Chart documentation of informed consent for operative vaginal delivery: is it adequate?Objectives: To determine the documentation frequency of informed consent for women undergoing a trial of nonemergent instrumental delivery. Study Design: A retrospective chart review of instrumented vaginal deliveries from 1992 to 2005 was performed. Cases were identified from a Labor and Delivery database and hospital records were reviewed for documentation of associated risks, general consent for the procedure, indication, and option of cesarean cesarean /ce·sar·e·an/ (se-zar´e-an) see under section. ce·sar·e·an or cae·sar·e·an or cae·sar·i·an or ce·sar·i·an adj. Of or relating to a cesarean section. delivery (CD). Results: Three hundred forty six charts were reviewed: 246 were excluded for an emergency delivery (19%), misclassification (25%), or lost notes (27%). In the remaining 100 cases, 61% had a general consent for instrumented vaginal delivery. Documentation of any maternal or neonatal risks was found in 3% and 0%, respectively. The option of a cesarean delivery was documented in 22% of the cases. When comparing 5-year time intervals before and after 2000, there was no increased frequency in documentation of maternal or neonatal risks. Conclusions: Documentation of informed consent for instrumented vaginal delivery is inconsistent and should be improved. Key Words: forceps, vacuum, operative delivery, maternal risks, neonatal risks, informed consent, chart documentation ********** Approximately 4% of women experience arrest of descent during the second stage of labor and are faced with the choice of an instrumented vaginal delivery or cesarean section cesarean section (sĭzâr`ēən), delivery of an infant by surgical removal from the uterus through an abdominal incision. The operation is of ancient origin: indeed, the name derives from the legend that Julius Caesar was born in this at full dilation dilation /di·la·tion/ (di-la´shun) 1. the act of dilating or stretching. 2. dilatation. di·la·tion n. 1. , each with inherent risk. (1) In the setting of maternal and fetal well being, women should be able to make an informed choice on the basis of the best available evidence, rather than on the opinion of the obstetrician obstetrician /ob·ste·tri·cian/ (ob?ste-trish´in) one who practices obstetrics. ob·ste·tri·cian n. A physician who specializes in obstetrics. alone. While cesarean section has become progressively safer, (2-4) the risks of instrumental vaginal delivery, (5) particularly with regard to future pelvic floor dysfunction, (6-11) remain significant. Operative vaginal delivery with either forceps or vacuum cup extractors has been associated with neonatal risks and both short- and long-term maternal risks. While neonatal mortality is not increased with operative vaginal delivery, neonatal morbidity has been well documented. The risks associated with both forceps and vacuums include skull fractures, (12) intracranial hemorrhage intracranial hemorrhage n. The escape of blood within the cranium due to the loss of integrity of vascular channels and frequently leading to formation of a hematoma. , (13,14) retinal hemorrhage Retinal Hemorrhage Definition Retinal hemorrhage is the abnormal bleeding of the blood vessels in the retina, the membrane in the back of the eye. , (15) cephalohematoma, (16,17) facial nerve facial nerve n. Either of a pair of nerves that originate in the pons, traverse the facial canal of the temporal bone, and pass through the parotid gland, reach the facial muscles through various branches, control facial muscles, and relay sensation injury, (18) brachial plexus injury brachial plexus injury Obstetrics The squashing of the brachial plexus, almost always due to a shoulder dystocia in a vaginal delivery, which is often associated with transient paralysis See Operative vaginal delivery. (18,19) and soft tissue bruising. (5) Neonatal trauma is greater after operative vaginal delivery than cesarean section. (1,13) Immediate maternal risks of instrumental delivery include cervical lacerations, (20) severe vaginal tears, (21) infection (1), and increased hospital stay. (22) Potential future risks include wound breakdown, (23) dyspareunia dyspareunia /dys·pa·reu·nia/ (-pah-roo´ne-ah) difficult or painful sexual intercourse. dys·pa·reu·ni·a n. Difficult or painful sexual intercourse. , (24) and pelvic floor disorders. (6,10,25) Over the past decade, there has been increasing awareness about the association that assisted vaginal deliveries have with bladder (6,10) and bowel dysfunction. (26,27) Operative delivery remains a major modifiable risk factor for anal sphincter anal sphincter n. Either of the two sphincter muscles of the anus. See under external and internal sphincter muscle of anus. injury in primiparous pri·mip·a·ra n. pl. pri·mip·a·ras or pri·mip·a·rae 1. A woman who is pregnant for the first time. 2. A woman who has given birth to only one child. women. Despite primary repair, 20 to 50% (28,29) of women report altered bowel continence continence /con·ti·nence/ (kon´tin-ens) the ability to control natural impulses.con´tinent con·ti·nence n. 1. Self-restraint; moderation. 2. after an anal sphincter laceration laceration /lac·er·a·tion/ (las?er-a´shun) 1. the act of tearing. 2. a torn, ragged, mangled wound. lac·er·a·tion n. 1. A jagged wound or cut. 2. is sustained. Materials and Methods After institutional review board approval was obtained, the Virginia Commonwealth University Formed by a merger between the Richmond Professional Institute and the Medical College of Virginia in 1968, VCU has a medical school that is home to the nation's oldest organ transplant program. Medical Center's computerized Labor and Delivery database was accessed to identify all operative vaginal deliveries from 1992 to present. After excluding all patients under the age of 18, the list order was randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. and was submitted to medical records for chart retrieval. Charts were then reviewed by the authors to confirm that a nonemergent operative vaginal delivery had actually been performed. Chart collection ceased after 100 cases were identified because we thought this was an adequate sample to reflect practice patterns over the study period. A review of the entire hospital record pertaining to the delivery was performed to determine if the following information was present: Written consent for forceps or vacuum, documentation of any maternal risks, documentation of any neonatal risks, the indication for operative delivery, whether the option of cesarean section was discussed and finally, if attending supervision was provided. Extracted data were recorded on printed data sheets for analysis. Statistical analysis was performed using SPSS A statistical package from SPSS, Inc., Chicago (www.spss.com) that runs on PCs, most mainframes and minis and is used extensively in marketing research. It provides over 50 statistical processes, including regression analysis, correlation and analysis of variance. version 11.5 (SPSS Inc., Chicago, IL). Categorical data categorical data data relating to category such as qualitative data, e.g. dog, cat, female. It may be nominal when a name is used, e.g. location, breed, or ordinal when a range of categories is used, e.g. calf, yearling, cow. were reported as ratios or proportions and were compared using chi-square statistic. P < 0.05 was considered statistically significant. Results Three hundred and forty-six charts were reviewed, of which 246 were excluded for an emergency delivery (19%), misclassification as an operative vaginal delivery (25%), or lost notes (27%). Of the 100 remaining cases, 96 were forceps deliveries, 4 vacuum deliveries and 2 failed vacuum ending in forceps deliveries (identified in both categories). There was an equal distribution of cases over the study period, with 1 to 9 cases from each year meeting inclusion criteria, with the exception of 1994, in which 35 cases were included. It is unclear why the discrepancy existed for this year. A general consent form for the use of vacuum or forceps was present in 61% of charts reviewed. Specific documentation of any of the known maternal or neonatal risks of operative vaginal delivery was found in 3% and 0% of cases, respectively. The option of proceeding with a cesarean section was documented in 22% of cases. Finally, the indication for operative vaginal delivery was recorded in 79%, and the presence of attending supervision was documented in 42% of cases. To determine if there was an improvement in informed consent over time, charts from 1992 to 1999 were compared with those from 2000 to 2005. We noted an increased frequency of written documentation in the areas of general consent for vacuum or forceps (41% from the first time period versus 100% in the later time period, P < 0.001), attending supervision (30% versus 65%, P < 0.001), indication for the procedure (74% versus 88%, P = 0.01) and documentation of the option of cesarean section (9% versus 47%, P < 0.001). There was no increase in documentation of maternal (3% versus 3%) or neonatal risks (0%) of operative vaginal delivery. Comment Deciding between cesarean section or attempted operative vaginal delivery when a woman fails to progress in the second stage of labor is complex and challenging. Traditionally this decision has been made based on attending obstetrician judgment. In the setting of neonatal or maternal compromise, such as acute terminal fetal bradycardia bradycardia: see arrhythmia. or cardiovascular collapse, sufficient time to discuss the risks and benefits of each intervention may not be present, rendering inclusion of the patient in the management decision suboptimal Suboptimal A solution is called suboptimal if a part of the solution has been optimized without regards to the overall objective. , if not impossible. In the absence of any emergency, however, patient choice about the management of second-stage arrest, based on informed consent, is paramount. From this retrospective chart review, we found a striking lack of documentation of the known maternal and neonatal risks of an elective instrumental delivery. The general consent documentation for operative vaginal delivery, present in only 61% of charts overall, did not detail the risks of neonatal trauma or maternal pelvic floor damage. It is standard surgical procedure to document major known risks of any operative intervention on a consent form. We cannot explain why obstetricians at our institution never documented the known neonatal risks of operative vaginal delivery. While there was an increase in the number of general consent forms found in charts for instrumental delivery between the two time periods studied, no increase in documentation of maternal or neonatal risk was found. Documentation of the option of cesarean section remained less than 50% throughout the study period. The morbidity associated with vaginal delivery, especially instrumental vaginal delivery, has received considerable attention over the last decade and the incidence of operative delivery continues to decrease in the United States. (30) Despite increased awareness about the potential negative impact of operative delivery on the pelvic floor, physicians may not routinely incorporate a discussion about anal incontinence, urinary incontinence Urinary Incontinence Definition Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it. and prolapse prolapse Protrusion of an internal organ out of its normal place, usually of the rectum or uterus outside the body when supporting muscles weaken. The membrane lining the rectum can push out through the anus, most often in old people with constipation who strain during when considering mode of delivery. In a survey of recent obstetrician-gynecologist graduates in the United States, less than one third of respondents indicated that they include risks of pelvic floor dysfunction when counseling patients about vaginal birth after cesarean vaginal birth after cesarean VBAC Obstetrics Vagina delivery of an infant after a cesarean section Complications Uterine apoplexy . (31) Our study again raises the concern that, given the findings of inconsistent documentation, women are not routinely participating in the informed consent process before nonemergent operative vaginal delivery. We acknowledge several limitations in our study. From a chart review, one cannot know what discussions actually took place between patient and physician before proceeding with a trial of operative vaginal delivery. It is possible that patients may have been well informed about the risks and benefits of each mode of delivery and may have made an informed choice based on the best available evidence. However, from a legal perspective in the United States, oral consent is not an accepted standard. The standard mantra of "what is not in the chart did not happen" clearly applies in this setting. Another limitation was that the random selection of 100 medical records raises the possibility that we did not include charts with increased frequencies of written documentation. Notably, we did not have an equal distribution of forceps versus vacuum deliveries in this review; and each of these delivery modes carry potentially similar AND different risks. Finally, because we reviewed medical records from one teaching hospital, our results are not generalizable to other obstetric practices. Written documentation of informed consent certainly does not ensure that women truly understand the complex nature of the issues that are involved, but it certifies that information regarding a trial of operative vaginal delivery was conveyed to the patient and they had an opportunity to participate in an informed decision. We should strive to use language that is readily understandable by the lay public and provide translated copies to non-English speaking patients. In the absence of results from a randomized prospective controlled trial controlled trial Clinical research A clinical study in which one group of participants receives an experimental drug while the other receives either a placebo or an approved–'gold standard' therapy. See Blinding, Double-blinded. of cesarean delivery versus operative vaginal delivery, obstetricians should strive to provide the best available evidence regarding options for management of the second-stage arrest and allow our patients to make an informed decision. Such a comprehensive consent process should probably not take place when a woman actually presents in labor as she may not be able to think clearly about the choices and issues that are presented to her. We recommend that a discussion regarding the risks and benefits of operative vaginal delivery for the management of second stage arrest take place in the third trimester and that appropriate reporting of these discussions takes place by means of a comprehensive written informed consent document. A written signed document provides the best legal proof that patients participated in an informed consent decision. References 1. Murphy DJ, Liebling RE, Verity L, et al. Early maternal and neonatal morbidity associated with operative delivery in second stage of labour: a cohort study. Lancet 2001;358:1203-1207. 2. Burrows LJ, Meyn LA, Weber AM. Maternal morbidity associated with vaginal versus cesarean delivery. Obstet Gynecol 2004;103:907-912. 3. Hannah ME, Hannah WJ, Hewson SA, et al. Planned caesarean section caesarean section: see cesarean section. versus planned vaginal birth for breech presentation breech presentation n. Presentation of the fetus during birth with the buttocks or less commonly the knees or feet first. Breech presentation at term: a randomised Adj. 1. randomised - set up or distributed in a deliberately random way randomized irregular - contrary to rule or accepted order or general practice; "irregular hiring practices" multicentre trial: Term Breech breech (brech) the buttocks. breech n. The lower rear portion of the human trunk; the buttocks. breech, britch the buttocks of an animal; the backs of the thighs. Trial Collaborative Group. Lancet 2000;356:1375-1383. 4. Wagner M. Choosing caesarean section. Lancet 2000;356:1677-1680. 5. Johanson RB, Menon BK. Vacuum extraction vacuum extraction Obstetrics Operator-assisted delivery in which suction is applied to the skull and the fetus delivered vaginally Complications Brachial plexus injury due to shoulder dystocia, scalp injuries, intracranial–especially, versus forceps for assisted vaginal delivery. Cochrane Database Syst Rev 2000:CD000224. 6. Liebling RE, Swingler R, Patel RR, et al. Pelvic floor morbidity up to one year after difficult instrumental delivery and cesarean section in the second stage of labor: a cohort study. Am J Obstet Gynecol 2004;191:4-10. 7. Christianson LM, Bovbjerg VE, McDavitt EC, et al. Risk factors for perineal perineal /peri·ne·al/ (-ne´al) pertaining to the perineum. Perineal The diamond-shaped region of the body between the pubic arch and the anus. injury during delivery. Am J Obstet Gynecol 2003;189:255-260. 8. Kamm MA. Obstetric damage and faecal fae·cal adj. Chiefly British Variant of fecal. Adj. 1. faecal - of or relating to feces; "fecal matter" fecal incontinence. Lancet 1994; 344:730-733. 9. MacLennan AH, Taylor AW, Wilson DH, et al. The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery. BJOG BJOG British Journal of Obstetrics and Gynaecology 2000;107:1460-1470. 10. Rortveit G, Daltveit AK, Hannestad YS, et al. Urinary incontinence after vaginal delivery or cesarean section. N Engl J Med 2003;348:900-907. 11. Johanson RB, Heycock E, Carter J, et al. Maternal and child health after assisted vaginal delivery: five-year follow up of a randomised controlled study comparing forceps and ventouse Ven´touse n. 1. A cupping glass. v. t. & i. 1. To cup; to use a cupping glass. . Br J Obstet Gynaecol 1999;106:544-549. 12. Dupuis O, Silveira R, Dupont C, et al. Comparison of 'instrument-associated' and 'spontaneous' obstetric depressed skull fractures in a cohort of 68 neonates. Am J Obstet Gynecol 2005;192:165-170. 13. Towner D, Castro MA, Eby-Wilkens E, et al. Effect of mode of delivery in nulliparous women on neonatal intracranial intracranial /in·tra·cra·ni·al/ (-kra´ne-al) within the cranium. in·tra·cra·ni·al adj. Within the cranium. injury. N Engl J Med 1999;341:1709-1714. 14. Jhawar BS, Ranger A, Steven D, et al. Risk factors for intracranial hemorrhage among full-term infants: a case-control study case-control study, n an investigation employing an epidemiologic approach in which previously existing incidents of a medical condition are used in lieu of gathering new information from a randomized population. . Neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system. neu·ro·sur·ger·y n. Surgery on any part of the nervous system. 2003;52:581-590; discussion 588-590. 15. Demissie K, Rhoads GG, Smulian JC, et al. Operative vaginal delivery and neonatal and infant adverse outcomes: population-based retrospective analysis. BMJ BMJ n abbr (= British Medical Journal) → vom BMA herausgegebene Zeitschrift 2004;329:24-29. 16. Johanson RB, Rice C, Doyle M, et al. A randomised prospective study comparing the new vacuum extractor policy with forceps delivery. Br J Obstet Gynaecol 1993;100:524-530. 17. Wen SW, Liu S, Kramer MS, et al. Comparison of maternal and infant outcomes between vacuum extraction and forceps deliveries. Am J Epidemiol 2001;153:103-107. 18. Perlow JH, Wigton T, Hart J, et al. Birth trauma: a five-year review of incidence and associated perinatal factors. J Reprod Med 1996;41:754-760. 19. Gilbert WM, Nesbitt TS, Danielsen B. Associated factors in 1611 cases of brachial plexus injury. Obstet Gynecol 1999;93:536-540. 20. Learman LA. Regional differences in operative obstetrics: a look to the South. Obstet Gynecol 1998;92:514-519. 21. Combs CA, Robertson PA, Laros RK Jr. Risk factors for third-degree and fourth-degree perineal lacerations in forceps and vacuum deliveries. Am J Obstet Gynecol 1990;163:100-104. 22. Leeman L, Spearman spear·man n. A man, especially a soldier, armed with a spear. M, Rogers R. Repair of obstetric perineal lacerations. Am Fam Physician 2003;68:1585-1590. 23. Fitzpatrick M, Behan M, O'Connell PR, et al. A randomized clinical trial randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. comparing primary overlap with approximation repair of third-degree obstetric tears. Am J Obstet Gynecol 2000;183:1220-1224. 24. Buhling KJ, Schmidt S, Robinson JN, et al. Rate of dyspareunia after delivery in primiparae according to mode of delivery. Eur J Obstet Gynecol Reprod Biol 2006;124:42-46. 25. MacArthur C, Glazener CM, Wilson PD, et al. Obstetric practice and faecal incontinence three months after delivery. BJOG 2001;108:678-683. 26. Sultan AH, Kamm MA, Bartram CI, et al. Anal sphincter trauma during instrumental delivery. Int J Gynaecol Obstet 1993;43:263-270. 27. Bofill JA, Rust OA, Schorr SJ, et al. A randomized prospective trial of the obstetric forceps versus the M-cup vacuum extractor. Am J Obstet Gynecol 1996;175:1325-1330. 28. Sultan AH, Kamm MA, Hudson CN, et al. Third-degree obstetric anal sphincter tears: risk factors and outcome of primary repair. BMJ 1994; 308:887-891. 29. Nichols CM, Lamb EH, Ramakrishnan V. Differences in outcomes after third- versus fourth-degree perineal laceration repair: a prospective study. Am J Obstet Gynecol 2005;193:530-534; discussion 534-536. 30. Martin JA, Hamilton BE, Sutton PD, et al. Births: final data for 2002. Natl Vital Stat Rep 2003;52:1-113. 31. Kenton K, Brincat C, Mutone M, et al. Repeat cesarean section and primary elective cesarean section: recently trained obstetrician-gynecologist practice patterns and opinions. Am J Obstet Gynecol 2005;192:1872-1875; discussion 1875-1876. Catherine Matthews Nichols, MD, Laura C. Pendlebury, MD, and Jamie Jennell From the Department of Obstetrics and Gynecology obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. and the School of Medicine, Medical College of Virginia/Virginia Commonwealth University Medical Center, Richmond, VA. Reprint requests to Catherine M. Nichols, MD, 1250 E. Marshall Street, Box 980034, Richmond, Virginia 23298-0034. Email: cmnichol@hsc.vcu.edu Accepted July 5, 2006. RELATED ARTICLE: Key Points * More than one-third of women undergoing an elective trial of instrumental vaginal delivery did not have chart documentation of general consent for the procedure. * Any maternal and/or neonatal risk of instrumental vaginal delivery was documented in 3% and 0% of charts reviewed, respectively. * Documentation of the known maternal and/or neonatal risks of instrumental vaginal delivery did not improve over time. * Documentation of informed consent for instrumental vaginal delivery is inconsistent and should be improved. |
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