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A randomised controlled trial of prednisolone for women with recurrent miscarriage and high levels of uterine natural killer cells in the endometrium

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28090716
Enrollment
136
Registered
2007-08-30
Start date
2007-08-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Recurrent miscarriage Pregnancy and Childbirth Spontaneous abortion

Interventions

Group one: these women will be allocated oral prednisolone, 20 mg a day for six weeks, then 10 mg for one week, then 5 mg for one week. Group two: these women will be allocated oral placebo tablets wi

Sponsors

Liverpool Women's NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women with three or more consecutive idiopathic first trimester miscarriages and more than 5% of endometrial cells CD56+ 2. Women aged between 20 and 40 years

Exclusion criteria

Exclusion criteria: 1. Known cause for pregnancy losses 2. Anti-phospholipid antibody syndrome 3. Parental balanced translocation, uterine anomaly 4. Known thrombophilia

Design outcomes

Primary

MeasureTime frame
Live birth rate, this outcome will be measured in accordance with each woman's achieved gestation period.

Secondary

MeasureTime frame
1. Conception rate 2. First trimester losses 3. Second trimester miscarriages 4. Still births 5. Intrauterine growth restriction 6. Pre-eclampsia 7. Abruption 8. Gestation at delivery 9. Foetal abnormality 10. Side effects of steroids Secondary outcomes will be measured during routine high risk antenatal clinic appointments (every 2 weeks up until 12 weeks gestation; 28 weeks and 34 weeks gestation). The women will be in regular contact with the Chief Investigator as and when they feel the need (if they have concerns) and during their routine clinic appointments - during which secondary outcomes will be reported.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026