Venous Thromboembolism Prophylaxis Post Cesarean Section (PROCS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by King Saud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
King AbdulAziz City for Science and Technology
Information provided by (Responsible Party):
Farjah Hassan AlGahtani, King Saud University
ClinicalTrials.gov Identifier:
NCT01321788
First received: March 22, 2011
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Bleeding
Venous Thromboembolism
Drug: TINZAPARIN
Drug: PLACEBO

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial)

Resource links provided by NLM:


Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Deep Vein Thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge.


Secondary Outcome Measures:
  • symptomatic DVT and bleeding [ Time Frame: Symptomatic DVT ] [ Designated as safety issue: Yes ]
    . Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period.


Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
STUDY GROUP
will receive the study drug Innohep ® for 14 days
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.
Other Name: Innohep
CONTROL
The group that will receive placebo for 14 days
Drug: 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.
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321788

Contacts
Contact: FARJAH H ALGAHTANI, MD 0505805919 falgahtani@gmail.com

Locations
Saudi Arabia
Security Forces Hospital Recruiting
Riyadh, Saudi Arabia
Contact: Farjah H AlGahtani, MD    0505805919    falgahtani@ksu.edu.sa   
Contact: , Pharm         
Principal Investigator: Farjah H AlGahtani, MD         
Sub-Investigator: Hessa AlDohami, MD         
Sponsors and Collaborators
King Saud University
King AbdulAziz City for Science and Technology
Investigators
Principal Investigator: FARJAH H ALGAHTANI, MD King Saud University
  More Information

Additional Information:
Publications:
Responsible Party: Farjah Hassan AlGahtani, Dr., King Saud University
ClinicalTrials.gov Identifier: NCT01321788     History of Changes
Other Study ID Numbers: PRO-CS TRIAL
Study First Received: March 22, 2011
Last Updated: February 3, 2012
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by King Saud University:
thromboprophylaxis
pregnancy
post-cesarian section

Additional relevant MeSH terms:
Hemorrhage
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Tinzaparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on September 14, 2014