Misoprostol (1) – Angusta®

• Clinical trials
  • The Young 2020 study was an open-label, three-arm RCT conducted between 1999 and 2000.
  • The study compares orally administered misoprostol with vaginally administered misoprostol and with dinoprostone.

Pregnant women with an indication for labour induction due to cervical immaturity (Bishop score < 7)

• An additional benefit is not proven.
• Overall, it is concluded that additional benefit for misoprostol in pregnant women with an indication for labour induction due to cervical immaturity (Bishop score < 7) is not proven.
• morbidity
  • In summary, it must be noted that the study presented (Young 2020) does not adequately represent either the intervention used or the appropriate comparator therapy that are relevant to the present benefit assessment.
• Health-related quality of life
  • In summary, it must be noted that neither the intervention nor the comparator therapy used in the presented study (Young 2020) are suitable for adequately representing the intervention and appropriate comparator therapy relevant to the present benefit assessment.
• Side effects
  • In summary, it must be noted that neither the intervention nor the comparator therapy used in the submitted study (Young 2020) are suitable for adequately representing the intervention and appropriate comparator therapy relevant to the present benefit assessment.

Courtesy translation only, please refer to the German original.