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Pre-EclampsiaPhase 2INOVASIANCT03648970

Indonesia Pravastatin to Prevent Preeclampsia Study

A Phase 2 study testing Pravastatin in people with Pre-Eclampsia, run by Universitas Airlangga at 7 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pre-Eclampsia
What is being tested?
Pravastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
7 sitesIndonesia
Study dates
1 Mar 2018to 1 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

Muhammad Ilham Aldika Akbar, MD, OBGYN contact

+6281703270900

dokter_aldi@yahoo.com

Gustaaf Dekker, MD, PhD contact

+61881829306

gustaaf.dekker@adelaide.edu.au

7 sites in 1 country

Indonesia7 sites, 7 recruiting

  • Hasan Sadikin General Hospital

    Bandung, West Java

    Muhammad Alamsyah Azis, MD, Obgyn, alamsyahaziz9119@gmail.com

    Muhammad Alamsyah Azis, MD, Obgyn

    Recruiting

  • Sanglah General Hospital

    Denpasar, Bali

    Ryan Saktika Mulyana, MD, OBGYN, ryanmul83@gmail.com

    Ryan Saktika Mulyana, MD, OBGYN

    Not yet recruiting

  • Dr. Wahidin Sudirohusodo General Hospital

    Makassar, South Sulawesi

    Deviana Soraya Riu, MD, OBGYN, virayariu@gmail.com

    Deviana Soraya Riu, MD, OBGYN

    Not yet recruiting

  • Adam Malik General Hospital

    Medan, North Sumatra

    Dudy Aldiansyah, dudya141277@gmail.com

    Dudy Aldiansyah, MD, OBGYN

    Not yet recruiting

  • Ramelan Naval Hospital

    Surabaya, East Java, 60244

    Agung Sunarko Putra, MD, OBGYN, +62811257852, dr.agung_sp@yahoo.com

    Agung Sunarko Putra, MD, OBGYN

    Not yet recruiting

  • Dr. Soetomo Hospital

    Surabaya, East Java, 60285

    Muhammad Ilham Aldika Akbar, MD, OBGYN, +6281703270900, dokter_aldi@yahoo.com

    Recruiting

  • Dr. Moewardi Hospital

    Surakarta, Central Java, 57126

    Muhammad Adrianes Bachnas, MD, OBGYN, +628122692928, bachnasadri@gmail.com

    Muhammad Adrianes Bachnas, MD, OBGYN

    Not yet recruiting

Other trials in Indonesia

About this study

Official title: Pravastatin to Prevent Preeclampsia and Reduce Maternal-Neonatal Mortality and Morbidity in High Risk Preeclampsia Patients

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.

Read more

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

Conditions
Pre-Eclampsia
Being tested
Pravastatin
Keywords
Preeclampsia, Pravastatin, Maternal morbidity, Neonatal mortality, Neonatal morbidity
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PravastatinDrug

    Also called Pravastatin Sodium

    The participant will be given pravastatin 2 x 20 mg per oral daily

Study groups in NCT03648970
Study groupRoleWhat they receive
Pravastatin Treatment GroupExperimentalIn 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.
Receives: Drug: Pravastatin
Control GroupNo interventionIn 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preeclampsia

    Including preeclampsia, preeclampsia with severe features, and gestational hypertension.

    Measured: From date of randomization until date of delivery

  2. Preterm delivery

    Including indicated preterm delivery < 34 weeks and < 37 weeks

    Measured: 20 - 34 weeks, and 34 - 37 weeks

  3. Maternal complication

    Any maternal complication caused by preeclampsia: eclampsia, seizure, HELLP syndrome, acute pulmonary edema, acute kidney injury, Cardivascular accident, liver failure, sepsis, and pneumonia

    Measured: From date of randomization until date of delivery

Secondary outcomes (2)

  1. Perinatal outcome

    Gestational age at birth (days), birthweight (gram), birthweight percentile (INTERGROWTH), Apgar Score

    Measured: At delivery

  2. Composite neonatal morbidity and mortality

    stillbirths, neonatal death, respiratory distress syndrome, intracerebral hemorrhage, neonatal sepsis, necrotizing enterocolitis, length NICU admission, and length of stay

    Measured: At delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start1 Mar 2018
  3. Primary completion1 Mar 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03648970
Sponsor's protocol ID
IND012018
Acronym
INOVASIA
Status last verified
Aug 2018
First submitted
22 Aug 2018
Last updated
28 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ahmed A, Ramma W. Unravelling the theories of pre-eclampsia: are the protective pathways the new paradigm? Br J Pharmacol. 2015 Mar;172(6):1574-86. doi: 10.1111/bph.12977.

    PubMed 25303561

  • Brennan LJ, Morton JS, Davidge ST. Vascular dysfunction in preeclampsia. Microcirculation. 2014 Jan;21(1):4-14. doi: 10.1111/micc.12079.

    PubMed 23890192

  • Cudmore M, Ahmad S, Al-Ani B, Fujisawa T, Coxall H, Chudasama K, Devey LR, Wigmore SJ, Abbas A, Hewett PW, Ahmed A. Negative regulation of soluble Flt-1 and soluble endoglin release by heme oxygenase-1. Circulation. 2007 Apr 3;115(13):1789-97. doi: 10.1161/CIRCULATIONAHA.106.660134. Epub 2007 Mar 26.

    PubMed 17389265

  • Costantine MM, Cleary K, Hebert MF, Ahmed MS, Brown LM, Ren Z, Easterling TR, Haas DM, Haneline LS, Caritis SN, Venkataramanan R, West H, D'Alton M, Hankins G; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Units Network. Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial. Am J Obstet Gynecol. 2016 Jun;214(6):720.e1-720.e17. doi: 10.1016/j.ajog.2015.12.038. Epub 2015 Dec 23.

    PubMed 26723196

  • Ramma W, Ahmed A. Therapeutic potential of statins and the induction of heme oxygenase-1 in preeclampsia. J Reprod Immunol. 2014 Mar;101-102(100):153-160. doi: 10.1016/j.jri.2013.12.120. Epub 2014 Jan 16.

    PubMed 24503248

  • Ahmed A, Cudmore MJ. Can the biology of VEGF and haem oxygenases help solve pre-eclampsia? Biochem Soc Trans. 2009 Dec;37(Pt 6):1237-42. doi: 10.1042/BST0371237.

    PubMed 19909254

  • Dulak J, Deshane J, Jozkowicz A, Agarwal A. Heme oxygenase-1 and carbon monoxide in vascular pathobiology: focus on angiogenesis. Circulation. 2008 Jan 15;117(2):231-41. doi: 10.1161/CIRCULATIONAHA.107.698316.

    PubMed 18195184

  • Dekker G, Sibai B. Primary, secondary, and tertiary prevention of pre-eclampsia. Lancet. 2001 Jan 20;357(9251):209-15. doi: 10.1016/S0140-6736(00)03599-6.

    PubMed 11213110

  • Granger JP, Alexander BT, Llinas MT, Bennett WA, Khalil RA. Pathophysiology of hypertension during preeclampsia linking placental ischemia with endothelial dysfunction. Hypertension. 2001 Sep;38(3 Pt 2):718-22. doi: 10.1161/01.hyp.38.3.718.

    PubMed 11566964

  • Seki H. Balance of antiangiogenic and angiogenic factors in the context of the etiology of preeclampsia. Acta Obstet Gynecol Scand. 2014 Oct;93(10):959-64. doi: 10.1111/aogs.12473. Epub 2014 Sep 17.

    PubMed 25139038

  • Huppertz B. Placental origins of preeclampsia: challenging the current hypothesis. Hypertension. 2008 Apr;51(4):970-5. doi: 10.1161/HYPERTENSIONAHA.107.107607. Epub 2008 Feb 7. No abstract available.

    PubMed 18259009

  • Ofori B, Rey E, Berard A. Risk of congenital anomalies in pregnant users of statin drugs. Br J Clin Pharmacol. 2007 Oct;64(4):496-509. doi: 10.1111/j.1365-2125.2007.02905.x. Epub 2007 May 15.

    PubMed 17506782

  • Tranquilli AL, Dekker G, Magee L, Roberts J, Sibai BM, Steyn W, Zeeman GG, Brown MA. The classification, diagnosis and management of the hypertensive disorders of pregnancy: A revised statement from the ISSHP. Pregnancy Hypertens. 2014 Apr;4(2):97-104. doi: 10.1016/j.preghy.2014.02.001. Epub 2014 Feb 15. No abstract available.

    PubMed 26104417

  • Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997 Feb;18(1):4-25. doi: 10.1210/edrv.18.1.0287. No abstract available.

    PubMed 9034784

  • Zarek J, Koren G. The fetal safety of statins: a systematic review and meta-analysis. J Obstet Gynaecol Can. 2014 Jun;36(6):506-509. doi: 10.1016/S1701-2163(15)30565-X.

    PubMed 24927189

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pravastatin in people with Pre-Eclampsia, run by Universitas Airlangga at 7 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Muhammad Ilham Aldika Akbar, MD, OBGYN (+6281703270900, dokter_aldi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preeclampsia (time frame: From date of randomization until date of delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03648970, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.

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Indonesia Pravastatin to Prevent Preeclampsia Study | AzTrials