PEPPI Study: Identification of Women at Risk for Placental Dysfunction

Cardiovascular Diseases Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

According to power calculations, altogether 3000 pregnant women will be recruited into PEPPI-study in Oulu area. Women will be recruited during their first visit to maternity care. Women will have blood samples for study purposes at first and third trimester of pregnancy. Participants will be divided into risk-, control- and polycystic ovary syndrome (PCOS) groups according to pre-eclampsia risk calculation program and questionnaire (PCOS: Rotterdam criteria) (N=300/group). Half of the women in risk- and control groups and all women in PCOS group will have a pregnancy ultrasound scan at 30-32 weeks of gestation. Fathers and children will be recruited at the Oulu University Hospital when the child is born.

Studies within PEPPI-study:

PEPPI-offspring: Children born for those 600 women in risk-, control and PCOS groups who have an extra ultrasound at gestational weeks 30-32 during PEPPI-study and children whose mother developed pre-eclampsia during the pregnancy regardless of her study group during PEPPI-study are recruited into PEPPI-offspring study. PEPPI-offspring study investigates the short- and long-term consequences of placental insufficiency/pre-eclampsia on the health of the children.

PEPPI-PCOS: Investigates pregnancy characteristics of women with PCOS. Women with PCOS form PCOS study group, have additional ultrasound scan at gestational weeks 30-32 and their children are recruited into PEPPI-offspring study.

FERPPI: FERPPI study investigates the possible connection between placental insufficiency and iron deficiency with or without anemia in both pregnant women and their children after birth. ;

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Eclampsia
• Fetal Growth Retardation
• Hypertension
• Hypertensive Disorder of Pregnancy
• Intrauterine Growth Restriction
• Iron-deficiency
• Polycystic Ovary Syndrome
• Pre-Eclampsia
• Proteinuria
• Proteinuria in Pregnancy
• Toxemia

• NCT number: NCT06115122
• Study type: Observational [Patient Registry]
• Source: Oulu University Hospital
• Contact: Jaana E Nevalainen, Assoc prof
• Phone: +358405801857
• Email: jaana.nevalainen@oulu.fi
• Status: Recruiting
• Start date: February 15, 2022
• Completion date: December 31, 2041