Venous Thromboembolism Prophylaxis Post Cesarean Section (PROCS)
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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) |
- 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.
- 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 |
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.
Inclusion Criteria:
- Age > 18 years old.
- Delivered by cesarean section (emergency or planned).
- Signed, informed consent.
- Ready access to a local health service.
- Capable of using Tinzaparin.
Exclusion Criteria:
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
- More than 36 hours since delivery
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
- Contraindication to heparin therapy, including history of heparin induced thrombocytopenia.
Contacts and Locations| Contact: FARJAH H ALGAHTANI, MD | 0505805919 | falgahtani@gmail.com |
| 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 | |
| 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 May 16, 2013