ISRCTN ISRCTN78732833
DOI https://doi.org/10.1186/ISRCTN78732833
Secondary identifying numbers CER Sainte-Justine 1006
Submission date
18/04/2008
Registration date
29/04/2008
Last edited
30/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Evelyne Rey
Scientific

3175 Côte sainte-Catherine
Montreal (QC)
H3T 1C5
Canada

Phone +1 514 345 4706
Email evelyne_rey@ssss.gouv.qc.ca

Study information

Study designRandomised open trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleDalteparin in prevention of recurrence of severe obstetrical complications in women without thrombophilia
Study objectivesA prophylactic dose of dalteparin may prevent the recurrence of placental mediated complications in women without thrombophilia.
Ethics approval(s)Ethics approval received from the Comité d’éthique de recherche (CER) du CHU Sainte-Justine on the 16th March 2000 (ref: 1006).
Health condition(s) or problem(s) studiedSevere obstetrical complications
InterventionRandomisation (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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dalteparin
Primary outcome measureComposite outcome of one of:
1. Severe preeclampsia
2. Severe IUGR
3. Major abruptio placentae

Primary outcomes will be measured at delivery.
Secondary outcome measures1. 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 study start date16/03/2000
Completion date20/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants276
Total final enrolment116
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment16/03/2000
Date of final enrolment20/06/2007

Locations

Countries of recruitment

  • Canada

Study participating centre

3175 Côte sainte-Catherine
Montreal (QC)
H3T 1C5
Canada

Sponsor information

Canadian Foundation for Women's Health (Canada)
Research organisation

780 Echo Drive
Ottawa (ON)
K1S 5R7
Canada

Phone +1 800 561 2416
Email helpdesk@sogc.com
Website http://www.cfwh.org
ROR logo "ROR" https://ror.org/0278syk25

Funders

Funder type

Research organisation

Canadian Foundation for Women's Health (Canada)

No information available

Pharmacia and Upjohn Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2009 30/12/2020 Yes No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.