Trials / Completed
CompletedNCT03853499
Development of a Risk Score to Predict the Vacuum Extraction Failure
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,743 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Besancon · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention (observational study) | No intervention (observational study) |
Timeline
- Start date
- 2017-07-29
- Primary completion
- 2017-11-20
- Completion
- 2017-11-20
- First posted
- 2019-02-25
- Last updated
- 2019-02-25
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03853499. Inclusion in this directory is not an endorsement.