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04 February 2012
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| [ Print-friendly version ] |
| Progesterone in recurrent miscarriages (PROMISE) study |
| ISRCTN | ISRCTN92644181 |
| ClinicalTrials.gov identifier | |
| Public title | Progesterone in recurrent miscarriages (PROMISE) study |
| Scientific title | First trimester progesterone therapy in women with a history of unexplained recurrent miscarriages: a randomised double-blind placebo-controlled multi-centre trial (The PROMISE [PROgesterone in recurrent MIScarriagE] Trial) |
| Acronym | The PROMISE trial |
| Serial number at source | HTA 08/38/01 |
| Study hypothesis |
1. In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice daily), started soon as possible after a positive pregnancy test (and no later than 6 weeks gestation) and continued to 12 weeks of gestation, compared to placebo, increases live births beyond 24 completed weeks by at least 10% (principal objective)
2. Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at 12 weeks, survival at 28 days of neonatal life 3. Progesterone, compared to placebo, does not incur substantial adverse effects to the mother or the neonate 4 Explore differential or subgroup effects of progesterone in prognostic subgroups 5. Perform an economic evaluation for cost-effectiveness |
| Lay summary | |
| Ethics approval | To be submitted as of 10/03/2009 |
| Study design | Randomised double-blind placebo-controlled multi-centre trial |
| Countries of recruitment | Netherlands, United Kingdom |
| Disease/condition/study domain | Unexplained recurrent miscarriages |
| Participants - inclusion criteria |
1. Women with unexplained recurrent miscarriages (3 or more consecutive first trimester miscarriages)
2. Age 18-39 years at randomisation (likelihood of miscarriages due to chromosomal aberrations is higher in older women; such miscarriages are unlikely to be prevented by progesterone therapy) 3. Spontaneous conception (as confirmed by urinary pregnancy tests) 4. Willing and able to give informed consent |
| Participants - exclusion criteria |
1. Inability to conceive spontaneously within 1 year of recruitment
2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice) 3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy) 4. Fibroids distorting uterine cavity 5. Abnormal parental karyotype 6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE) |
| Anticipated start date | 01/05/2009 |
| Anticipated end date | 01/05/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 790 |
| Interventions |
Intervention group: Progesterone pessaries (400 mg twice daily) started soon as possible after a positive pregnancy test (and no later than 6 weeks gestation) and continued to 12 weeks of gestation
Control group: Placebo Total duration of follow-up per participant: 42 weeks Details of Principal Investigator: Dr Rajendra Rai Department of Obstetrics & Gynaecology St Mary's Hospital Mint Wing South Wharf Road London W2 1PG United Kingdom Tel: +44 (0)207 886 2475 Fax: +44 (0)207 886 6054 Email: r.rai@imperial.ac.uk |
| Primary outcome measure(s) | Live births beyond 24 weeks |
| Secondary outcome measure(s) |
1. Gestation at delivery
2. Clinical pregnancy at 6-8 weeks 3. On-going pregnancy at 12 weeks (range 11-13 weeks) 4. Miscarriage rate 5. Survival at 28 days of neonatal life 6. Congenital abnormalities with specific examination for genital anomalies 7. Adverse events |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | http://www.medscinet.net/promise |
| Publications | |
| Contact name | Dr Arri Coomarasamy |
| Address |
3rd Floor, Academic Department
Birmingham Women's Hospital Metchley Park Road Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TG |
| Country | United Kingdom |
| Tel | +44 (0)121 623 6835 |
| Fax | +44 (0)121 623 6875 |
| a.coomarasamy@bham.ac.uk | |
| Sponsor | Imperial College London (UK) |
| Address |
Clinical Research Governance Office
GO2 Sir Alexander Fleming Building Exhibition Road |
| City/town | London |
| Zip/Postcode | SW7 2AZ |
| Country | United Kingdom |
| Tel | +44 (0)20 7594 1188 |
| Fax | +44 (0)20 7594 1792 |
| gary.roper@imperial.ac.uk | |
| Sponsor website: | http://www.imperial.ac.uk |
| Date applied | 10/03/2009 |
| Last edited | 17/03/2009 |
| Date ISRCTN assigned | 17/03/2009 |
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