Thrombin Generation and Gestational Outcome

Thrombophilia Clinical Trial

Official title:

Thrombin Generation and Gestational Outcome in Women With Recurrent Pregnancy Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139670
• Other study ID #: thrombin generation- pregnancy
• Status: Completed
• Phase: N/A
• First received: August 26, 2013
• Last updated: February 28, 2018
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In total 120 pregnant women's with history of recurrent miscarriages, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). The relation between pregnancy outcome and thrombin measurements will be determined

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18

• signed inform consent

• first trimester

• two early miscarriages(before week 10) or one later abortions (after week 10)

Exclusion Criteria:

• Chronic treatment with aspirin or other anticoagulants

Related Conditions & MeSH terms

• Thrombophilia

Locations

Country	Name	City	State
Israel	Haemek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy outcome		2 years