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Biomedical subjects

C D Chambers

Publications and source records attributed to C D Chambers.

At least 19 recordsLinked to original sources
PubMed2001

Selection bias in Teratology Information Service pregnancy outcome studies.

BACKGROUND: Pregnancy outcome studies conducted through Teratology Information Services (TIS) rely on volunteer subjects. If these subjects tend to have different risk profiles than the population from which they are drawn, the results of TIS studies may have limited generalizability. METHODS: We selected all subjects who enrolled in the California Teratogen Information Service (CTIS) pregnancy outcome study for prenatal exposure to carbamazepine or valproic acid between 1990 and 1997 and who received prenatal care through Kaiser Permanente of Southern California (n = 13). We compared these subjects to Kaiser patients identified through the Maternal Serum Alpha Fetoprotein Program with exposure to carbamazepine or valproic acid but who had not enrolled in the CTIS project. The controls were matched by Kaiser location and pregnancy year using a 2:1 ratio (n = 26). Medical records were reviewed and the prevalence of 14 pregnancy risk factors was compared between the two groups. RESULTS: There were no significant differences between the groups on any one risk factor; however, a notably higher proportion of women who did not enroll in the CTIS study used tobacco or had a positive family history of congenital anomalies. CONCLUSIONS: Although the sample was small, and results may not apply to other exposures in different health care environments, these data provide some evidence that women who enroll in TIS pregnancy outcome studies do not have a substantially different pregnancy risk profile than women who do not. Efforts to address possible selection bias should be incorporated in future TIS study design.

Abnormalities, Drug-Induced↗
PubMed2001

Postmarketing surveillance for human teratogenicity: a model approach.

BACKGROUND: Most congenital defects associated with prenatal exposures are notable for a pattern of major and minor malformations, rather than for a single major malformation. Thus, traditional epidemiological methods are not universally effective in identifying new teratogens. The purpose of this report is to outline a complementary approach that can be used in addition to other more established methods to provide the most comprehensive evaluation of prenatal exposures with respect to teratogenicity. METHODS: We describe a multicenter prospective cohort study design involving dysmorphological assessment of liveborn infants. This design uses the Organization of Teratology Information Services, a North American network of information providers who also collaborate for research purposes. Procedures for subject selection, methods for data collection, standard criteria for outcome classification, and the approach to analysis are detailed. RESULTS: The focused cohort study design allows for evaluation of a spectrum of adverse pregnancy outcomes ranging from spontaneous abortion to functional deficit. While sample sizes are typically inadequate to identify increased risks for single major malformations, the use of dysmorphological examinations to classify structural anomalies provides the unique advantage of screening for a pattern of malformation among exposed infants. CONCLUSIONS: As the known human teratogens are generally associated with patterns of structural defects, it is only when studies of this type are used in combination with more traditional methods that we can achieve an acceptable level of confidence regarding the risk or safety of specific exposures during pregnancy.

Abnormalities, Drug-Induced↗
PubMed1999

Weight gain in infants breastfed by mothers who take fluoxetine.

OBJECTIVE: Despite the manufacturer's recommendation that fluoxetine not be used by women while breastfeeding, many women choose to do so. There is little information available in the literature to suggest that this practice is or is not safe. The purpose of this study was to examine weight gain in infants who are breastfed by mothers who take fluoxetine, compared with weight gain in infants who are breastfed by mothers who do not take any psychotherapeutic medication. A secondary goal was to assess the frequency of reported side effects in infants who are breastfed by mothers who take fluoxetine. METHODOLOGY: A retrospective cohort study design was used. Subjects were identified from an ongoing pregnancy outcome study conducted through the California Teratogen Information Service and Clinical Research Program. A total of 64 women were interviewed who had taken fluoxetine during a pregnancy between the 1989 and 1997; 26 of these women breastfed their infants and continued to take the medication, and 38 breastfed their infants but did not take the medication. Postnatal weight gain was taken from pediatric records, and the frequency of side effects was measured by maternal response to the interview questionnaire. RESULTS: Using linear regression analysis, the infants who were breastfed by mothers taking fluoxetine demonstrated a growth curve significantly below that of infants who were breastfed by mothers who did not take the drug. The average deficit in measurements taken between 2 weeks and 6 months of age was 392 g (95% confidence interval: -5, -780). Using a repeated measures analysis of covariance for those infants with more than one postnatal weight measurement available, the difference between the two groups was similar, approximately 1.2 standard deviations (P =.005). In response to interview questions regarding side effects, no mother who breastfed her infant while taking fluoxetine reported any unusual symptoms that could be attributed to the medication. CONCLUSIONS: These data do not suggest that women who breastfeed while taking fluoxetine are likely to note unusual behavior in their infants that they consider related to use of the medication. However, although there was no excess of infants in the fluoxetine group with postnatal weight measurements >2 standard deviations below the mean, these data indicate that breastfeeding while taking fluoxetine is associated with reduced growth that may be of clinical importance in situations in which infant weight gain is already of concern.

Antidepressive Agents, Second-Generation↗
PubMed1998

Maternal fever and birth outcome: a prospective study.

Although maternal fever has been implicated as a human teratogen in several studies, no prospective study has adequately addressed the full spectrum of birth outcomes following such exposure in pregnancy. The purpose of this study was to determine whether or not maternal fever is associated with an increased risk for structural malformations, prematurity, growth retardation, or pregnancy loss. Using a prospective cohort study design, we ascertained women who had called the California Teratogen Information Service and Clinical Research Program between 1979-1996 with questions regarding fever in a current pregnancy. Of these women, 115 who reported a fever of at least 38.9 degrees C lasting for at least 24 h (high fever group) and 147 women who reported a fever of either less than 38.9 degrees C or lasting less than 24 h (low fever group) were enrolled in the cohort. An additional 298 pregnant women who reported having no fever at any time in pregnancy were enrolled in a control group. All pregnancies were followed in a similar fashion, and outcomes were compared among the three groups. The combined prevalence of all major structural malformations was increased, but not significantly so, in the offspring of women who had a high fever in the first trimester of pregnancy compared to those with a lower fever or to controls (relative risk 1.80 for high fever group compared to controls; 95% confidence interval, 0.54, 6.03; relative risk 1.21 for low fever group compared to controls; 95% confidence interval, 0.36, 4.03). However, 2/34 or 5.9% of women who had a high fever during the critical period for neural tube closure carried fetuses with anencephaly compared to none in the low fever group or controls. Specific minor defects were found more frequently in the high fever group compared to controls and were consistent with the pattern of defects previously reported in a retrospective case series. In addition, stillbirth occurred more frequently in the high fever group compared to controls (2.6% vs. 0%). These data support the conclusion that high maternal fever early in pregnancy is a human teratogen. Women who experience fevers of 38.9 degrees C or higher for extended periods of time in the first month of pregnancy should be considered at increased risk for neural tube defects and should be provided appropriate counseling.

Cohort Studies↗
PubMed1996

Birth outcomes in pregnant women taking fluoxetine.

BACKGROUND: Although fluoxetine is the most frequently prescribed antidepressant drug in the United States, its safety in pregnant women has not been established. METHODS: From 1989 through 1995, we prospectively identified 228 pregnant women taking fluoxetine. We compared the outcomes of their pregnancies with those of 254 women identified in a similar manner who were not taking fluoxetine. RESULTS: The rate of spontaneous pregnancy loss did not differ significantly between the women treated with fluoxetine and the control women (10.5 percent and 9.1 percent, respectively), nor was the rate of major structural anomalies significantly different (5.5 percent vs. 4.0 percent). Among the 97 infants exposed to fluoxetine who were evaluated for minor anomalies, the incidence of three or more minor anomalies was significantly higher than among 153 similarly examined control infants (15.5 percent vs. 6.5 percent, P=0.03). As compared with the 101 infants exposed to fluoxetine only during the first and second trimesters, the 73 infants exposed during the third trimester had higher rates of premature delivery (relative risk, 4.8; 95 percent confidence interval, 1.1 to 20.8), admission to special-care nurseries (relative risk, 2.6; 95 percent confidence interval, 1.1 to 6.9), and poor neonatal adaptation, including respiratory difficulty, cyanosis on feeding, and jitteriness (relative risk, 8.7; 95 percent confidence interval, 2.9 to 26.6). Birth weight was also lower and birth length shorter in infants exposed fluoxetine late in gestation. CONCLUSION: Women who take fluoxetine during pregnancy do not have an increased risk of spontaneous pregnancy loss or major fetal anomalies, but women who take fluoxetine in the third trimester are at increased risk for perinatal complications.

Abnormalities, Drug-Induced↗
PubMed1994

Offspring of women infected with varicella during pregnancy: a prospective study.

Despite the well-recognized association between maternal varicella infection and a specific pattern of malformation in the offspring referred to as fetal varicella syndrome, the full spectrum of this disorder as well as its frequency in the offspring of women infected with varicella during pregnancy is unknown. In order to resolve these issues, we have evaluated pregnancy outcome in 194 women who contacted us during pregnancy, soon after the onset of their infection: 132 (68%) during the 1st trimester and 171 (88%) prior to the onset of the 20th week, the most critical period relative to fetal susceptibility. Of those 171 women, there were 146 liveborn babies, 6 spontaneous abortions, 7 therapeutic abortions (one because of an anencephalic fetus), 2 stillborn infants, and nine pregnancies lost to follow-up. Of the 146 liveborn births, there were 2 with features consistent with the fetal varicella syndrome: one a child with mild cutaneous scars on her face, arms, and legs, Horner syndrome involving her left eye and a scar on her retina, leading to blindness in that eye; and the other, a child with horizontal nystagmus who is otherwise normal at 1 year of age. An additional four liveborn infants had a single major malformation which included unilateral microtia, bowel obstruction secondary to an ileal band, bilateral double ureters, and a thyroglossal duct cyst. This study suggests that prenatal varicella infection is associated with a wider spectrum of severity than has been previously appreciated and indicates that maternal varicella infection prior to the 20th week of pregnancy is associated with only a small risk for the developing fetus.

Adult↗
PubMed1980

Characteristics of high-frequency consumers of prescription psychoactive drugs.

Two cohorts of white middle-class housewives who reported themselves as high-frequency consumers of prescription sedatives, tranquilizers, and stimulants have been studied and their characteristics have been reported. One group of these women are residents of a Midwestern state, and the other in a Southern state. These women can best be described as follows: Most reported their primary physician as being a general practitioner (60%), and most reported they had consulted two or more separate physicians during the last year (78%). More than a third (36%) had seen at least three different physicians. Interestingly, while most of these women were consulting general practitioners and/or internists, almost a third were presenting them with general psychological complaints. The self-reported high-frequency users most frequently used the relaxants/minor tranquilizers (64%), followed by sedatives (41%), stimulants (31%), and major tranquilizers (7%). Almost half of all these high-frequency medicine consumers were also regular drinkers (47%), and some 13 to 17% could be considered as heavy drinkers. The majority of the relaxant/minor tranquilizer users had been taking the medications daily or several times a week for at least six months. Less than half of these users, however, felt their "condition" had gotten "better." The majority of the sedative users had also been taking the medications daily or several times a week for at least six months. Less than a third of these users felt the condition that precipitated the prescription had improved during this period of use. Of major importance, only a minority of these long-term high-frequency users of sedatives and relaxants/minor tranquilizers believe these drugs to be habit-forming or to have any potential for physical or psychological harm. Although the stimulant-users were also found to be high-frequency consumers, stimulant-users were found to have been using these drugs for a shorter period of time. There also appears to be more confusion about the potential for physical and/or psychological damage in the long-term use of stimulants among those women than among the users of sedatives and/or minor tranquilizers. It is significant to note that stimulant-users felt that they had gotten "better" more than those who had used sedatives and/or tranquilizers. These two interview studies among housewives tend to confirm several of our earlier survey findings among people who use these drugs.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed1975

A demographic evaluation of acute drug reactions in a hospital emergency room.

This study investigated a sample of persons treated for acute drug reactions (overdoses) in a hospital emergency room setting to determine the general characteristics of these drug abusers and the incidence of drugs responsible for their admission. Detailed information is provided on the race and sex composition of these drug abusing patinets and comparisons are made with the general population of the area serviced by the hospital. The sample consisted of 1,128 persons who entered Jackson Memorial Hospital, Miami, Dade County, Florida during 1972. A profile of the typical admission for emergency care of a nonfatal overdose reveals a white female, who is 18 to 24 years old and who has overdosed on a single legally manufactured and distributed substance, usually a sedative. Implications from the data for changes in health care delivery for acute drug reactions are provided.

Accidents↗
PubMed1975

Demographic characteristics of emergency room admissions of acute drug reactions.

This study investigated a sample of persons treated for acute drug reactions (overdoses) in a hospital emergency room setting to determine the general characteristics of these drug abusers and the incidence of drugs responsible for their admission. Detailed information is provided on the race and sex composition of these drug-abusing patients and comparisons are made with the general population of the area serviced by the hospital. The sample consisted of 506 persons who entered Jackson Memorial Hospital, Miami, Dade County, Florida during January-June 1972. A profile of the typical admission for emergency care of a nonfatal overdose reveals a White female who is 18-24 hears old and who has overdosed on a single legally manufactured and distributed substance, usually a sedative.

Adolescent↗