Will folic acid supplements taken throughout pregnancy reduce the incidence of recurrent pre-eclampsia in women with high blood homocysteine concentrations?

Prevention of recurrent pre-eclampsia by folic acid supplementation in pregnant women with hyperhomocysteinaemia.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001241628

Acronym

HOPE

Enrollment

626

Registered

2014-11-26

Start date

1999-09-01

Completion date

2004-05-12

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

Women who experience the pregnancy disease pre-eclampsia, and in particular those who develop the disease before 38 weeks of a pregnancy, are more likely to have high blood levels of the chemical homocysteine. They are also at higher risk of pre-eclampsia in a subsequent pregnancy. High levels of homocysteine have been shown to make blood vessels more prone to clog up, one of the underlying processes of pre-eclampsia. High blood levels of homocysteine can usually be reduced by taking the vitamin folic acid. It is not known, however, whether this can effect the chances of pre-eclampsia happening again. This study will help to determine whether taking a folic acid supplement can prevent recurrent pre-eclampsia in women with high homocysteine levels. Women in the trial will receive either folic acid or a placebo tablet. Neither the women nor their carers will know which treatment they are receiving.

Interventions

Folic Acid Group: women allocated to this group will receive folic acid 5mg tablets to be taken orally as a single tablet daily from week 12-20 of gestation through to delivery Monitoring of adherence will be drug tablet return

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Healthy volunteers

Inclusion criteria

Singleton pregnancy between > or = 12 and < or = 20 weeks gestation; past history of severe pre-eclampsia; hyperhomocysteinaemia (>11 umol in pregnancy, >13 outside pregnancy).

Exclusion criteria

No known vitamin B12 deficiency; no epilepsy taking anticonvulsants; no known homocystinuria; no multiple pregnancy; no medical need for folate supplementation.

Outcome results