Status:
RECRUITING
PEPPI Study: Identification of Women at Risk for Placental Dysfunction
Lead Sponsor:
Oulu University Hospital
Collaborating Sponsors:
PerkinElmer, Inc.
Roche Diagnostics GmbH
Conditions:
Pre-Eclampsia
Intrauterine Growth Restriction
Eligibility:
All Genders
Brief Summary
The main purpose of this study is to evaluate Fetal Medicine Foundation's pre-eclampsia risk calculator using maternal characteristics, first trimester serum placental growth factor (PlGF) and mean ar...
Detailed Description
According to power calculations, altogether 3000 pregnant women will be recruited into PEPPI-study in Oulu area. Women will be recruited during their first visit to maternity care. Women will have blo...
Eligibility Criteria
Inclusion
- Mothers
- Inclusion Criteria for PEPPI-study
- Pregnant (first trimester)
- Understands Finnish
- ≥18 years
- Signed informed consent
- Exclusion Criteria
- Multiple pregnancy
- Miscarriage/termination of the index pregnancy
- No first trimester blood sampling
- Inclusion Criteria for FERPPI-study
- Participates in PEPPI-study (criteria above)
- Blood samples at first and third trimester of pregnancy
- Permits blood sampling from the umbilical cord when the baby is born
- Exclusion Criteria
- No first or third trimester blood sampling
- No umbilical cord blood sample after baby is born
- Fathers
- Inclusion Criteria
- Biological father to the child born for the mother who participated in PEPPI study
- ≥18 years
- Signed informed consent
- Exclusion Criteria
- • Does not understand Finnish
- Children
- Inclusion Criteria for PEPPI-study
- Born to mother who participated in PEPPI study
- Signed informed consent from parent(s)
- Exclusion Criteria
- • No consent from parent(s)
- Inclusion Criteria for PEPPI-offspring study • Mother in risk-, control-, or PCOS group during PEPPI-study with ultrasound information at gestational weeks 30-32 or a mother who developed pre-eclampsia during the pregnancy regardless of their study group during PEPPI-study
- Exclusion Criteria
- • Mother/father declines participation
- Inclusion Criteria for FERPPI-study
- Signed informed consent from parent(s)
- Mother has blood samples taken at first and third trimester (iron status)
- Child has blood samples taken at birth and at 3 months of age
- Exclusion Criteria
- No consent from parent(s)
- No blood samples from mother
- No blood samples from child
Exclusion
Key Trial Info
Start Date :
February 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2041
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06115122
Start Date
February 15 2022
End Date
December 31 2041
Last Update
August 5 2025
Active Locations (1)
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1
The Wellbeing Services County of North Ostrobothnia
Oulu, Finland, 90100