Abstract
Objective:
To describe an innovative electronically-controlled vacuum extractor (VE) in detail and to illustrate its performance characteristics, as observed in a laboratory study.
Design:
Thirty simulated, vacuum-assisted deliveries.
Main outcome measure(s):
(1) The ability to measure in real-time of the pull applied and to sound an alert, when the traction approaches the negative pressure under the cup, to prevent its detachment. (2) The recording and printing of a graphic representation of the pull applied (vacuum delivery graph). (3) The emission of a warning signal when the 15-min time limit of continuous cup application on the fetal scalp, is reached.
Results:
No cup detachment occurred in any of the 15 vacuum-assisted deliveries, in which traction was kept below the adhesive force of the cup [44 lb (20 kg)], except in three cases, due to loss of negative pressure. In the remaining 15 tests, in which traction was greater than the adhesive force of the cup, “pull-offs” inevitably occurred. Furthermore, upon reaching the 15-min time limit of continuous cup application on the fetal cephalic model, a warning signal was emitted, as programmed.
Conclusions
We demonstrated that the electronically-controlled VE, with its distinctive pull-sensing handle, performs suitably for its intended purposes. The ability of the modernized device to decrease the incidence of cup detachment, secondary to the inadvertent application of excessive traction, may result in considerable safety, medico-legal and didactic advantages.
Author’s Statement
Conflict of interest: Authors state no conflict of interest.
Material and Methods: Informed consent: Informed consent has been obtained from all individuals included in this study.
Ethical approval: The research related to human subject use has complied with all the relevant national regulations, and institutional policies, and is in accordance with the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board or equivalent committee.
Disclosure: The author reports holding US Patent 7,291,156 B1 – obstetrical vacuum extractor with a pull-sensing handle grip.
References
[1] Martin JA, Hamilton BE, Ventura SJ, Osterman MJK, Mathews TJ. Births: final data for 2011. National vital statistics reports; vol 62 no 1. Hyattsville, MD: National Center for Health Statistics; 2013.Search in Google Scholar
[2] Simpson JV. On a suction tractor; or new mechanical power, as a substitute for the forceps in tedious labours. Monthly J Med. 1849;9:556–9.Search in Google Scholar
[3] Malmström, T. The vacuum extractor, an obstetrical instrument. Acta Obstetricia at Gynecologica Scandinavica. 1957;6:5–50.10.3109/00016345709156821Search in Google Scholar
[4] Bird GC. Modification of Malmström’s vacuum extractor. Br Med J. 1969;3:526.10.1136/bmj.3.5669.526Search in Google Scholar
[5] Bird GC. The importance of flexion in vacuum extraction delivery. Br J Obstet Gynaecol. 1976;83:194–200.10.1111/j.1471-0528.1976.tb00808.xSearch in Google Scholar
[6] Office of Surveillance and Biometrics. Food and Drug Administration. FDA Public Health Advisory: need for caution when using vacuum assisted delivery devices. Rockville, Md: Center for Devices and Radiological Health. US Dept of Health and Human Services, May 21, 1998. http://www.fda.gov/cdrh/fetal1598.html.Search in Google Scholar
[7] Plauché WC. Fetal cranial injuries related to delivery with Malmström vacuum extractor. Obstet Gynecol. 1979;53:750–7.Search in Google Scholar
[8] Bird GC. The use of the vacuum extractor. Clin Obstet Gynaecol. 1982;9:641–61.10.1016/S0306-3356(21)00536-7Search in Google Scholar
[9] Towner D, Castro MA, Eby-Wilkens E, Gilbert WM. Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med. 1999;341:1709–14.10.1056/NEJM199912023412301Search in Google Scholar PubMed
[10] Cunningham FC, Gant NF, Leveno KJ, Gilstrap LC, Hauth JC, Wenstrom KD, editors. Vacuum extraction. In: Williams obstetrics. 21st ed. New York: McGraw-Hill; 2001. p. 503–8.Search in Google Scholar
[11] Rosa P. Defense de l’extraction par ventouse. Bruxelles-médical. 1955;27:1590–7.Search in Google Scholar
[12] Duchon MA, De Mund MA, Brown RH. Laboratory comparison of modern vacuum extractors. Obstet Gynecol. 1988; 71:155–8.Search in Google Scholar
[13] Hofmeyr GJ, Gobetz L, Sonnendecker EWW, Turner MJ. New design rigid and soft vacuum extractor cups: a preliminary comparison of traction forces. Br J Obstet Gynaecol 1990; 97:681–5.10.1111/j.1471-0528.1990.tb16238.xSearch in Google Scholar PubMed
[14] Malmström T, Jansson I. Use of the vacuum extractor. Clin Obstet Gynecol. 1965;8:893–913.10.1097/00003081-196512000-00008Search in Google Scholar
[15] Muise KL, Duchon MA, Brown RH. The effect of artificial caput on performance of vacuum extractors. Obstet Gynecol. 1993;81:170–3.Search in Google Scholar
[16] Mishell D, Kelly JV. The obstetrical forceps and the vacuum extractor: an assessment of their compressive force. Obstet Gynecol. 1962;19:204–6.Search in Google Scholar
[17] Vacca A. Operative vaginal delivery: clinical appraisal of a new vacuum extraction device. Aust N Z J Obstet Gynaecol. 2001;41:156–60.10.1111/j.1479-828X.2001.tb01200.xSearch in Google Scholar
[18] Vacca A. The ‘sacral hand wedge’: a cause of arrest of descent of the fetal head during vacuum assisted delivery. Br J Obstet Gynaecol. 2002;109:1063–5.10.1111/j.1471-0528.2002.02534.xSearch in Google Scholar PubMed
[19] Vacca A. Handbook of vacuum extraction in obstetric practice. Vacca Research; 1999.Search in Google Scholar
[20] Halme J, Ekbladh L. The vacuum extractor for obstetric delivery. Clin Obstet Gynecol. 1982;25:167–75.10.1097/00003081-198203000-00022Search in Google Scholar PubMed
[21] Lasbrey AH, Orchard CD, Crichton D. A study of the relative merits and scope of vacuum extraction as opposed to forceps delivery. S Afr J Obstet Gynecol. 1964;2:1–3.Search in Google Scholar
[22] Martin JA, Hamilton BE, Osterman MJK, Curtin SC, Matthews TJ. Births: final data for 2013. National vital statistics reports; vol 64 no 1. Hyattsville, MD: National Center for Health Statistics; 2015.Search in Google Scholar
[23] Henderson J, Mc Candish R, Kumiega L, Petrou S. Systematic review of economic aspects of alternative modes of delivery. Br J Obstet Gynecol. 2001;108:149–57.Search in Google Scholar
[24] Klagholz J, Strunk AL. Overview of the 2012 ACOG Survey on Professional Liability. American College of Obstetricians and Gynecologists. Washington, DC.Search in Google Scholar
©2018 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- Editorial
- Corner of Academy
- Peripartum cardiomyopathy – from pathogenesis to treatment
- Original articles – Obstetrics
- Is forty the new thirty? Population based study of advanced maternal age
- The laboratory control of anticoagulant thromboprophylaxis during the early postpartum period after cesarean delivery
- Epidural analgesia at trial of labor after cesarean (TOLAC): a significant adjunct to successful vaginal birth after cesarean (VBAC)
- Postpartum infection in relation to maternal characteristics, obstetric interventions and complications
- A technological advance for 21st century obstetricians: the electronically-controlled vacuum extractor
- Five years’ experience in an anesthesiology antenatal clinic for high-risk patients
- Clinical analyses of 383 cases with maternal cardiac diseases
- Induction of labor in patients with an unfavorable cervix after a cesarean using an osmotic dilator versus vaginal prostaglandin
- The misoprostol vaginal insert compared with oral misoprostol for labor induction in term pregnancies: a pair-matched case-control study
- Adiponectin concentration in mid-trimester amniotic fluid varies with the α-amylase level and maternal and neonatal outcomes
- Placental examination in nonmacerated stillbirth versus neonatal mortality
- Neurodevelopmental outcome at the age of 4 years according to the planned mode of delivery in term breech presentation: a nationwide, population-based record linkage study
- An observation of umbilical coiling index in a low risk population in Nigeria
Articles in the same Issue
- Frontmatter
- Editorial
- Editorial
- Corner of Academy
- Peripartum cardiomyopathy – from pathogenesis to treatment
- Original articles – Obstetrics
- Is forty the new thirty? Population based study of advanced maternal age
- The laboratory control of anticoagulant thromboprophylaxis during the early postpartum period after cesarean delivery
- Epidural analgesia at trial of labor after cesarean (TOLAC): a significant adjunct to successful vaginal birth after cesarean (VBAC)
- Postpartum infection in relation to maternal characteristics, obstetric interventions and complications
- A technological advance for 21st century obstetricians: the electronically-controlled vacuum extractor
- Five years’ experience in an anesthesiology antenatal clinic for high-risk patients
- Clinical analyses of 383 cases with maternal cardiac diseases
- Induction of labor in patients with an unfavorable cervix after a cesarean using an osmotic dilator versus vaginal prostaglandin
- The misoprostol vaginal insert compared with oral misoprostol for labor induction in term pregnancies: a pair-matched case-control study
- Adiponectin concentration in mid-trimester amniotic fluid varies with the α-amylase level and maternal and neonatal outcomes
- Placental examination in nonmacerated stillbirth versus neonatal mortality
- Neurodevelopmental outcome at the age of 4 years according to the planned mode of delivery in term breech presentation: a nationwide, population-based record linkage study
- An observation of umbilical coiling index in a low risk population in Nigeria