number of Adverse Neonatal Outcomes | 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum | Any adverse health outcomes experienced by the neonate following delivery (i.e., hypoglycemia, tachypnea, respiratory distress, acidemia). |
Countries
United States
Contacts
CONTACTNicola F Tavella, MPH
PRINCIPAL_INVESTIGATORAngela Bianco, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed