A randomised controlled trial of prednisolone for women with recurrent miscarriage and high levels of uNK cells in the endometrium - recurrent miscarriage and prednisolone

Phase 1

• Conditions: Idopathic recurrent miscarriage

• Registration Number: EUCTR2005-003307-36-GB
• Lead Sponsor: niversity of Liverpool/Liverpool Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 694

Inclusion Criteria

Three or more consecutive idiopathic first trimester miscarriages and >5% of endometrial cells CD56+. Age between 20 and 40.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known cause for pregnancy losses; anti-phospholipid antibody syndrome (positive ACA or LA on two separate occasions at least 6 weeks apart), parental balanced translocation, uterine anomaly (subseptate uterus cervical weakness diagnosed at hysteroscopy), known thrombophilia (APCR resistance, leiden factor V, protein C, S, deficiency, prothombin gene mutation, antithrombin 3 deficiency, homozygosity for MTHFR mutation)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Live birth rate;Main Objective: To test whether prednisolone therapy during the first trimester of pregnancy is able to reduce the chance of miscarriage compared to placebo in women with idiopathic recurrent miscarriage and raised uNK cell number in their endometrium.;Secondary Objective: To asssess whether prednisolone administration in the first trimester of pregnancy is assocaited with any obstetric cimplications