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Trial registered on ANZCTR


Registration number
ACTRN12614001241628
Ethics application status
Approved
Date submitted
6/03/2001
Date registered
26/11/2014
Date last updated
14/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Will folic acid supplements taken throughout pregnancy reduce the incidence of recurrent pre-eclampsia in women with high blood homocysteine concentrations?
Scientific title
Prevention of recurrent pre-eclampsia by folic acid supplementation in pregnant women with hyperhomocysteinaemia.
Secondary ID [1] 416 0
Perinatal Trials Registry: PTR362
Universal Trial Number (UTN)
Trial acronym
HOPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hyperhomocysteinaemia. 2055 0
pre-eclampsia 293589 0
Condition category
Condition code
Reproductive Health and Childbirth 2144 2144 0 0
Antenatal care
Metabolic and Endocrine 293878 293878 0 0
Other metabolic disorders
Cardiovascular 293879 293879 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1090 0
Treatment: Drugs
Intervention code [2] 290620 0
Prevention
Comparator / control treatment
Placebo group: women allocated to this group will receive placebo tablets equivalent in size and colour to the folic acid tablets taken by the women in the active treatment arm, to be taken orally as single tablet daily as above from week 12-20 of gestation through to delivery
Monitoring of adherence will be drug tablet return
Control group
Placebo

Outcomes
Primary outcome [1] 2990 0
Recurrent pre-eclampsia diagnosed after 20 weeks gestation by hypertension >=140/90 mm Hg (Korotkoff phase V), confirmed by 2 readings 6 hr apart, with de novo proteinuria (300 mg/24 hr, or >=2+ protein on dipstix on two occasions 4 hr apart, or spot urine protein/ creatinine ratio >=30 mg protein/mmol creatinine, in the absence of urinary tract infection
Timepoint [1] 2990 0
After delivery
Secondary outcome [1] 5045 0
Birth weight
Timepoint [1] 5045 0
At delivery

Eligibility
Key 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).
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No known vitamin B12 deficiency; no epilepsy taking anticonvulsants; no known homocystinuria; no multiple pregnancy; no medical need for folate supplementation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software, with stratified allocation by centre
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/09/1999
Actual
1/09/1999
Date of last participant enrolment
Anticipated
Actual
12/05/2004
Date of last data collection
Anticipated
Actual
Sample size
Target
626
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 3146 0
Womens and Childrens Hospital - North Adelaide
Recruitment outside Australia
Country [1] 6478 0
Netherlands
State/province [1] 6478 0
Amsterdam
Country [2] 6479 0
South Africa
State/province [2] 6479 0
Cape Province

Funding & Sponsors
Funding source category [1] 2302 0
Other
Name [1] 2302 0
Murdoch Children's Research Institute Trainee Research Scholarship
Country [1] 2302 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Road
North Adelaide
SA 5006
Country
Australia
Secondary sponsor category [1] 2080 0
University
Name [1] 2080 0
Discipline of Obstetrics
School of Paediatrics and Reproductive Health
University of Adelaide
Address [1] 2080 0
Frome Road
Adelaide
SA 5000
Country [1] 2080 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4115 0
Women's & Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 4115 0
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 4115 0
Australia
Date submitted for ethics approval [1] 4115 0
Approval date [1] 4115 0
21/08/1998
Ethics approval number [1] 4115 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Very poor recruitment led to termination of the study.

Contacts
Principal investigator
Name 36267 0
Dr William "Bill" Hague
Address 36267 0
Department of Obstetrics
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 36267 0
Australia
Phone 36267 0
+61 4 11114575
Fax 36267 0
Email 36267 0
[email protected]
Contact person for public queries
Name 10279 0
William "Bill" Hague
Address 10279 0
Department of Obstetrics
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 10279 0
Australia
Phone 10279 0
+61 4 11114575
Fax 10279 0
Email 10279 0
[email protected]
Contact person for scientific queries
Name 1207 0
William "Bill" Hague
Address 1207 0
Department of Obstetrics
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 1207 0
Australia
Phone 1207 0
+61 4 11114575
Fax 1207 0
Email 1207 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Documents added automatically
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