ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

EPPI trial - Enoxaparin for the Prevention of Preeclampsia and Intrauterine growth restriction - a pilot randomised open-label trial.

Secondary ID [2]

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

Intrauterine growth restriction

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

rate of preeclampsia

Timepoint [1]

from 20 weeks pregnancy until delivery

Primary outcome [2]

rate of intrauterine growth restriction

Timepoint [2]

from 20 weeks pregnancy until delivery

Secondary outcome [1]

To determine the effect of enoxaparin on uterine artery Doppler waveforms using antenatal Doppler ultrasound

Timepoint [1]

20 and 24 weeks gestation

Secondary outcome [2]

To determine the effect of enoxaparin on maternal serum markers and placental and angiogenic growth factors

Timepoint [2]

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]

Sunshine Hospital - St Albans

Recruitment hospital [2]

Royal Hospital for Women - Randwick

Recruitment hospital [3]

Mercy Hospital for Women - Heidelberg

Recruitment postcode(s) [1]

3052

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Country [2]

Netherlands

State/province [2]

Amsterdam

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Auckland

Country

New Zealand

Secondary sponsor category [1]

Hospital

Name [1]

Auckland City Hospital

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X Regional Ethics Committee

Ethics committee address [1]

Private Bag 92-522
Wellesley St
Auckland

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

26/06/2009

Approval date [1]

07/09/2009

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Dr Claire McLintock

Address

National Women's Health Auckland City Hospital Park Road Grafton Auckland

Country

New Zealand

Phone

+6493670000

Fax

CMcLintock@adhb.govt.nz

Contact person for public queries

Name

Dr Claire McLintock

Address

National Women's Health Level 9 Support Building Auckland City Hospital 2 Park Rd Grafton Auckland 1023

Country

New Zealand

Phone

+6493670000

Fax

CMcLintock@adhb.govt.nz

Contact person for scientific queries

Name

Dr Claire McLintock

Address

National Women's Health Level 9 Support Building Auckland City Hospital 2 Park Rd Grafton Auckland 1023

Country

New Zealand

Phone

+64 9 367 0000

Fax

CMcLintock@adhb.govt.nz

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

Source	Title	Year of Publication	DOI
Embase	Low-molecular-weight heparin for prevention of placenta-mediated pregnancy complications: Protocol for a systematic review and individual patient data meta-analysis (AFFIRM).	2015	https://dx.doi.org/10.1186/2046-4053-3-69
Embase	Enoxaparin 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.	2016	https://dx.doi.org/10.1186/s12884-016-1162-y
Embase	Enoxaparin for the prevention of preeclampsia and intrauterine growth restriction in women with a history: a randomized trial.	2017	https://dx.doi.org/10.1016/j.ajog.2017.01.014
Dimensions AI	4: Is magnesium sulfate use of benefit post partum? A randomized controlled trial	2017	https://doi.org/10.1016/j.ajog.2016.11.005

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically