NCT01542411

Brief Summary

This study evaluated the effect of anticoagulant treatment on the live-birth rate in women with a history of at least two continuous unexplained miscarriages or thrombophilia. It also compared two methods of treatment with aspirin and aspirin plus heparin.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
Last Updated

March 2, 2012

Status Verified

February 1, 2012

First QC Date

February 25, 2012

Last Update Submit

March 1, 2012

Conditions

Recurrent Pregnancy Loss

Study Arms (3)

recurrent pregnancy loss

thrombophilia, aspirin

heparin

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This project evaluated 520 women with unexplained recurrent miscarriage for four years. They had referred to recurrent abortion clinic of Yazd Reproductive sciences institute. Women with unexplained recurrent miscarriage included in this study

You may qualify if:

  • unexplained recurrent miscarriage,
  • women had previous venous or arterial thromboembolism or who were heterozygous or homozygous for mutations for FV Leiden G1691A, prothrombin gene G20210A (FII G20210A), and methyltetrahydrofolate reductase C677T (MTHFR C677T)

You may not qualify if:

  • abnormal karyotypes of both partners,
  • uterine and cervical anatomical disorders on pelvic ultrasonography or hysteroscopy,
  • abnormal ovaries and abnormal endocrine tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research and Clinical Centre for Infertility

Yazd, Yazd Province, Iran

Location

Study Officials

  • Tahere Jahaninejad, MSC

    Yazd Shahid Sadoughi Medical Sciences University and Health Services, Yazd, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2012

First Posted

March 2, 2012

Study Start

April 1, 2008

Last Updated

March 2, 2012

Record last verified: 2012-02

Locations

IR(1)