Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No.4 (December 2004) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority Fetal Lacerations Associated with Cesarean Section P A-PSRS has received a number of reports of a complication during delivery that may be pre- vented or substantially reduced: fetal lacerations A common prevention strategy involves blunt entry into the uterine cavity. Blunt entry can be done us- ing fingers or blunt-ended or bandage scissors. For associated with Cesarean section (C-section). While example, scoring the uterus with a scalpel along the approximately half of the reports of this type of oc- length of the proposed incision, the uterine cavity is currence are reported under Event Type F.5.d. then entered bluntly by inserting fingers into the (neonatal complication, birth injury or trauma), the central portion of the incision and moving the fin- remainder are classified under other Event Types. gers in both directions laterally.5 Incidence in Reporting The use of blunt-ended or bandage scissors is a While most of the lacerations reported to date have generally recognized good practice.1,4 Other forms been superficial, some have required suturing of instrumentation require greater evaluation before and/or plastic surgery intervention. This occurrence they can be suggested for widespread use. Ishii has been reported by at least 20 facilities, ranging and Endo6 describe a serrated, blunt-edged scalpel from university medical centers to small community that splits uterine muscle fibers to open the uterus hospitals. Consistent with the clinical literature, ap- but does not penetrate the uterine wall. Hulbert8 proximately 70% of the lacerations occurred on the claims to have prevented neonatal lacerations by face, head, and ear. Approximately 20% of the lac- scoring with a scalpel to begin the incision and us- erations occurred below the waist (buttocks, leg, ing a pean clamp to enter the uterus. The incision is ankle), while 10% were on the back. Emergency C- continued either bluntly or with blunt-edged scis- sections were documented in 20% of the reports. sors. Background Another method involves moving the uterine wall A range of incidence rates for this complication ex- away from the fetus prior to incision. For example, ists in the clinical literature. In studies involving a forceps or Allis clamps are used to grasp the lateral review of nearly 900 C-sections, the rate of fetal edges of the uterine incision, to elevate the incision laceration injury ranged from 1.5% to 1.9%.1,2 How- from the fetal presenting part. Then bandage scis- ever, in one larger study involving over 2,000 C- sors can be used to complete uterine entry.1,6 In sections, the incidence of fetal laceration was addition, if the direction of the cutting action occurs 0.74%.3 One study indicated that a non-vertex pres- from within the uterine cavity outward, the fetus entation was associated with a 6% fetal laceration may be less likely to be cut.7 rate.1 However, this factor was not found to be sta- tistically significant in other studies.2-4 Removing abdominal wall retractors prior to deliv- ery of the fetus may also reduce laceration risk.1,5 Risk factors associated with increased risk for neo- Frequent, thorough suctioning at the time of enter- natal laceration identified in the literature include:3-5 ing the uterus increases visibility.2 Seeing the pre- senting fetal tissue, such as hair in non-vertex pres- • Ruptured membranes prior to C-section entations,1 may help the surgeon to avoid that area • Low transverse uterine incision • Active labor This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 1, No. • Emergent/urgent C-section 4—December 2004. The Advisory is a publication of the Pennsylvania Patient • Inexperience of the surgeon or resident Safety Authority, produced by ECRI & ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). Prevention Strategies Several interventions may reduce the risk of this Copyright 2004 by the Patient Safety Authority. This publication may be re- printed and distributed without restriction, provided it is printed or distributed in injury, including use of blunt instrumentation, mov- its entirety and without alteration. Individual articles may be reprinted in their ing the uterine wall away from the fetus prior to inci- entirety and without alteration provided the source is clearly attributed. sion, and removing abdominal wall retractors prior To see other articles or issues of the Advisory, visit our web site at to delivery. www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2004 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 4 (December 2004) Fetal Lacerations Associated with Cesarean Section (Continued) when using sharp instrumentation. Additional Considerations Timely reporting and documentation of this occur- rence may facilitate quality improvement. Several studies reveal an incidental finding during reviews of C-section records: documentation of fetal laceration injuries was poor.1-3 A minority of obstetric records contained documentation when such lacerations occurred. The exact location and dimension of the injury often was not specified. Treatment was rarely described, and documentation was lacking concern- ing notification of/discussion with the parents con- cerning the injury. It is possible that such injuries may not be identified at the time of delivery and, therefore, may not be recognized by obstetricians. Heightening awareness of staff to this complication may reduce the risk of injury. Interventions such as including prevention strategies in emergency C- section drills and providing blunt instrumentation in all C-section kits may help to mitigate risk. Docu- menting review of this occurrence prior to leaving the delivery room might be incorporated into an ex- isting standardized checklist. Routine disclosure of this complication can be incorporated into the in- formed consent process for patients that are about to undergo C-section.1-3,5 Knowledge of this risk, particularly in situations where risk factors are pre- sent or elective C-section is being considered may help patients make more informed decisions con- cerning the delivery and the well being of the infant. Notes 1. Smith JF, Hernandez C, Wax JR. Fetal laceration injury at Cesar- ean delivery. Obstetrics and Gynecology 1997 Sep;90(3):344-6. 2. Wiener JJ, Westwood J. Fetal lacerations at Caesarean section. J Obstetrics and Gynecology 2002;22(1):23-4. 3. Haas DM, Ayres AW. Laceration injury at Cesarean section. J Matern Fetal Neonatal Med 2002;11(3):196-8. 4. Puza S, Roth N, Macones GA, Mennuti MT, Morgan MA. Does Cesarean section decrease the incidence of major birth trauma? J Perinatol 1998;18:9-12. 5. Gerber, AH. Accidental incision of the fetus during Cesarean sec- tion delivery. Int J Gynaecol Obstet 1974;12:46-8. 6. Ishii S, Masahiro E. Blunt-edged, notched scalpel for Cesarean incision. Obstetrics & Gynecology (1999) Sep;94(3):469-70. 7. Hulbert L. Fetal laceration at Cesarean delivery. ACOG Clinical Review (1998) May-Jun;3(3):15-15. Page 2 ©2004 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No.4 (December 2004) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. ©2004 Pennsylvania Patient Safety Authority Page 3