Spiral Artery Remodelling (SPAR) in Normal Pregnancy and Pre-eclampsia * Pilot Study

Spiral Artery Remodelling (SPAR) in Normal Pregnancy and Pre-eclampsia * Pilot Study - SPAR study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39443

Enrollment

Registered

2012-01-11

Start date

2012-05-13

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

preeclampsia toxemia of pregnancy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women having preeclampsia in need of a caesarean section Women having a intra uterine growth restriction in need of a caesarean section Women having a normal pregnancy in need of a caesarean section

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the evaluation of a systematic pathologic scoring system for placental bed lesions	—

Secondary

Measure	Time frame
The secondary endpoint is a feasibility score for placental bed biopsies. Thirdly, vascular pathology between both groups will be compared and scored. Also the additional value of the analysis in Southampton to the scoringsystem will be evaluated. The future endpoint of the main study encompasses the correlation between pathological score of placental bed from pregnancies complicated by pre-eclampsia or intrauterine growth restriction and cardiovascular health of the mother. Therefore samples from the pilot study will also be used for the intended main study.	—

Measure

Time frame

The secondary endpoint is a feasibility score for placental bed biopsies. Thirdly, vascular pathology between both groups will be compared and scored. Also the additional value of the analysis in Southampton to the scoringsystem will be evaluated. The future endpoint of the main study encompasses the correlation between pathological score of placental bed from pregnancies complicated by pre-eclampsia or intrauterine growth restriction and cardiovascular health of the mother. Therefore samples from the pilot study will also be used for the intended main study.

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Countries

Netherlands

Outcome results