First trimester progesterone therapy to reduce miscarriages in women with a history of unexplained recurrent miscarriages: A randomised, double blind, placebo-controlled, multi-centre trial.
- Conditions
- recurrent miscarriage (unexplained)10000211
- Registration Number
- NL-OMON33690
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. Women with unexplained RM (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.
1. Inability to conceive spontaneously within 1 year of recruitment
2. Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin antibodies [IgG or IgM])
3. other recognised thrombophilic conditions (testing according to usual clinic practice)
4. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram or hysteroscopy)
5. Submucous fibroids
6. Abnormal parental karyotype
7. Other identifiable causes of RM (tests initiated only if clinically indicated): e.g. diabetes, thyroid disease and SLE.
8. previous enrolment in the Promise trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>live birth beyond 24 weeks;</p><br>
- Secondary Outcome Measures
Name Time Method <p>ongoing pregnancy at 12 weeks (range 11 * 13 weeks), miscarriage rate,<br /><br>gestation at delivery, survival at 28 days of neonatal life, adverse events,<br /><br>subgroup effects of progesterone (see 2. secondary objectives)</p><br>