Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2019 |
| First Submitted: | 10/29/2015 |
| Estimated Enrollment Submitted: | 11/05/2015 |
| First Posted: | 11/08/2015 |
| Last Update Submitted: | 01/20/2020 |
| Last Update Posted: | 01/22/2020 |
| Actual Study Start Date: | 11/30/2014 |
| Estimated Primary Completion Date: | 07/30/2019 |
| Estimated Study Completion Date: | 06/30/2020 |
Condition or disease
Intervention/treatment
Drug: enoxaparin
Other: no intervention
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Other: enoxaparin A prospective study that will evaluate all pregnant women admitted for clinical treatment and / or surgery 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 both groups. | Drug: enoxaparin Patients who score higher or equal to 3, receive a prophylactic dose of enoxaparin. The first dose of enoxaparin is administered 8 hours after vaginal or abdominal delivery. Subsequent doses are administered daily for up to 15 days. The dose depends on patient weight. |
| Other: no intervention Pregnant women admitted in hospital for clinical treatment and/or delivery and that does not score for thromboprophylaxis. | Other: no intervention Hospitalized patients that score less than three are not prescribed enoxaparin. |
Eligibility Criteria
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - All pregnant women hospitalized. Exclusion Criteria: - Previous use of anticoagulation |
Outcome
Primary Outcome Measures
1. 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. [4 years]
