Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for
labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.
Design: Non-interventional observational case control study.
Setting: Tertiary-care academic centre in Germany.
Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
Methods: Induction of labour with MVI in a consecutive series of women using standard
(MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.
Main outcome measures: The primary outcomes were the time from induction to delivery and the
caesarean section rate. The secondary outcomes included the need for additional measures to
induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained
amniotic fluid, umbilical arterial pH, and Apgar score.