Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LWH0606
Study information
Scientific title
Acronym
Prednisolone study
Study hypothesis
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 uterine Natural Killer (uNK) cell numbers in their endometrium.
Ethics approval
Ethics approval received from Liverpool Research Ethics Committee on the 9th November 2005 (ref: 05/Q1505/115).
Study design
Randomised double-blind, placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Recurrent miscarriage
Intervention
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 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 type
Drug
Phase
Not Specified
Drug names
Prednisolone
Primary outcome measure
Live birth rate, this outcome will be measured in accordance with each woman's achieved gestation period.
Secondary outcome measures
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.
Overall trial start date
01/08/2007
Overall trial end date
01/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
68 women in each arm (136 total)
Participant exclusion criteria
1. Known cause for pregnancy losses
2. Anti-phospholipid antibody syndrome
3. Parental balanced translocation, uterine anomaly
4. Known thrombophilia
Recruitment start date
01/08/2007
Recruitment end date
01/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool Women's NHS Foundation Trust
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
Liverpool Women's NHS Foundation Trust (UK)
Sponsor details
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 702 4346
lynne.webster@lwh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Current sources of funding as of 19/08/2008:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Moulton Charitable Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Previous sources of funding:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Liverpool Women's NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19903335
Publication citations
-
Results
Tang AW, Alfirevic Z, Turner MA, Drury J, Quenby S, Prednisolone Trial: Study protocol for a randomised controlled trial of prednisolone for women with idiopathic recurrent miscarriage and raised levels of uterine natural killer (uNK) cells in the endometrium., Trials, 2009, 10, 102, doi: 10.1186/1745-6215-10-102.