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
Pregnant (first trimester)
Understands Finnish
≥18 years
Signed informed consent
Multiple pregnancy
Miscarriage/termination of the index pregnancy
No first trimester blood sampling
Participates in PEPPI-study (criteria above)
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.
Cohort
Prospective
Pre-eclampsia screening program
Other interventionPregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
6
Treatment groupsSee each treatment group below.
Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate
Severe hypertension (blood pressure \[BP\]≥ 160/110) or mild hypertension (BP≥140/90) ≥ 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (SGA, below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or neonatal death
Severe Hypertension
Women who had severe hypertension only and those who had severe hypertension with elevated liver enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, medically indicated preterm birth, fetal-growth restriction, or fetal death after 20 weeks of gestation, or neonatal death.
Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels
Elevated liver enzyme levels are specified as an aspartate aminotransferase level of ≥ 100 U/l. Women who met more than one component of the primary outcome are counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia
Thrombocytopenia defined as a platelet count of \<100 × 109/l. Women who meet more than one component of the primary outcome are counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Pre-eclampsia (Mild, Severe, HELLP Syndrome, Eclampsia).
HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.
Superimposed Pre-eclampsia (Mild, Severe, HELLP Syndrome, Eclampsia).
Women with Hypertension before pregnancy week 20. HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.
Pregnancy Associated Hypertension.
Women with Hypertension after pregnancy week 20.
Medically Indicated Delivery Because of Hypertension.
Click on the lead sponsor to view all of their trials.
Oulu University Hospital
Lead sponsor
PerkinElmer, Inc.
Collaborator
Roche Diagnostics GmbH
Collaborator
Academy of Finland
Collaborator
Sigrid Jusélius Foundation
Collaborator
Finnish Medical Foundation
Collaborator
University of Oulu
Collaborator
