Identifying Women at Risk for Placental Dysfunction
PEPPI Study: Identification of Women at Risk for Placental Dysfunction During the First and Third Trimesters of Pregnancy
This study is trying to see if a new tool can help identify pregnant women at risk for placental problems by looking at their health information and blood tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Sex | All |
| Sponsor | Oulu University Hospital Academic / other |
| Locations | 1 site (Oulu) |
| Trial ID | NCT06115122 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the Fetal Medicine Foundation's pre-eclampsia risk calculator by analyzing maternal characteristics, first trimester serum placental growth factor (PlGF), and mean arterial pressure (MAP) in a Finnish population. A total of 3000 pregnant women will be recruited during their first maternity care visit, with blood samples collected in the first and third trimesters. Participants will be categorized into risk, control, and polycystic ovary syndrome (PCOS) groups based on pre-eclampsia risk calculations. Additionally, ultrasound scans will be performed for certain groups at 30-32 weeks of gestation to monitor pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women in their first trimester who understand Finnish and are at least 18 years old.
Not a fit: Patients who are not pregnant, have multiple pregnancies, or do not meet the language or age requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of women at risk for placental dysfunction, potentially reducing complications during pregnancy.
How similar studies have performed: Other studies have shown success in using risk calculators for pre-eclampsia, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oulu
- The Wellbeing Services County of North Ostrobothnia — Oulu, Finland (Recruiting)
Study contacts
- Principal investigator: Jaana Nevalainen, Assoc prof — The Wellbeing Services County of North Ostrobothnia
- Study coordinator: Jaana E Nevalainen, Assoc prof
- Email: jaana.nevalainen@oulu.fi
- Phone: +358405801857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.