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

ISRCTN ISRCTN28090716
DOI https://doi.org/10.1186/ISRCTN28090716
Secondary identifying numbers LWH0606
Submission date
05/07/2007
Registration date
30/08/2007
Last edited
08/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Siobhan Quenby
Scientific

Liverpool Women's NHS Foundation Trust
University of Liverpool Department
Crown Street
Liverpool
L8 7SS
United Kingdom

Study information

Study designRandomised double-blind, placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymPrednisolone study
Study objectivesPrednisolone 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 uterine Natural Killer (uNK) cell numbers in their endometrium.
Ethics approval(s)Ethics approval received from Liverpool Research Ethics Committee on the 9th November 2005 (ref: 05/Q1505/115).
Health condition(s) or problem(s) studiedRecurrent miscarriage
InterventionGroup 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 with identical packaging and instructions to group one.

All women will have fortnightly monitoring of blood pressure and blood glucose, and for side effects. Women will be followed up throughout the course of their pregnancies.

Joint Sponsor details:
University of Liverpool (UK)
Research and Business Services
The Foresight Centre
3 Brownlow Street
Liverpool, L69 3GL
United Kingdom
Director of Research: Ian Carter
E-mail: i.carter@liv.ac.uk
Website: http://www.liverpool.ac.uk
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Prednisolone
Primary outcome measureLive birth rate, this outcome will be measured in accordance with each woman's achieved gestation period.
Secondary outcome measures1. 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.
Overall study start date01/08/2007
Completion date01/08/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants68 women in each arm (136 total)
Key inclusion criteria1. 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
Key exclusion criteria1. Known cause for pregnancy losses
2. Anti-phospholipid antibody syndrome
3. Parental balanced translocation, uterine anomaly
4. Known thrombophilia
Date of first enrolment01/08/2007
Date of final enrolment01/08/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Liverpool Women's NHS Foundation Trust
Liverpool
L8 7SS
United Kingdom

Sponsor information

Liverpool Women's NHS Foundation Trust (UK)
Hospital/treatment centre

Crown Street
Liverpool
L8 7SS
England
United Kingdom

Phone +44 (0)151 702 4346
Email lynne.webster@lwh.nhs.uk
Website http://www.lwh.org.uk/
ROR logo "ROR" https://ror.org/04q5r0746

Funders

Funder type

Charity

Current sources of funding as of 19/08/2008:

No information available

Moulton Charitable Foundation (UK)

No information available

Previous sources of funding:

No information available

Liverpool Women's NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/11/2009 Yes No