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ID06115122

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

Led by Oulu University Hospital · Updated on 2025-08-05

3000

Participants Needed

1

Research Sites

730 weeks

Total Duration

On this page

Sponsors

O

Oulu University Hospital

Lead Sponsor

P

PerkinElmer, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Fetal Medicine Foundation's pre-eclampsia risk calculator by using maternal characteristics, first trimester serum placental growth factor (PlGF), and mean arterial pressure (MAP) in a general Finnish pregnant population. The study focuses on pre-eclampsia, intrauterine growth restriction, and polycystic ovary syndrome (PCOS), aiming to identify women at risk for placental dysfunction during pregnancy. This observational study will recruit 3000 pregnant women in the Oulu area and includes substudies investigating children's health and pregnancy characteristics in women with PCOS. Participants will be divided into risk, control, and PCOS groups based on the pre-eclampsia risk calculator and a questionnaire applying Rotterdam criteria for PCOS. Blood samples will be collected during the first and third trimesters. Certain groups will have additional ultrasound scans at 30-32 weeks gestation. Fathers and children will also be recruited for long-term follow-up. The study includes substudies investigating placental insufficiency, iron deficiency, and pregnancy outcomes related to PCOS. During the study, participants will provide blood samples and complete questionnaires. Ultrasound scans and pregnancy monitoring occur at specified gestational weeks. Researchers will track pregnancy-associated hypertension, birth outcomes, and child development through clinical examinations and blood tests up to 12 months of age. Fathers and children will be followed with health data collected from national registers until children reach 15 years. The study aims to measure various maternal and child health outcomes including blood markers, growth, and pregnancy complications.

CONDITIONS

Brief Title

PEPPI Study: Identification of Women at Risk for Placental Dysfunction

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women in their first trimester
  • At least 18 years old
  • Understands Finnish
  • Signed informed consent
  • Participates in blood sampling during first and third trimesters (FERPPI study)
  • Permits umbilical cord blood sampling at birth (FERPPI study)
  • Biological fathers of children born to participating mothers
  • Signed informed consent for fathers
  • Children born to participating mothers with parental consent
  • Mothers in risk, control, or PCOS groups with ultrasound at 30-32 weeks or who developed pre-eclampsia
  • Signed informed consent for children in FERPPI study
Not Eligible

You will not qualify if you...

  • Multiple pregnancy
  • Miscarriage or termination of current pregnancy
  • No first trimester blood sampling
  • No third trimester blood sampling (FERPPI study)
  • No umbilical cord blood sample after birth (FERPPI study)
  • Fathers who do not understand Finnish
  • No parental consent for children
  • Mother or father declines child participation in offspring study
  • No blood samples from mother or child (FERPPI study)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during first trimester maternity care visit

Monitoring during Pregnancy

Duration - From first trimester to 32 weeks of gestation

Participants have blood samples collected during the first and third trimesters and may have an ultrasound scan at 30-32 weeks of gestation depending on group assignment.

At least 2 visits for blood sampling and 1 ultrasound scan for some participants

Birth and Immediate Postnatal Period

Duration - From delivery through discharge up to 18 weeks

Health information of mothers, fathers, and newborn children is collected at birth and during the immediate postnatal period.

1 visit at birth plus follow-up assessments during hospital stay

Long-term Monitoring of Children

Duration - Up to 15 years after birth

Children born to participating mothers are followed for health outcomes through national registers and periodic assessments up to 15 years of age.

Periodic assessments at birth, 3 months, and 6-12 months; long-term follow-up via health records

Trial Site Locations

Total: 1 location

1

The Wellbeing Services County of North Ostrobothnia

Oulu, Finland, 90100

Actively Recruiting

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Research Team

J

Jaana E Nevalainen, Assoc prof

T

Terhi Piltonen, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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Published Research Related To This Trial

Increased maternal pregnancy complications in polycystic ovary syndrome appear to be independent of obesity-A systematic review, meta-analysis, and meta-regression.

Mahnaz Bahri Khomami, Anju E Joham, Jacqueline A Boyle...

https://pubmed.ncbi.nlm.nih.gov/30674081

Placental Growth Factor Is Secreted by the Human Endometrium and Has Potential Important Functions during Embryo Development and Implantation.

Natalie K Binder, Jemma Evans, Lois A Salamonsen...

https://pubmed.ncbi.nlm.nih.gov/27711226

Cord transferrin and ferritin values in newborn infants at risk for prenatal uteroplacental insufficiency and chronic hypoxia.

U M Chockalingam, E Murphy, J C Ophoven...

https://pubmed.ncbi.nlm.nih.gov/3612404

Evidence for central hypercortisolism and elevated blood pressure in adolescent offspring of mothers with pre-eclampsia.

David Henley, Suzanne Brown, Craig Pennell...

https://pubmed.ncbi.nlm.nih.gov/27144974