Chinese Herbal Medicine and Micronized Progesterone for Live Births in Threatened Miscarriage
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Threatened miscarriage is manifested by vaginal bleeding, with or without abdominal pain,
while the cervix is closed and the fetus is viable and inside the uterine cavity. Threatened
miscarriage is a common complication of pregnancy occurring in 20% of all clinically
recognized pregnancies and about half of these will eventually result in pregnancy loss. The
goal of this double-bind, randomized and double dummy controlled trial is to determine which
of the two oral medications, CHM or micronized progesterone, and will mostly likely result in
live birth in women with threatened miscarriage. We will evaluate the efficacy and safety of
CHM and micronized progesterone for treating threatened miscarriage in this trial. Our
primary outcome of this trial is a live birth. We hypothesize that: 1. treatment with CHM
plus micronized progesterone placebo or micronized progesterone plus CHM placebo or CHM plus
Micronized progesterone is more likely to result in live birth than the control arm which
will be CHM placebo plus micronized progesterone placebo; 2. CHM plus micronized progesterone
placebo and micronized progesterone plus CHM placebo will have similar treatment effects.