Venous Thromboembolism Prophylaxis Post Cesarean Section

Venous Thromboembolism Clinical Trial

— PROCS  

Official title:

Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01321788
• Other study ID #: PRO-CS TRIAL
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2011
• Last updated: February 3, 2012
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2012
• Source: King Saud University
• Contact: FARJAH H ALGAHTANI, MD
• Phone: 0505805919
• Email: falgahtani[@]gmail.com
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Age > 18 years old.

2. Delivered by cesarean section (emergency or planned).

3. Signed, informed consent.

4. Ready access to a local health service.

5. Capable of using Tinzaparin.

Exclusion Criteria:

1. at high risk for thromboembolism (any one of the following):

• age more than 35 years old

• obesity (more than 80 kg)

• parity more than 4

• gross varicose veins

• current infection

• pre-eclampsia

• immobility prior to surgery (more than 4 days)

• Major current disease: including heart or lung disease, cancer,inflammatory bowel disease and nephrotic syndrome.

• Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy)

• Patients with a family history of VTE

• History of superficial phlebitis

2. More than 36 hours since delivery

3. Need for anticoagulation, including:

• women with a confirmed thrombophilia

• women with paralysis of lower limbs

• women with personal history of VTE

• women with antiphospholipid antibody syndrome (APLA)

• women with mechanical heart valves

4. Contraindication to heparin therapy, including history of heparin induced thrombocytopenia.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bleeding
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• TINZAPARIN
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.
• PLACEBO
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.

Locations

Country	Name	City	State
Saudi Arabia	Security Forces Hospital	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Saud University	King AbdulAziz City for Science and Technology

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (4)

Chan WS. Venous thromboembolism in pregnancy. Expert Rev Cardiovasc Ther. 2010 Dec;8(12):1731-40. doi: 10.1586/erc.10.169. Review. — View Citation

Kujovich JL. Hormones and pregnancy: thromboembolic risks for women. Br J Haematol. 2004 Aug;126(4):443-54. Review. — View Citation

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. — View Citation

Samuelsson E, Hellgren M, Högberg U. Pregnancy-related deaths due to pulmonary embolism in Sweden. Acta Obstet Gynecol Scand. 2007;86(4):435-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   National Guideline Clearinghouse | Venous thromboembolism
•   Venous Thromboembolism During Pregnancy
•   Venous thromboembolism in pregnancy
•   Venous Thromboembolism in Pregnancy Study