Venous Thromboembolism Prophylaxis Post Cesarean Section

King Saud University300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Bleeding Venous Thromboembolism

Interventions

TINZAPARINDRUG

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.

PLACEBODRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

Security Forces Hospital

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

Outcomes

Primary Outcomes

Deep Vein Thrombosis

The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: Symptomatic DVT

Central Contacts

FARJAH H ALGAHTANI, MD

CONTACT

0505805919 falgahtani@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.