Vacuum Extraction Clinical Trial
— FADSOfficial title:
Development of a Risk Score to Predict the Vacuum Extraction Failure
| NCT number | NCT03853499 |
| Other study ID # | P/2017/326 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 29, 2017 |
| Est. completion date | November 20, 2017 |
| Verified date | September 2018 |
| Source | Centre Hospitalier Universitaire de Besancon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1743 |
| Est. completion date | November 20, 2017 |
| Est. primary completion date | November 20, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital of Besançon | Besançon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Besancon |
France,
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):1017-22. doi: 10.1097/AOG.0b013e3181bbf3be. — View Citation
Gopalani S, Bennett K, Critchlow C. Factors predictive of failed operative vaginal delivery. Am J Obstet Gynecol. 2004 Sep;191(3):896-902. — View Citation
Langeron A, Mercier G, Chauleur C, Varlet MN, Patural H, Lima S, Seffert P, Chêne 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. — View Citation
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. French. — View Citation
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):501-6. doi: 10.1097/AOG.0000000000001273. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |