First trimester threatened miscarriage treatment with human chorionic gonadotrophins: a randomised controlled trial

Abstract

OBJECTIVE: To determine whether administration of exogenous human chorionic gonadotrophin (hCG) treatment improve the pregnancy outcome in first trimester threatened miscarriages. DESIGN: A prospective, double blind, randomised, placebo-controlled trial. SETTING: The Early Pregnancy Assessment Unit, Royal Bolton Hospital, Bolton, United Kingdom. POPULATION: One hundred and eighty-three women with vaginal bleeding and a viable fetus seen on ultrasound scan (USS) in the first 12 weeks of pregnancy. METHODS: The patients were randomised to receive either hCG or placebo treatment until 14 weeks of gestation. MAIN OUTCOME MEASURES: The primary objective of the trial was to determine the miscarriage rate in the hCG arm compared from the placebo arm. RESULTS: Of the 183 cases, 87 were randomised to treatment with hCG while 96 were randomised to receive a placebo. Forty-seven (25%) did not comply with the study protocol. The mean [SD] gestational age at presentation was 7 [1.33] weeks. The mean [SD] age of women in study was 27 [5] years in the placebo and 28 [5] in the hCG group. The mean body mass index (kg/m(2)) was 25 [5] in the study. The number of patients actively bleeding per vaginum at presentation was 85 (93%) in placebo group and 79 (96%) in the hCG group. The median number of hCG or placebo injections for both groups was 7. Ten women (11%) in the placebo group proceeded to have a complete miscarriage, as did 10 women (12%) in the hCG group, relative risk (RR) [95% confidence interval (CI)] of 1.1 (0.63-1.6). CONCLUSION: Our study showed no evidence of a difference in the outcome of threatened miscarriages when treated with hCG in the first trimester, this may be because our study sample size was small and follow up was suboptimal. A large, randomised, multicentre trial is still needed to establish the usefulness of hCG treatment in cases of threatened miscarriage.