Clinical trial NCT02600260: Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial
Official title: Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombophilia Associated With Pregnancy
Perioperative/Postoperative Complications
Venous Thrombosis
Pulmonary Embolism
Other Specified Risk Factors in Pregnancy
Deep Vein Thrombosis
Keywords: thrombophilia
thrombosis
Pregnancy, High-Risk
venous thrombosis
enoxaparin
risk assessment
deep vein thrombosis
pulmonary embolism
hospitalization
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 7212
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of these patients. The application of a protocol for assessing the risk of VTE reduces mortality and morbidity of these phenomena.

Detailed description: Thromboembolic events are among the leading causes of maternal morbidity and mortality in pregnancy / postpartum period. They are the leading cause of maternal death in developed countries. Risk factors for venous thromboembolism (VTE) during pregnancy and postpartum as family history or personal history of VTE, thrombophilia, age over 35, obesity and high parity has been the most studied. One of the main risk factors is hospitalization, which increases up to 20 times the risk of VTE.

Objective: The objective of the study is to identify early risk factors for VTE in hospitalized pregnant women and institute appropriate prophylaxis to reduce the incidence and morbidity.

Methods: A prospective study that will evaluate all pregnant women admitted for clinical treatment and / or surgery in the Department of Obstetrics and Gynecology, Clinics Hospital, University of São Paulo through the application of a thromboprophylaxis protocol with risk assessment score. The patient in whom prophylaxis would be indicated are those with scores greater than or equal to 3. The drug to be used is enoxaparin and the dose to be used depends on the weight of the patient.

It will be further assessed: adverse effects of treatment with enoxaparin, protocol failure in the group treated and untreated (without anticoagulation) and bleeding incidence in the untreated group.

Risk score description: score 3 - previous thrombosis/thromboembolism, homozygous mutations, combined thrombophilia risk factors, antiphospholipid syndrome, cancer(stomach, pancreas, lung), inflammatory conditions, lupus, sickle cell disease, nephrotic syndrome, heart disease; Score 2 - Protein C deficiency, Protein S deficiency, heterozygous F5 Leiden, heterozygous F2 G20210A mutation, cancer(last 6 months), chemotherapy(last 6m), immobility, bed rest \>4d prior to C-section, current serious infections, BMI≥40 kg/m2 , age≥40y, lung disease(cyanosis), postpartum hemorrhage \>1L; Score 1 - age ≥ 35 and ≤39 y, parity ≥3, multiple pregnancy, hyperemesis, gross varicose veins, smoker ≥20, surgical procedure.

Eligibility criteria: Inclusion Criteria:

* All pregnant women hospitalized.

Exclusion Criteria:

* Previous use of anticoagulation

Primary outcomes:
measure: Number of hospitalized pregnant patients with venous thromboembolism (VTE), death and adverse events after applying an in hospital risk score for thrombosis at 12 weeks post discharge.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Venina V Barros, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Royal College of Obstetricians and Gynaecologists. Reducing the risk of thrombosis and embolism during pregnancy and the puerperium. Green-top Guideline No. 37a 2009.
citation: Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos AM, Vandvik PO. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-e736S. doi: 10.1378/chest.11-2300.
citation: Abbasi N, Balayla J, Laporta DP, Kezouh A, Abenhaim HA. Trends, risk factors and mortality among women with venous thromboembolism during labour and delivery: a population-based study of 8 million births. Arch Gynecol Obstet. 2014 Feb;289(2):275-84. doi: 10.1007/s00404-013-2923-8. Epub 2013 Jul 18.
citation: Hase EA, Barros VIPVL, Igai AMK, Francisco RPV, Zugaib M. Risk assessment of venous thromboembolism and thromboprophylaxis in pregnant women hospitalized with cancer: Preliminary results from a risk score. Clinics (Sao Paulo). 2018 Oct 18;73:e368. doi: 10.6061/clinics/2018/e368.
citation: Barros V, Igai A, Fernanda B, Bortolotto M, Francisco R, Zugaib M. Preventing Maternal Death and Morbidity from Venous Thromboembolism (VTE): Results from a VTE Risk Score Trial during Hospitalization [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/preventing-maternal-death-and-morbidity-from-venous- thromboembolism-vte-results-from-a-vte-risk-score-trial-during-hospitalization/. Accessed August 6, 2020.