A Prospective observational study to assess the efficacy of oral progestogen in patients with first trimester threatened miscarriage

Abstract

Miscarriage is a common complication of pregnancy occurring in 15-20% of all clinically recognized pregnancies. Threatened miscarriage is characterised by vaginal bleeding associated with or without abdominal pain, where the cervix is closed and the fetus is still viable intrauterine. The aim of this study was to establish the efficacy of oral progestogen (intervention group) compared to conservative management, which was bed rest (control group) in subjects with the first trimester threatened miscarriage. The primary outcome of this study was represented based on the number of miscarriages by 20 weeks of gestation. This prospective observational study was conducted at gynaecology ward and Early Pregnancy Assessment Unit (EPAU) of Hospital Sultanah Nur Zahirah and the Department of Obstetrics and Gynaecology, Sultan Ahmad Shah Medical Centre IIUM for ten months, from June 2019 until March 2020. A total of 217 pregnant women were recruited as the subjects in this study. They were presented with threatened miscarriage of less or equal to 12 weeks of gestation, who fulfilled inclusion criteria and provided informed consent. They were divided into the intervention and control groups. In the intervention group, the subjects were given 40 mg (4 tablets) of dydrogesterone orally at once, then 10 mg (1 tablet) in the interval of every 8 h until the symptoms abate, while the subjects in the control group were advised for bed rest as conservative management. The baseline demographic data in both studied groups were similar and there was no significant (p>0.05) difference in age, BMI, parity, and time interval to pregnancy in both groups. Based on the outcome, there was a smaller number of miscarriages in the intervention group (23, 46%) compared to the control group (27, 54%). However, it was not statistically significant (p>0.05). In conclusion, oral progestogen therapy was an ineffective way to reduce the number of miscarriages in patients with the first trimester threatened miscarriage.