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Report for Clinical Trial NCT02600260

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial

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.

NCT02600260 Thrombophilia Associated With Pregnancy Perioperative/Postoperative Complications Venous Thrombosis Pulmonary Embolism Other Specified Risk Factors in Pregnancy Deep Vein Thrombosis
MeSH: Pulmonary Embolism Thrombosis Embolism Venous Thrombosis Thrombophilia Postoperative Complications
HPO: Deep venous thrombosis Hypercoagulability Pulmonary embolism Venous thrombosis

2 Interventions

Name: Enoxaparin

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.

Type: Drug

enoxaparin

Name: No intervention

Description: Hospitalized patients that score less than three are not prescribed enoxaparin.

Type: Other

no intervention


Primary Outcomes

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.

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.

Time: 4 years

Purpose: Prevention

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 G20210A

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. --- G20210A ---



HPO Nodes


HPO:
Deep venous thrombosis
Genes 17
PROC HABP2 F5 SERPINC1 PMM2 F2 AKT1 SERPIND1 SERPINC1 PIEZO1 PROS1 MTHFR PROC THBD F13A1 PLAT F9
Hypercoagulability
Genes 19
PROC SPTA1 SPTB F5 MYD88 EPB42 SLC4A1 PROS1 AGGF1 HRG PROC GATA2 THBD PLAT ANK1 PROS1 F9 DLD PIGA
Pulmonary embolism
Genes 57
GDF2 MPL TLR4 COX1 SERPINC1 AKT1 STAT4 CCR1 PROS1 CBS TRNF TET2 TRNH GNAQ ND1 ACVRL1 ND4 SERPINC1 GNAQ F2 TRNW COX3 PROS1 ERAP1 AGGF1 TRNL1 PROC F13A1 KLRC4 IL10 PROS1 UBAC2 HLA-B PIGA PROC COX2 HABP2 TRNQ CD55 C4A SMAD4 IL12A-AS1 IL12A TRNS2 IL23R KCNJ5 ND6 MEFV TRNS1 PTEN ND5 MTHFR PROC FAS PLP1 ENG JAK2
Venous thrombosis
Genes 96
HLA-DPA1 FGA GDF2 MPL TLR4 PTPN22 MET SPINK1 FGG SERPINC1 AKT1 STAT4 CCR1 PROS1 TP53 SAA1 CBS TET2 GNAQ IDH1 FGB JAK2 ACVRL1 IDH2 F5 SERPINC1 CPA1 GNAQ F2 AKT1 SERPIND1 PDGFRA CTRC NOTCH1 JAK2 HBB PROS1 PIEZO1 ERAP1 AGGF1 CDH23 PROC HLA-DPB1 THBD KIF11 F13A1 KLRC4 TET2 IL10 PROS1 UBAC2 PIGM HLA-B IDH2 PROC HABP2 MPL MPL CD55 C4A SMAD4 IL12A-AS1 THPO CALR IL12A CALR IL23R JAK2 HBB CTNNB1 PLAT F9 PRSS1 MEFV TET2 PMM2 IDH1 PTEN CTLA4 PTH1R CASR SH2B3 USP8 MTHFR PROC PRTN3 MPL FAS EPOR CFTR PRKAR1A PDE4D PRSS2 ENG JAK2 PGM1