The Wellbeing Services County of North Ostrobothnia
Oulu, 90100, Finland
Location status: Recruiting
NCT Number: NCT06115122
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
Interested in participating?
Request InfoAll sexes
Observational
Oulu, 90100, Finland
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
Time frame: 20 weeks through discharge following delivery
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
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
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
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
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
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
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
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
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: at 13 gestational weeks
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: 13 gestational weeks through discharge following delivery
As described above.
Time frame: At 0, 3 and 6-12 months of age
Measurement of height (cm)
Time frame: At 0, 3 and 6-12 months of age
Measurement of weight (g, kg)
Time frame: At 0, 3 and 6-12 months of age
Measurements of height (cm) and weight (kg) combined as BMI (kg/m2)
Time frame: At 0, 3 and 6-12 months of age
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
Time frame: At 0, 3 and 6-12 months of age
Time frame: At 0, 3 and 6-12 months of age
Time frame: At 0, 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 3 and 6-12 months of age
Time frame: At 0, 3 and 6-12 months of age
Measurement of perineum with centimeters (cm)
Time frame: At 3 and 6-12 months of age
Measurement with millimeters (mm)
Time frame: At 3 and 6-12 months of age
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
Time frame: At 3 and 6-12 months of age
Time frame: At birth
Grams
Time frame: At birth
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
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: Delivery through discharge up to 18 weeks
NICU denotes neonatal intensive care unit.
Time frame: At birth
Time frame: At birth
Fetal iron deficiency defined by reticulocyte hemoglobin < 29 pg from umbilical cord blood collected at birth
Time frame: At 30-32 weeks of gestation
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
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: 20 weeks through discharge following delivery.
HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.
Time frame: 20 weeks through discharge following delivery.
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.
Women with Hypertension after pregnancy week 20.
Time frame: 20 weeks through discharge following delivery.
Time frame: 30-32 weeks.
Time frame: At 30-32 weeks.
According to calculator provided by Fetal Medicine Foundation (https://fetalmedicine.org/research/utpi).
Time frame: 20 weeks through discharge.
Time frame: 20 weeks through discharge.
Time frame: From delivery to 24 hours after child birth
Massive postpartum hemorrhage defined≥ 1000ml blood loss within 24 hours after child birth.
Time frame: From 22nd gestational week until delivery
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
Defined as the placenta separates from the inner wall of the uterus before birth.
Time frame: From gestation until delivery
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: At Birth.
Time frame: At Birth.
Time frame: During pregnancy or within 42 days after delivery
Time frame: Within 42 days after delivery
Time frame: Within 42 days after delivery
Time frame: Within 42 days after delivery
Duration of the time spend at the hospital after delivery (measured as days and weeks)
Time frame: At Delivery.
Time frame: At Birth.
Defined as first, second, third or fourth degree lacerations during birth.
Time frame: From gestation until delivery, on average during 9 months
Time frame: From gestation until delivery, on average during 9 months
Time frame: From 22nd gestational week until delivery
Time frame: Birth until 4 weeks' of age
Time frame: Birth until 4 weeks' of age
Time frame: Birth until 4 weeks' of age
Time frame: Birth until 4 weeks' of age
Time frame: Birth until 4 weeks' of age
Time frame: Birth until 4 weeks' of age
Time frame: Birth until 18 weeks' of age
Time frame: At 30-32 gestational weeks
Measured with Doppler ultrasound
Time frame: At 30-32 gestational weeks
Measured with Doppler ultrasound
Time frame: At 30-32 gestational weeks
Measured with Doppler ultrasound
Time frame: At 30-32 gestational weeks
Measured with ultrasound using fetal BPD, HC, AC and FL measurements (Hadlock)
Time frame: At 30-32 gestational weeks
Ultrasound measurements of maximum velocity pocket (cm) and amniotic fluid index (cm)
Time frame: At 30-32 gestational weeks
Estimated as a whole with inspection of body movements, limb movements and breathing movement
Time frame: At birth.
Time frame: From 22nd pregnancy week until four weeks after delivery
Defined as red blood cell transfusion received by patient (mother or child).
Interested in participating?
Request InfoOulu University Hospital
Other
PEPPI Study: Identification of Women at Risk for Placental Dysfunction During the First and Third Trimesters of Pregnancy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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