PEPPI Study: Identification of Women at Risk for Placental Dysfunction During the First and Third Trimesters of Pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-Eclampsia
- Sponsor
- Oulu University Hospital
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Estradioli (girls)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
Jaana Nevalainen
Associate professor
Oulu University Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Estradioli (girls)
Time Frame: At 3 and 6-12 months of age
Parathyroid hormone
Time Frame: At 3 and 6-12 months of age
Heart auscultation with stethoscope.
Time Frame: At 3 and 6-12 months of age
Phosphate
Time Frame: At 3 and 6-12 months of age
Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia
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.
The weight of the child during the first year of life.
Time Frame: At 0, 3 and 6-12 months of age
Measurement of weight (g, kg)
Luteinizing hormone
Time Frame: At 3 and 6-12 months of age
Testosterone (boys)
Time Frame: At 3 and 6-12 months of age
Sebum measurement
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.
Birth Weight
Time Frame: At birth
Grams
Hepcidin
Time Frame: At 0, 3 and 6-12 months of age
Dehydroepiandrosterone
Time Frame: At 3 and 6-12 months of age
Inhibin-B
Time Frame: At 3 and 6-12 months of age
Small for Gestational Age
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)
Severe Hypertension
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.
Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels
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.
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
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.
Prevalence of high pre-eclampsia risk score in women with PCOS compared to non-PCOS women
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.
The height of the child during the first year of life.
Time Frame: At 0, 3 and 6-12 months of age
Measurement of height (cm)
Basic blood count
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
Cortisol
Time Frame: At 3 and 6-12 months of age
Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level
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.
Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure
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.
Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32-34-37 Weeks of Gestation Owing to Hypertension-related Disorders
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.
Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death
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.
Ferritin
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
Anti-mullerian hormone
Time Frame: At 3 and 6-12 months of age
Alkaline phosphatase
Time Frame: At 3 and 6-12 months of age
Clinical examination of mammary glands
Time Frame: At 3 and 6-12 months of age
Measurement with millimeters (mm)
Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate
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
11. All the above mentioned outcomes (1-10) in PCOS group compared to non-PCOS group.
Time Frame: 13 gestational weeks through discharge following delivery
As described above.
The body mass index (BMI) of the child during the first year of life.
Time Frame: At 0, 3 and 6-12 months of age
Measurements of height (cm) and weight (kg) combined as BMI (kg/m2)
Hypersensitive-C-reactive protein
Time Frame: At 0, 3 and 6-12 months of age
Corticotropin
Time Frame: At 3 and 6-12 months of age
Progesterone
Time Frame: At 3 and 6-12 months of age
Follicle stimulating hormone
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
Clinical examination of genitals
Time Frame: At 0, 3 and 6-12 months of age
Measurement of perineum with centimeters (cm)
Ultrasound scan of the heart (echo)
Time Frame: At 3 and 6-12 months of age
Admission to NICU
Time Frame: Delivery through discharge up to 18 weeks
NICU denotes neonatal intensive care unit.
Apgar Score ≤3 at 5 Minutes
Time Frame: At birth
Iron deficiency during third trimester of pregnancy
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.
Large for gestational age
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)
Fetal iron deficiency
Time Frame: At birth
Fetal iron deficiency defined by reticulocyte hemoglobin \< 29 pg from umbilical cord blood collected at birth
Severe iron deficiency during third trimester of pregnancy
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.
Secondary Outcomes
- Aspartate Aminotransferase ≥100 U/Liter.(20 weeks through discharge.)
- Postpartum Pulmonary Edema.(Within 42 days after delivery)
- Hematocrit ≤24% With Transfusion.(Within 42 days after delivery)
- Neonatal Death.(Birth until 4 weeks' of age)
- Retinopathy of Prematurity.(Birth until 4 weeks' of age)
- Massive postpartum hemorrhage.(From delivery to 24 hours after child birth)
- Premature Rupture of Membranes.(From 22nd gestational week until delivery)
- Placental Abruption.(From 22nd gestational week until delivery)
- Cesarean Delivery.(At Birth.)
- Fetal Death.(From 22nd gestational week until delivery)
- Pre-eclampsia (Mild, Severe, HELLP Syndrome, Eclampsia).(20 weeks through discharge following delivery.)
- Fetal Weight Estimation under 3rd percentile at gestational weeks 30-32 ultrasound scan.(30-32 weeks.)
- Gestational Diabetes.(From gestation until delivery)
- Maternal Death.(During pregnancy or within 42 days after delivery)
- Perineal Lacerations.(At Birth.)
- Intraventricular Hemorrhage, Grade III or IV.(Birth until 4 weeks' of age)
- Neonatal sepsis.(Birth until 4 weeks' of age)
- Necrotizing Enterocolitis.(Birth until 4 weeks' of age)
- Fetal weight estimation(At 30-32 gestational weeks)
- Medically Indicated Delivery Because of Hypertension.(20 weeks through discharge following delivery.)
- Maternal Hospital Stay.(Within 42 days after delivery)
- Number of Visits at Tertiary Maternity Care Hospital.(From gestation until delivery, on average during 9 months)
- Respiratory Distress Syndrome.(Birth until 4 weeks' of age)
- Apgar Score ≤7 at 5 minutes.(At birth.)
- Superimposed Pre-eclampsia (Mild, Severe, HELLP Syndrome, Eclampsia).(20 weeks through discharge following delivery.)
- Pregnancy Associated Hypertension.(20 weeks through discharge following delivery.)
- Abnormal uterine artery pulsatility index at gestational weeks 30-32 ultrasound scan(At 30-32 weeks.)
- Amniotic fluid measurement(At 30-32 gestational weeks)
- Estimation of fetal movement during ultrasound scan(At 30-32 gestational weeks)
- Gestational Age at Delivery.(At Delivery.)
- Number of Visits to Maternity Health Care During Pregnancy.(From gestation until delivery, on average during 9 months)
- Neonatal Hospital Stay.(Birth until 18 weeks' of age)
- Creatinine ≥90 µmol/l.(20 weeks through discharge.)
- Vacuum Extraction Delivery.(At Birth.)
- Umbilical artery pulsatility index(At 30-32 gestational weeks)
- Ductus venousus pulsatility index(At 30-32 gestational weeks)
- Blood transfusion.(From 22nd pregnancy week until four weeks after delivery)
- Mean cerebral artery pulsatility index(At 30-32 gestational weeks)