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Indonesia Pravastatin to Prevent Preeclampsia Study (INOVASIA)

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ClinicalTrials.gov Identifier: NCT03648970
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Muhammad Ilham Aldika Akbar, MD, OBGYN, Universitas Airlangga

Tracking Information
First Submitted Date  ICMJE August 22, 2018
First Posted Date  ICMJE August 28, 2018
Last Update Posted Date August 28, 2018
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Preeclampsia [ Time Frame: From date of randomization until date of delivery ]
    Including preeclampsia, preeclampsia with severe features, and gestational hypertension.
  • Preterm delivery [ Time Frame: 20 - 34 weeks, and 34 - 37 weeks ]
    Including indicated preterm delivery < 34 weeks and < 37 weeks
  • Maternal complication [ Time Frame: From date of randomization until date of delivery ]
    Any maternal complication caused by preeclampsia: eclampsia, seizure, HELLP syndrome, acute pulmonary edema, acute kidney injury, Cardivascular accident, liver failure, sepsis, and pneumonia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Perinatal outcome [ Time Frame: At delivery ]
    Gestational age at birth (days), birthweight (gram), birthweight percentile (INTERGROWTH), Apgar Score
  • Composite neonatal morbidity and mortality [ Time Frame: At delivery ]
    stillbirths, neonatal death, respiratory distress syndrome, intracerebral hemorrhage, neonatal sepsis, necrotizing enterocolitis, length NICU admission, and length of stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 23, 2018)
The side effect of Pravastatin [ Time Frame: Up to 6 month after birth ]
Including adverse reactions, Serious Adverse Event (SAE), and Suspected Unexpected Serious Adverse Reaction (SUSAR)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Indonesia Pravastatin to Prevent Preeclampsia Study
Official Title  ICMJE Pravastatin to Prevent Preeclampsia and Reduce Maternal-Neonatal Mortality and Morbidity in High Risk Preeclampsia Patients
Brief Summary

BACKGROUND Preeclampsia is a major cause of maternal and neonatal morbidity worldwide. There is currently no cure for preeclampsia, the only definitive treatment is termination of pregnancy by induction of labour or caesarean section. Statin has been proposed to represent a new approach to improve disease outcome/prevent preeclampsia based on its multilayered activity toward pregnancy protection, including: protection of vascular endothelial cells survival, induce expression of heme oxygenase 1 (HO-1), inhibiting the release of soluble FMS-like tirosine kinase-1 (sFlt-1) and soluble endoglin (sEng), two main culprits in the pathophysiology of preeclampsia.

OBJECTIVE The aim of this study is to observe the effect of pravastatin administration in patients with high risk of preeclampsia in order to reduce maternal and neonatal mortality and morbidity.

METHODS This is a prospective randomized controlled clinical trial. The research will be held in 5 maternal fetal medicine centers in Indonesia (multicenter study). The recruitment will be done by permuted block random sampling methods, with sample size around 280 patients divides into two group. Patients with high risk of preeclampsia will be randomized either to get pravastatin 2 x 20 mg per oral and aspirin 1 x 80 mg (treatment group) or low dose aspirin only (control group). The patient will be followed regularly until delivery to obtain detailed maternal and neonatal outcome.

OUTCOME Primary Outcomes: Maternal preeclampsia, severe preeclampsia, gestational hypertension, indicated preterm delivery less than 37 weeks, indicated preterm delivery less than 34 weeks, maternal complications, length of hospital stay, and any serious adverse event.

Secondary Outcomes: Composite fetal/neonatal mortality and morbidity (stillbirth, neonatal death, respiratory distress syndrome, intracerebral hemorrhage, neonatal sepsis, intra uterine growth restriction [Small for Gestational Age (SGA) < 5th centile], and necrotizing enterocolitis), birthweight, birthweight percentile, level of care (well baby, intermediate, NICU), NICU length of stay, ventilator usage, and length of perinatal hospital stay.

KEYWORDS: pravastatin, preeclampsia, neonatal mortality, neonatal morbidity

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicenter Randomized Non Blinded Trial comparing low dose aspirin versus low dose aspirin and pravastatin in patients with high risk developing preeclampsia
Masking: Single (Outcomes Assessor)
Masking Description:
The diagnosis is made by resident unaware of the medication patients received
Primary Purpose: Prevention
Condition  ICMJE Pre-Eclampsia
Intervention  ICMJE Drug: Pravastatin
The participant will be given pravastatin 2 x 20 mg per oral daily
Other Name: Pravastatin Sodium
Study Arms  ICMJE
  • Experimental: Pravastatin Treatment Group
    In this arm, the participant will be given aspirin 80 mg daily per oral and the study drugs, Pravastatin 2 x 20 mg per oral daily.
    Intervention: Drug: Pravastatin
  • No Intervention: Control Group

    In this arm, the participant will be given aspirin 80 mg daily per oral and the study drugs, Pravastatin 2 x 20 mg per oral daily.

    In this arm, the participant will be given aspirin 80 mg daily per oral, as it already a standard protocol for the high risk preeclampsia group

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gestational Age 10 wk - 19 wk 6 day
  • History of previous preeclampsia requiring birth < 37 weeks (risk 30%), or
  • Patients with a combination of at least 2 major risk factors plus an abnormal uterine artery Doppler at 11-20 weeks gestation (risk preeclampsia 30%):

    • Major clinical risk factors (Obesity, strong family history of preeclampsia [mother or sister], maternal age > 40 years old, chronic hypertension, Policystic Ovarian Syndrome (PCOS), Chronic kidney disease, diabetes mellitus, multiple pregnancies, first pregnancy, pregnancy interval more than 10 years, new partner/husband, Reproductive technologies (IVF pregnancy), heritable thrombophilias, Booking Blood pressure >130/80 mmHg, family history of early onset cardiovascular disease, lower socioeconomic status)
    • Abnormal uterine artery Doppler defined as (Second trimester screening:

average resistance index > 0.58 and/or or early-diastolic diastolic notch. First trimester screening: Pulsatility index > 95th centile or PI > 1.5) or:

  • First trimester screening (11+0 to 14+1 weeks): Combination of maternal risk factors, elevated MAP, and increased Uterine artery pulsatility index (UTPI).
  • Second trimester screening (19+0 to 24+6 weeks): Combination of maternal risk factors, elevated MAP, and increased Uterine artery pulsatility index (UTPI).
  • Combination of elevated mean arterial pressure (MAP > 90 mmHg) in the second trimester with abnormal uterine artery Doppler
  • Combination elevated booking blood pressure (> 130/85 mmHg) with abnormal uterine artery Doppler
  • Live fetus, no detectable fetal anomaly

Exclusion Criteria:

  • Condition where the pregnancies should be terminated within 48 hours, on the basis of any indication (patients consume pravastatin less than 2 days).
  • Contraindication to the statin use:

    • Hypersensitivity to pravastatin
    • Active liver disease
    • Pre pregnant renal insufficiency/kidney failure (history of hemodialysis)
  • Current use of statin
  • Participation in any other controlled trial of investigational medical products in pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Muhammad Ilham Aldika Akbar, MD, OBGYN +6281703270900 dokter_aldi@yahoo.com
Contact: Gustaaf Dekker, MD, PhD +61881829306 gustaaf.dekker@adelaide.edu.au
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03648970
Other Study ID Numbers  ICMJE IND012018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Muhammad Ilham Aldika Akbar, MD, OBGYN, Universitas Airlangga
Study Sponsor  ICMJE Universitas Airlangga
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muhammad Ilham Aldika Akbar, MD, OBGYN Universitas Airlangga
PRS Account Universitas Airlangga
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP