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

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 Overview

• Status: Completed
• Conditions: Vacuum Extraction
• Intervention / Treatment: Other: No intervention (observational study)

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.

• Study Type: Observational
• Enrollment (Actual): 1743

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • University Hospital of Besancon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All the patients who delivered in the Regional Teaching Hospital of Besançon (France) between January 2010 and December 2015 and who met the inclusion criteria

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Publications and helpful links

General Publications

• Verhoeven CJ, Nuij C, Janssen-Rolf CR, Schuit E, Bais JM, Oei SG, Mol BW. Predictors for failure of vacuum-assisted vaginal delivery: a case-control study. Eur J Obstet Gynecol Reprod Biol. 2016 May;200:29-34. doi: 10.1016/j.ejogrb.2016.02.008. Epub 2016 Mar 2.
• Miot S, Riethmuller D, Deleplancque K, Teffaud O, Martin M, Maillet R, Schaal JP. [Cesarean section for failed vacuum extraction: risk factors and maternal and neonatal outcomes]. Gynecol Obstet Fertil. 2004 Jul-Aug;32(7-8):607-12. doi: 10.1016/j.gyobfe.2004.04.003. French.
• Palatnik A, Grobman WA, Hellendag MG, Janetos TM, Gossett DR, Miller ES. Predictors of Failed Operative Vaginal Delivery in a Contemporary Obstetric Cohort. Obstet Gynecol. 2016 Mar;127(3):501-506. doi: 10.1097/AOG.0000000000001273.
• Alexander JM, Leveno KJ, Hauth JC, Landon MB, Gilbert S, Spong CY, Varner MW, Caritis SN, Meis P, Wapner RJ, Sorokin Y, Miodovnik M, O'Sullivan MJ, Sibai BM, Langer O, Gabbe SG; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Failed operative vaginal delivery. Obstet Gynecol. 2009 Nov;114(5):1017-1022. doi: 10.1097/AOG.0b013e3181bbf3be.
• Langeron A, Mercier G, Chauleur C, Varlet MN, Patural H, Lima S, Seffert P, Chene G. [Failed forceps extraction: risk factors and maternal and neonatal morbidity]. J Gynecol Obstet Biol Reprod (Paris). 2012 Jun;41(4):333-8. doi: 10.1016/j.jgyn.2011.11.001. Epub 2012 Jan 9. French.
• Gopalani S, Bennett K, Critchlow C. Factors predictive of failed operative vaginal delivery. Am J Obstet Gynecol. 2004 Sep;191(3):896-902. doi: 10.1016/j.ajog.2004.05.073.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2017
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): November 20, 2017

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Cesarean Section; Failure; Forceps Delivery; Affecting Fetus or Newborn; Vacuum Extraction
• Other Study ID Numbers: P/2017/326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No