Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000699268
Ethics application status
Approved
Date submitted
8/06/2009
Date registered
13/08/2009
Date last updated
1/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The EPPI Trial – Enoxaparin for the Prevention of Preeclampsia and Intrauterine growth restriction – a pilot randomised open-label trial.
Scientific title
The EPPI Trial – Enoxaparin for the Prevention of Preeclampsia and Intrauterine growth restriction – a pilot randomised open-label trial.
Secondary ID [1] 251698 0
EPPI trial - Enoxaparin for the Prevention of Preeclampsia and Intrauterine growth restriction - a pilot randomised open-label trial.
Secondary ID [2] 281160 0
EPPI trial - Enoxaparin for the Prevention of Preeclampsia and Intrauterine growth restriction - a pilot randomised open-label trial.
Universal Trial Number (UTN)
Trial acronym
EPPI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preeclampsia 236946 0
Intrauterine growth restriction 236947 0
Condition category
Condition code
Reproductive Health and Childbirth 237297 237297 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
enoxaparin 40mg once daily subcutaneous injection from randomisation (between 6 weeks to 15 weeks + 6 days gestation) until delivery or 35 weeks + 6 days gestation
Intervention code [1] 236727 0
Prevention
Comparator / control treatment
Control treatment is standard of care i.e. low dose aspirin (75-100mg) and calcium (1-1.5g) daily for women with previous preeclampsia or low dose aspirin alone (75-100mg) daily for women with a previous small-for-gestational age pregnancy
Control group
Active

Outcomes
Primary outcome [1] 238109 0
rate of preeclampsia
Timepoint [1] 238109 0
from 20 weeks pregnancy until delivery
Primary outcome [2] 238186 0
rate of intrauterine growth restriction
Timepoint [2] 238186 0
from 20 weeks pregnancy until delivery
Secondary outcome [1] 242319 0
To determine the effect of enoxaparin on
uterine artery Doppler waveforms using antenatal Doppler ultrasound
Timepoint [1] 242319 0
20 and 24 weeks gestation
Secondary outcome [2] 242320 0
To determine the effect of enoxaparin on
maternal serum markers and placental and angiogenic growth factors
Timepoint [2] 242320 0
Recruitment, 2nd and 3rd trimesters

Eligibility
Key inclusion criteria
Women who have developed previous preeclampsia delivered <36 weeks in last pregnancy, previous intrauterine growth restriction (IUGR)<10th centile delivered <36 weeks in last pregnancy or previous IUGR<3rd centile in last pregnancy.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any contraindication to low molecular weight heparin (LMWH), requirement for LMWH eg. previous thrombosis or antiphospholipid syndrome, previous successful pregnancy with LMWH, multiple pregnancy, known pre-existing type 1/2 diabetes, renal disease (with serum creatinine >150), thrombocytopenia (platelet count <80) or known major fetal anomaly.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
26/07/2010
Date of last participant enrolment
Anticipated
Actual
28/10/2015
Date of last data collection
Anticipated
Actual
26/04/2016
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5471 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 5472 0
Royal Hospital for Women - Randwick
Recruitment hospital [3] 5473 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 5718 0
3052
Recruitment outside Australia
Country [1] 1829 0
New Zealand
State/province [1] 1829 0
Country [2] 7720 0
Netherlands
State/province [2] 7720 0
Amsterdam

Funding & Sponsors
Funding source category [1] 237124 0
University
Name [1] 237124 0
University of Auckland
Country [1] 237124 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Level 12
Support Building
Auckland City Hospital
2 Park Rd
Grafton
Auckland
1023
Country
New Zealand
Secondary sponsor category [1] 4617 0
Hospital
Name [1] 4617 0
Auckland City Hospital
Address [1] 4617 0
National Women's Health
Level 9
Support Building
Auckland City Hospital
2 Park Rd
Grafton
Auckland
1023
Country [1] 4617 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239224 0
Northern X Regional Ethics Committee
Ethics committee address [1] 239224 0
Private Bag 92-522
Wellesley St
Auckland
Ethics committee country [1] 239224 0
New Zealand
Date submitted for ethics approval [1] 239224 0
26/06/2009
Approval date [1] 239224 0
07/09/2009
Ethics approval number [1] 239224 0

Summary
Brief summary
Brief summary: Preeclampsia and fetal intrauterine growth restriction (IUGR) are common complications during pregnancy that can cause long lasting health effects for mother and baby in later life. It is believed both conditions are caused by abnormal development of the placenta (whenua/after-birth) and can often recur in future pregnancies. There are several therapies that have been studied to prevent these diseases but, until now, none have been proven to be very effective. Heparin is a drug that prevents blood clots and is believed to help the placenta to develop well. Some studies have suggested that heparin may reduce the risk of preeclampsia and IUGR but this has not been properly assessed in a randomised trial. Our study will invite women who have had a previous pregnancy severely affected by these conditions. Half of the women will be given the heparin injection each day as well as current standard of care (aspirin for all women and calcium for women with previous preeclampsia) and the other half will receive the current standard of care. All women will be monitored very closely. At the end of the study we will be able to assess if the heparin injections reduce the risk of preeclampsia and IUGR.
Trial website
www.eppi.org.nz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29714 0
Dr Claire McLintock
Address 29714 0
National Women's Health
Auckland City Hospital
Park Road
Grafton
Auckland
Country 29714 0
New Zealand
Phone 29714 0
+6493670000
Fax 29714 0
Email 29714 0
[email protected]
Contact person for public queries
Name 12961 0
Dr Dr Claire McLintock
Address 12961 0
National Women's Health
Level 9 Support Building
Auckland City Hospital
2 Park Rd
Grafton
Auckland
1023
Country 12961 0
New Zealand
Phone 12961 0
+6493670000
Fax 12961 0
Email 12961 0
[email protected]
Contact person for scientific queries
Name 3889 0
Dr Dr Claire McLintock
Address 3889 0
National Women's Health
Level 9 Support Building
Auckland City Hospital
2 Park Rd
Grafton
Auckland
1023
Country 3889 0
New Zealand
Phone 3889 0
+64 9 367 0000
Fax 3889 0
Email 3889 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEnoxaparin for the prevention of preeclampsia and intrauterine growth restriction in women with a history: a randomized trial.2017https://dx.doi.org/10.1016/j.ajog.2017.01.014
EmbaseLow-molecular-weight heparin for prevention of placenta-mediated pregnancy complications: Protocol for a systematic review and individual patient data meta-analysis (AFFIRM).2015https://dx.doi.org/10.1186/2046-4053-3-69
EmbaseEnoxaparin for the prevention of preeclampsia and intrauterine growth restriction in women with a prior history - an open-label randomised trial (the EPPI trial): Study protocol.2016https://dx.doi.org/10.1186/s12884-016-1162-y
Dimensions AI4: Is magnesium sulfate use of benefit post partum? A randomized controlled trial2017https://doi.org/10.1016/j.ajog.2016.11.005
N.B. These documents automatically identified may not have been verified by the study sponsor.