Progesterone in recurrent miscarriages (PROMISE) study

Not Applicable

Completed

• Conditions: nexplained recurrent miscarriages; Pregnancy and Childbirth; Spontaneous abortion

• Registration Number: ISRCTN92644181
• Lead Sponsor: Imperial College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-17
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 790

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified