OBGMANAGEMENT

A SUPPLEMENT TO OBG MANAGEMENT, FEBRUARY 2004

VACUUM-ASSISTED DELIVERY Improving patient outcomes and protecting yourself against litigation

VACUUM-ASSISTED DELIVERY Practical techniques to improve patient outcomes by Aldo Vacca, MD b/Gyns in general prefer vacuum-assisted delivery (VAD) over forceps-assisted delivery, although increased usage has also Obeen associated with more frequent reports of adverse out- comes.1,2 Attention to the details of technique can help prevent prob- lems and ensure the best patient outcomes.

This supplement to THE FLEXION POINT: OBG MANAGEMENT serves as a A CRITICAL LANDMARK FOR VAD companion to Preserving the The fetal head is in complete flexion when the mentovertical diameter Option of , points in the direction of descent (Figure 1). During deliveries in which an article appearing in the February 2004 issue. the fetal head is normally molded, the mentovertical diameter emerges on the sagittal suture approximately 3 cm anterior to the posterior fontanelle.4 This flexion point is a critical landmark for VAD; when the center of the extraction cup has been placed over the flexion point and axis traction is applied, conditions are optimal for delivery (Figure 2). Contents 1 VACUUM-ASSISTED DELIVERY Aldo Vacca, MD, Editor Disclosures Practical techniques to improve Associate Professor of Dr Vacca serves on the speaker’s Obstetrics and Gynecology bureau for Clinical Innovations, patient outcomes The University of Queensland Inc. Drs Billings and Vines by Aldo Vacca, MD Brisbane, Australia have no commercial relationships to disclose. R. Gail Billings, PhD THE PHYSICS OF VACUUM EXTRACTION 7 Senior Research Scientist This supplement is supported Medical Physics Proper use of compression and traction by a grant from Clinical Salt Lake City, Utah for better patient outcomes Innovations, Inc. by R. Gail Billings, PhD Victor L. Vines, MD (www.clinicalinnovations.com) Clinical Associate Professor of Obstetrics and Gynecology Copyright © 2004 Dowden Health 8 ESTABLISHING A PROTOCOL University of Texas Media The first step for reducing potential Southwestern Medical School for litigation Dallas, Texas by Victor L. Vines, MD

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FIGURE 1 FIGURE 2 Fetal head and direction of descent Optimum placement for delivery

3 cm

3 cm F = flexion point F = flexion point

During normal delivery conditions, the mentovertical The center of the extraction cup has been placed diameter emerges on the sagittal suture approximately over the flexion point, and axis traction is applied. 3 cm in front of the posterior fontanelle.

Regardless of the head’s position, the clinician proximal interphalangeal joint is 5 to 6 cm, must be able to find the flexion point and cor- calculate the distance from the flexion point rectly position the cup. to the posterior fourchette of the perineum. This information is used to determine how far the center of the cup must be inserted. To facil- When the center of the cup is itate insertion, the suction tubes of some extrac- placed over the flexion point, tor cups have distance markers to indicate how conditions are optimal for delivery far the cup has been inserted (Figure 4).

Cup selection and position Guidelines for patient selection and deter- Anterior devices. The pull devices attached to soft mination of VAD risk are described in the (silicone or plastic) and rigid (plastic or metal) Sidebar (p S4) and in Tables 1 and 2. anterior extractor cups are semirigid, limiting maneuverability within the canal and pre- Locating the flexion point senting a handicap whenever the flexion point is A practical approach to locating the flexion point not readily accessible.5 Anterior cups are best is as follows:5 used for deliveries in which the station is low or Use the middle finger to identify the posteri- outlet and the fetal position is occipitoanterior or fontanelle, then move the finger forward (OA), rotated less than 45˚ (Table 3). along the sagittal suture approximately 3 cm Posterior devices. Maneuverability of rigid posteri- to the flexion point (Figure 3). or cups is not restricted; the suction tube on With the finger on the flexion point and pal- these devices is in the same plane as the cup mar surface in a superior direction, note body. Posterior cups can be used for deliveries in where the back of the finger makes contact the occipitoposterior (OP) and occipital trans- with the fourchette. verse (OT) positions and for deliveries in Keeping in mind that in an adult, the dis- the oblique OA position when the fetal scalp is tance from the tip of the middle finger to the not visible.

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FIGURE 3 FIGURE 4 Locating the flexion point Inserting the cup

6 cm

5 – 6 cm Distance markers on the suction Locating the flexion point and calculating the tube of the OmniCup indicate how distance from the posterior fourchette using the far the center of the cup has been examining finger. inserted.

FIGURE 5 Confirming cup position Method of traction The extractor cup is correctly positioned over the flexion point when palpation indicates that the anterior fontanelle is at least 3 cm from the edge of the cup, and the sagittal suture is under the cup midline. Nonvisual digital confirmation of correct positioning is made possible because all com- monly used cups have maximum diameters of 6 to 7 cm and the fetal sagittal suture is 9 to 10 cm long.5 Therefore, in cups with a 6-cm diameter and with 9 cm as the distance between anterior One hand provides traction and posterior fontanelles in the normal infant, the and direction while the other distance from the anterior fontanelle to the cup monitors descent and prevents edge is approximately 3 cm. cup detachment. A correctly positioned cup is called a flexing median application (Figures 2 and 4). Other applications promote extension and asynclitism of the fetal head and either increase or fail to decrease the diameters of the presenting part. In PERFORMING THE PROCEDURE a deflexing application, the cup has been placed Inducing a vacuum closer to the anterior fontanelle; in a paramedian When correct positioning of the extractor cup has application, the extraction cup has been placed been confirmed, a vacuum of 500 to 600 mm Hg more than 1 cm to either side of the midline. is induced in 1 step.6 When the station is low or

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Appropriate patient selection: TABLE 1 Critical to success Predicting risk associated with VAD

ndications for VAD vary with each case. Station Low-risk VAD Iof the fetal head is commonly used to predict Fetal caput visible and station low or outlet degree of risk (low versus high) in operative • Arrest of descent in second stage of labor .3 Similarly, the risk associated with • Nonreassuring fetal status VAD can be predicted based on whether the scalp • Maternal exhaustion but satisfactory uterine is visible at the introitus (Table 1). Other variables contractions and some expulsive effort that may influence VAD outcome are listed in • Selective shortening of second stage Table 2; the presence of 3 or more of these • Delivery of “floating” head at cesarean section indicates a high-risk VAD. VAD should also be avoided in cases with: High-risk VAD* • Cephalopelvic disproportion; brow, face, or Fetal caput not visible and station low or mid breech presentation; gestation <34 weeks; or • Arrest of descent in second stage of labor high fetal head station (above ischial spines). • Nonreassuring fetal status • Inconclusive fetal position where scalp is not • Maternal exhaustion, epidural analgesia, and visible at introitus. diminished expulsive effort • Delivery of severely compromised fetus as • OA >45˚, OP/OT fetal positions a rescue procedure. Such an infant may be depressed at birth, and the VAD operator may * Contraindicated except for “qualified grade” operators be blamed. (see Physician Training, page 6) • Maternal exhaustion—do not increase VAD = vacuum-assisted delivery, OA = occipitoanterior, traction force to compensate for reduced OP = occipitoposterior, OT = occipital transverse expulsive power. • Excessive fetal head molding; traction force increases the risk of intracranial injury in unison. One hand provides traction and direc- in such cases. tion while the other monitors progress and pre- • Incomplete cervical dilation. Beware of the anterior lip of the ; do not attempt VAD vents cup detachment (Figure 5). The crossbar of before the cervix is completely dilated. the pull device should be held in the fingertips to limit traction force. outlet, a finger should be swept around the Traction should be maintained smoothly for periphery of the cup to ensure that no maternal the duration of the contraction and for as long as tissue has been trapped between the cup and the mother is pushing. As soon as the contraction scalp. Other safety tips for performing successful passes or the mother stops pushing, traction VAD are listed in Table 4. should cease. It should not be continued to pre- vent retraction of the head, because the lowest Establishing traction station reached at the end of 1 contraction is Gentle traction with the cup extractor is begun as regained quickly at the beginning of the next. soon as a contraction starts and the mother push- Some sign of progress should be evident es. Between contractions, the vacuum may be with each pull: descent of the presenting part, either maintained or decreased, depending on flexion of the head or correction of asynclitism, operator preference.3 There is no evidence that and autorotation from OP and OT positions. If maintaining the vacuum is harmful or that no progress is observed after 2 pulls, stop traction decreasing it is beneficial.7 and complete delivery by cesarean section if the Traction is meant to be an adjunct to the scalp is not visible at the outlet. mother’s expulsive efforts, not the primary force to overcome resistance to descent. Traction Cup detachment (“pop-off”) should be performed with both hands working Correct cup application and traction directed

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TABLE 2 TABLE 3 Factors that increase risk Classification and use of associated with VAD* vacuum extractor cups

• Nonreassuring fetal status Indicated for outlet and low OA <45° extractions • Prolonged second stage of labor Soft cups (silicone or plastic) • Caput not visible at introitus • Kiwi ProCup and Tender Touch cups • OP/OT positions (including OA >45˚) • Standard Mityvac and Soft Touch cups • Significant molding (2+) • Silc, Gentle Vac, and Secure cups • Epidural analgesia • Silastic, Reusable, and Vac-U-Nate cups • Weak, infrequent contractions Rigid “anterior” cups (plastic or metal) • Diminished expulsive effort • Kiwi OmniCup • Estimated large fetal size • M-Style Mityvac cup • Small maternal stature • Flex cup *3 or more = high-risk VAD (ie, relative contraindications) • Malmstrom, Bird, and O’Neil anterior cups VAD = vacuum-assisted delivery, OA = occipitoanterior, OP = occipitoposterior, OT = occipital transverse Indicated for low OA >45°, OP, OT extractions Rigid “posterior” cups (plastic or metal) • Kiwi OmniCup along the axis of the pelvis will prevent most • M-Select Mityvac cup “pop-offs.” Sudden cup detachment is not a • Bird and O’Neil posterior cups built-in safety feature of VAD devices. Most cup OA = occipitoanterior, OP = occipitoposterior, OT = occipital transverse detachments occur at the outlet because of: Incorrect traction technique, pulling too hard or in an upward direction, or when maternal expulsive powers are weak Scalp abrasion or blood vessel Paramedian or deflexing applications damage may result if a “pop-off” Large caput succedaneum (for soft vacuum occurs during strong traction cups) Maternal tissue or scalp electrode trapped under the cup of traction exerted. However, a review of the Inadequate vacuum or faulty equipment number of acceptable pulls for a “normal” VAD Scalp abrasion (most often caused by sudden is warranted by several recent changes in obstet- “pop-off ”) or underlying blood vessel damage rical practice: (1) increasing use of epidural anal- may result if “pop-off ” occurs during strong trac- gesia, (2) extending the “normal” duration of the tion. Complete detachment may be avoided by second stage of labor, and (3) decreasing use of applying counterpressure with the thumb of the to facilitate delivery across the per- non-pulling hand during traction and by timing ineum. The first 2 may interfere with the mater- pulls with contractions and the mother’s pushes.5 nal expulsive effort (especially if the mother is If the cup detaches twice and the fetal head has exhausted), and the third, that is, an intact per- not yet descended to the outlet, stop the VAD and ineum, provides greater resistance to delivery. complete the delivery by cesarean section. The greatest amount of traction force during VAD occurs during delivery of the head across Duration of VAD the pelvic floor and perineum.8 Completion of delivery in 3 pulls has been For these reasons, I now divide VAD into 2 viewed as a criterion for a safe VAD. After 3 pulls, phases—the descent and perineal phases. In the risk of scalp injury increases with the amount nulliparous women who have had epidural anal-

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TABLE 4 VAD, even though head rotation during rota- Safety tips for successful VAD tional VAD occurs automatically as a passive • Aim for flexing median cup applications, event similar to the internal rotation that is an regardless of head position. integral part of normal labor. Autorotation of the • Initiate oxytocin infusion if contractions are weak malpositioned head occurs in about 90% of cases, or infrequent. provided the cup is positioned correctly and trac- 5,9,13,14 • Do not increase traction force to compensate for tion is directed along the axis of the pelvis. decreased maternal expulsive effort. In other words, the method of rotational VAD is • Apply traction only during contraction and when identical to the standard technique. On no the mother is pushing. account should the clinician attempt to rotate the • Expect some progress with each pull. If signifi- head by physically manipulating the cup. cant descent has not occurred in 3 pulls, stop the procedure and deliver by cesarean section. INFANT CARE AFTER VAD • When extraction is initiated before fetal caput is Immediately after VAD, the infant’s head should visible, expect the head to descend to the introi- be carefully examined and then reexamined at tus within 3 pulls. Allow 3 additional pulls to com- regular intervals to exclude bleeding into the plete delivery of the head over the perineum. scalp. If a warming bonnet has been placed on • Do not regard cup detachment as a safety feature the baby’s head, neonatal attendants should of the VAD device. If the cup pops off twice and remove it periodically to inspect the scalp. the head has not yet descended to the outlet, Results of the inspection, including accuracy of stop the procedure. Complete delivery by cup placement in relation to the flexion point, cesarean section. should be recorded for educational and auditing • The majority of VADs should be completed within purposes. If the scalp was injured, arrangements 15 minutes. Unless delivery is imminent, do not continue with VAD for longer than 20 minutes. for appropriate follow-up should be made.

VAD = vacuum-assisted delivery On the day after the delivery, the clinician should examine the baby in the mother’s presence, answer her questions, and allay any concerns. gesia, 3 pulls during each phase are acceptable, provided that some progress is observed with PHYSICIAN TRAINING FOR VAD each pull. The graduated program that follows is a guide Arbitrary VAD time limits ranging from 15 for resident training in VAD. The numbers and to 45 minutes have been suggested as protection types of VADs may vary with the trainee’s against the effects of prolonged or excessive trac- progress. Each trainee monitors his/her progress tion.9,10 Extensive observational data have with a detailed log of all VADs performed. demonstrated that, with efficient uterine con- Level C (Beginner grade) tractions and good maternal expulsive effort, Trainee has experience in managing normal most VADs can be completed within 15 minutes labor and its common problems. and almost all within 20 minutes. Therefore, Trainee receives instruction in at least 5 low- unless delivery is imminent, the procedure risk VADs (scalp visible at introitus, OA should not be continued longer than 20 minutes. position) under supervision of qualified trainer. Rotational VAD Level B (Trainee grade) The restrictions imposed on rotational forceps Trainee has achieved level C competency. deliveries11,12 also have been applied to rotational Trainee receives instruction in at least 5

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moderate-risk VADs (scalp not visible at the 4. Rydberg E. The mechanism of labour. Springfield, Ill: CC Thomas, 1954:1-180. 5. Vacca A. Handbook of vacuum delivery in obstetric practice, 2nd ed. Brisbane: Vacca introitus, OP/OT positions) under supervi- Research, 2003. sion of qualified trainer. 6. Lim FTH, Holm JP, Schuitemaker NEW, et al. Stepwise compared with rapid application of vacuum in ventouse extraction procedures. Br J Obstet Gynaecol. Level A (Qualified grade) 1997;104:33-36. Trainee has achieved level B competency. 7. Bofill JA, Rust OA, Schorr SJ, et al. A randomized trial of two vacuum extrac- Trainee may undertake all types of clinically tion techniques. Obstet Gynecol. 1997;89:758-762. 8. Vacca A. The “sacral hand wedge,” a cause of arrest of descent of the fetal appropriate VADs at discretion of qualified head during vacuum assisted delivery. Br J Obstet Gynaecol. 2002;109:1063-1065. trainer. 9. Bird GC. The use of the vacuum extractor. Clin Obstet Gynaecol. 1982;9:641-661. 10. Ross MG. Vacuum delivery by soft cup extraction. Contemp Obstet Gynecol. 1994;39:48-53. REFERENCES 11. Hankins GDV, Rowe TF. Operative vaginal delivery—year 2000. Am J Obstet Gynecol. 1996;175:275-282. 1. Food and Drug Administration. FDA Public Health Advisory: Need for caution when using vacuum-assisted delivery devices. Rockville, Md: US Department of Health and 12. Yeomans ER, Hankins GDV. Operative vaginal delivery in the 1990s. Clin Human Services, Center for Devices and Radiological Health; May 21, 1998. Obstet Gynecol. 1992;35:487-493. 2. Ross MG, Fresquez M, El-Haddad MA. Impact of FDA Advisory on reported 13. Bird GC. The importance of flexion in vacuum extraction delivery. Br J Obstet vacuum-assisted delivery and morbidity. J Matern Fetal Med. 2000;9:321-326. Gynaecol. 1976;83:194-200. 3. American College of Obstetricians and Gynecologists Committee on Practice 14. Vacca A. Vacuum-assisted delivery. Best Pract Res Clin Obstet Gynaecol. Bulletins. Operative vaginal delivery. ACOG Practice Bulletin No. 17, June 2000. 2002;16:17-30.

THE PHYSICS OF VACUUM EXTRACTION Proper use of compression and traction for better patient outcomes by R. Gail Billings, PhD

atural is marked by forces of local atmospheric pressure and the pressure compression: the uterus contracts, the inside the extractor cup. The differential pres- Ncervix dilates, the pressure around the sure is expressed as a positive number—the fetus increases on all surfaces except those at the more complete the vacuum, the higher the cervical outlet, and forces resulting from the number. Typically, a vacuum of about 600 mm pressure differential expel the fetus. Fetal tissues Hg is applied between the fetal scalp and the are well suited to withstand this stress, but not extraction cup. With an internal cup diameter well adapted to withstand the traction or tensile forces that are applied with forceps or vacuum Proper VAD seeks to correct a extraction. In addition, the materials in the feto- malpositioned fetal head; maternal system are varied in the properties that constitute strength and endurance making ana- normal forces deliver the baby lytical prediction of the “failure points” very dif- ficult. Therefore, proper vaginal vacuum-assist- of 5 cm, this degree of vacuum should allow a ed delivery (VAD) seeks to correct a malposi- maximum traction force of 16 kg (35 lb) before tioned fetal head; assistance from normal forces the cup separates. delivers the baby. Any traction must be of mini- In practice, however, maximum traction mal force and duration. force is about 11 kg (24 lb) because the force is not applied precisely perpendicular to the pull Vacuum as a means of applying traction device’s attachment point, and the seal on the Vacuum is the differential pressure between cup’s rim is not uniform or perfect. The equation

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Force = Vacuum x Area, shows that cups with only causes the cup to slide. In practice, scalp tis- larger diameters allow more traction force. sue is forced into the cup to form an artificial caput or chignon, which provides a wedge that Amount of traction force required prevents sliding. Oblique traction also results in A 5-cm cup with 600-mm Hg vacuum provides lower net delivery force. more than enough traction force (16 kg) to Simultaneous torsion and oblique traction properly orient the head and deliver the fetus. should be held to a minimum to prevent sudden detachment of the extractor cup, a potential haz- A 5-cm cup with 600 mm Hg ard to the baby. Some extractors have cup and traction-link attachments designed to minimize of vacuum provides 16 kg this effect. The soft cups with stems protruding (35 lb) of attachment force from the back of the cup lack low profiles and do not minimize simultaneous torsion and oblique More than 14 kg (30 lb) is usually not required traction, especially during OP or OT deliveries. for VAD, even in the presence of leakage. The Such soft-cup devices should be used only for volume of space within a cup and the leakage direct occipitoanterior deliveries in which the rate determine how long the cup stays attached. fetus is at the outlet when the cup is placed. Thus, if leaks do not occur, large-volume mechanical pumps and systems are not neces- Effects of vacuum cup on fetal scalp sary to create forces sufficient to assist in vacu- When the vacuum cup is pulled, its rim com- um delivery. presses fetal scalp tissues underneath it and arte- rial blood flow is blocked. When the extractor Direction of traction forces cup is not being pulled, blood and fluid are dri- Traction forces applied through the vacuum ven into the circular tissue bed under the cup. extractor are usually oblique, rather than per- The differential pressure driving the liquid pendicular, to the plane of pull-device attach- beneath the cup is the sum of mean arterial pres- ment. When an oblique force is applied to the sure and vacuum (subatmospheric pressure)— cup to reposition the fetal head, the force at the typically about 600 mm Hg or 5 times the nor- pull device’s attachment point can be resolved mal differential pressure across any vascular bed. into perpendicular and lateral components. If the vacuum persists and the cup is not pulled, Importance of reducing lateral torsion. The torsion- tissues underneath the cup engorge; when the induced lateral component is minimal when the vacuum is broken and circulation resumes, this pull-device attachment is close to the fetal head; chignon formation usually resolves sponta- it increases as the distance between pull-device neously without sequelae within 24 to 48 hours. attachment and cup increases. Thus in occipito- Chignon formation is often most pro- posterior (OP) and occipital transverse (OT) nounced with vacuum extractors that have a positions, a cup with a low profile in which the hard plastic or metal cup with a rounded ridge force is attached closest to the base of the cup will on its rim. Soft, pliable cups tend to spread out reduce the lateral component. over the fetal head during vacuum application, Stemmed cups do not minimize this effect; leaving behind no defined borders This edema moreover, their design prohibits proper place- should not be confused with hematoma forma- ment. In the absence of friction, a lateral force tion and will resolve spontaneously.

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ESTABLISHING A PROTOCOL The first step for reducing potential for litigation by Victor L. Vines, MD t has been argued that, as a profession, we code identified or obstetricians focus on the worst possible out- hematoma, a complication more frequently Icome and undertake intensely interventional associated with VAD than other modes of (albeit potentially ineffective) methods to pre- delivery and associated with significant fetal vent that outcome. Many view this as the only morbidity and mortality if it remains undiag- legally safe course of action.1 As a result, nosed. That hindrance to data collection was respected obstetric researchers and educators2 remedied when the National Center for have predicted that vacuum devices and forceps Health Statistics12 adopted a new code may disappear from our practices and that all (767.11) specific for subgaleal hemorrhage. future deliveries will be either easy spontaneous vaginal deliveries or easy cesarean sections. Fortunately, obstetricians can undertake strate- Will vacuum and forceps delivery gies to maintain professional protection and disappear from our practices provide best patient outcomes. because of liability concerns?

SELECTING THE MOST APPROPRIATE MODE OF DELIVERY The physician-patient relationship: Decisions concerning mode of delivery are com- The basis for informed consent plex. Most important is deciding whether a safe A physician-patient relationship may take sever- vacuum-assisted delivery (VAD) can be per- al forms.13 The most effective models (the delib- formed based on assessment of the fetal position erative and interpretive) establish a fully engaged and size relative to the maternal pelvis. Beyond relationship between physician and patient/fam- the clinical assessment, effective decision-mak- ily and form the essence of informed consent. ing for VAD can be made using basic principles. Patient concerns are discussed during the prena- tal course or early in labor. The physician Guidelines for vacuum extraction addresses or allays patient fears through infor- Obstetricians face challenges in VAD: Existing mation, and incorporates patient preferences guidelines are generally considered Level B/C into delivery decisions. For instance, the patient data, derived from observational studies or pub- may fear application of instruments to her baby’s lished as opinions by experts in the field of head, or she may fear an abdominal incision. VAD.3–7 No profession-wide consensus dictates Communication about concerns also helps to the amount/ duration of traction, the manage liability risk.14 amount/duration of maximum vacuum, the number of pulls required to effect delivery, the Ethical principles and decision-making total time of applied vacuum, or the acceptable for mode of delivery number of involuntary releases (“pop-offs”).8,9 Well-defined ethical principles15 also guide deliv- Collecting accurate diagnostic data ery decisions: regarding mode of delivery and fetal compli- Patient autonomy. Generally, the patient has the cations has been difficult.10,11 For example, right to refuse unwanted treatment, whether until August 2003, no specific ICD-9-CM cesarean section or VAD.

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VAD and litigation Did the physician provide appropriate standard of care?

recent suit filed against an obstetrician, her group The verdict. After an 8-day trial, the jury deliberated for Apractice, and the maternity specialty hospital illus- 2 hours before returning a verdict for the defense. trates key points. An infant delivered by vacuum-assist- Discussion. This case illustrates issues arising with ed delivery (VAD) sustained a subgaleal hematoma and VAD-related litigation. Questions were raised regarding brain injury with resulting cerebral palsy. Importantly, the FHR tracing for several hours early in the course of the patient labored approximately 24 hours before VAD the mother’s prostaglandin induction and whether was performed. injury happened early in labor. The infant could possibly Expert testimony for the plaintiffs. A neuroradiologist have sustained the same injury had he been delivered testified that the source of injury was hypoxia, experi- earlier by cesarean section, or the injury may have been enced during labor; other experts identified VAD as the avoided. Based on the tracings, it was not possible to source of brain damage. reasonably predict that such an outcome was pending Allegations maintained that the vacuum was and could have been avoided. applied at too high a station, the fetal head was rotated The physician’s performance appears to have been during delivery, and delivery details were inaccurately within the standard of care; her medical judgment and documented. Cavalier use of the device and lack of use of the device were not negligent. However, sparse understanding of its correct use were suggested. Failure documentation of her decision-making (clinical judg- to recognize fetal heart rate (FHR) abnormalities ment) and details of the delivery gave the plaintiffs’ throughout the labor was alleged, as was failure to per- attorney opportunity to cast doubt on the quality of her form a timely cesarean section, which would have care and behavior. They argued that her documentation avoided the need for VAD. and her use of the device were not in keeping with the Arguments for the defense. The defense held that the care that a prudent obstetrician would provide in this or nurse and physician notes were accurate, the vacu- a similar circumstance. um was used for a total of 5 minutes and 2 pulls, and A comprehensive delivery note for VAD is neces- neither the FHR nor the blood gas determination sary to provide written evidence of the clinician’s judg- after delivery indicated fetal distress or hypoxia. It ment and of the details of the procedure. This instru- was noted that the rate of cerebral palsy has not ment is featured in Operative Vaginal Delivery, in the

changed over the past 30 years, despite the use of accompanying article presented in OBG MANAGEMENT, electronic fetal monitoring and an enormous February 2004. These details are also important for increase in the rate of cesarean sections. It was quality assurance/performance improvement activities argued that the injuries were of unknown causes and by the obstetrical department. could not have been predicted. —Source: www.verdictsearch.com. November 10, 2003.

Beneficence. If VAD is selected, the procedure would be more or less harmful to the mother and should provide good outcomes for mother and infant. newborn, sparing the infrequent complications Justice. The cost/benefit to patients, hospital, and longer recovery associated with abdominal payer, and society in general should be assessed. delivery. Costs to all parties increase with cesarean section Nonmaleficence. An unskilled obstetrician should compared with vaginal delivery.16,17 Additionally, not attempt operative vaginal delivery without obstetricians must consider the magnitude of an experienced partner. The obstetrician should cost if all of their operative vaginal deliveries also consider whether VAD or cesarean section were converted to cesarean sections.

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Veracity. Obstetricians should honestly assess In the United States, VAD is used 2 their skills and limitations and provide honest to 3 times more often than forceps documentation regarding the delivery per- formed, regardless of outcome. for operative delivery

The evidence: Performing VAD safely mental delivery and avoid prolonged Despite insufficiencies in the literature, the expe- repeated or excessive traction attempts rience of respected clinicians provide much guid- without progress. ance for clinicians in terms of safe and effective Physician assessment of fetal head position use of VAD, as reflected in this publication’s arti- in relationship to the pelvic outlet and cle by Aldo Vacca, MD, and Preserving the Option attempts to advance.19 of Vacuum Extraction, appearing within this issue of OBG MANAGEMENT. Forthcoming research RECOMMENDATIONS TO PROMOTE should elucidate the potential relationships SAFE USE OF VAD among vacuum, traction, and subsequent fetal Obstetrics Department injury and avoid these injuries where possible. Review credentialing to ensure that privileges grant- ed for performance of VAD are supported by res- Physician integrity, competence, idency or other postgraduate training. and capability Develop an organized mentoring program to allow In the United States, VAD is used 2 to 3 times physicians new to VAD to add this skill to their more often than forceps for operative delivery;18 delivery choices. many physicians prefer to use VAD because it Provide continuing medical education about VAD. has less potential for maternal trauma and is Develop a departmental policy regarding operative easier to use than forceps. Still, VAD requires vaginal delivery if one does not already exist. specific skills and techniques. Many physicians Incorporate review of operative vaginal delivery are not trained to use vacuum devices as resi- outcomes in the departmental quality assur- dents; others may have received limited train- ance/performance improvement process, and ing. These physicians should seek the assistance inform coding personnel that a new of a mentor or obtain training before offering code (767.11) specific for subgaleal hemorrhage this mode of delivery to patients. is available. Standardize documentation of operative vaginal AVOIDING LITIGATION CLAIMS deliveries. IN YOUR PRACTICE Inappropriate use of VAD/forceps leading to Obstetricians fetal trauma and/or preventable shoulder dysto- Use the correct instrument for the clinical circum- cia7 is the fifth most common source of liability stance, taking into account your experience and claims from obstetric care. Most VAD-associat- the presentation of the fetal head. ed malpractice litigation derives from questions Ensure that there is an appropriate indication for oper- concerning: ative assisted delivery. Discuss the indication Use of adequate and informed medical judg- with your patient and obtain her permission ment in assessing appropriate use of VAD. prior to proceeding with VAD. Limitations of VAD and the need for alter- Avoid operative vaginal delivery if you suspect the native plans in case of VAD failure. fetal size to exceed the capacity of the maternal Decisions on when to terminate instru- pelvis.

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Most vacuum deliveries associated Using vacuum devices prudently—that is, with poor fetal outcomes arise from for appropriate reasons and with the appropriate skill—and then documenting the procedure abnormalities of the labor process properly will bolster the ability of the obstetrics specialty to defend the use of operative vaginal delivery techniques and preserve them as viable Have personnel and an operating room available tools for future use. immediately in the event of a failed attempt at VAD. REFERENCES Be prepared to deal with . 1. Huber PW. Galileo’s Revenge. New York, NY: HarperCollins, 1991. 2. Phelan JP, Clark SL. In Pursuit of Vaginal Delivery: Why? HCI Perinatal Risk Follow generally accepted guidelines for use of the Management Congress VIII, August 4-6, 2003, Miami, Fla. device (typically printed by manufacturers on the 3. Vacca A. Vacuum-assisted delivery. Best Pract Res Clin Obstet Gynaecol. product packaging). 2002;16:17-30. 4. Vacca A. Handbook of vacuum delivery in obstetric practice. Brisbane: Vacca Document the indications and processes completely, Research. 2003. preferably on a standardized form such as the 5. Koscica KL, Gimovsky ML. Vacuum extraction—optimizing outcomes, reduc- ing legal risk. OBG Manage. 2002;14:89-94. template accompanying the roundtable discus- 6. Ventolini G, Croom CS, Hurd WH. Keys to minimizing liability in obstetrics. sion on VAD in this issue of OBG MANAGEMENT. Contemporary OB/GYN. 2003;48:81-96. 7. Schwartz ML, O’Grady JP. The obstetric vacuum extractor: recent innovations If you are experienced with VAD, offer to mentor and best practices. Contemporary Ob/Gyn. 2002;5:114-126. physicians who desire to learn or expand their 8. Cunningham FG, et al, eds. Williams Obstetrics, 21st ed. New York, NY: McGraw-Hill, 2001. experience with it. 9. American College of Obstetricians and Gynecologists. Technical Bulletin #196. Operative vaginal delivery. Washington, DC: American College of Obstetricians and Gynecologists, 1994 Conclusion 10. Gardella C, Taylor M, Benedetti T, Hitti J, Critchlow C. The effect of sequen- Correctly performed, VAD can and should con- tial use of vacuum and forceps for assisted vaginal delivery on neonatal and maternal outcomes. Am J Obstet Gynecol. 2001;185:896-902. tinue, and practitioners and hospitals may 11. Towner D, Castro MA, Eby-Wilkens E, Gilbert WM. Effect of mode of deliv- remain confident that obstetric experts will ery in nulliparous women on neonatal intracranial injury. N Engl J Med. 1999; 341: 1709-1714. remain available to prudent physicians who 12. Federal Register. Vol. 68, No. 148; August 1, 2003 / Rules and continue to perform VAD. Most vacuum deliv- Regulations:45595. 13. American College of Obstetricians and Gynecologists. Committee Opinion eries associated with a poor fetal outcome do #289. Surgery and Patient Choice: The Ethics of Decision Making, Washington, not result from negligence on the part of the DC: American College of Obstetricians and Gynecologists, 2003. 14. American College of Obstetricians and Gynecologists. Committee Opinion obstetrician or the hospital nursing personnel, #286. Patient Safety in Obstetrics and Gynecology, Washington, DC: American but rather arise from abnormalities of the labor College of Obstetricians and Gynecologists, 2003. 15. American College of Obstetricians and Gynecologists. Ethics in Obstetrics and 11 process. Negligence, which may be defined as Gynecology, American College of Obstetricians and Gynecologists, 2002. the failure to provide ordinary care (care that Available at: http://www.acog.org/from_home/publications/ethics/. 16. Petrou S, Henderson J, Glazener C. Economic aspects of would be provided by a prudent nurse or physi- and alternative modes of delivery. Best Pract Res Clin Obstet Gynaecol. cian in the same or similar circumstance), may 2001;15:145-163, 17. Bost BW. Cesarean delivery on demand: what will it cost? Am J Obstet not be present in cases such as the one present- Gynecol. 2003;188:1418-1423. ed, but everyone would like to avoid the uncer- 18. Curtin S, Park M. Centers for Disease Control and Prevention: National Vital Statistics Report, December 2, 1999. tainty of a lawsuit and the prospect of years of 19. O’Grady JP, Gimovsky ML, McIlhargie CJ, eds. Vacuum Extraction in Modern anxiety and worry. Obstetric Practice. New York, NY: Parthenon Publishing Group, 1995.

This supplement is supported by a grant from Clinical Innovations, Inc. Copyright © 2004 Dowden Health Media

S12 FEBRUARY 2004 SUPPLEMENT TO OBG MANAGEMENT