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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• Pregnant (first trimester)

• Understands Finnish

• ≥18 years

• Signed informed consent

• 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

• Biological father to the child born for the mother who participated in PEPPI study

• ≥18 years

• Signed informed consent

• Born to mother who participated in PEPPI study

• Signed informed consent from parent(s)

• 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

Locations
Other Locations
Finland
The Wellbeing Services County of North Ostrobothnia
RECRUITING
Oulu
Contact Information
Primary
Jaana E Nevalainen, Assoc prof
jaana.nevalainen@oulu.fi
+358405801857
Backup
Terhi Piltonen, Professor
terhi.piltonen@oulu.fi
+358405008266
Time Frame
Start Date: 2022-02-15
Estimated Completion Date: 2041-12-31
Participants
Target number of participants: 3000
Treatments
Pre-eclampsia risk group
Approximately 300 women will be enrolled into a risk group according to a pre-eclampsia risk calculator.
PCOS group
Women enrolled into study who fulfill ≥2 Rotterdam criteria. Women with PCOS may be included in risk- or control groups.
Control group
Approximately 300 women in low risk for pre-eclampsia according to a pre-eclampsia risk calculator.
Follow up group
Approximately 2100 women who are not enrolled into risk-, control- or PCOS groups.
Children
Mothers and fathers will be asked for permission to follow the child's health information from national registers until the age of 15 years. Approximately 300 children will be recruited to PEPPI-offspring follow up study (including also PCOS offspring).
Fathers
The role of fathers in the development of pregnancy complications and on the health of the offspring.
Related Therapeutic Areas
Preeclampsia
Polycystic Ovary Syndrome
Ovarian Cysts
Intrauterine Growth Restriction
Sponsors
Collaborators: PerkinElmer, Inc., Finnish Medical Foundation, Roche Diagnostics GmbH, Academy of Finland, Sigrid Jusélius Foundation, University of Oulu
Leads: Oulu University Hospital

This content was sourced from clinicaltrials.gov

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