Preeclampsia (PE), intrauterine growth restriction (IUGR) and placental abruption Pregnancy and Childbirth Preeclampsia (PE), intrauterine growth restriction (IUGR) and placental abruption
Conditions
Interventions
Following the diagnosis of placental insufficiency, either at the outpatient clinic level or following a referral from a private practice to the high-risk pregnancy clinic and confirmation by the head
Sponsors
Aristotle University of Thessaloniki
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women with PE and/or IUGR diagnosed between 20 and 34 gestational weeks, irrespective of maternal age. 2. PE will be defined as a newly onset hypertension in pregnancy (SAP > 140 mm ?g or DAP > 90 mm ?g) and significant proteinuria (>300mg/24h) 3. IUGR is defined as an estimated fetal weight 95th percentile) or reduced amniotic fluid (maximum vertical pocket < 2 cm) The control group: 1. Historical sample of women that were hospitalised during the 5 previous years in the Maternal fetal medicine unit of the 3rd Obstetrics and Gynecology University clinic 2. Pravastatin not used in treating the disease 3. Controlled for maternal age and the estimated fetal weight percentile.
Exclusion criteria
Exclusion criteria: 1. Pre-existing hypertension 2. Renal 3. Liver or connective tissue disease 4. Uterine malformations 5. Twin pregnancy 6. Fetal chromosomal abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pregnancy prolongation interval from diagnosis to delivery is estimated between day of entrance in the trial (which is the first day of pravastatin administration) and day of pregnancy delivery 2. Intrauterine or neonatal death in fetuses/neonates is measured using medical records from the day of entrance in the trial (which is the first day of pravastatin administration) until the 28th day of neonatal life | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MAP (SAP and DAP) is measured using blood pressure measurement at 1 week 2. PI values of the Umbilical, MCA, DV uterine arteries are measured using obstetrical ultrasound (brandname GE Voluson S10) twice a week, namely the 3rd and 7th day of every consecutive week (days 0,3,7,10, 14…) until the day of pregnancy delivery 3. Endothelial parameters values, especially endogline and sflt-1, measured using Western blot between the start of therapy and serial measurements until delivery as previously mentioned 4. Neonatal morbidity parameters, more specifically respiratory distress syndrome, cerebral bleeding, sepsis and necrotic enterocolitis, are measured using neonatal medical records during Neonatal Intensive Care Unit (NICU) hospitalization from the day of NICU admission until NICU dischargement | — |
Countries
Greece
Outcome results
None listed