Preventing Maternal and Neonatal Harm During Vacuum-Assisted Vaginal Delivery

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Preventing Maternal and Neonatal Harm During Vacuum-Assisted Vaginal Delivery Pennsylvania Patient Safety Advisory Preventing Maternal and Neonatal Harm during Vacuum-Assisted Vaginal Delivery ABSTRACT with instruments, occurring in 160.5 deliveries per When women in the second stage of labor fail to 1,000 instrument-assisted vaginal births.4 progress to a spontaneous delivery, vacuum extractors While VAVD is viewed as a safe alternative to forceps have been used to successfully aid delivery. Data from deliveries, there are known maternal and fetal risks the U.S. Department of Health and Human Services’ associated with vacuum devices, including maternal National Center for Health Statistics revealed that perineal injury and fetal cranial hemorrhages, some vacuum-assisted deliveries accounted for approxi- of which can be fatal. These life-threatening complica- mately 5% of all deliveries in 2004, based on a tions led the U.S. Food and Drug Administration to seven-state sample of the expanded health data on issue a public health advisory in 1998. The advisory birth certificates. Additionally, the use of vacuum highlighted the increased risk of serious fetal intra- extraction devices has increased over the last 10 cranial injury or death associated with the use of years, while the use of forceps has decreased. Like vacuum devices and discussed a five-fold increase in other operative procedures, vacuum-assisted vaginal the reports of fetal death or serious injury from 1994 delivery has known risk factors and complications. The to 1998 .5 Pennsylvania Patient Safety Authority received 367 reports of problems involving vacuum-assisted In 2004, the Joint Commission issued a Sentinel delivery from July 2004 through April 2009. Of these Event Alert titled “Preventing Infant Death and reports, 64 (17%) documented maternal injury and Injury during Delivery.” From 1996 through 2004, 221 (60%) documented neonatal injury. To maximize the Joint Commission received 47 reports of perinatal the success of vacuum extraction procedures and to death or permanent disability (i.e., sentinel events). minimize complications, clinicians must understand Of the events, 46% were related to vaginal deliveries, both indications and contraindications for this proce- of which 21% were vacuum-assisted. Analysis revealed dure. Performing a thorough preoperative maternal that communication issues topped the list of identi- and fetal assessment, technical proficiency with the fied root causes for these events (72%).6 As of June vacuum device, setting goals, maintaining situational 2009, 197 cumulative cases of perinatal death or loss awareness, and concluding the delivery with a tar- of function had been reported to the Joint Commis- geted postoperative assessment of both the mother sion as sentinel events.7 and neonate are all important patient safety concepts associated with vacuum-assisted vaginal delivery pro- Authority Reports cedures. (Pa Patient Saf Advis 2009 Dec 16;6[Suppl Analysis of reports submitted to the Pennsylvania 1]:7-17.) Patient Safety Authority from July 2004 through April 2009 identified 367 reports of problems related to VAVD. Of the 367 reports, 282 (77%) included some Introduction form of maternal or neonatal injury. Sixty-four of the reports (17%) documented maternal injury, including Obstetric trauma associated with instrument-assisted third- and fourth-degree perineal tears, cervical lacera- vaginal delivery and birth trauma (i.e., injury to the tions, vaginal sulcus tears, hematomas, anal sphincter neonate) are hospital-level Patient Safety Indicators tears, and postpartum hemorrhage. Two hundred developed by the Agency for Healthcare Research and twenty-one reports (60%) documented neonatal Quality (AHRQ).1 Vacuum-assisted vaginal delivery injury, including scalp lacerations, cephalhematomas, (VAVD) is used in specific circumstances during the epidural, subdural and subgaleal hematomas (SGHs), second stage of labor. An analysis of National Hos- fractures, and respiratory distress. Fifty-one reports pital Discharge Survey data in 1992 showed that the (14%) were serious injuries, including four neonatal vacuum-assisted delivery rate increased from 0.6% deaths (1%) (see Table 1). One root-cause analysis was reported, and the reported root cause was “commu- in 1980 to 3.3% in 1987. 2 Furthermore, in 2004, nication among staff members.” The top three most vacuum-assisted deliveries accounted for approxi- frequently cited contributing factors in the Authority mately 5% of all deliveries in the United States, based reports were “procedures not followed,” “communica- on a seven-state sampling of expanded health data on tion problems between providers,” and “issues related birth certificates collected by the U.S. Department to proficiency.” of Health and Human Services’ National Center for Health Statistics.3 In June 2009, AHRQ released a Indications statistical brief which revealed that in 2006 nearly Indications for VAVD include termination of a pro- 157,700 potentially avoidable injuries to mothers longed second stage of labor, suspicion of immediate and neonates occurred. The highest rates of obstetric or potential fetal compromise, and shortening of the trauma for mothers took place during vaginal births second stage of labor for maternal benefit. Vol. 6, Suppl. 1—December 16, 2009 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Page 7 Pennsylvania Patient Safety Advisory Table 1. Maternal and Neonatal Serious Injuries by Type TYPE AND NUMBER OF MATERNAL INJURY TYPE AND NUMBER OF NEONATAL INJURY Perineal or cervical tears or lacerations resulting in 8 Fractured clavicle or humerus 11 hemorrhage and blood transfusion Fourth-degree perineal tears requiring operative 4 Respiratory distress 9 (2 deaths) repair Miscellaneous lacerations requiring operative repair 3 Cephal, subdural, or subgaleal 8 (1 death) hematoma or skull fracture Vaginal sulcus tears requiring operative repair 2 Miscellaneous injuries 6 (1 death) A prolonged second stage of labor is defined by maternal pelvis before proceeding with any type of the American College of Obstetrics and Gynecol- operative vaginal delivery.8 If the clinician cannot ogy (ACOG) as the lack of continuing progress in a determine fetal position, lie, presentation, or degree nulliparous woman for three hours with regional anes- of engagement or asynclitism, vacuum extraction thesia or two hours without regional anesthesia, and should be avoided. lack of continuing progress in a multiparous woman for two hours with regional anesthesia and one hour Complications without regional anesthesia. 8 A retrospective cohort Maternal study of 15,759 nulliparous women demonstrated VAVDs produce fewer maternal perineal injuries than that maternal morbidity increased significantly after use of forceps.15 However, complications from VAVD 3 hours of the second stage of labor, and increased arise in the form of cervical lacerations, vaginal hema- further after 4 hours. However, there was no indica- tomas, hemorrhage, third- and fourth-degree perineal tion of neonatal morbidity where increased fetal tears, and anal sphincter injury. surveillance and timely obstetric intervention were used.9 Therefore, absolute times are not as important Examples of maternal injuries reported to the Author- as tracking progressive fetal descent during the second ity include the following: stage of labor in conjunction with continuous assess- During a VAVD, the patient sustained cervical and ment of both fetal and maternal well-being. vaginal lacerations. She was bleeding heavily . the While immediate or suspected fetal compromise is lacerations were repaired but she continued to bleed . an indication for VAVD, obstetricians must carefully her hemoglobin dropped to 6. At this point the decision consider whether VAVD, forceps use, or cesarean was made to perform a hysterectomy . section is most likely to produce better maternal and OR [operating room] team called for repair of fourth- fetal outcome. With VAVD, the obstetrician should degree vaginal laceration . [patient was] returned be prepared to move immediately to an alternative to the OR for heavy rectal bleeding . proctoscope, delivery mode if the vacuum-assisted delivery fails. surgical repair of 6 cm rectal laceration, VAVD is indicated when maternal expulsive effort is and diversion . medically contraindicated, such as with severe cardiac Patient underwent VAVD . episiotomy cut, but disease, hypertension, cerebral aneurysm, risk of aor- patient extended to third-degree laceration with a tic dissection, proliferative retinopathy, cardiac failure, complete transection of the anal sphincter, resulting or in cases of maternal exhaustion. 10 in extensive repair . Contraindications [The patient was] admitted at term and underwent Gestational age of less than 34 weeks is a contrain- VAVD . approximately an hour later, [patient was] dication to vacuum extraction due to increased risk noted to have large amount of vaginal bleeding. of intraventricular hemorrhage.8 , 1 1 - 1 4 The procedure A pelvic exam revealed cervical laceration. [The is not performed in the presence of fetal bleeding patient was] taken to OR for repair. disorders such as alloimmune thrombocytopenia, Maternal postoperative bleeding, hypovolemic shock, or with predisposition to fracture such as with unplanned hysterectomy, and severe anal sphincter osteogenesis imperfecta. Vacuum extraction is also injury are some of the Serious Events reported to the contraindicated if the fetal head is not engaged in Authority. Anal sphincter injury can lead to maternal the pelvis; with
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