Methods |
2‐arm placebo‐controlled randomised trial, plus a non‐intervention control group. |
Participants |
360 women were randomised in a hospital setting in India. The population comprised women aged 18‐35 years with a history of idiopathic, ≥ 3 first‐trimester pregnancy losses and currently in the first trimester with a live pregnancy (preferably 2‐8 weeks' gestation). Exclusion criteria comprised women with a known cause of recurrent miscarriage, women who had taken an injection of hCG or hydroxyprogesterone. |
Interventions |
20 mg oral dydrogesterone (taken as 2 x 10 mg tablets) from time of enrolment to 20 weeks versus placebo. The trial also included an additional control group of women without a history of miscarriage who were age‐matched, healthy, pregnant women with at least 1 live birth. |
Outcomes |
The study recorded the following outcomes relevant for this review: miscarriage and preterm birth. |
Notes |
Evidence of trial documentation and data requested from the corresponding author, who replied but did not answer all of our queries or provide the requested data by the time that this review was published. |