Development of a Risk Score to Predict the Vacuum Extraction Failure
NCT ID: NCT03853499
Last Updated: 2019-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1743 participants
OBSERVATIONAL
2017-07-29
2017-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section
NCT03298594
Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols
NCT07258459
Vaginal Birth After Caesarean Section and Levator Ani Avulsion
NCT03420001
Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery
NCT04566705
The Effect of Independent Obstetric Operating Room on Decision-to-delivery Interval for Emergency Cesarean Section
NCT05208515
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Successful vacuum extraction
Patients for whom vacuum extraction was successful
No intervention (observational study)
No intervention (observational study)
Failed vacuum extraction
Patients who had an emergency caesarean section after failed vacuum extraction
No intervention (observational study)
No intervention (observational study)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention (observational study)
No intervention (observational study)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* from 37 weeks of amenorrhea
* cephalic presentation
* epidural anesthesia
* vacuum extraction attempt (failure or success)
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Besançon
Besançon, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P/2017/326
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.