Condition category
Pregnancy and Childbirth
Date applied
20/03/2007
Date assigned
02/05/2007
Last edited
28/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.utoronto.ca/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes