Contact information
Type
Scientific
Primary contact
Prof John Kingdom
ORCID ID
Contact details
Department of Obstetrics & Gynecology
700 University Ave
3rd Floor
Toronto
M5G 1Z4
Canada
jkingdom@mtsinai.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Does heparin improve pregnancy outcomes for women with evidence of placental dysfunction? A randomised controlled trial
Acronym
HEPRIN: HEparin for the PRevention of complications related to placental INsufficiency
Study hypothesis
The administration of heparin to women with identified placental dysfunction will:
1. Reduce the risk of intra-uterine foetal death
2. Reduce the risk of other adverse pregnancy outcomes
Ethics approval
Approval received from the Mount Sinai Hospital (Canada) on the 6th March 2007.
Study design
Randomised controlled open label trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy; placental dysfunction
Intervention
Daily subcutaneous heparin (7500 units twice daily from randomisation [18 to 24 weeks gestation] until birth) versus standard care (no medication administered).
Follow up was performed on women and their infants up to four months of age; longer term follow up may be possible subject to further successful funding.
Intervention type
Drug
Phase
Not Specified
Drug names
Heparin
Primary outcome measure
1. Intrauterine foetal death
2. Adverse pregnancy complications (including pre-eclampsia, preterm birth, infant small for gestational age, neonatal death)
These will be assessed during the antenatal period (in relation to side effects of medication) and after the time of birth for birth and postpartum outcomes.
Secondary outcome measures
1. Adverse neonatal outcomes
2. Adverse maternal outcomes
3. Maternal quality of life and emotional wellbeing: this will be assessed at four months postpartum using standard questionnaires (the Edinburgh depression scale; the 36-item Short Form health survey [SF-36] and the Speilberger anxiety trait questionnaires)
4. Placental pathology
These will be assessed during the antenatal period (in relation to side effects of medication) and after the time of birth for birth and postpartum outcomes.
Overall trial start date
21/03/2007
Overall trial end date
28/02/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women with a singleton pregnancy at 18 to 22 weeks gestation
2. Evidence of placental dysfunction in their current pregnancy as determined by two or more of the following:
a. abnormal ultrasonographic placental morphology
b. abnormal uterine artery Doppler waveforms
c. one or more abnormal biochemical markers on first or second trimester maternal serum screening
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
102 women
Participant exclusion criteria
1. Women with known positive thrombophilic screening
2. Known lethal foetal anomaly
3. Any contraindication to heparin therapy or continuation of the pregnancy (e.g., chorioamnionitis requiring delivery)
4. Clinical need for heparin therapy during pregnancy (e.g., previous venous thrombo-embolic episode)
5. Multiple pregnancy
6. Hypertension
7. Language barrier requiring official translator
Recruitment start date
21/03/2007
Recruitment end date
28/02/2010
Locations
Countries of recruitment
Canada
Trial participating centre
Department of Obstetrics & Gynecology
Toronto
M5G 1Z4
Canada
Sponsor information
Organisation
University of Toronto (Canada)
Sponsor details
Mt Sinai Hospital
600 University Avenue
Toronto
M5G 1Z4
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Physicians Services Incorporated Foundation (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list