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Regulation of vascular function in women with pregnancy disorders

Conditions
10010273
10057166
pregnancy disease
Pregnancy disorder
Registration Number
NL-OMON53670
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
290
Inclusion Criteria

In order to be eligible to participate in this study, a control subject must
meet all of the following criteria:
- Pregnant persons >= 18 years old
- Sufficient command of the Dutch or English language
- Willing to donate a small sample of subcutaneous fat tissue and omental tissue
- Willing to provide written informed consent
- Undergoing elective caesarean section
- Blood pressures in a relatively normal range, which is 90-140
(systolic)/60-90 (diastolic).

In order to be eligible to participate in this study, a study subject must meet
all of the following criteria:
- Women >= 18 years old
- Sufficient command of the Dutch or English language
- Willing to donate a small sample of subcutaneous fat tissue and omental tissue
- Willing to provide written informed consent
- Undergoing elective or emergency caesarean section
- Clinically diagnosed with either one of the following conditions:
preeclampsia, FGR, preterm birth, obesity, dysbiotic microbiome, and diabetes

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Admission to an Intensive Care Unit (ICU) for any reason
- Admission during an obstetric emergency (Control group only)
- A viral infection (SARS-CoV-2 only during the third trimester)
- Severe fetal congenital anomalies
- Placenta praevia, placenta accreta/increta.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The vascular reactivity of arteries from omental tissue, subcutaneous fat and<br /><br>placental tissue will be studied using 1) wire myography to assess vascular<br /><br>contractions and relaxations to agonists, as well as the effects of antagonists<br /><br>on these contractions and relaxations, 2) pressure myography to assess vascular<br /><br>distensibility and flow-mediated vasodilation, 3) biomarker concentrations in<br /><br>maternal and umbilical cord blood, 4) molecular response of placental and<br /><br>vascular cell types.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- To determine if and how alterations in maternal vascular reactivity correlate<br /><br>with alterations in foetoplacental vascular reactivity.<br /><br>- To examine whether (novel) therapeutics can restore this altered response.<br /><br>- To determine if and how alterations in maternal and placental vascular<br /><br>reactivity correlate with biomarker concentrations in maternal blood an<br /><br>umbilical cord blood.<br /><br>- To detect placental alterations at the tissue level and at the molecular<br /><br>level for different cell types contributing to the maternal-placental<br /><br>interface. </p><br>
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