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SPiral Artery Remodelling (SPAR) in Normal and Complicated Pregnancy

SPiral Artery Remodelling (SPAR) in Normal and Complicated Pregnancy - SPAR study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43217
Enrollment
536
Registered
2016-06-13
Start date
2016-08-08
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

intrauterine growth restriction Intrauterine growth retardation preeclampsia toxemia of pregnancy

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women having preeclampsia/intrauterine growth restriction in need of a caesarean section. Women having a normal pregnancy in need of a caesarean section

Exclusion criteria

Exclusion criteria: Both/Cases: In case of operative complications in terms of, for example, excessive blood loss the surgeon in charge may decide that there is no time to perform the placental biopsies. Congenital abnormalities in the foetus.

Design outcomes

Primary

MeasureTime frame
Primary endpoint is the correlation between pathological score of placental bed from pregnancies complicated by pre-eclampsia or intrauterine growth restriction and cardiovascular health of the mother. Placental bed pathology will be correlated to placental patholgy. De results of the pilot study will also be included in the analysis.

Secondary

MeasureTime frame
- Utilize and further investigate the feasibility of our newly devised scoring system for spiral artery pathology and the myometrium. - Assessments of feasibility, tissue sampling quality and yield for the detection of acute atherosis lesions in the placental bed. - Investigate local maternal-fetal immune interactions involved in spiral artery remodelling (flow cytometry, transciptomic, mRNA, chromatin analysis)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)