Recruiting

PEPPI Study: Identification of Women at Risk for Placental Dysfunction

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

ClinicalTrials.gov IDNCT06115122

PhaseNot Applicable

Enrollment3000

SponsorOulu University Hospital

AgeNot reported

SexALL

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Conditions studied

Pre-Eclampsia, Intrauterine Growth Restriction, Polycystic Ovary Syndrome, Iron-deficiency, Cardiovascular Diseases, Hypertensive Disorder of Pregnancy, Proteinuria in Pregnancy

About this study

Interventions

Other: Pre-eclampsia screening program — Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.

Primary outcomes

Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate (20 weeks through discharge following delivery)
Severe Hypertension (20 weeks through discharge following delivery)
Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels (20 weeks through discharge following delivery)
Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia (20 weeks through discharge following delivery)
Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level (20 weeks through discharge following delivery)
Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure (20 weeks through discharge following delivery)
Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32-34-37 Weeks of Gestation Owing to Hypertension-related Disorders (20 weeks through discharge following delivery)
Severe or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the - 2 SD) Adjusted for Sex and Race or Ethnic Group (20 weeks through discharge following delivery)

Eligibility information

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

Study locations

The Wellbeing Services County of North Ostrobothnia, Oulu, 90100 Finland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-07.