CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,743 enrolled
Drug / intervention
No intervention (observational study)other
Likely dose
Not stated in record
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Search/NCT03853499
NCT03853499N/ACompleted

Development of a Risk Score to Predict the Vacuum Extraction Failure

Centre Hospitalier Universitaire de Besancon·observational·Posted Feb 25, 2019·Updated Feb 25, 2019

In Brief

An observational study evaluating No intervention (observational study) for Vacuum Extraction. Completed, enrolled 1,743 participants across 1 site.

Detailed Summary

Safe operative vaginal delivery requires a careful assessment of the clinical situation. During the pushing efforts, the complexity of the delivery can lead to choose between an operative vaginal delivery attempt and a caesarean section straightaway. An emergency caesarean section for failed operative vaginal delivery is associated with a higher fetal and maternal morbidity, compared to a successful operative vaginal delivery and to a caesarean section straightaway. The objective of this study was to develop a risk score of failed vacuum extraction leading to an emergency caesarean section. This score could be an objective tool to help the obstetricians to choose between a vacuum extraction attempt and a caesarean section straightaway. The investigators included patients who benefited from a vacuum extraction attempt in the Regional Teaching Hospital of Besançon (France) between January 2010 and December 2015. Patients were separated into two groups : the vacuum extraction failure group and the vacuum extraction success group. The investigators selected maternal, fetal and labor characteristics which could influence success or failure of the vacuum extraction and compared them between the two groups. The score was developed with the characteristics which significantly influence the vacuum extraction failure.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 25, 2019
Enrollment StartJul 29, 2017
Primary CompletionNov 20, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.4 years ago

Interventions

No intervention (observational study)other

No intervention (observational study)