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.
Study Type
OBSERVATIONAL
Enrollment
138
Time from induction to delivery in minutes
Time frame: August 2016
Rate of participants receiving a caesarean section compared to all participants being induced
Time frame: August 2016
Number of participants with treatment-related tachysystole as assessed by cardiotocography
Time frame: August 2016
Number of participants with treatment-related adverse events following tocolysis with Partusisten
Time frame: August 2016
Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value
Time frame: August 2016
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