PregnancyPhase 3TIPPSNCT00967382
TIPPS: Thrombophilia in Pregnancy Prophylaxis Study
A Phase 3 study testing dalteparin sodium in people with Pregnancy and Thrombophilia, run by Ottawa Hospital Research Institute at 12 sites in 2 countries.
Trial summary
The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and venous thromboembolism (VTE) in women with thrombophilia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Thrombophilia, Pregnancy Complications
- What is being tested?
- dalteparin sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jul 2000to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One or more of the following:
- Previous preeclampsia
- Previous unexplained intra-uterine growth restriction
- Previous recurrent miscarriage:
- three(3) or more unexplained miscarriage at less than 10 weeks gestation;
- two (2) or more unexplained fetal loss between 10 and 16 weeks gestation;
Show all 28Show fewer
- one (1) or more unexplained fetal loss at or greater than 16 weeks gestation
- Previous abruptio placenta
- Previous personal history of VTE:
- Previous documented secondary proximal VTE,
- Previous documented calf-vein thrombosis (idiopathic or secondary),
- Previous superficial phlebitis
- First degree relative with symptomatic thrombophilia
- Pregnancy - > 4weeks gestation and < 20 weeks gestation
- Thrombophilia:
- Two abnormal tests, and no normal tests
- 3.1 Protein S
- 3.2 Protein C
- 3.3 Antithrombin
- Two positive tests
- 3.4 Anticardiolipin immunoglobulin M (IgM) (>30 U/ml)
- 3.5 Anticardiolipin immunoglobulin G (IgG) (>30 U/ml)
- 3.6 Anti-b2 glycoprotein IgG (>20 U/ml)
- 3.7 Anti-b2 glycoprotein IgM (>20 U/ml)
- 3.8 Lupus anticoagulant
- One positive test
- 3.9 Factor V Leiden (heterozygous or homozygous)
- 3.10Prothrombin gene defect (heterozygous or homozygous)
Who cannot join
- Less than 4 weeks gestation or greater than 20 weeks gestation
- No confirmed thrombophilia
- Contraindication to heparin therapy
- History of heparin induced thrombocytopenia
- Platelet count less than 100,000 109/L
- History of osteoporosis or steroid use
Show all 22Show fewer
- Actively bleeding
- Documented peptic ulcer within 6 weeks
- Heparin, bisulfite or fish allergy
- Severe hypertension (Systolic Blood Pressure >200mmhg and/or Diastolic Blood Pressure >120mmHg)
- Serum creatinine greater than 80 umol/L (1.3mg/dl) and an abnormal 24 hour urine creatine clearance (<30ml/min)
- Severe hepatic failure (INR >1.8)
- Geographic inaccessibility
- Need for anticoagulants, discretion of the investigator such as but not limited to:
- Recurrent fetal loss and phospholipid antibody syndrome
- Prior idiopathic proximal VTE:
- History of idiopathic deep venous thrombosis (DVT) or pulmonary embolism (PE) treated with anticoagulants (> 1 month of heparin or warfarin) or inferior vena cava (IVC) interruption;
- Idiopathic is a VTE occurring outside all of the following periods: antepartum, postpartum, oral contraceptive use, surgery, immobilization, cast, and malignancy
- Mechanical heart valve
- Legal lower age limitations (country specific)
- Prior participation in TIPPS
- Unable/unwilling to provide informed consent
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada10 sites
Royal Alexandra Hospital
Edmonton, Alberta
QEII Health Sciences Centre
Halifax, Nova Scotia
Hamilton Health Sciences Centre
Hamilton, Ontario
SMBD Jewish General Hospital
Montreal, Quebec
St Mary's Hospital Centre
Montreal, Quebec
The Ottawa Hospital, Civic Campus
Ottawa, Ontario
CHA, Hopital Enfant Jesus
Québec, Quebec
Royal University Hospital
Saskatoon, Saskatchewan
Mount Sinai Hospital
Toronto, Ontario
Women's College Health Sciences Centre
Toronto, Ontario
United States2 sites
University of Utah Health Sciences Centre
Salt Lake City, Utah, 84132
Saint Louis University
St Louis, Missouri, 63117
About this study
Official title: TIPPS - Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women.
The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE), intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?
Read the detailed description
TIPPS is a multicentre, multi-national open-label randomized controlled clinical trial. Two hundred and eighty-four thrombophilic women at risk for VTE or placenta mediated pregnancy complications will be recruited. Patients who require anticoagulant prophylaxis during this pregnancy (as judged by the local investigator) or have participated in TIPPS before will not be eligible for the trial.
The study consists of five periods: screening, randomization, antenatal follow-up, labour and delivery, and the post-partum follow-up.
Eligible and consenting patients will be assigned to one of two groups (treatment or control), stratified by gestational age at randomization: less than 8 weeks, 8 weeks +1 day to 12 weeks , 12 weeks +1 day to 19 weeks + 6 days.
Treatment Group - Subjects randomized to the treatment group will receive daily injections of dalteparin during the ante-natal period. They will be taught how to self-administer sub-cutaneous injections of dalteparin 5000 International units (IU) once daily (o.d.) until gestational week 20, then twice daily (bid) until 37 weeks gestation or onset of labour.
Control Group- Subjects randomized to control will receive identical obstetrical care and follow-up, but no ante-natal dalteparin.
Visit Schedule Subject will be evaluated for study eligibility and once the consent has been signed a baseline assessment will be completed. Randomization is done within 7 days of the baseline visit.
All patients will be seen in person for the first follow-up visit 7-9 days after randomization. Subsequent visits are based on the gestational age of the fetus and will be as follows:
- Monthly (+/- 1 week) from gestational week 8 to 28 -
- Every 2 weeks (+/- 1 week) from gestational week 28 to 34
- Every week from gestational week 35 until delivery.
The following visits are required in-person at day 7-9 and at gestational weeks 12, 20, 28, 32 and/or 36 and at 6 weeks post-partum to coincide with safety blood draws for hematology and biochemistry regardless of treatment allocation.
The remaining visits can be done in person or by phone calls: at gestational weeks 8, 16, 24, 30, 34, 35, 37, 38, 39 and 40. If available, results for hematology and biochemistry done at gestational age 8, 16, 24 and 40 will be recorded.
At each visit, weight and blood pressure measurements will be recorded and all subjects will be monitored for study progress, study outcomes, adverse events (AEs), and concomitant medications. Subjects randomized to receive dalteparin will have their compliance assessed through the monthly visits. Subjects will be required to complete the patient injection diary and will be asked to bring it with them at all in-person-visits. The diary will be collected at the completion of study participation.
Labour and delivery: outcomes and AEs will be assessed through a review of subjects' medical records. If available, results from blood drawn for hematology and biochemistry will be recorded. Data pertaining to the labour and delivery, as well as foetal weight and health at birth, will be documented. For those subjects randomized to receive dalteparin, the date and time of the last injection will be noted.
During the six-week postpartum period, all subjects will receive dalteparin 5,000 IU o.d. for VTE prophylaxis. Subjects randomized to control will be taught to self-administer the subcutaneous injections prior to starting their postpartum injections. Subjects will be asked to complete the patient injection diary and to return it at the final visit. The final study visit occurs at 6 weeks post-partum (+/- 1week) or at early termination; at this visit study progress, study outcomes, adverse events, results from blood drawn for hematology and biochemistry and compliance with study drug will be documented.
- Conditions
- Pregnancy, Thrombophilia, Pregnancy Complications
- Being tested
- dalteparin sodium
- Keywords
- Pregnancy, Thrombophilia, High-risk pregnancy, LMWH prophylaxis, Placenta mediated pregnancy complications
- Medical subject headings
- Thrombophilia, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalteparin sodiumDrug
Also called Fragmin
Subject's randomize to treatment arm will receive dalteparin sodium 5,000 IU s.c. daily starting on randomization day until 20 weeks gestational age then;
dalteparin sodium 5,000 IU s.c. bid from 20 weeks to onset of labour or 37 weeks gestation (discontinued at the discretion of the investigator/obstetrician)
Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects randomized to control will receive identical obstetrical care and follow-up, but not antenatal dalteparin. Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum |
| dalteparin sodium | Active comparator | Subjects randomized to the treatment group will receive daily injections of dalteparin during the antenatal period. They will be taught how to self-administer sub-cutaneous injections of dalteparin 5000 IU once daily (o.d.) until gestational age 20, then twice daily (bid) until 37 weeks gestation or onset of labour.
Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum Receives: Drug: dalteparin sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss)
Measured: 6 weeks post-partum
Secondary outcomes (3)
Identify if prophylactic LMWH will reduce rates of pregnancy induced hypertension (PIH), preterm labor and abruptio placenta in pregnant thrombophilic women compared to control
Measured: 6 weeks post-partum
Determine the safety of LMWH use in pregnancy (Specifically rates of bleeding, thrombocytopenia and fractures)
Measured: 6 weeks post-partum
Identify whether prolonged use of LMWH in pregnancy results in decreased bone mineral density (BMD) compared to control
Measured: 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJul 2000
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Marc A Rodger, MD, Principal investigator, Ottawa Hospital Research Institute, Ottawa, CanadaWilliam Hague, MD, Principal investigator, Women's and Children's Hospital, Adelaide, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967382
- Sponsor's protocol ID
- 1999210-01H
- Other IDs
- IND 72,350, ISRCTN 87441504, CIHR 200602MCT-157533-RFA, Trial number 2004/244, 2007-000284-21
- Acronym
- TIPPS
- Status last verified
- May 2014
- First submitted
- 29 May 2009
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
PubMed 33779986Rodger MA, Hague WM, Kingdom J, Kahn SR, Karovitch A, Sermer M, Clement AM, Coat S, Chan WS, Said J, Rey E, Robinson S, Khurana R, Demers C, Kovacs MJ, Solymoss S, Hinshaw K, Dwyer J, Smith G, McDonald S, Newstead-Angel J, McLeod A, Khandelwal M, Silver RM, Le Gal G, Greer IA, Keely E, Rosene-Montella K, Walker M, Wells PS; TIPPS Investigators. Antepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial. Lancet. 2014 Nov 8;384(9955):1673-83. doi: 10.1016/S0140-6736(14)60793-5. Epub 2014 Jul 24.
PubMed 25066248Bennett SA, Bagot CN, Arya R. Pregnancy loss and thrombophilia: the elusive link. Br J Haematol. 2012 Jun;157(5):529-42. doi: 10.1111/j.1365-2141.2012.09112.x. Epub 2012 Mar 26.
PubMed 22449204
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIPPS - Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women.
- ClinicalTrials.gov ID
- NCT00967382
- Acronym / sponsor ID
- TIPPS / 1999210-01H
- Conditions
- Pregnancy, Thrombophilia, Pregnancy Complications
- Keywords
- Pregnancy, Thrombophilia, High-risk pregnancy, LMWH prophylaxis, Placenta mediated pregnancy complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2000
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE), intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?
Detailed description
TIPPS is a multicentre, multi-national open-label randomized controlled clinical trial. Two hundred and eighty-four thrombophilic women at risk for VTE or placenta mediated pregnancy complications will be recruited. Patients who require anticoagulant prophylaxis during this pregnancy (as judged by the local investigator) or have participated in TIPPS before will not be eligible for the trial.
The study consists of five periods: screening, randomization, antenatal follow-up, labour and delivery, and the post-partum follow-up.
Eligible and consenting patients will be assigned to one of two groups (treatment or control), stratified by gestational age at randomization: less than 8 weeks, 8 weeks +1 day to 12 weeks , 12 weeks +1 day to 19 weeks + 6 days.
Treatment Group - Subjects randomized to the treatment group will receive daily injections of dalteparin during the ante-natal period. They will be taught how to self-administer sub-cutaneous injections of dalteparin 5000 International units (IU) once daily (o.d.) until gestational week 20, then twice daily (bid) until 37 weeks gestation or onset of labour.
Control Group- Subjects randomized to control will receive identical obstetrical care and follow-up, but no ante-natal dalteparin.
Visit Schedule Subject will be evaluated for study eligibility and once the consent has been signed a baseline assessment will be completed. Randomization is done within 7 days of the baseline visit.
All patients will be seen in person for the first follow-up visit 7-9 days after randomization. Subsequent visits are based on the gestational age of the fetus and will be as follows:
- Monthly (+/- 1 week) from gestational week 8 to 28 -
- Every 2 weeks (+/- 1 week) from gestational week 28 to 34
- Every week from gestational week 35 until delivery.
The following visits are required in-person at day 7-9 and at gestational weeks 12, 20, 28, 32 and/or 36 and at 6 weeks post-partum to coincide with safety blood draws for hematology and biochemistry regardless of treatment allocation.
The remaining visits can be done in person or by phone calls: at gestational weeks 8, 16, 24, 30, 34, 35, 37, 38, 39 and 40. If available, results for hematology and biochemistry done at gestational age 8, 16, 24 and 40 will be recorded.
At each visit, weight and blood pressure measurements will be recorded and all subjects will be monitored for study progress, study outcomes, adverse events (AEs), and concomitant medications. Subjects randomized to receive dalteparin will have their compliance assessed through the monthly visits. Subjects will be required to complete the patient injection diary and will be asked to bring it with them at all in-person-visits. The diary will be collected at the completion of study participation.
Labour and delivery: outcomes and AEs will be assessed through a review of subjects' medical records. If available, results from blood drawn for hematology and biochemistry will be recorded. Data pertaining to the labour and delivery, as well as foetal weight and health at birth, will be documented. For those subjects randomized to receive dalteparin, the date and time of the last injection will be noted.
During the six-week postpartum period, all subjects will receive dalteparin 5,000 IU o.d. for VTE prophylaxis. Subjects randomized to control will be taught to self-administer the subcutaneous injections prior to starting their postpartum injections. Subjects will be asked to complete the patient injection diary and to return it at the final visit. The final study visit occurs at 6 weeks post-partum (+/- 1week) or at early termination; at this visit study progress, study outcomes, adverse events, results from blood drawn for hematology and biochemistry and compliance with study drug will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects randomized to control will receive identical obstetrical care and follow-up, but not antenatal dalteparin. Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum |
| dalteparin sodium | Active comparator | Drug: dalteparin sodiumSubjects randomized to the treatment group will receive daily injections of dalteparin during the antenatal period. They will be taught how to self-administer sub-cutaneous injections of dalteparin 5000 IU once daily (o.d.) until gestational age 20, then twice daily (bid) until 37 weeks gestation or onset of labour. Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Previous preeclampsia
- Previous unexplained intra-uterine growth restriction
- Previous recurrent miscarriage:
- Previous abruptio placenta
- Previous personal history of VTE:
Key exclusion criteria (22 listed)
- Less than 4 weeks gestation or greater than 20 weeks gestation
- No confirmed thrombophilia
- Contraindication to heparin therapy
- Geographic inaccessibility
- Need for anticoagulants, discretion of the investigator such as but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dalteparin sodiumAlso: FragminSubject's randomize to treatment arm will receive dalteparin sodium 5,000 IU s.c. daily starting on randomization day until 20 weeks gestational age then; dalteparin sodium 5,000 IU s.c. bid from 20 weeks to onset of labour or 37 weeks gestation (discontinued at the discretion of the investigator/obstetrician) Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum | Drug | dalteparin sodium |
Primary outcome
The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss)
Time frame: 6 weeks post-partum
3 secondary outcomes
Identify if prophylactic LMWH will reduce rates of pregnancy induced hypertension (PIH), preterm labor and abruptio placenta in pregnant thrombophilic women compared to control
Time frame: 6 weeks post-partum
Determine the safety of LMWH use in pregnancy (Specifically rates of bleeding, thrombocytopenia and fractures)
Time frame: 6 weeks post-partum
Identify whether prolonged use of LMWH in pregnancy results in decreased bone mineral density (BMD) compared to control
Time frame: 6 weeks post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Derived from this study: PubMed 33779986Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
- Derived from this study: PubMed 25066248Rodger MA, Hague WM, Kingdom J, Kahn SR, Karovitch A, Sermer M, Clement AM, Coat S, Chan WS, Said J, Rey E, Robinson S, Khurana R, Demers C, Kovacs MJ, Solymoss S, Hinshaw K, Dwyer J, Smith G, McDonald S, Newstead-Angel J, McLeod A, Khandelwal M, Silver RM, Le Gal G, Greer IA, Keely E, Rosene-Montella K, Walker M, Wells PS; TIPPS Investigators. Antepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial. Lancet. 2014 Nov 8;384(9955):1673-83. doi: 10.1016/S0140-6736(14)60793-5. Epub 2014 Jul 24.
- Derived from this study: PubMed 22449204Bennett SA, Bagot CN, Arya R. Pregnancy loss and thrombophilia: the elusive link. Br J Haematol. 2012 Jun;157(5):529-42. doi: 10.1111/j.1365-2141.2012.09112.x. Epub 2012 Mar 26.
- The Ottawa Hospital Research Institute is the sponsor for TIPPS. This site provides information about the lead institution and provides a link the to coordinating centre located within the thrombosis program.Link provided by the sponsor.
- Site of the Canadian Institutes of Health Research - information regarding the terms of reference related to the TIPPS grant can be found herein.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc A Rodger, MD principal investigator
Ottawa Hospital Research Institute, Ottawa, Canada
William Hague, MD principal investigator
Women's and Children's Hospital, Adelaide, Australia
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dalteparin sodium in people with Pregnancy and Thrombophilia, run by Ottawa Hospital Research Institute at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss) (time frame: 6 weeks post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00967382, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.