Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06314009 |
| Other study ID # |
EH23-302 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2024 |
| Est. completion date |
December 2026 |
Study information
| Verified date |
March 2024 |
| Source |
NorthShore University HealthSystem |
| Contact |
Olivert Mbah |
| Phone |
847-570-2243 |
| Email |
OMbah[@]northshore.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to evaluate the flow of oxygen and blood necessary for nutrient
transfer across the placenta during the second and third trimesters in pregnancy in women who
are obese before pregnancy compared to women who have an average weight before pregnancy.
This study will evaluate blood flow across the placenta by functional Magnetic Resonance
Imaging (fMRI) using arterial spin labeling (ASL). The investigators hypothesize that there
will be differences in placental oxygenation and blood flow among women with obesity as
compared to those with normal weight. Participants will be asked to complete Magnetic
Resonance Imaging scans (MRIs), the first in the second trimester at 20-24 weeks and the
second in the third trimester at 30-34 weeks.
Description:
The transfer of oxygen and nutrients from the mother to the baby across the placenta is
essential to successful pregnancy outcomes. Conversely, poor transfer of oxygen from the
mother to the baby through the placenta is associated with adverse outcomes, including poor
fetal growth, preterm delivery, and stillbirth. Babies need oxygen to maintain good health.
Babies born to women who are obese before pregnancy have a higher risk of experiencing health
problems in pregnancy and long-term health problems such as metabolic syndrome, obesity, and
diabetes. Obesity has continued to increase in the United States over the past decades, and a
quarter of pregnancy complications, such as preterm birth, gestational diabetes,
hypertension, and large gestational infants, can be attributed to maternal obesity.
In this study, the investigators propose using a novel method, arterial spin labeling (ASL))
to measure placental blood flow. The study aims to evaluate the feasibility and reliability
of assessing placental blood flow by this novel method. The investigators will also evaluate
the mean global placental perfusion of second and third trimester placentas among obese women
as compared to those with a normal weight before pregnancy. To provide an innovative and
comprehensive evaluation of placental oxygen delivery and insights into the delivery of
nutrients, investigators will compare global placental perfusion of second and third
trimester placentas with measurements of placental oxygenation by R2* relaxation rates.
