PEPPI Study: Identification of Women at Risk for Placental Dysfunction

Trial Title: PEPPI Study: Identification of Women at Risk for Placental Dysfunction

NCT ID: NCT06115122

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

Conditions: Official terms:
Toxemia
Polycystic Ovary Syndrome
Eclampsia
Pre-Eclampsia
Proteinuria
Fetal Growth Retardation
Cardiovascular Diseases
Hypertension
Iron Deficiencies

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Pre-eclampsia screening program
Description: Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
Arm group label: Control group
Arm group label: Follow up group
Arm group label: PCOS group
Arm group label: Pre-eclampsia risk group

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

Detailed 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.

Criteria for eligibility:

Study pop:
All pregnant women eligible for the study will be invited to participate the study during their first visit to maternity care. Children born to these women and children's fathers will be asked to participate in the study at the labor hospital.

Sampling method: Non-Probability Sample
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

Gender: All

Gender based: Yes

Gender description: Participants recruited for PEPPI are pregnant women (females), their partners (males) and babies (female/male).

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: The Wellbeing Services County of North Ostrobothnia

Address:
City: Oulu
Zip: 90100
Country: Finland

Status: Recruiting

Contact:
Last name: Jaana E Nevalainen, Assoc Prof

Phone: +358405801857
Email: jaana.nevalainen@oulu.fi

Contact backup:
Last name: Terhi Piltonen, Professor

Phone: +358405008266
Email: terhi.piltonen@oulu.fi

Investigator:
Last name: Marja Ojaniemi, Assoc Prof
Email: Sub-Investigator

Investigator:
Last name: Liisa Laatio, PhD
Email: Sub-Investigator

Investigator:
Last name: Hilkka Nikkinen, PhD
Email: Sub-Investigator

Investigator:
Last name: Pekka Pinola, PhD
Email: Sub-Investigator

Investigator:
Last name: Tiina Kantomaa, MD
Email: Sub-Investigator

Start date: February 15, 2022

Completion date: December 31, 2041

Lead sponsor:
Agency: Oulu University Hospital
Agency class: Other

Collaborator:
Agency: PerkinElmer, Inc.
Agency class: Industry

Collaborator:
Agency: Roche Diagnostics GmbH
Agency class: Industry

Collaborator:
Agency: Academy of Finland
Agency class: Other

Collaborator:
Agency: Sigrid Jusélius Foundation
Agency class: Other

Collaborator:
Agency: Finnish Medical Foundation
Agency class: Other

Collaborator:
Agency: University of Oulu
Agency class: Other

Source: Oulu University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06115122
http://www.peppitutkimus.fi
http://thl.fi/fi/web/lapset-nuoret-ja-perheet/sote-palvelut/aitiys-ja-lastenneuvola/aitiysneuvola