Condition category
Pregnancy and Childbirth
Date applied
05/07/2007
Date assigned
30/08/2007
Last edited
08/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Siobhan Quenby

ORCID ID

Contact details

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

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 measures

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

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

http://www.lwh.org.uk/

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19903335

Publication citations

  1. 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.

Additional files

Editorial Notes