Trials / Completed
CompletedNCT03016208
The Misoprostol Vaginal Insert for Labour Induction
The Misoprostol Vaginal Insert Used in Standard Compared With Adjusted Criteria for Labour Induction in Term Pregnancies: a Non-interventional Case Control Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 138 (actual)
- Sponsor
- Asklepios Kliniken Hamburg GmbH · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Misoprostol vaginal insert |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2015-12-01
- Completion
- 2016-05-01
- First posted
- 2017-01-10
- Last updated
- 2017-01-11
Source: ClinicalTrials.gov record NCT03016208. Inclusion in this directory is not an endorsement.