Clinical trial NCT01321788: Venous Thromboembolism Prophylaxis Post Cesarean Section
Official title: Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bleeding
Venous Thromboembolism
Keywords: thromboprophylaxis
pregnancy
post-cesarian section
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: King AbdulAziz City for Science and Technology
First posted: 2011-03-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Deep Vein Thrombosis
timeFrame: 24 months
Secondary outcomes:
measure: symptomatic DVT and bleeding
timeFrame: Symptomatic DVT
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
Study officials:
affiliation: King Saud University
name: FARJAH H ALGAHTANI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
citation: Chan WS. Venous thromboembolism in pregnancy. Expert Rev Cardiovasc Ther. 2010 Dec;8(12):1731-40. doi: 10.1586/erc.10.169.
citation: 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.