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] Funded by NIHR-HTA(UK) 08/38/01 for £1.2million - Progesterone in Recurrent Miscarriages (PROMISE) Study

Phase 1

• Conditions: Recurrent Miscarriage

• Registration Number: EUCTR2009-011208-42-GB
• Lead Sponsor: Imperial College, London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-18
• Study Completion: 2014-09-01
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 836

Inclusion Criteria

1. Women with unexplained recurrent miscarriages (3 or more 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 the 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 SLE. 7. Current heparin therapy. 8. Contraindications to progesterone use (e.g. allergy to progesterone).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified