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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003307-36-GB

Enrollment

694

Registered

2005-11-09

Start date

2005-12-08

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Idopathic recurrent miscarriage

Interventions

Trade Name: prednisolone Product Name: prednisolone Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of admi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026