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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000699268
Acronym
EPPI
Enrollment
160
Registered
2009-08-13
Start date
2010-07-26
Completion date
2015-10-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 11, 2026