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Methodology citations and the quality of randomized controlled trials in obstetrics and gynecology.

OBJECTIVES: Randomized controlled trials offer the best chance for valid treatment comparisons, yet most trials are of poor quality. This may reflect a lack of awareness of the requirements for conducting and reporting this type of research. If so, then citation of methodology references might indicate knowledge of how to conduct these studies and vice versa. Our study tests the hypothesis that the methodologic quality of published trials is related to citation of methodology references. STUDY DESIGN: We performed a hand search of the American Journal of Obstetrics and Gynecology, the British Journal of Obstetrics and Gynaecology, the Journal of Obstetrics and Gynaecology, and Obstetrics and Gynecology to identify all randomized controlled trials published in 1990 and 1991 (N = 206). We reviewed the reference lists of all reports of randomized controlled trials and evaluated the adequacy of randomization methods by accepted criteria. RESULTS: Most reports (81.6%) cited no methodology text or article. Although lack of any methodology reference was not significantly related to failure to report an adequate random method of sequence generation, this was highly related (p < 0.001) to failure to report adequate allocation concealment. Scanning the reference list of reports took a mean of 16 seconds and identified most poorly done trials. CONCLUSIONS: Investigators who conduct randomized controlled trials should be thoroughly familiar with this type of research or should get expert help. Poorly done trials are wasteful and often misleading.

Bibliographies as Topic↗

Acute pancreatitis after gynecologic and obstetric surgery.

OBJECTIVE: Our goal was to evaluate the prevalence and comorbidity of acute postoperative pancreatitis after gynecologic and obstetric surgery. STUDY DESIGN: We reviewed the Mayo Medical Center surgical database (January 1953-January 1997) to identify all confirmed cases of acute pancreatitis occurring within the standard 6-week postoperative convalescence after obstetric and gynecologic surgical procedures. Pancreatitis as a result of concurrent pancreatic or biliary surgery was excluded. Pertinent clinical data were reviewed. RESULTS: Eleven cases of postoperative pancreatitis were identified, with an overall incidence of 1 in 17,000 surgical procedures. Postoperative pancreatitis was more common after obstetric surgery. Identifiable risk factors were noted in 45% of cases, with occult cholelithiasis the predominant factor. Presenting signs and symptoms were primarily epigastric pain, oliguria, and ileus. Significant morbidity or mortality was noted in 27% of the cases. CONCLUSIONS: Acute postoperative pancreatitis is a rare complication after gynecologic and obstetric surgery. Signs and symptoms of pancreatitis are nonspecific in the postoperative setting. Prompt diagnosis and supportive therapy are essential to minimize morbidity and mortality.

Acute Disease↗

Improving emergency obstetric care at a state referral hospital, Kebbi State, Nigeria. The Sokoto PMM Team.

PRELIMINARY STUDIES: An inventory at Birnin Kebbi Specialist Hospital in Nigeria revealed poor capacity in emergency obstetric care and excessive delays. Focus group discussions among community members emphasized poor services as a reason for not seeking care. INTERVENTIONS: During 1992-1993, several specialist obstetricians visited the hospital. They provided training to general physicians and midwives and care to patients, and stayed approximately five weeks each. An obstetric first-aid box with essential drugs and supplies was introduced. Midwives were trained in recognition and management of obstetric complications. Subsequent community interventions focused on improving access and reducing delay in seeking care. RESULTS: The number of cesarean sections performed increased from 101 in 1990 to 131 in 1995. The case fatality rate among women with complications dropped from 22% to 5% over the same period. The number of women with complications seeking treatment in the hospital increased from 200 in 1990 to 227 in 1994, and then declined to 152 in 1995. COSTS: The cost of improvements at the hospital was approximately US$12,300, with 10% contributed from government sources. CONCLUSION: Improving hospital obstetric services is feasible and affordable. Better services, however, may not be sufficient to reverse declining hospital utilization related to worsening economic conditions.

Emergencies↗

Changing obstetric practices associated with decreasing incidence of meconium aspiration syndrome.

OBJECTIVE: To describe changes in neonatal and obstetric practices that may have contributed to the decreasing incidence of meconium aspiration syndrome in our population during this time. METHODS: We compared neonatal and obstetric characteristics of 61 infants diagnosed with meconium aspiration syndrome with 1365 infants born through moderate or thick meconium-stained amniotic fluid at more than 37 weeks' completed gestation. Data were prospectively collected, and all respiratory diagnoses were concurrently made. Three distinct birth year groups were analyzed based on changing obstetric practice paradigms. RESULTS: Meconium aspiration syndrome decreased nearly four-fold from 1990-1992 to 1997-1998 (5.8% to 1.5% of meconium-stained infants more than 37 weeks; P <.003). The only change in neonatal characteristics was a 33% decrease in births more than 41 weeks with a reciprocal 33% increase in births 38-39 weeks during 1997-1998. Significant changes in obstetric practice included more frequent diagnosis of nonreassuring fetal heart rate patterns, greater use of amnioinfusion, and increased cesarean delivery rate in 1997-1998. By logistic regression analysis, the only consistent risk factor for meconium aspiration syndrome across all three epochs was the presence of tracheal meconium. CONCLUSION: Reduction in post-term delivery was the most important factor in reducing meconium aspiration syndrome.

Cesarean Section↗

Attitudes and educational practices of obstetric providers regarding infant hepatitis B vaccination.

OBJECTIVE: To survey the current knowledge, attitudes, and practices of obstetric providers regarding the education of pregnant women about infant hepatitis B vaccination. METHODS: A questionnaire was mailed to 264 physicians providing obstetric services in San Francisco. Of these, 113 were confirmed to be providing prenatal care. RESULTS: Seventy-six obstetric providers returned completed questionnaires. Among eligible respondents, 79% believed that hepatitis B vaccine should be administered to all infants at birth, and 92% believed that it is feasible to educate all expectant mothers about infant hepatitis B vaccination. However, only 53% of respondents provided such education to all their pregnant patients. Only 23% provided education about other routine childhood immunizations. CONCLUSIONS: Obstetric providers in San Francisco are willing to educate pregnant patients about hepatitis B vaccination but are not always doing so. Providing education in a consistent manner may improve infant hepatitis B vaccination rates and may increase coverage with other childhood vaccines.

Female↗

Obstetrics & Gynecology in 1996: marking the progress toward evidence-based medicine by classifying studies based on methodology.

OBJECTIVE: To test the hypothesis that researchers in obstetrics and gynecology favor an observational type of study design. DATA SOURCES: The 12 regular issues of Obstetrics & Gynecology published during 1996 were analyzed. METHOD OF STUDY SELECTION: All articles in the journal Obstetrics & Gynecology were reviewed for the year 1996, except that separate issues covering case reports, case condensations, and reviews were excluded. TABULATION, INTEGRATION, AND RESULTS: Studies were classified as observational or experimental. Observational studies were subclassified as either descriptive, case-control, or cohort. Experimental studies were subclassified as either randomized controlled trial (RCT) or uncontrolled trial. Other study designs were noted. Of the 316 studies published during 1996, 241 (76%) were observational, 43 (14%) experimental, and 32 (10%) other. There were 162 (51%) descriptive studies, 44 (14%) case-control studies, 35 (11%) cohort studies, 35 (11%) RCTs, and eight (3%) uncontrolled trials. CONCLUSION: Researchers who publish in Obstetrics & Gynecology favor an observational study design. With evidence-based medicine growing in popularity as a new standard or paradigm, the reliance on observational studies may have implications.

Evidence-Based Medicine↗

The use and failure rates of protective equipment to prevent blood and bodily fluid contamination in the obstetric health care worker.

OBJECTIVE: To determine the frequency of use and the failure rate of protective equipment by obstetric staff during common obstetric procedures. METHODS: A prospective observational study was conducted of multiple obstetric procedures. The presence, area of specialty, level of training, and gender of each team member were recorded along with the use of protective equipment (cap, mask, eyewear, gown, gloves, and shoe protection). These observations were recorded by two trained observers. Blood and bodily fluid contamination of the protective equipment was quantified and recorded for each person. A forensic medicine reagent (Luminol; Cluefinders Inc., Tampa, FL) was used to detect trace amounts of blood on the inner surface of a selected subset of gowns that had gross external contamination but no obvious penetration. RESULTS: Two hundred forty-one obstetric procedures were observed involving 1022 medical personnel. The use of at least one piece of protective equipment was noted 88% of the time. Compliance with universal precautions by attending and resident physicians in all deliveries (vaginal, forceps, vacuum, cesarean) was observed in 65 (25.2%) medical personnel. The use of protective equipment varied by the type of procedure, area of specialty, and level of training of the team member. In the gowns examined with the forensic medicine reagent, 44% of the cases demonstrated laboratory evidence of penetration. The frequency of gown failure varied with the type of surgical gown used. CONCLUSION: Despite the mandate in the medical community for universal precautions, the rate of compliance remains low. However, even among the compliant medical staff, protective equipment labeled as impenetrable has a high failure rate.

Blood↗

Applications for residency programs in obstetrics and gynecology, 1996-1997.

OBJECTIVE: The purpose of this work is to report on application patterns for residency positions in obstetrics and gynecology. METHODS: The Electronic Residency Application Service (ERAS) of the Association of American Medical Colleges (AAMC) records each application for a position in a participating residency program. In the 1996-97 application cycle, all but 16 obstetrics and gynecology residency programs participated. Electronic records were analyzed to obtain a statistical picture of the residency application process. RESULTS: Applications for residency positions in obstetrics and gynecology were processed for 1607 graduates of US medical schools, including 110 graduates of osteopathic medical schools. Canadian applicants were six, and other foreign applicants numbered 524. More than two-thirds of US applicants were women, and nine of ten were citizens or permanent residents. Most applicants sent official United States Medical Licensure Examination (USMLE) transcripts to all programs to which they applied. Ninety-five percent of applicants supplied an e-mail address. CONCLUSION: The introduction of ERAS has been successful for obstetrics and gynecology and has provided new information about patterns of applications. The ease of application using the electronic system did not lead to a substantial increase in numbers of applications. Statistics regarding the number of applicants, ratio of women to men, and participation of foreign medical graduates will be of interest to manpower planners.

Electronic Data Processing↗

A blueprint for academic obstetrics and gynecology.

A consensus conference sponsored by the Council of University Chairs of Obstetrics and Gynecology in February 1997 formulated the organization's response to the many external issues affecting academic medicine and obstetrics and gynecology including 1) a new practice model based on "wellness," 2) reimbursement changes that have jeopardized traditional revenue sources, 3) an emphasis on quality assurance based on outcomes research and evidence-based medicine, 4) the concept of lifelong learning dictated by an expanding knowledge base and new technology, 5) insufficient resources for basic and clinical investigation in obstetrics and gynecology, 6) workforce statistics indicating stabilization in the number of subspecialists, 7) the increasing diversity of the United States population. Recommendations were developed that are intended to foster change and contribute to the design of academic programs. These include appropriate training for residents as providers of primary care, with an emphasis on continuity clinics, an interdisciplinary curriculum in women's health for medical students; promotion of gender, racial, and ethnic diversity at all levels of medical education and academic leadership; creation of clinical trials research units; and the development of expanded opportunities for research in obstetrics and gynecology supported by the National Institutes of Health.

Consensus Statements as Topic↗

Practice management in obstetrics and gynecology residency curriculum.

OBJECTIVE: To establish the current level of instruction in practice management in obstetrics and gynecology residency programs; review recommendations of medical school practice management executives and current and former residents on design of practice management instruction programs; and develop recommendations for future management instruction by residency programs in obstetrics and gynecology. METHODS: A questionnaire was sent to 101 practice plan executives of obstetrics and gynecology departments at medical schools in the United States and Canada. A modified version was sent to 44 current obstetrics and gynecology residents and 72 former residents from the University of Tennessee, Memphis. RESULTS: The response rates were 71% (practice executives), 93% (current residents), and 81% (former residents). There were no formal management programs at 87% of responding institutions, although most respondents (62%) thought there should be mandatory participation in management programs, probably given by organizations outside the university. Potential subjects that received high ratings were current procedural terminology and diagnosis coding, managed care, billing procedures, contractual agreements between medical doctors, patient record management, and practice economics. CONCLUSION: Residency programs should establish formal practice management instruction programs and make participation mandatory. Funding should come from the medical school and university. Instructional help should come from extradepartmental organizations and individuals.

Canada↗

Adverse outcome of pregnancy and the quality of obstetric care.

The case-control method was used to study the relation between four possibly preventable adverse outcomes of pregnancy and suboptimal antepartum and intrapartum obstetric care defined by clinical consensus. Fetuses whose deaths were ascribed to asphyxia or trauma, and babies born at term who had seizures within 48 h of delivery, were significantly more likely than controls to have received suboptimal care during pregnancy. Babies with seizures, as well as those with terminal apnoea, were also substantially more likely than controls to have been born after a failure to react appropriately to signs of severe fetal distress during labour. Most of the babies who received suboptimal obstetric care, however, did not have any of these adverse outcomes. In addition, most babies with these adverse outcomes had apparently received satisfactory obstetric care. No relation was detected between cerebral palsy and suboptimal obstetric care.

Adolescent↗

Obstetric factors, urbanization and psychosis.

BACKGROUND: Epidemiologic evidence as early as the 1930s has suggested urbanization is linked to schizophrenia, either by place of admission, place of upbringing, or, more recently, place of birth. In the past decade, obstetric complications have been implicated in the etiology of schizophrenia. METHODS: With appropriate protections for anonymity, the files of the Danish Medical Birth Register were linked with the files of the Danish Psychiatric Case Register. The linkage produced 132 cases of schizophrenia and 69 cases of affective psychosis, who were born in 1973 or later, who entered a Danish psychiatric hospital before 1994. Controls were drawn from a 10% sample of the Medical Birth Register. Analysis was by logistic regression. RESULTS: The risk of hospitalization for schizophrenia was 4.20 times higher (95% CI=2.4-7.4) for those born in Copenhagen versus those born in rural areas of Denmark, and a linear relationship was demonstrated between urbanization of birthplace and risk. There was no difference in risk of hospitalization for affective psychosis for those born in Copenhagen versus rural areas. Obstetric complications had a moderate sized relationship to schizophrenia, but the relationship of urban birth to schizophrenia was unaffected by adjustment for obstetric complications. CONCLUSION: Urban birth is a strong risk factor for schizophrenia, not mediated by obstetric complications, which deserves further exploration.

Adult↗

The tremendous cost of seeking hospital obstetric care in Bangladesh.

In Bangladesh, maternal mortality is estimated to be 320 per 100,000 live births, among the highest in the world, and most deliveries in rural areas occur at home. Women with obstetric complications fear to seek hospital care for various reasons; one of which is the tremendous cost. This paper shows how cost impedes rural, poor women's access to emergency obstetric care. The data are from a larger ethnographic study of childbirth practices in 2000--01 in Apurbabari village, the adjacent sub-district health complex and more distant tertiary hospitals at district level. Families had to spend what for them added up to a fortune for a caesarean section and other surgery, medicines, laboratory investigations, blood transfusion, food, travel and other expenses. Corruption in the form of demands for under-the-table payments to obtain these aspects of essential care is rife. Adequate resources should be allocated to the different health facilities, including for emergency obstetric treatment. Thana health complexes (sub-district hospitals) should be upgraded to provide comprehensive obstetric care. The system for prescribing drugs should be reformed and the causes of corruption investigated and addressed. Hospital care should not be allowed to further impoverish the poor. Addressing these issues will help to encourage rural, poor women to seek skilled delivery and post-partum care, particularly in emergency situations.

Bangladesh↗

Obstetric fistula in developing countries: a review article.

Obstetric fistula, one of the most devastating consequences of prolonged obstructed labour, is a historical issue in the developed world. However, it is still prevalent in resource poor countries like Ethiopia. The objective of this review article is to describe the epidemiology of obstetric fistula and its management, with specific emphasis on the experience of the Addis Ababa Fistula Hospital. Published and unpublished literature on obstetric fistula was reviewed, and expert opinions are used in augmentation. Most obstetric fistulas result from neglected obstructed labour, often affecting very poor, young, illiterate, rural women and girls. The women are often in labour for days, helped by unskilled family members. They deliver a stillborn child, become incontinent of urine and/or feces, and become outcast and divorced as a result. Surgical repair mends the lives of thousands of women, although not all injured cases have access to treatment. Although prevention should be the ultimate goal, the need for curative care services for the sufferers is shown to be significant.

Adolescent↗

Obstetric complications in schizophrenia and the validity of maternal recall.

The significance of the excess of obstetric complications which appears to characterize the histories of schizophrenic patients is critically dependent on the validity of the source of obstetric information, especially when this is obtained by maternal recall. Twenty-one biological mothers of 17 schizophrenic and four other patients were interviewed for their recollections of individual events characterizing the pregnancy and delivery relating to each patient. These were then compared with those events documented in maternity hospital records. Only in two of the 21 instances (9.5%) were inconsistencies of detail apparent which would have affected the designation of the relevant patient as having, or as not having, experienced major obstetric complication(s). It is concluded that maternal recall can be a surprisingly accurate source of obstetric information in relation to research on schizophrenia.

Adult↗

Association between psychotic disorder and urban place of birth is not mediated by obstetric complications or childhood socio-economic position: a cohort study.

BACKGROUND: Although urban place of birth has been identified as a risk factor for schizophrenia, the extent to which this association is mediated by socially patterned risk factors such as obstetric complications and childhood socio-economic position is unclear. The diagnostic specificity of the association within the clinical psychotic syndromes is also unclear. METHOD: A population cohort of 696025 males and females, born in Sweden between 1973 and 1980 and with linked birth and socio-economic data was followed up from age 16 for up to 9.8 years. Hospitalized cases of schizophrenia and other non-affective psychosis were identified from the Swedish Inpatient Discharge Register. We examined associations of these disorders with a three-level measure of urbanicity of birthplace before and after controlling for measures of foetal nutrition, obstetric complications and level of maternal education. RESULTS: Urban compared to rural birthplace was associated both with increased risk of adult onset schizophrenia (hazard ratio 1.34, CI 0.91-1.96) and other non-affective psychoses (hazard ratio 1.63, CI 1.18-2.26). None of these associations was greatly affected by adjustment for obstetric complications or maternal educational level. In the group of other non-affective psychoses urban-rural differences in disease risk were strongest among those born in the winter months. CONCLUSION: Urbanization of birthplace is associated with increased risk of non-affective psychosis but this is not confined to narrowly defined cases. The magnitude of the association in Sweden is lower than that reported in other studies. Causal factors underlying this association appear to operate independently of risks associated with obstetric complications and parental educational status.

Adolescent↗

Electrodermal activity and obstetric complications in schizophrenia.

The pregnancy and birth records of 79 schizophrenic patients, from whom adult electrodermal data were available, were systematically evaluated for obstetric complications using 34 criteria of nonoptimality in pregnancy, delivery, and postpartum periods. Patients with many obstetric complications had lower levels of electrodermal activity. For frequency of skin conductance responses and spontaneous fluctuations in skin conductance, the association was more evident for women than for men. However, the ratio of stimulus-elicited to spontaneous skin conductance responses showed a reliable association with obstetric complications without any gender differences. The relationship between obstetric complications and electrodermal activity was interpreted in terms of neurodevelopmental insults resulting in structural brain abnormalities interfering with orienting and electrodermal activity.

Adolescent↗

Non-obstetric surgery during gestation: risk factors for lower birthweight.

OBJECTIVE: To assess the risk for preterm birth and low birthweight for women undergoing non-obstetric surgery during gestation. DESIGN: Two perinatal tertiary care centres. POPULATION: Women undergoing non-obstetric surgery during gestation between January 1989 and June 1999. MATERIALS AND METHODS: A chart review was carried out. Cervical cerclages, procedures carried out under local anaesthesia or intravenous sedation, or carried out in combination with Caesarean delivery were excluded. MAIN OUTCOME MEASURES: Preterm birth (<37 weeks), birthweight. RESULTS: A total of 116 of 69 800 women (0.2%) underwent non-obstetric surgery, with 96 women delivering under our care. Procedures were more commonly carried out in the second trimester (53%), versus the first (23%) or third trimester (24%). Surgery in the second trimester resulted in the lowest rate of preterm birth (11%). The overall preterm birth rate was 21% (20/96), with 13 out of 20 (65%) occurring between 35 and 37 weeks. The mean interval from surgery to delivery was 18.7 weeks. Rates of preterm birth were similar for either intra- versus extra-abdominal procedures, or general versus regional anaesthetic. Use of a general anaesthetic was associated with a significant decrease in birthweight (3053 vs 3515 g, P = 0.01) despite similar gestational ages at delivery (37.6 vs 38.6 weeks, P = 0.08). Multiple linear regression controlled for gestational age showed that general anaesthesia, longer surgery duration, and intra-abdominal procedures were all significant independent risk factors for lower birthweight. CONCLUSION: While non-obstetric surgery appears to be relatively safe during gestation, general anaesthesia, longer surgery time, and intra-abdominal procedures are associated with lower birthweights.

Anesthesia, General↗