Impact of dalteparin in pregnancy

ISRCTN	ISRCTN78732833
DOI	https://doi.org/10.1186/ISRCTN78732833
Protocol serial number	CER Sainte-Justine 1006
Sponsor	Canadian Foundation for Women's Health (Canada)
Funders	Canadian Foundation for Women's Health (Canada), Pharmacia and Upjohn Inc. (USA)

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

Primary study design	Interventional
Study design	Randomised open trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dalteparin
Primary outcome measure(s)	Composite outcome of one of: 1. Severe preeclampsia 2. Severe IUGR 3. Major abruptio placentae Primary outcomes will be measured at delivery.
Key secondary outcome measure(s)	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
Completion date	20/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.