Pravastatin for Pregnancies complicated by Ischemical Placental Disease

• Register: ISRCTN
• Last refreshed on: 30 April 2018
• Main ID: ISRCTN10186987
• Date of registration: 17/03/2018
• Prospective Registration: Yes
• Primary sponsor: Aristotle University of Thessaloniki
• Public title: Pravastatin for Pregnancies complicated by Ischemical Placental Disease
• Scientific title: Effect of PRAvastatin in Pregnancies complicated by Ischemical Placental Disease: prospective observational study
• Date of first enrolment: 01/04/2018
• Target sample size: 70
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN10186987
• Study type: Observational
• Study design: Longitudinal observational study (Treatment)

Countries of recruitment

Greece

Contacts

• Name: Stamatios Petousis

Key inclusion & exclusion 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 <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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Preeclampsia (PE), intrauterine growth restriction (IUGR) and placental abruption
Pregnancy and Childbirth
Preeclampsia (PE), intrauterine growth restriction (IUGR) and placental abruption

Intervention(s)

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 of the Maternal Fetal medicine unit, Prof Mamopoulos, the patient will be offered participation in the study. In case of acceptance, 20 mg of pravastatin will be administered orally. The patient will remain hospitalised and routine examinations including clinical assessment, laboratory tests and ultrasound scans will be performed according to the clinic’s protocols. For the purposes of the study, peripheral blood samples will be taken every 3 days until delivery and these will be centrifuged and stored in a freezer at -80o Celsius.

For every pregnant woman enrolled in the study, a full gynaecologic, obstetric, personal and family history will be recorded. Furthermore, all participants will be examined as follows:
1. Blood pressure using an automated electronic device (daily)
2. Protein in 24h collected urine (at admission)
3. Blood tests every 3 days (full blood count, urea, creatinine, tranaminases, glucose, K,Na, INR, fibrinogen, PT, aPTT) and urine protein
4. Ultrasound performed weekly, at which the estimated fetal weight, umbilical artery PI, middle cerebral artery PI, PI in the ductus venosus, uterine arteries PI and the max vertical pocket of amniotic fluid will be recorded

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

1276

Source(s) of Monetary Support

Aristotle University of Thessaloniki

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

• Results available: Yes
• Date Completed: 31/12/2020