Condition category
Pregnancy and Childbirth
Date applied
18/04/2008
Date assigned
29/04/2008
Last edited
29/04/2008
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

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 d’éthique 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

http://www.cfwh.org

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

Publication citations

Additional files

Editorial Notes