Development of a Risk Score to Predict the Vacuum Extraction Failure

Study Overview
=================
Brief 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.

Official Title
-----------------
Development of a Risk Score to Predict the Vacuum Extraction Failure

Conditions
-----------------
Vacuum Extraction

Intervention / Treatment
-----------------
* Other: No intervention (observational study)


Participation Criteria
=================
Eligibility 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)
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Successful vacuum extraction<br>Patients for whom vacuum extraction was successful | Other: No intervention (observational study)<br>* No intervention (observational study)<br>|
| Failed vacuum extraction<br>Patients who had an emergency caesarean section after failed vacuum extraction | Other: No intervention (observational study)<br>* No intervention (observational study)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final mode of delivery | The final mode of delivery corresponds to : a vacuum assisted vaginal delivery in case of successful vacuum extraction an emergency caesarean section in case of failed vacuum extraction | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Failure, Forceps Delivery, Cesarean Section, Affecting Fetus or Newborn, Vacuum Extraction