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| Name | Class |
|---|---|
| King AbdulAziz City for Science and Technology | OTHER |
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Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism (VTE). VTE remains the most common cause of maternal death in the developed world. It is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy-related VTE occurs during the six weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold.
This is a double blind- a randomized controlled study of prophylactic LMWH in women at low risk for VTE following a cesarean section procedure. The sample size is 300 patients, Eligible, consenting, and randomized participants will receive once-daily injections of study drug (4,500 IU Tinzaparin Sodium [Innohep®] within 12- to 24-hours postpartum and continue for two weeks versus Placebo in the other arm and follow for six (6) weeks postpartum.
On the day of hospital discharge, bilateral leg imaging with compression, leg ultrasounds, and pelvic vein imaging with MRV will be completed. The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge. Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period. All outcomes will be adjudicated by an independent committee of experts blinded to study drug allocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STUDY GROUP | will receive the study drug Innohep ® for 14 days |
| |
| CONTROL | The group that will receive placebo for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TINZAPARIN | Drug | Eligible women following cesarean section will randomly receive once-daily injections of study drug (4,500 IU tinzaparin sodium within 12 to 24 hours postpartum and continued for two (2) weeks postpartum. |
| Measure | Description | Time Frame |
|---|---|---|
| Deep Vein Thrombosis | The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| symptomatic DVT and bleeding | . Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period. | Symptomatic DVT |
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Inclusion Criteria:
Exclusion Criteria:
at high risk for thromboembolism (any one of the following):
More than 36 hours since delivery
Need for anticoagulation, including:
Contraindication to heparin therapy, including history of heparin induced thrombocytopenia.
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Consecutive adult patients (aged over 18 years) that had been delivered by emergency or elective cesarean section with no previous history of VTE are eligible for the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FARJAH H ALGAHTANI, MD | Contact | 0505805919 | falgahtani@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| FARJAH H ALGAHTANI, MD | King Saud University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Security Forces Hospital | Recruiting | Riyadh | Riyadh Region | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15287937 | Background | Kujovich JL. Hormones and pregnancy: thromboembolic risks for women. Br J Haematol. 2004 Aug;126(4):443-54. doi: 10.1111/j.1365-2141.2004.05041.x. | |
| 17486465 | Background | Samuelsson E, Hellgren M, Hogberg U. Pregnancy-related deaths due to pulmonary embolism in Sweden. Acta Obstet Gynecol Scand. 2007;86(4):435-43. doi: 10.1080/00016340701207500. |
| Label | URL |
|---|---|
| Venous Thromboembolism During Pregnancy | View source |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D000078222 | Tinzaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
| PLACEBO | Drug | Eligible women following cesarean section will receive a once-daily injections of placebo within 12 to 24 hours postpartum and continued for two (2) weeks postpartum. |
|
| 20128859 | Background | Morris JM, Algert CS, Roberts CL. Incidence and risk factors for pulmonary embolism in the postpartum period. J Thromb Haemost. 2010 May;8(5):998-1003. doi: 10.1111/j.1538-7836.2010.03794.x. Epub 2010 Feb 1. |
| 21108555 | Background | Chan WS. Venous thromboembolism in pregnancy. Expert Rev Cardiovasc Ther. 2010 Dec;8(12):1731-40. doi: 10.1586/erc.10.169. |
| 33779986 | Derived | 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. |
| Venous Thromboembolism in Pregnancy Study | View source |
| Venous thromboembolism in pregnancy | View source |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002241 |
| Carbohydrates |