search
Back to results

Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial

Primary Purpose

Thrombophilia Associated With Pregnancy, Perioperative/Postoperative Complications, Venous Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Enoxaparin
No intervention
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thrombophilia Associated With Pregnancy focused on measuring thrombophilia, thrombosis, Pregnancy, High-Risk, venous thrombosis, enoxaparin, risk assessment, deep vein thrombosis, pulmonary embolism, hospitalization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All pregnant women hospitalized.

Exclusion Criteria:

  • Previous use of anticoagulation

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

enoxaparin

no intervention

Arm Description

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.

Pregnant women admitted in hospital for clinical treatment and/or delivery and that does not score for thromboprophylaxis.

Outcomes

Primary Outcome Measures

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.
Identify early risk factors for VTE in hospitalized pregnant women and prescribe appropriate prophylaxis to reduce the incidence, morbidity and mortality of VTE. The patients that score ≥ 3 will receive enoxaparin. This group will be analyzed for the incidence of adverse outcomes: VTE, bleeding, death until 3 months post hospitalization. This same analysis will be done in those patients who have not received heparin. The patients that could not receive heparin due to bleeding risk will be analyzed also. The analysis of the score will also describe if the higher the score, the higher the index of adverse events, mainly when it is not possible to prescribe the prophylaxis.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2015
Last Updated
April 27, 2021
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02600260
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enoxaparin
Arm Type
Other
Arm Description
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.
Arm Title
no intervention
Arm Type
Other
Arm Description
Pregnant women admitted in hospital for clinical treatment and/or delivery and that does not score for thromboprophylaxis.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
lovenox, clexane
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No intervention
Other Intervention Name(s)
No enoxaparin, Score lower than three
Intervention Description
Hospitalized patients that score less than three are not prescribed enoxaparin.
Primary Outcome Measure Information:
Title
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.
Description
Identify early risk factors for VTE in hospitalized pregnant women and prescribe appropriate prophylaxis to reduce the incidence, morbidity and mortality of VTE. The patients that score ≥ 3 will receive enoxaparin. This group will be analyzed for the incidence of adverse outcomes: VTE, bleeding, death until 3 months post hospitalization. This same analysis will be done in those patients who have not received heparin. The patients that could not receive heparin due to bleeding risk will be analyzed also. The analysis of the score will also describe if the higher the score, the higher the index of adverse events, mainly when it is not possible to prescribe the prophylaxis.
Time Frame
4 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All pregnant women hospitalized. Exclusion Criteria: Previous use of anticoagulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venina V Barros, MD, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
22315276
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.
Results Reference
background
PubMed Identifier
23864199
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.
Results Reference
background
PubMed Identifier
30365820
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.
Results Reference
result
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.
Results Reference
result

Learn more about this trial

Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial

We'll reach out to this number within 24 hrs