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Regulation of vascular function in women with pregnancy disorders

Regulation of vascular function in women with pregnancy disorders - Vascular function in pregnancy disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53670
Enrollment
290
Registered
2023-08-07
Start date
2023-06-01
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pregnancy disease Pregnancy disorder

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The vascular reactivity of arteries from omental tissue, subcutaneous fat and placental tissue will be studied using 1) wire myography to assess vascular contractions and relaxations to agonists, as well as the effects of antagonists on these contractions and relaxations, 2) pressure myography to assess vascular distensibility and flow-mediated vasodilation, 3) biomarker concentrations in maternal and umbilical cord blood, 4) molecular response of placental and vascular cell types.

Secondary

MeasureTime frame
- To determine if and how alterations in maternal vascular reactivity correlate with alterations in foetoplacental vascular reactivity. - To examine whether (novel) therapeutics can restore this altered response. - To determine if and how alterations in maternal and placental vascular reactivity correlate with biomarker concentrations in maternal blood an umbilical cord blood. - To detect placental alterations at the tissue level and at the molecular level for different cell types contributing to the maternal-placental interface.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)