Pravastatin for Pregnancies complicated by Ischemical Placental Disease

Recruiting

• Conditions: Preeclampsia (PE), intrauterine growth restriction (IUGR) and placental abruption; Pregnancy and Childbirth

• Registration Number: ISRCTN10186987
• Lead Sponsor: Aristotle University of Thessaloniki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-17
• Last Update Posted: 30 April 2018
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 70

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 <10th percentile with associated findings of placental insufficiency as a high resistance in the uterine arteries or in the umbilical artery (Pulsatility Index>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

1. Pre-existing hypertension
2. Renal
3. Liver or connective tissue disease
4. Uterine malformations
5. Twin pregnancy
6. Fetal chromosomal abnormalities

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
1. MAP (SAP and DAP) is measured using blood pressure measurement at 1 week<br>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<br>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<br>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