Neonatal subgaleal hemorrhage in a multihospital healthcare system: prevalence, associations, and outcomes RD Christensen1,2, VL Baer1,2, and E Henry1,3 1 Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT, Division of Neonatology and 3The Institute for Healthcare Delivery Research, Salt Lake City, UT, USA. 2 Address correspondence to Robert D. Christensen, MD; Intermountain Healthcare, 4401 Harrison Blvd, Ogden, UT 84403, FAX 801-387-4316; Phone, 801-387-4300; E-mail, rdchris4@ihc.com RUNNING TITLE: Neonatal Subgaleal Hemorrhage FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose. ABSTRACT Objective: Neonatal subgaleal hemorrhage is more common after operative delivery (vacuum or forceps) than after non-instrumented delivery, but can occur when neither vacuum nor forceps were used. We sought to describe recent vacuum and forceps usage in a multihospital system and to identify all cases of subgaleal hemorrhage and to associate these with delivery type. Methods: Using data repositories of Intermountain Healthcare we tabulated vacuum and forceps use during the past 8½ years, seeking trends over time and as a function of the size of the delivery service. Records were reviewed of all neonates where subgaleal hemorrhage was recognized, seeking associations with delivery practices, and describing the outcomes. Results: Vacuum-assisted deliveries constituted a higher proportion of deliveries in hospitals with fewer than 1000 births per year, but forceps use was not associated with delivery service size. Vacuum assistance occurred in 4.8% of all deliveries in the system, with no yearly change in usage, but forceps use diminished from 5.3% of deliveries in 2002 to 4.7% in 2003 and to 2.4% thereafter. During this period 38 neonates were recognized to have a subgaleal hemorrhage. Twenty-one occurred after vacuum, two after forceps, four after vacuum followed by forceps, and 11 when neither vacuum nor forceps were used. Thirty-five were admitted to an intensive care unit. Transfusions were given to 13, but no transfusions were given in the group where neither vacuum nor forceps was used, suggesting their hemorrhages were less severe. Adverse outcomes of subgaleal hemorrhage included death in two, persistent seizures in one, and neurodevelopmental delay in another. All others where follow-up data were available (n=23) were normal. In this health system the prevalence of recognized subgaleal hemorrhage is one case per 7123 deliveries, one per 598 vacuum-assisted deliveries, and one per 1059 forcepsassisted deliveries. Conclusion: In our system, severe subgaleal hemorrhage is invariably associated with the use of vacuum or forceps. It is uncertain whether the poor outcome seen in 10% of our neonates with subgaleal hemorrhage is due to the hemorrhage itself, or is the consequence of events preceding or unrelated to the bleeding. We suggest that is it a wise practice, when vacuum or forceps are December 1, 2010 Page 1 used, to convey this information to the pediatrician. We also suggest that the topic of subgaleal hemorrhage be periodically reviewed, as continuing education for all involved in neonatal care. INTRODUCTION Hemorrhage into the subgaleal space can be a life-threatening neonatal complication (1,2). However, the spectrum of severity ranges widely, from a small asymptomatic hemorrhage to a massive one causing hypovolemic shock. Associations are well known between vacuum or forceps-assisted delivery and subgaleal hemorrhage, but some cases occur when neither vacuum nor forceps were applied (3-5). Ali and Norwitz recently estimated that five to ten percent of vaginal deliveries in the United States utilize either vacuum or forceps (6). An ACOG Practice Bulletin suggested that subgaleal hemorrhages are detected in two to five percent of these operative vaginal deliveries (7). Most published reports of neonatal subgaleal hemorrhage are from an individual hospital, or are cases reported to the Centers for Disease Control (8,9). Neither source of information is ideal for estimating the prevalence of neonatal subgaleal hemorrhage, or in assigning the risk of such hemorrhage when vacuum or forceps are used. Intermountain Healthcare is a multihospital healthcare system in Utah and Idaho. Using the data repositories of this system we determined vacuum and forceps usage, analyzing trends in usage over the recent past, and examining use as a function of the size of the delivery service. We simultaneously reviewed the records of all neonates in the system where a subgaleal hemorrhage was identified, and correlated the obstetrical and neonatal findings with outcomes. METHODS We conducted a cross-sectional, multihospital, retrospective data analysis of individuals with dates of birth from January 1, 2002 through July 31, 2010 in the Intermountain Healthcare databases. Intermountain Healthcare is a not-for-profit organization that, during the period of study, owned and managed 21 hospitals with labor and delivery services in the Intermountain West of the USA. In October 2003 an ICD-9 code for neonatal subgaleal hemorrhage was introduced at Intermountain Healthcare. Medical records were reviewed for every neonate where this code was applied between October 1, 2003 and July 31, 2010. All diagnoses were ascertained from electronic data marts; Case Mix (the billing, coding, and financial data mart used by Intermountain Healthcare), EVOX (the extended VermontOxford database), Storkbytes (the labor and delivery database), and ICD-9. The EMR is a modified subsystem of Clinical Workstation. The 3M Company (Minneapolis, MN, USA) approved the structure and definitions of all data points for use within the EMR program and data were managed and accessed by authorized data analysts only. Fisher exact was used for statistical analysis. P <0.05 was considered statistically significant. The study was approved by the Institutional Review Board of Intermountain Healthcare as a retrospective deidentified analysis not requiring individual consent. RESULTS In the 8½ year period studied, 261,921 live births were recorded at 21 hospitals. As shown in table 1, hospitals delivering <1000/year utilized vacuum-assistance in a larger December 1, 2010 Page 2 proportion of deliveries than did hospitals with more deliveries. In contrast, forceps use was not associated with the size of the delivery service. Vacuum-assisted vaginal deliveries constituted 4.8% of all deliveries during the entire period, with no change from year to year. In contrast, forceps-assistance diminished from 5.3% of deliveries in 2002 to 4.7% in 2003 and to 2.4% thereafter for the remainder of the period studied. A small number of caesarean section deliveries involved vacuum-assistance to withdraw the fetus from the hysterotomy. This constituted less than 1% of the vacuum use and these cases are not included in the table. Table 1. Vacuum-assisted and forceps-assisted vaginal deliveries at Intermountain Healthcare Hospitals in the 8½ year period January 2002 through July 31, 2010. Hospitals grouped according to number of live births/year* >3000/year 1000-2999/year 100-999/year <100/year TOTAL N 5 5 7 4 21 Live births during the period of study 136,505 107,827 16,476 1,113 261,921 Vacuum-assisted vaginal deliveries 5866 (4.3%) 4909 (4.5%) 1734 (11.0%)** 65 (5.8%)** 12,574 (4.8%) Forceps-assisted vaginal deliveries 4563 (3.3%) 2968 (2.8%) 127 (0.7%) 42 (3.8%) 7700 (2.9%) Hospitals were grouped based on deliveries/year in 2009. N= number of hospitals in this grouping *The largest of the current obstetrical services (Intermountain Medical Center) opened in October 2007. One hospital closed the obstetrical service in 2003 and another did so in 2007. **P<0.001 vs. hospital delivering ≥1000/year Of the 261,921 live births 15,204 (5.8%) were admitted to a NICU (Table 2). NICU admission was not more likely after vacuum-assisted delivery (4.0% of all vacuum deliveries were admitted to a NICU) or forceps-assisted delivery (4.8% of forceps deliveries were admitted to a NICU). December 1, 2010 Page 3 Table 2. NICU admissions following all attempted (successful or failed) vacuum or forceps delivery. Hospitals grouped according to number of deliveries/year* >3000/year 1000-2999/year 100-999/year <100/year TOTAL NICU admissions following any delivery 9892 (7.2%) 4900 (4.5%) 336 (2.0%) 76 (6.8%) 15,204 (5.8%) NICU admissions following vacuumassisted delivery 396 (6.8%) 100 (2.0%) 11 (0.6%) 2 (3.0%) 509 (4.0%) NICU admissions following forcepsassisted delivery 265 (5.8%) 104 (3.5%) 1 (0.8%) 1 (2.3%) 371 (4.8%) *The largest of the current obstetrical services (Intermountain Medical Center) opened in October 2007. One hospital closed the obstetrical service in 2003 and another did so in 2007. During the period studied 38 neonates were recognized to have a subgaleal hemorrhage. Thirty of these were born at an Intermountain Healthcare hospital and eight were born at other hospitals and transported into an Intermountain Healthcare hospital. No neonate with a subgaleal hemorrhage was born in an Intermountain Healthcare hospital and transported to a nonIntermountain Healthcare hospital. Since the ICD-9 code for subgaleal hemorrhage was instituted in October 2003, 213,706 births were recorded in this system, of which 30 had the diagnosis of subgaleal hemorrhage. On this basis, the prevalence estimate is one case per 7124 births. Of 11,365 vacuum-assisted deliveries during this period 19 had the diagnosis of subgaleal hemorrhage. Thus the prevalence estimate is one case per 598 vacuum-assisted births. Of 5294 forceps-assisted deliveries five had the diagnosis of subgaleal hemorrhage, with a prevalence estimate of one case per 1059 forceps-assisted births. As shown in table 3, three or four cases of subgaleal hemorrhage were recognized each year from 2004 through 2007, with eight cases in 2008, eight in 2009, and six in the first six months of 2010. Birth weights of affected neonates were 3482±625 grams (mean±SD), gestational age was 38±2 weeks and 68% were male. Twenty-one of the 38 cases of subgaleal hemorrhage occurred after vacuum-assistance, two after forceps, and four after vacuum followed by forceps. Eleven cases occurred when neither vacuum nor forceps were used; eight of these were vaginal deliveries and three were caesarean. December 1, 2010 Page 4 Table 3. Features of 38 neonates with a subgaleal hemorrhage. g, grams; w, weeks; vag, vaginal; fcp, forceps; Csec, cesarean section; ICU, admitted to an Birth Year Birth weight (g) Gest Age (w) Delivery Mode 2003 2004 2004 2004 2004 2005 2005 2005 2005 2006 2006 2006 2007 2007 2007 2007 2008 2008 2008 2008 2008 2008 2008 2008 2009 2009 2009 2009 2009 2009 2009 2009 2010 2010 2010 2010 2010 2010 3627 3012 3375 3102 3385 4621 2389 4097 2580 3125 3770 3449 3200 3468 3650 3279 2373 3605 3215 2779 4233 4005 3510 3175 4895 2572 2940 4145 4430 4905 3685 3754 3616 3455 3435 2807 3600 3063 37 40 40 35 39 40 34 39 37 35 38 41 37 38 41 39 33 39 39 34 40 40 38 35 39 34 37 41 40 40 37 39 38 40 40 37 39 39 Vag/Vac Vag/Vac Vag/Vac/Fcp Vag/Vac Vag Vag Csec Vag/Vac Vag/Vac Vag/Vac Csec Vag/Vac Vac/Csec Vac/Fcp/Csec Vag/Fcp Vag/Fcp Vag Vag/Vac Vac/Fcp/Csec Vag/Vac Vag/Vac Vag Vag/Vac Vag/Vac Vag/Vac Vag Vag/Vac Vag/Vac/Fcp Vag/Vac /Csec Vag Csec Vag/Vac Vag/Vac/Csec Vag/Vac Vag/Vac Vag Vag Vag/Vac Apgar score @5 min 8 4 4 7 7 7 9 9 5 9 8 4 6 5 8 4 8 8 9 8 9 8 7 9 9 5 9 5 9 9 8 9 8 8 8 4 9 8 Age at diag (h) ICU (Y vs. N) 3 Birth Birth Birth Birth Birth Birth 4 Birth Birth 1 Birth 8 Birth Birth Birth Birth Birth Birth Birth Birth Birth Birth Birth 7 8 5 Birth Birth Birth Birth Birth 1 2 Birth Birth Birth Birth Y Y Y Y N Y Y Y Y Y Y Y Y Y N Y Y Y Y Y Y Y Y Y N Y Y Y Y Y Y Y Y Y Y Y Y Y Diagnosis confirmed by imaging (Y vs. N) N Y Y N Y Y Y Y Y Y N N N Y Y Y Y Y Y Y Y Y Y Y N N Y Y Y Y Y N Y Y N Y Y Y RBC trans given (N) 0 1 0 1 0 0 0 1 2 0 0 2 2 2 0 3 0 0 1 0 0 0 0 1 0 0 0 0 1 0 0 0 1 0 0 0 0 1 LOS (d) Outcome 12 7 2 2 4 3 10 43 72 14 6 10 17 9 4 4 18 3 8 6 7 2 4 12 2 13 7 4 7 6 6 4 6 7 7 19 23 11 Norm Norm Norm Expired Norm NA NA Norm NA Norm Norm NA NA NA Norm Expired Norm Norm Norm Seizures NA NA Norm Norm Norm Norm Norm Norm NA NA Norm Norm Norm Norm Norm * Norm NA intensive care unit; diag, diagnosis; h, hours; d, days; LOS, length of hospital stay *Multiple problems related to hypoxic ischemic encephalopathy December 1, 2010 Page 5 Five minute Apgar scores in the 38 neonates ranged from 4 to 9. Most cases (29/38) were recognized to have a subgaleal hemorrhage at the time of birth; four were not recognized at delivery but were seen during the first three hours, and five were not recognized until four to eight hours after birth. Thirty-five of the 38 neonates were admitted to an intensive care unit; 34 to a NICU and one a cardiac intensive care unit. The other three were cared for in a well baby nursery. One or more erythrocyte transfusions were administered to 13 of the 38. None who developed a subgaleal hemorrhage where neither vacuum nor forceps were used (n=11) received a transfusion, compared with 13 of the 27 where vacuum or forceps were used (P=0.013). About half of those with a subgaleal hemorrhage following vacuum received a transfusion (10 of 21), which is the same proportion of those transfused after forceps (1 of 2) and where both vacuum and forceps were used (2 of 4). None of the 38 received recombinant Factor VIIa and none were treated with head wrapping. Twenty-nine had an imaging study to confirm the diagnosis of subgaleal hemorrhage. The length of hospital stay ranged from two to 72 days. Those with a stay exceeding 20 days included one with myotonic dystrophy, one with hypoplastic left heart, and one with significant feeding problems who was discharged home with a feeding tube. Adverse outcomes of the affected patients included death in two, a persistent seizure disorder in one, and significant neurodevelopmental delay in another. The two who died had refractory hypotension and acidosis, and both received a transfusion. One died on day 2 (35 wk gestation after vacuumassisted vaginal delivery) and the other died on day 4 (39 wk gestation after forceps-assisted vaginal delivery). The two survivors with a subgaleal hemorrhage who are known to have a poor neurodevelopmental outcome did not receive a transfusion (a 34 week gestation after vacuumassisted vaginal delivery and a 37 wk gestation after vaginal delivery). Of the remaining 34 neonates, 23 had follow-up in an Intermountain Healthcare facility all were judged to be normal. Eleven had follow-up in an outside facility and their outcomes are unknown to us. DISCUSSION Using the data repositories of a multihospital healthcare system, we described patterns of vacuum-assisted and forceps-assisted deliveries over a recent 8½ year period. Because of the association between operative delivery and subgaleal hemorrhage, we used the same data-sets to locate all instances where a neonatal subgaleal hemorrhage was identified. The pathogenesis of neonatal subgaleal hemorrhage involves trauma to the scalp. The subgaleal space is a potential space, meaning two adjacent tissues, not tightly adjoined, can be separated to create a previously non-existent cavity. The two tissues bordering the subgaleal space are the periosteum of the skull and the flat broad tendinous material covering the cranium called the galea aponeurotica (also known as the epicranial aponeurosis or the aponeurosis epicranialis). The subgaleal space can fill with blood following rupture of veins that connect scalp veins to the dural sinus. Veins traversing this potential space, termed emissary veins, can rupture after twisting, sheering, or torsion of the scalp. McQuivey suggested that the subgaleal space of a neonate can accommodate 50 to 80% of the blood volume (10), and consequently massive bleeding can occur into this space, resulting in hypovolemic shock. December 1, 2010 Page 6 A subgaleal hemorrhage can be noted at birth, or can appear gradually over the first hours (11,12). Such was the case in this series where most were evident at birth but some were not recognized for up to eight hours. The diagnosis is clinical in many cases, with an enlarging head due to swelling which crosses suture lines, ending at the orbits anteriorly and at the nape of the neck posteriorly, and accompanied by clinical and laboratory evidence of diminishing circulating blood volume. Chang et al recently reported the prevalence of subgaleal hemorrhage in Taiwan to be one case per 1667 deliveries and one case per 218 vacuum-assisted deliveries (13). This was based on the period January 1995 to December 2004. We found a lower prevalence; specifically we found one case per 7124 deliveries, one per 598 vacuum-assisted deliveries, and one per 1059 forceps-assisted deliveries. Although our study period is more current (2003 – 2010) our figures might be underestimates on the basis that recognition of this complication is likely increasing in our system. For instance, if we consider only the data from January 2008 our overall prevalence is one case per 4707 deliveries. We speculate that the odds of a subgaleal hemorrhage is even higher when multiple attempts at vacuum delivery have failed, but we were unable to calculate this as our data does not include the number of vacuum applications. Moreover, the odds are probably higher when vacuum and forceps fail to result in vaginal delivery and emergency cesarean section is required. However, the relative rarity of this situation in our data prevents any meaningful estimate of odds. Management of neonatal subgaleal hemorrhage involves NICU monitoring and serial quantification of the hemoglobin or hematocrit. In our series, over 1/3rd received RBC transfusions. We speculate that transfusion recipients generally had the largest subgaleal blood loss, although this cannot be determined using retrospective methods. Half of the neonates with a subgaleal hemorrhage after vacuum or forceps received one or more transfusions. In contrast none of those with a subgaleal hemorrhage when neither vacuum nor forceps were used had a RBC transfusion. On this basis we speculate that the volume of blood loss into the subgaleal space is generally larger when subgaleal hemorrhage follows use of a vacuum or forceps. Another management option, pressure wrapping of the head, has been advocated by some but it is not clear that this is helpful and might contribute to increased intracranial pressure (2,14). Recombinant activated factor VII has been used in cases where hemorrhage would not stop using plasma and platelet transfusion to correct coagulopathy and thrombocytopenia (15,16). Coagulopathy should be considered, particularly when hypotension and acidosis accompany a falling hemoglobin. Among severe cases renal failure should also be anticipated. Even in less severe cases hyperbilirubinemia should be anticipated, and sometimes requires prolonged phototherapy. It seems to us that most neonates with a subgaleal hemorrhage have a good outcome, and perhaps this is improving over time. For instance, the mortality rate in the Taiwan study was 12% and in ours was 5%. This is in contrast to earlier reports where mortality rates of 17 to 25% were cited (17,18). Neurodevelopmental problems were present in 17% in the Taiwan report and in 5% of our cases, but it is not clear whether the neurological damage is ascribable to the hemorrhage itself, or is the result of events preceding or coexisting with the hemorrhage. December 1, 2010 Page 7 Owing to the relative rarity of severe cases of subgaleal hemorrhage, many clinicians have not managed neonates who have this problem. Although most cases seem to do well, vigilance is needed to avoid morbidity and mortality. To foster anticipatory neonatal care for these patients, we advocate that when vacuum or forceps are used, this information be conveyed to the clinician who will provide the neonatal care. We also advocate continuing education for all who participate in neonatal care, regarding diffuse neonatal swelling of the head, crossing suture lines, prompting a consideration of subgaleal hemorrhage with subsequent institution of appropriate monitoring and, where indicated, treatment strategies. ACKNOWLEDGEMENT The authors thank Heather Major, MD, Division of Maternal/Fetal Medicine, McKay-Dee Hospital center, for valuable assistance with this study design. REFERENCES 1. Christensen RD and Ohls RK. Anemias unique to the newborn period: Fetal anemia due to hemorrhage. In Wintrobe’s Clinical Hematology, Editors Greer JP, Foerster J, Rodgers GM, Paraskevas F, Glader B, Arber DA, and Means RT Jr. 12th Edition, Lippincott, Williams & Wilkins, Philadelphia, 2009, pp 1253-1255. 2. Modanlou HD. Subgaleal hemorrhage following vacuum extraction vaginal delivery: A frequently undiagnosed problem. Neo Today 2010:5; 6-8. 3. Kilani RA, Wetmore J. 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