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 |
| Protocol serial number | LWH0606 |
| Sponsor | Liverpool Women's NHS Foundation Trust (UK) |
| Funders | Current sources of funding as of 19/08/2008:, Moulton Charitable Foundation (UK), Previous sources of funding:, Liverpool Women's NHS Foundation Trust (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Liverpool Women's NHS Foundation Trust
University of Liverpool Department
Crown Street
Liverpool
L8 7SS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind, placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Prednisolone study |
| Study objectives | 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(s) | Ethics approval received from Liverpool Research Ethics Committee on the 9th November 2005 (ref: 05/Q1505/115). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Prednisolone |
| Primary outcome measure(s) |
Live birth rate, this outcome will be measured in accordance with each woman's achieved gestation period. |
| Key secondary outcome measure(s) |
1. Conception rate |
| Completion date | 01/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 136 |
| Key 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 |
| Key exclusion criteria | 1. Known cause for pregnancy losses 2. Anti-phospholipid antibody syndrome 3. Parental balanced translocation, uterine anomaly 4. Known thrombophilia |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/08/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
L8 7SS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
