NCT06115122 PEPPI Study: Identification of Women at Risk for Placental Dysfunction
| NCT ID | NCT06115122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oulu University Hospital |
| Condition | Pre-Eclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2022-02-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2022-02-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 arterial pressure (MAP) in a Finnish general population. Condition or disease: pre-eclampsia, intrauterine growth restriction, polycystic ovary syndrome
Eligibility 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
Contact & Investigator
Jaana Nevalainen, Assoc prof
PRINCIPAL INVESTIGATOR
The Wellbeing Services County of North Ostrobothnia
Frequently Asked Questions
Who can join the NCT06115122 clinical trial?
This trial is open to participants of all sexes, studying Pre-Eclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06115122 currently recruiting?
Yes, NCT06115122 is actively recruiting participants. Contact the research team at jaana.nevalainen@oulu.fi for enrollment information.
Where is the NCT06115122 trial being conducted?
This trial is being conducted at Oulu, Finland.
Who is sponsoring the NCT06115122 clinical trial?
NCT06115122 is sponsored by Oulu University Hospital. The principal investigator is Jaana Nevalainen, Assoc prof at The Wellbeing Services County of North Ostrobothnia. The trial plans to enroll 3,000 participants.