PEPPI Study: Identification of Women at Risk for Placental Dysfunction

Oulu University Hospital

Status: Enrolling

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

Treatments: Other: Pre-eclampsia screening program

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT06115122

OuluUH_PEPPI

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

3,000 participants in 6 patient groups

Pre-eclampsia risk group

Description:

Approximately 300 women will be enrolled into a risk group according to a pre-eclampsia risk calculator.

Treatment:

Other: Pre-eclampsia screening program

PCOS group

Description:

Women enrolled into study who fulfill ≥2 Rotterdam criteria. Women with PCOS may be included in risk- or control groups.

Treatment:

Other: Pre-eclampsia screening program

Control group

Description:

Approximately 300 women in low risk for pre-eclampsia according to a pre-eclampsia risk calculator.

Treatment:

Other: Pre-eclampsia screening program

Follow up group

Description:

Approximately 2100 women who are not enrolled into risk-, control- or PCOS groups.

Treatment:

Other: Pre-eclampsia screening program

Children

Description:

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

Description:

The role of fathers in the development of pregnancy complications and on the health of the offspring.