Impact of dalteparin in pregnancy
| 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
Scientific
3175 Côte sainte-Catherine
Montreal (QC)
H3T 1C5
Canada
| Phone | +1 514 345 4706 |
|---|---|
| evelyne_rey@ssss.gouv.qc.ca |
Study information
| Study design | Randomised open trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Dalteparin in prevention of recurrence of severe obstetrical complications in women without thrombophilia |
| Study objectives | A 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 déthique de recherche (CER) du CHU Sainte-Justine on the 16th March 2000 (ref: 1006). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dalteparin |
| Primary outcome measure | 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 study start date | 16/03/2000 |
| Completion date | 20/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 276 |
| Total final enrolment | 116 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/03/2000 |
| Date of final enrolment | 20/06/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
3175 Côte sainte-Catherine
Montreal (QC)
H3T 1C5
Canada
H3T 1C5
Canada
Sponsor information
Canadian Foundation for Women's Health (Canada)
Research organisation
Research organisation
780 Echo Drive
Ottawa (ON)
K1S 5R7
Canada
| Phone | +1 800 561 2416 |
|---|---|
| helpdesk@sogc.com | |
| Website | http://www.cfwh.org |
"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 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 |
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.
