Progesterone in recurrent miscarriages (PROMISE) study

Conditions

Unexplained recurrent miscarriages Pregnancy and Childbirth Spontaneous abortion

Yealin Chung, Christina Easter, Arri Coomarasamy, Adam Devall

Human Reproduction2023-06-011 citations

PROMISE: first-trimester progesterone therapy in women with a history of unexplained recurrent miscarriages - a randomised, double-blind, placebo-controlled, international multicentre trial and economic evaluation.

Coomarasamy A, Williams H, Truchanowicz E, Seed PT, Small R, Quenby S, Gupta P, Dawood F, Koot YE, Atik RB, Bloemenkamp KW, Brady R, Briley A, Cavallaro R, Cheong YC, Chu J, Eapen A, Essex H, Ewies A, Hoek A, Kaaijk EM, Koks CA, Li TC, MacLean M, Mol BW, Moore J, Parrott S, Ross JA, Sharpe L, Stewart J, Trépel D, Vaithilingam N, Farquharson RG, Kilby MD, Khalaf Y, Goddijn M, Regan L, Rai R.

2016-05-0148 citations

10.3310/hta20410

A Randomized Trial of Progesterone in Women with Recurrent Miscarriages

Arri Coomarasamy, Helen Williams, Ewa Truchanowicz, Paul T. Seed, Rachel Small et al. (35 authors)

New England Journal of Medicine2015-11-25298 citations

10.1056/nejmoa1504927

Interventions

Intervention group: Progesterone pessaries (400 mg twice daily) started soon as possible after a positive pregnancy test (and no later than 6 weeks gestation) and continued to 12 weeks of gestation C

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Live births beyond 24 weeks	—

Secondary

Measure	Time frame
1. Gestation at delivery 2. Clinical pregnancy at 6-8 weeks 3. Ongoing pregnancy at 12 weeks (range 11-13 weeks) 4. Miscarriage rate 5. Survival at 28 days of neonatal life 6. Congenital abnormalities with specific examination for genital anomalies 7. Adverse events	—

Countries

Netherlands, United Kingdom

Outcome results

None listed