Overview of progress in patient safety.

In the 11 years since the Institute of Medicine reported ubiquitous problems with the quality and safety of patient care in the United States, efforts been made to improve health care. Obstetrics and gynecology has made some improvements; however, similar to other areas of health care, progress has been slow. The major deterrents are complexities in our health care system and culture and an immature science of safety and quality that makes measurement and evaluation of progress difficult. This article describes the efforts that have been made in obstetrics and gynecology to identify causes or factors that contribute to adverse outcomes, to develop measures of quality and safety, and to make improvements. It also offers a framework to help organize patient safety research and improvement. Finally, this article offers ways the American Congress of Obstetricians and Gynecologists can organize and support future work.

A systematic review of the role of intrapartum hypoxia-ischemia in the causation of neonatal encephalopathy.

The object of this review was to determine the incidence, morbidity, and mortality of an umbilical arterial pH < 7.0; the incidence of hypoxic-ischemic encephalopathy; and the proportion of cerebral palsy associated with intrapartum hypoxia-ischemia in nonanomalous term infants. A systematic review of the English language literature on the association between intrapartum hypoxia-ischemia and neonatal encephalopathy was conducted by using Pubmed and Embase. For nonanomalous term infants, the incidence of an umbilical arterial pH < 7.0 at birth is 3.7 of 1000, of which 51 of 297 (17.2%) survived with neonatal neurologic morbidity, 45 of 276 (16.3%) had seizures, and 24 of 407 (5.9%) died during the neonatal period. The incidence of neonatal neurologic morbidity and mortality for term infants born with cord pH < 7.0 was 23.1%. The incidence of hypoxic-ischemic encephalopathy is 2.5 of 1000 live births. The proportion of cerebral palsy associated with intrapartum hypoxia-ischemia is 14.5%. The vast majority of cases of cerebral palsy in nonanomalous term infants are not associated with intrapartum hypoxia-ischemia.

Intrapartum electronic fetal heart rate monitoring and the prevention of perinatal brain injury.

OBJECTIVE: Electronic fetal heart rate monitoring (EFM) is the most widely used method of intrapartum surveillance, and our objective is to review its ability to prevent perinatal brain injury and death. DATA SOURCES: Studies that quantified intrapartum EFM and its relation to specific neurologic outcomes (seizures, periventricular leukomalacia, cerebral palsy, death) were eligible for inclusion. MEDLINE was searched from 1966 to 2006 for studies that examined the relationship between intrapartum EFM and perinatal brain injury using these MeSH and text words: "cardiotocography," "electronic fetal monitoring," "intrapartum fetal heart rate monitoring," "intrapartum fetal monitoring," and "fetal heart rate monitoring." METHODS OF STUDY SELECTION: This search strategy identified 1,628 articles, and 41 were selected for further review. Articles were excluded for the following reasons: in case reports, letters, commentaries, and review articles, intrapartum EFM was not quantified, or specific perinatal neurologic morbidity was not measured. Three observational studies and a 2001 meta-analysis of 13 randomized controlled trials were selected for determination of the effect of intrapartum EFM on perinatal brain injury. TABULATION, INTEGRATION, AND RESULTS: Electronic fetal monitoring was introduced into widespread clinical practice in the late 1960s based on retrospective studies comparing its use to historical controls where auscultation was performed in a nonstandardized manner. Case-control studies have shown correlation of EFM abnormalities with umbilical artery base excess, but EFM was not able to identify cerebral white matter injury or cerebral palsy. Of 13 randomized controlled trials, one showed a significant decrease in perinatal mortality with EFM compared with auscultation. Meta-analysis of the randomized controlled trials comparing EFM with auscultation have found an increased incidence of cesarean delivery and decreased neonatal seizures but no effect on the incidence of cerebral palsy or perinatal death. CONCLUSION: Although intrapartum EFM abnormalities correlate with umbilical cord base excess and its use is associated with decreased neonatal seizures, it has no effect on perinatal mortality or pediatric neurologic morbidity.

Maternal race, procedures, and infant birth weight in type 2 and gestational diabetes.

OBJECTIVE: To examine the relation between race and cesarean delivery, episiotomy, and low birth weight infants in pregnancies with type 2 and gestational diabetes mellitus and to identify factors that might explain racial differences. METHODS: Population-based, cross-sectional study of 1999-2004 Maryland hospital discharge data. Hospitalizations for delivery of pregnancies with type 2 and gestational diabetes mellitus were identified and matched to infants. The independent variable was maternal race. Dependent variables were cesarean delivery, episiotomy, and low infant birth weight. Stepwise logistic regression models were developed to estimate the independent effect of race on use of each procedure and infant birth weight, after adjusting for sociodemographic, hospital, and clinical factors. RESULTS: We examined 6,310 deliveries for pregnancies with type 2 (15%) and gestational (85%) diabetes. Before adjustment, black race was associated with a higher odds of cesarean delivery (odds ratio [OR] 1.40, 95% confidence interval [CI] 1.24-1.58) and low birth weight infants (OR 1.94, 95% CI 1.57-2.40) compared with white race. Adjustment for racial differences in preeclampsia and fetal heart rate abnormalities accounted for a modest degree of the racial variation in outcomes. With full adjustment, black race was still associated with a higher odds of cesarean delivery (OR 1.38, 95% CI 1.20-1.60) and low birth weight (OR 1.81, 95% CI 1.41-2.34) and a lower odds of episiotomy (OR 0.45, 95% CI 0.36-0.57). CONCLUSION: In pregnancies with diabetes, adjustment for sociodemographic, hospital, and clinical factors only partially explains racial differences in procedure use and infant low birth weight.

The need for a new outlook on labor monitoring.

Fetal heart rate monitors, including the newer pulse-oximetry and STAN monitors, are designed to detect fetal distress that affects less than 1% of women in labor. Non-progressive labor is a much more common disorder than fetal distress, with approximately 50% of women in labor requiring oxytocin. Current technology assessing labor progress is subjective and inaccurate. There is a need for objective and accurate technology to measure labor progress and the effect it may have on managing labor and, specifically, non-progressive labor.

Can electronic fetal monitoring identify preterm neonates with cerebral white matter injury?

OBJECTIVE: Although preterm delivery occurs in only 10% of all births, these infants are at high risk for cerebral white matter injury and constitute a third of all cerebral palsy cases. Our objective was to estimate if electronic monitoring can identify preterm fetuses diagnosed with brain injury during the neonatal period. METHODS: In this case-control study, 150 consecutive neonates with ultrasonography-diagnosed cerebral white matter injury were matched by gestational age within 7 days to 150 controls with normal head ultrasonograms. Tracings were retrieved for 125 cases (83%) and 121 controls (81%) and reviewed by 3 perinatologists blinded to outcome. Vaginal (64 cases, 72 controls) and cesarean deliveries (61 cases, 49 controls) were analyzed separately. RESULTS: There was no difference in baseline heart rate, tachycardia, bradycardia, short-term variability, accelerations, reactivity, number or types of decelerations, or bradycardic episodes between cases and controls in either the vaginal or cesarean delivery groups. For the 6 neonates with metabolic acidosis severe enough to increase the risk for long-term neurologic morbidity, there was a significant increase in baseline amplitude range less than 5 beats per minute; however, its positive predictive value in predicting severe metabolic acidosis was only 7.7%. Increasing late decelerations were associated with decreasing umbilical arterial pH and base excess, but were not significantly different in the acidosis and control groups (1.0 +/- 1.8, 0.55 +/- 1.23 late decelerations per hour, P = .39). CONCLUSION: Although decreased short-term variability and increased late decelerations are associated with decreasing umbilical arterial pH and base excess, electronic fetal monitoring is unable to identify preterm neonates with cerebral white matter injury.

Provider attitudes toward clinical protocols in obstetrics.

The Johns Hopkins Oxytocin Protocol (JHOP) Survey was distributed to clinical labor and delivery staff to compare obstetrical providers' attitudes toward clinical protocols and the JHOP. Agreement by registered nurses (RNs), physicians in training (PIT), and attending physicians (APs) and certified nurse midwives (CNMs) was assessed with each of 4 attitudinal statements regarding whether clinical protocol and JHOP use result in better practice and are important to ensure patient safety. Odds of agreement with positive statements regarding clinical protocols did not differ significantly among groups. Odds of agreement with JHOP use resulting in better practice also did not differ significantly among provider groups. Odds of agreement with the JHOP being important to ensure patient safety were lower for the AP/CNM group compared with the RN group. Clinical protocol use is generally well received by obstetrical providers; however, differences exist in provider attitudes toward the use of an institutional oxytocin protocol.

Relations between fetal head descent and cervical dilatation during individual uterine contractions in the active stage of labor.

The relationship between instantaneous changes in fetal head station and cervical dilatation within the individual contraction during the active stage of labor were studied and an index of labor progress was suggested. Cervix dilatation and fetal head station were measured continuously in 30 nullipara women (mean age 27.5, standard deviation 4.8). The continuous measurements enabled the analysis of each variable and the analysis of the relations between these two variables. The relationship between the head station and the cervical dilatation were demonstrated by plotting one against the other during a contraction. This led to the definition of a contraction vector that integrates the interaction between the two variables. The angle of this vector, that indicates this relation, was plotted against mean head station to demonstrate change along the delivery process regardless of time to normalize the progress and allow comparison between different women with different labor durations. This plot showed a sharp change from almost zero into a steep curve at about zero head station. A zero angle indicates that the cervix dilates during a contraction with little effect on head station while a steep angle indicates a significant effect of cervical dilatation on head station during the contraction. The contraction-vector angle reflects the changing intra-contraction relationship between head station and cervical dilatation. The angle of this vector may serve as an indicator of labor progress.

Impact of surgeon specialty on ovarian-conserving surgery in young females with an adnexal mass.

PURPOSE: To evaluate the patterns of surgical care among pediatric and adolescent females undergoing operative intervention for an adnexal mass with particular attention toward factors associated with ovarian-conserving surgery and access to gynecologic care. METHODS: All female patients aged < or = 18 years undergoing surgery for an adnexal mass between January 1, 1991 and December 31, 2002 were retrospectively identified and demographic, operative, and pathologic data abstracted. Logistic regression analyses were used to identify factors independently associated with ovarian-conserving surgery and access to gynecologic care. RESULTS: Eighty-two consecutive cases were identified. The median age at surgery was 15 years, and 91.7% of patients were > or = 12 years of age. A malignant ovarian neoplasm was present in 14.6% of cases. Oophorectomy was performed in 52.4% of cases, while 47.6% of patients underwent ovarian-conserving surgery. Multivariate regression analysis revealed that ovarian-conserving surgery was significantly less likely in the setting of malignancy, torsion, and an ovarian size of > or = 6 cm. The presence of a gynecologic surgeon, compared to other surgical specialties, was statistically significantly and independently associated with ovarian-conserving surgery (odds ratio [OR] 8.71, 95% confidence interval [CI] 2.12-41.41, p = .001). Post-menarchal status and age > or = 16 years were the characteristic most predictive of access to gynecologic surgical care. CONCLUSIONS: In pediatric and adolescent patients, operative intervention for an adnexal mass is significantly more likely to result in ovarian conservation when performed by a gynecologic surgeon. For such patients, improved access to gynecologic consultation prior to surgical intervention may reduce the number of patients subjected to oophorectomy for benign conditions.

Intracranial hemorrhage as the initial manifestation of a congenital disorder of glycosylation.

Intracranial hemorrhage in a term neonate is a rare event in the absence of an identifiable precipitating factor such as severe thrombocytopenia, mechanical trauma, asphyxia, infections, or congenital vascular malformations. Congenital disorders of glycosylation are a genetically and clinically heterogeneous group of multisystem disorders characterized by the abnormal glycosylation of a number of glycoproteins. Although bleeding caused by abnormal glycosylation of various coagulation factors is a well-known clinical complication of several types of congenital disorders of glycosylation, intracranial hemorrhage has not been reported as an initial manifestation of this entity. Here we report the detailed history of a family with 2 consecutive male infants, both born at term with intracranial hemorrhage diagnosed within the first 24 hours of life. The diagnosis of a congenital disorder of glycosylation was established in the second infant by an abnormal glycosylation of serum transferrin detected by electrospray-ionization mass spectrometry. Both infants showed significant neurologic deterioration during the first month of life, and both died at 5 months of age. Intracranial hemorrhage in a term neonate without a potential precipitating factor represents yet another clinical feature that should raise the suspicion for a congenital disorder of glycosylation.

Transplanted human embryonic germ cell-derived neural stem cells replace neurons and oligodendrocytes in the forebrain of neonatal mice with excitotoxic brain damage.

Stem cell therapy is a hope for the treatment of some childhood neurological disorders. We examined whether human neural stem cells (hNSCs) replace lost cells in a newborn mouse model of brain damage. Excitotoxic lesions were made in neonatal mouse forebrain with the N-methyl-D-aspartate (NMDA) receptor agonist quinolinic acid (QA). QA induced apoptosis in neocortex, hippocampus, striatum, white matter, and subventricular zone. This degeneration was associated with production of cleaved caspase-3. Cells immunopositive for inducible nitric oxide synthase were present in damaged white matter and subventricular zone. Three days after injury, mice received brain parenchymal or intraventricular injections of hNSCs derived from embryonic germ (EG) cells. Human cells were prelabeled in vitro with DiD for in vivo tracking. The locations of hNSCs within the mouse brain were determined through DiD fluorescence and immunodetection of human-specific nestin and nuclear antigen 7 days after transplantation. hNSCs survived transplantation into the lesioned mouse brain, as evidenced by human cell markers and DiD fluorescence. The cells migrated away from the injection site and were found at sites of injury within the striatum, hippocampus, thalamus, and white matter tracts and at remote locations in the brain. Subsets of grafted cells expressed neuronal and glial cell markers. hNSCs restored partially the complement of striatal neurons in brain-damaged mice. We conclude that human EG cell-derived NSCs can engraft successfully into injured newborn brain, where they can survive and disseminate into the lesioned areas, differentiate into neuronal and glial cells, and replace lost neurons. (c) 2005 Wiley-Liss, Inc.

Medical students' gender is a predictor of success in the obstetrics and gynecology basic clerkship.

BACKGROUND AND PURPOSE: The objective of this study was to investigate whether a gender difference exists in student performance on any component of the grading scheme in an obstetrics and gynecology clerkship. METHODS: Evaluation of medical students' performance in the obstetrics and gynecology clerkship at our institution includes an Objective Standardized Clinical Examination with an interpersonal skills subsection, a written examination, and faculty evaluations. Performance data from 355 medical students enrolled in the clerkship between 1995 to 1998 were analyzed. RESULTS: Female students performed better than their male colleagues on the written examination (d = .56), the overall Objective Standardized Clinical Examination (d = .46) and its interpersonal skills subsection (d = .49), and the final clerkship score (d = .48). There were no differences between male and female students in faculty evaluation scores. Female students received better final scores for the clerkship. CONCLUSIONS: Female students performed about 1/2 standard deviation better on the majority of the assessment tools used in the obstetrics and gynecology clerkship.

Parity and route of delivery: does cesarean delivery reduce bladder symptoms later in life?

OBJECTIVE: This study was undertaken to investigate the impact of reproductive factors on the prevalence of urinary symptoms. STUDY DESIGN: Participants were women scheduled for hysterectomy (n=1299). Before surgery, urinary symptoms were assessed by questionnaire. Multiple logistic regression analysis was used to investigate the association between bladder symptoms and parity, route of delivery, and other characteristics. RESULTS: Stress incontinence and urinary urgency were more prevalent among parous than nulliparous women (P <.01). Controlling for parity and other characteristics, women who had a history of cesarean delivery were significantly less likely to report stress incontinence than women with a history of vaginal delivery (odds ratio 0.60; 95% CI 0.39-0.93). CONCLUSION: Women who have undergone vaginal delivery are more likely to report stress incontinence than women who have delivered by cesarean section. Although this suggests that cesarean delivery might reduce incontinence later in life, further research is needed to clarify the long-term risks, benefits, and costs of cesarean delivery.

Ovarian cancer surgery in Maryland: volume-based access to care.

PURPOSE: To characterize the patterns of primary surgical care for ovarian cancer in a statewide population according to annual surgeon and hospital case volume. METHODS: The Maryland hospital discharge database was accessed for annual surgeon and hospital ovarian cancer case volume for the time intervals: 1990-1992, 1993-1995, 1996-98, and 1999-2000. Annual surgeon case volume was categorized as low (/=10). Annual hospital case volume was categorized as low (/=20). Logistic regression models were used to evaluate for significant trends in case volume distribution over time and factors associated with access to high-volume care. RESULTS: Overall, 2417 cases were performed by 531 surgeons at 49 hospitals. The distribution according to annual surgeon case volume was low (56.3%), intermediate (9.2%), and high (34.5%). Between 1993 and 2000, there was no significant increase in the proportion of cases performed by high-volume surgeons (OR = 1.03, 95% CI = 0.81-1.33, P = 0.79). Access to high-volume surgeons was positively associated with care at high-volume hospitals and negatively associated with residence >/=50 miles from a high-volume hospital. The overall hospital volume case distribution was low (49.6%), intermediate (27.6%), and high (22.8%). There was a statistically significant decrease in access to high-volume hospitals between 1990 and 1998 (OR = 0.39, 95% CI = 0.30-0.50, P < 0.0001). CONCLUSION: A large proportion of primary ovarian cancer surgeries are performed by low-volume surgeons at low-volume hospitals. In light of positive volume-outcomes data for malignancies treated with technically complex operative procedures, increased efforts to concentrate the surgical care of women with ovarian cancer are warranted. Condensed abstract. A large proportion of primary ovarian cancer surgeries are performed by low-volume surgeons at low-volume hospitals. In light of positive volume-outcomes data for malignancies treated with technically complex operative procedures, increased efforts to concentrate the surgical care of women with ovarian cancer are warranted.