ISRCTN92644181Completed未知
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)
Imperial College London (UK)0 sites790 target enrollmentStarted: March 17, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 790
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
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
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)
Investigators
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