PROMISE study

Question 1

Study design?

Answer 1

A randomised, double-blind, placebo-controlled, international multicentre study,
with economic evaluation, conducted in hospital settings across the UK (36 sites) and in the Netherlands
(nine sites).

Question 2

Participants and intervention?

Answer 2

836 Women with unexplained RM (three or more first-trimester losses), aged between 18 and 39 years, conceiving naturally, received either 400mg PV Progesterone or placebo vaginal capsules twice daily, administered vaginally from soon after a positive
urinary pregnancy test (and no later than 6 weeks of gestation) until 12 completed weeks of gestation
(or earlier if the pregnancy ended before 12 weeks)

Question 3

Primary outcomes

Answer 3

Live birth beyond 24 completed weeks of gestation (primary outcome), 
clinical pregnancy at 6–8 weeks, 
ongoing pregnancy at 12 weeks, 
miscarriage, 
gestation at delivery, 
neonatal survival at 28 days of life, 
congenital abnormalities 
resource use

Question 4

Results

Answer 4

No change in either primary or secondary outcomes with use of progesterone

Question 5

Limitations

Answer 5

did not explore the effect of treatment with other progesterone preparations or treatment during the luteal phase of the menstrual cycle.