Contact information
Type
Scientific
Primary contact
Dr Evelyne Rey
ORCID ID
Contact details
3175 Côte sainte-Catherine
Montreal (QC)
H3T 1C5
Canada
+1 514 345 4706
evelyne_rey@ssss.gouv.qc.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CER Sainte-Justine 1006
Study information
Scientific title
Dalteparin in prevention of recurrence of severe obstetrical complications in women without thrombophilia
Acronym
Study hypothesis
A prophylactic dose of dalteparin may prevent the recurrence of placental mediated complications in women without thrombophilia.
Ethics approval
Ethics approval received from the Comité déthique de recherche (CER) du CHU Sainte-Justine on the 16th March 2000 (ref: 1006).
Study design
Randomised open trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Severe obstetrical complications
Intervention
Randomisation (1:1) to dalteparin (5000 IU daily) versus no treatment from randomisation until 36 - 37 weeks of pregnancy. Total duration of follow-up for all treatment arms will be from randomisation until departure from the hospital after delivery.
Intervention type
Drug
Phase
Not Specified
Drug names
Dalteparin
Primary outcome measures
Composite outcome of one of:
1. Severe preeclampsia
2. Severe IUGR
3. Major abruptio placentae
Primary outcomes will be measured at delivery.
Secondary outcome measures
1. Non-severe preeclampsia, measured at delivery
2. Non-severe IUGR, measured at delivery
3. Gestational age at delivery, measured at delivery
4. Pregnancy complications, measured at delivery
5. Hospitalisation length, measured at delivery and departure from the hospital after delivery
6. Admission to intensive care unit, measured at departure from the hospital after delivery
Overall trial start date
16/03/2000
Overall trial end date
20/06/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Normal thrombotic screen
2. Female patients aged more than 17 years
3. Pregnancy less than 17 weeks
4. Signature of the consent form
5. One of the following in previous pregnancy:
5.1. Severe preeclampsia with delivery less than 34 weeks
5.2. Severe intrauterine growth restriction (IUGR)
5.3. Abruptio placentae with delivery less than 34 weeks or foetal death
5.4. One idiopathic foetal death after 20 weeks
5.5. Two or more of idiopathic foetal death between 12 - 19 weeks
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
276
Participant exclusion criteria
1. Multiple pregnancy
2. Alcohol or illicit drug use
3. Severe medical condition other than chronic hypertension
4. Foetal malformation or chromosomal anomaly
5. Uterine malformation or infection
6. Abdominal trauma
7. Any known cause of foetal death
Recruitment start date
16/03/2000
Recruitment end date
20/06/2007
Locations
Countries of recruitment
Canada
Trial participating centre
3175 Côte sainte-Catherine
Montreal (QC)
H3T 1C5
Canada
Sponsor information
Organisation
Canadian Foundation for Women's Health (Canada)
Sponsor details
780 Echo Drive
Ottawa (ON)
K1S 5R7
Canada
+1 800 561 2416
helpdesk@sogc.com
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Foundation for Women's Health (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pharmacia and Upjohn Inc. (USA)
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