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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01321788 |
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Date of registration:
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22/03/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Venous Thromboembolism Prophylaxis Post Cesarean Section
PROCS |
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Scientific title:
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Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial) |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01321788 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Farjah H AlGahtani, MD |
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Address:
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Telephone:
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0505805919 |
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Email:
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falgahtani@ksu.edu.sa |
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Affiliation:
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Name:
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FARJAH H ALGAHTANI, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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King Saud University |
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Name:
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FARJAH H ALGAHTANI, MD |
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Address:
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Telephone:
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0505805919 |
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Email:
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falgahtani@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Bleeding
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Venous Thromboembolism
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Intervention(s)
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Drug: PLACEBO
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Drug: TINZAPARIN
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Primary Outcome(s)
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Deep Vein Thrombosis
[Time Frame: 24 months]
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Secondary Outcome(s)
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symptomatic DVT and bleeding
[Time Frame: Symptomatic DVT]
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Secondary ID(s)
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PRO-CS TRIAL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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