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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol vaginal insert for max. 24hrs | 69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours |
| |
| Misoprostol vaginal insert for max. 10hrs | 69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol vaginal insert | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from induction to delivery in minutes | August 2016 | |
| Rate of participants receiving a caesarean section compared to all participants being induced | August 2016 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related tachysystole as assessed by cardiotocography | August 2016 | |
| Number of participants with treatment-related adverse events following tocolysis with Partusisten | August 2016 |
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Inclusion Criteria:
Exclusion Criteria:
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A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
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| Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value | August 2016 |