CompletedPhase 4

Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

Egypt700 participantsStarted 2012-09

Plain-language summary

In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 28 weeks of gestation, compared to placebo, ).

Who can participate

Age range20 Years – 39 Years

SexFEMALE

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Inclusion criteria

✓. Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages).
✓. 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).
✓. Spontaneous conception (as confirmed by urinary pregnancy tests).
✓. Willing and able to give informed consent.

Exclusion criteria

✕. Age less than twenty or above forty years old.
✕. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice)
✕. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
✕. Fibroids distorting uterine cavity.
✕. Abnormal parental karyotype.
✕. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

What they're measuring

Number of patients continued the pregnancy beyond 20 weeks gestation.

Timeframe: 2 years

Trial details

NCT IDNCT01670929

SponsorWoman's Health University Hospital, Egypt

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05

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