Does heparin improve pregnancy outcomes for women with evidence of placental dysfunction?

ISRCTN	ISRCTN88675588
DOI	https://doi.org/10.1186/ISRCTN88675588
Secondary identifying numbers	N/A

Submission date: 20/03/2007
Registration date: 02/05/2007
Last edited: 28/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Kingdom
Scientific

Department of Obstetrics & Gynecology
700 University Ave, 3rd Floor
Toronto
M5G 1Z4
Canada

Email	jkingdom@mtsinai.on.ca

Study information

Study design	Randomised controlled open label trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Does heparin improve pregnancy outcomes for women with evidence of placental dysfunction? A randomised controlled trial
Study acronym	HEPRIN: HEparin for the PRevention of complications related to placental INsufficiency
Study objectives	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(s)	Approval received from the Mount Sinai Hospital (Canada) on the 6th March 2007.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	21/03/2007
Completion date	28/02/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	102 women
Key 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
Key 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
Date of first enrolment	21/03/2007
Date of final enrolment	28/02/2010

Locations

Countries of recruitment

Canada

Study participating centre

Department of Obstetrics & Gynecology

Toronto
M5G 1Z4
Canada

Sponsor information

University of Toronto (Canada)
University/education

Mt Sinai Hospital
600 University Avenue
Toronto
M5G 1Z4
Canada

Website	http://www.utoronto.ca/
"ROR"	https://ror.org/03dbr7087

Funders

Funder type

Research organisation

The Physicians Services Incorporated Foundation (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan