An observational study in Pre-Eclampsia, Intrauterine Growth Restriction and Polycystic Ovary Syndrome, sponsored by Oulu University Hospital. Recruiting at 1 site in Finland. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Oulu University Hospital · Observational
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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
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.
917 studies on the registry are indexed under Pre-Eclampsia; 244 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Oulu University Hospital is the lead sponsor of 40 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Mothers
Inclusion Criteria for PEPPI-study
Exclusion Criteria
Inclusion Criteria for FERPPI-study
Exclusion Criteria
Fathers
Inclusion Criteria
Exclusion Criteria
Children
Inclusion Criteria for PEPPI-study
Exclusion Criteria
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
Inclusion Criteria for FERPPI-study
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 300 women will be enrolled into a risk group according to a pre-eclampsia risk calculator.
Other: Pre-eclampsia screening program
Women enrolled into study who fulfill ≥2 Rotterdam criteria. Women with PCOS may be included in risk- or control groups.
Other: Pre-eclampsia screening program
Approximately 300 women in low risk for pre-eclampsia according to a pre-eclampsia risk calculator.
Other: Pre-eclampsia screening program
Approximately 2100 women who are not enrolled into risk-, control- or PCOS groups.
Other: Pre-eclampsia screening program
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).
The role of fathers in the development of pregnancy complications and on the health of the offspring.
Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
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
Time frame: 20 weeks through discharge following delivery
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.
Time frame: 20 weeks through discharge following delivery
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.
Time frame: 20 weeks through discharge following delivery
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.
Time frame: 20 weeks through discharge following delivery
Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level
Elevated serum creatinine defined as ≥90 µmol/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.
Time frame: 20 weeks through discharge following delivery
Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure
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.
Time frame: 20 weeks through discharge following delivery
Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32-34-37 Weeks of Gestation Owing to Hypertension-related Disorders
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.
Time frame: 20 weeks through discharge following delivery
Severe or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the - 2 SD) Adjusted for Sex and Race or Ethnic Group
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.
Time frame: 20 weeks through discharge following delivery
Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death
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.
Time frame: 20 weeks through discharge or prior to discharge following delivery admission
Prevalence of high pre-eclampsia risk score in women with PCOS compared to non-PCOS women
Pre-eclampsia risk score is calculated with LifeCycle risk calculation program and a risk of 1:100 or higher is considered as high risk for pre-eclampsia.
Time frame: at 13 gestational weeks
11. All the above mentioned outcomes (1-10) in PCOS group compared to non-PCOS group.
As described above.
Time frame: 13 gestational weeks through discharge following delivery
The height of the child during the first year of life.
Measurement of height (cm)
Time frame: At 0, 3 and 6-12 months of age
The weight of the child during the first year of life.
Measurement of weight (g, kg)
Time frame: At 0, 3 and 6-12 months of age
The body mass index (BMI) of the child during the first year of life.
Measurements of height (cm) and weight (kg) combined as BMI (kg/m2)
Time frame: At 0, 3 and 6-12 months of age
Basic blood count
B-Hb, B-Leuk, B-Hkr, B-Eryt, E-MCV, E-RDW, E-MCH, E-MCHC, B-Trom
Time frame: At 0, 3 and 6-12 months of age
Ferritin
Time frame: At 0, 3 and 6-12 months of age
Hepcidin
Time frame: At 0, 3 and 6-12 months of age
Saturation of transferrin
Time frame: At 0, 3 and 6-12 months of age
Hypersensitive-C-reactive protein
Time frame: At 0, 3 and 6-12 months of age
Anti-mullerian hormone
Time frame: At 3 and 6-12 months of age
Cortisol
Time frame: At 3 and 6-12 months of age
Corticotropin
Time frame: At 3 and 6-12 months of age
Dehydroepiandrosterone
Time frame: At 3 and 6-12 months of age
Progesterone
Time frame: At 3 and 6-12 months of age
Inhibin-B
Time frame: At 3 and 6-12 months of age
Luteinizing hormone
Time frame: At 3 and 6-12 months of age
Follicle stimulating hormone
Time frame: At 3 and 6-12 months of age
Testosterone (boys)
Time frame: At 3 and 6-12 months of age
Estradioli (girls)
Time frame: At 3 and 6-12 months of age
Vitamin D
Time frame: At 3 and 6-12 months of age
Calcium
Time frame: At 3 and 6-12 months of age
Phosphate
Time frame: At 3 and 6-12 months of age
Alkaline phosphatase
Time frame: At 3 and 6-12 months of age
Parathyroid hormone
Time frame: At 3 and 6-12 months of age
Clinical examination of genitals
Measurement of perineum with centimeters (cm)
Time frame: At 0, 3 and 6-12 months of age
Clinical examination of mammary glands
Measurement with millimeters (mm)
Time frame: At 3 and 6-12 months of age
Sebum measurement
Measurement is done with Sebumeter ®. The cassette is placed on the skin for a defined length of time and then returned to the aperture. The change in the amount of light transmission represents the sebum content of the tape, which is displayed in units from 0-350.
Time frame: At 3 and 6-12 months of age
Heart auscultation with stethoscope.
Time frame: At 3 and 6-12 months of age
Ultrasound scan of the heart (echo)
Time frame: At 3 and 6-12 months of age
Birth Weight
Grams
Time frame: At birth
Small for Gestational Age
A baby whose birth weight is less than the - 2 standard deviations is considered to be small for gestational age (adjusted for sex and race or ethnic group)
Time frame: At birth
Large for gestational age
A baby whose birth weight is more than the + 2 standard deviations is considered to be small for gestational age (adjusted for sex and race or ethnic group)
Time frame: At birth
Admission to NICU
NICU denotes neonatal intensive care unit.
Time frame: Delivery through discharge up to 18 weeks
Apgar Score ≤3 at 5 Minutes
Time frame: At birth
Fetal iron deficiency
Fetal iron deficiency defined by reticulocyte hemoglobin \< 29 pg from umbilical cord blood collected at birth
Time frame: At birth
Iron deficiency during third trimester of pregnancy
Iron deficiency defined as serum ferritin \< 30 µg/l at gestational weeks 30-32 with or without anemia defined as Hb ≤ 110 g/l.
Time frame: At 30-32 weeks of gestation
Severe iron deficiency during third trimester of pregnancy
Iron deficiency defined as serum ferritin \< 15 µg/l at gestational weeks 30-32 with or without anemia defined as Hb ≤ 110 g/l.
Time frame: At 30-32 weeks of gestation
Pre-eclampsia (Mild, Severe, HELLP Syndrome, Eclampsia).
HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.
Time frame: 20 weeks through discharge following delivery.
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.
Time frame: 20 weeks through discharge following delivery.
Pregnancy Associated Hypertension.
Women with Hypertension after pregnancy week 20.
Time frame: 20 weeks through discharge following delivery.
Medically Indicated Delivery Because of Hypertension.
Time frame: 20 weeks through discharge following delivery.
Fetal Weight Estimation under 3rd percentile at gestational weeks 30-32 ultrasound scan.
Time frame: 30-32 weeks.
Abnormal uterine artery pulsatility index at gestational weeks 30-32 ultrasound scan
According to calculator provided by Fetal Medicine Foundation (https://fetalmedicine.org/research/utpi).
Time frame: At 30-32 weeks.
Aspartate Aminotransferase ≥100 U/Liter.
Time frame: 20 weeks through discharge.
Creatinine ≥90 µmol/l.
Time frame: 20 weeks through discharge.
Massive postpartum hemorrhage.
Massive postpartum hemorrhage defined≥ 1000ml blood loss within 24 hours after child birth.
Time frame: From delivery to 24 hours after child birth
Premature Rupture of Membranes.
If the water breaks before the 37th week of pregnancy, it is called preterm premature rupture of membranes (PPROM).
Time frame: From 22nd gestational week until delivery
Placental Abruption.
Defined as the placenta separates from the inner wall of the uterus before birth.
Time frame: From 22nd gestational week until delivery
Gestational Diabetes.
Defined as abnormal glucose tolerance test during pregnancy (≥ 5.3 mmol/l (0 h), ≥ 10.0 mmol/l (1 h) and/or ≥ 8.6 mmol/l (2 h). Treatment either with diet or medicine (metformin and/or insulin therapy).
Time frame: From gestation until delivery
Cesarean Delivery.
Time frame: At Birth.
Vacuum Extraction Delivery.
Time frame: At Birth.
Maternal Death.
Time frame: During pregnancy or within 42 days after delivery
Postpartum Pulmonary Edema.
Time frame: Within 42 days after delivery
Hematocrit ≤24% With Transfusion.
Time frame: Within 42 days after delivery
Maternal Hospital Stay.
Duration of the time spend at the hospital after delivery (measured as days and weeks)
Time frame: Within 42 days after delivery
Gestational Age at Delivery.
Time frame: At Delivery.
Perineal Lacerations.
Defined as first, second, third or fourth degree lacerations during birth.
Time frame: At Birth.
Number of Visits to Maternity Health Care During Pregnancy.
Time frame: From gestation until delivery, on average during 9 months
Number of Visits at Tertiary Maternity Care Hospital.
Time frame: From gestation until delivery, on average during 9 months
Fetal Death.
Time frame: From 22nd gestational week until delivery
Neonatal Death.
Time frame: Birth until 4 weeks' of age
Respiratory Distress Syndrome.
Time frame: Birth until 4 weeks' of age
Intraventricular Hemorrhage, Grade III or IV.
Time frame: Birth until 4 weeks' of age
Neonatal sepsis.
Time frame: Birth until 4 weeks' of age
Necrotizing Enterocolitis.
Time frame: Birth until 4 weeks' of age
Retinopathy of Prematurity.
Time frame: Birth until 4 weeks' of age
Neonatal Hospital Stay.
Time frame: Birth until 18 weeks' of age
Umbilical artery pulsatility index
Measured with Doppler ultrasound
Time frame: At 30-32 gestational weeks
Mean cerebral artery pulsatility index
Measured with Doppler ultrasound
Time frame: At 30-32 gestational weeks
Ductus venousus pulsatility index
Measured with Doppler ultrasound
Time frame: At 30-32 gestational weeks
Fetal weight estimation
Measured with ultrasound using fetal BPD, HC, AC and FL measurements (Hadlock)
Time frame: At 30-32 gestational weeks
Amniotic fluid measurement
Ultrasound measurements of maximum velocity pocket (cm) and amniotic fluid index (cm)
Time frame: At 30-32 gestational weeks
Estimation of fetal movement during ultrasound scan
Estimated as a whole with inspection of body movements, limb movements and breathing movement
Time frame: At 30-32 gestational weeks
Apgar Score ≤7 at 5 minutes.
Time frame: At birth.
Blood transfusion.
Defined as red blood cell transfusion received by patient (mother or child).
Time frame: From 22nd pregnancy week until four weeks after delivery
Plan to share: Yes — Data will deposited into Oulu University Hospital's and Oulu University's data bank.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data is available on request 10 years from study completion
Access criteria: Data available according to policies of the Oulu University Hospital and Oulu University.
Started Feb 2022 (actual). Primary completion is estimated for Dec 2027, 70 months after the start.
Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 70 months is above that.
Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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