Development of a Risk Score to Predict the Vacuum Extraction Failure

NCT03853499 | Completed

• 1 other identifier: P/2017/326
• Study Type: observational
• Target: 1,743
• Locations: 1 country
• Sites: 1

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.

Conditions

Vacuum Extraction

Keywords

Failure; Forceps Delivery; Cesarean Section; Affecting Fetus or Newborn; Vacuum Extraction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Successful vacuum extraction

Patients for whom vacuum extraction was successful

Other: No intervention (observational study)

Failed vacuum extraction

Patients who had an emergency caesarean section after failed vacuum extraction

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

No intervention (observational study)

Failed vacuum extraction; Successful vacuum extraction

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

University Hospital of Besançon

Besançon, 25000, France

Location

Related Publications (6)

• 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.

  PMID: 26967343 BACKGROUND

• 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.

  PMID: 15450259 BACKGROUND

• 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.

  PMID: 26855108 BACKGROUND

• 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.

  PMID: 20168101 BACKGROUND

• 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.

  PMID: 22227232 BACKGROUND

• 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.

  PMID: 15467561 BACKGROUND

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 25, 2019
• Study Start: July 29, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: February 25, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)