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
Scientific
Liverpool Women's NHS Foundation Trust
University of Liverpool Department
Crown Street
Liverpool
L8 7SS
United Kingdom
Study information
| Study design | Randomised double-blind, placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/08/2007 |
| Completion date | 01/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 68 women in each arm (136 total) |
| 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
- England
- United Kingdom
Study participating centre
Liverpool Women's NHS Foundation Trust
Liverpool
L8 7SS
United Kingdom
L8 7SS
United Kingdom
Sponsor information
Liverpool Women's NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Crown Street
Liverpool
L8 7SS
England
United Kingdom
| Phone | +44 (0)151 702 4346 |
|---|---|
| lynne.webster@lwh.nhs.uk | |
| Website | http://www.lwh.org.uk/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
