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A prospective study on blood coagulation and fibrinolysis in the peripartum period using rotational thromboelastometry (ROTEM)

A prospective study on blood coagulation and fibrinolysis in the peripartum period using rotational thromboelastometry (ROTEM) - A prospective study on blood coagulation and fibrinolysis in the peripartum period using rotational thromboelastometry (ROTEM)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000048160
Enrollment
160
Registered
2022-06-27
Start date
2022-06-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pregnancy and postpartum period

Interventions

None listed

Sponsors

Hamamatsu University Scool of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Singleton pregnancy women in the third trimester (from 28 to 40 weeks of pregnancy) who are expected vaginal delivery or cesarean section. 1. Pregnant women before the onset of labor (before and after 37 weeks of gestation) 2. Pregnant women during the labor 3. Postpartum women on day 1 postpartum

Exclusion criteria

Exclusion criteria: 1. Patients medicated with antiplatelets or anticoagulants. 2. Patients who have venous thromboembolism. 3. Patients with postpartum hemorrhage during delivery (in vaginal delivery >= 800 mL, in cesarean section >= 1500 mL). 4. Patients complicated with disease involving platelets, coagulation, fibrinolysis, anticoagulation, or antifibrinolysis system. 5. Patients with anemia (hemoglobin concentration <8.0 g/dL) before the delivery. 6. Patients with severe liver disease (or AST >= 100 U/L). 7. Patients with severe renal disease (or serum creatinine >= 1.3 mg/dL).

Design outcomes

Primary

MeasureTime frame
The parameters of ROTEM assays (CT, CFT, alpha, A10, MCF, LI30, LI60 in NATEM, EXTEM, FIBTEM, and APTEM assays)

Secondary

MeasureTime frame
1) Hemoglobin concentration, hematocrit, platelet count, prothrombin time, activated partial thromboplastin time, fibrinogen level, prothrombin fragment 1+2, plasmin alpha2-plasmin inhibitor complex, D-dimer 2) Correlation between ROTEM assays and coagulation/fibrinolysis parameters

Countries

Japan

Contacts

Public ContactChie Fukuchi

Hamamatsu University School of Medicine Department of Obstetrics and Gynecology

cfukuchi@hama-med.ac.jp053-435-2309

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026