Clinical trial Recruiting at 1 site Observational

Identifying Women at Risk for Placental Dysfunction

Official title: PEPPI Study: Identification of Women at Risk for Placental Dysfunction During the First and Third Trimesters of Pregnancy

Run by Oulu University Hospital · NCT06115122 · Data updated 2026-11-12

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 typeObservational
SexAll
Enrollment3000 (estimated)
SponsorOulu University Hospital
Academic / other
Locations1 site (Oulu)
StatusRecruiting
StartedFebruary 15, 2022
Main results expectedDecember 31, 2027
Study endsDecember 31, 2041
Registry record updatedAugust 5, 2025
Trial IDNCT06115122 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are pregnant women in their first trimester who understand Finnish and are at least 18 years old.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown success in using risk calculators for pre-eclampsia, indicating that this approach has potential based on previous findings.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.