PEPPI Study: Identification of Women at Risk for Placental Dysfunction
Recruiting · NCT06115122 · Observational (researchers observe without assigning treatment) · Lead sponsor: Oulu University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Pre-eclampsia screening program
What this trial is about
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 arterial pressure (MAP) in a Finnish general population. Condition or disease: pre-eclampsia, intrauterine growth restriction, polycystic ovary syndrome
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- The Wellbeing Services County of North Ostrobothnia - Oulu, Finland