Development of a Risk Score to Predict the Vacuum Extraction Failure (FADS)

C

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Vacuum Extraction

Treatments

Other: No intervention (observational study)

Study type

Observational

Funder types

Other

Identifiers

NCT03853499
P/2017/326

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,743 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • delivery in the Regional Teaching Hospital of Besançon (France) between January 2010 and December 2015
  • from 37 weeks of amenorrhea
  • cephalic presentation
  • epidural anesthesia
  • vacuum extraction attempt (failure or success)

Trial design

1,743 participants in 2 patient groups

Successful vacuum extraction
Description:
Patients for whom vacuum extraction was successful
Treatment:
Other: No intervention (observational study)
Failed vacuum extraction
Description:
Patients who had an emergency caesarean section after failed vacuum extraction
Treatment:
Other: No intervention (observational study)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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