Sumatriptan: what do we know about fetal risks?
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Denmark↗
Biomedical subjects
J Olsen
Publications and source records attributed to J Olsen.
Voice recognition software versus a traditional transcription service for physician charting in the ED.
This study was conducted to compare real-time voice recognition software to a traditional transcription service. Two emergency department (ED) physicians dictated 47 charts using a voice dictation software program and a traditional transcription service. Accuracy, word per minute dictation time and turnaround time were calculated from the data. The transcription service used in our study was more accurate than the voice recognition program with an accuracy of 99.7 percent versus 98.5 percent for the voice recognition program. The average number of corrections per chart was 2.5 for the voice recognition program and 1.2 for the traditional transcription service. Turnaround time was much better using the computer voice recognition program with an average turnaround time of 3.65 minutes versus a turnaround time of 39.6 minutes for the traditionally transcribed charts. The charts dictated using the voice recognition program were considerably less costly than the manually transcribed charts. In summary, computer voice recognition is nearly as accurate as traditional transcription, it has a much shorter turnaround time and is less expensive than traditional transcription. We recommend its use as a tool for physician charting in the ED.
Confidence Intervals↗
Use of cephalosporins during pregnancy and in the presence of congenital abnormalities: a population-based, case-control study.
OBJECTIVE: Our purpose was to study the human teratogenic potential of cephalosporin treatment during pregnancy. STUDY DESIGN: Pair analysis of cases with congenital abnormalities and matched controls without congenital abnormalities was performed. The population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996, was used. The participants included 22,865 pregnant women who had fetuses or newborn infants with congenital abnormalities, 38,151 pregnant women who had infants without any defects (population control group), and 812 mothers who were delivered of babies affected with Down syndrome (patient controls). RESULTS: In the case group, 308 (1.35%) pregnant women were treated with cephalosporin. In the population and patient control groups, 440 (1.15%) and 16 (1.97%) pregnant women had similar treatments. The somewhat higher use of cephalosporins, mainly oral cephalexin, in the case and patient control groups was explained by recall bias. The comparison of the occurrence of medically documented cephalosporin treatments during the second to third months of gestation (ie, the critical period for major congenital abnormalities) in different congenital abnormality groups with the referent data of the total population control group and the patient control group did not indicate a detectable human teratogenic potential of the studied drug. CONCLUSION: Treatment with the studied cephalosporins during pregnancy does not seem to present a detectable teratogenic risk to the fetus. However, further studies are needed to clarify the teratogenic and fetal toxic effects of different cephalosporins separately.
Abnormalities, Drug-Induced↗
A population-based case-control teratologic study of ampicillin treatment during pregnancy.
OBJECTIVE: This was a study of the association between ampicillin treatment during pregnancy and prevalence of different congenital abnormalities. STUDY DESIGN: The paired analysis of case patients with congenital abnormalities and matched population control subjects was performed in the population-based Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. Of 38,151 pregnant women who had babies without any defects (population control group), 2632 (6.9%) had been treated with ampicillin. Of 22,865 pregnant women who had offspring with congenital abnormalities (case patients), 1643 (7.2%) had been treated with ampicillin (crude odds ratio, 1.0; 95% confidence interval, 0.7-1.2). Of 812 mothers who were delivered of babies affected by Down syndrome (patient control subjects), 61 (7.5%) had ampicillin treatment, and these were also compared with the case group. RESULTS: The prevalence of ampicillin use during the second and third months of gestation, which is the critical period for most major congenital abnormalities, showed significant difference in the case-control pair analysis only for cleft palate (odds ratio, 4.2; 95% confidence interval, 1.4-16.3). This possible association was confirmed by the analysis of medically recorded ampicillin use and by the comparison of ampicillin treatment between the group with cleft palate and the patient control subjects. CONCLUSION: Treatment with ampicillin during pregnancy may pose little if any teratogenic risk in human beings. Only a higher prevalence of cleft palate was found after the ampicillin treatment during the second and third months of gestation. The lack of an experimental animal model and the lack of consistency with previous epidemiologic studies may indicate that even this apparent risk is not real and instead is a chance association; further investigation is therefore necessary.
Abnormalities, Drug-Induced↗
Induced abortion and prematurity in a subsequent pregnancy: a study from Shanghai.
To evaluate the impact of a first trimester induced abortion on the risks of low birth weight (LBW) and preterm birth in a subsequent pregnancy we conducted a pregnancy-based cohort study in Shanghai, China with recruitment from 15 general hospitals (or maternity and infant health institutes) from November 1993 to March 1998. Pregnant women with a history of induced abortion entered the abortion cohort and a reference cohort was established among women without such a history. All the subjects were enrolled before 64 days of gestation and interviewed five times until 42 days after delivery. Only singleton live births were analysed in this study. A total of 2953 pregnant women were enrolled and 2707 gave birth to live singletons. The overall incidence of LBW was 1.7%, 2.0% in the abortion cohort and 1.4% in the reference cohort. After controlling the potential confounders using logistic regression, the adjusted odds ratios were 1.7 (95% CI: 0.8-3.3) for LBW, 2.0 (95% CI: 0.9-4.7) for term LBW and 1.0 (95% CI: 0.6-1.5) for preterm birth, following an induced abortion pregnancy. Birth weight in the abortion cohort was 38.5 g higher than that of the reference cohort after adjustment for calendar year at recruitment, couples' occupation, education, age, infant sex, maternal body mass index at recruitment, contraceptive use and gestation age. Previous first trimester induced abortion did not significantly increase the risk of LBW or preterm birth. The study was performed in a low-risk population and results may not be applicable to other settings.
Journal Article↗
Moderate alcohol consumption and waiting time to pregnancy.
BACKGROUND: Recent research indicates that even a moderate consumption of alcohol in women trying to become pregnant is associated with longer waiting time to pregnancy. The findings, though, are based upon few observations. METHODS: Self-reported data on alcohol intake and waiting time to pregnancy (0-2, 3-5, 6-12 and >12 months) was used for 39 612 pregnant women, recruited to the Danish National Birth Cohort within the first 24 weeks of pregnancy from 1997 to 2000. Main outcome measures were odds ratios (OR) for a prolonged waiting time to pregnancy according to alcohol intake. RESULTS: In nulliparous women neither moderate nor high alcohol intake was related with longer waiting time to pregnancy compared with a low intake. In parous women, a modest association was seen only among those with an intake of >14 drinks per week (subfecundity OR 1.3; 95% confidence interval 1.0-1.7). Women who reported no alcohol intake had a slightly longer waiting time (subfecundity OR 1.2; 95% confidence interval 1.1-1.3) than women with a moderate intake of alcohol. CONCLUSIONS: Our findings do not corroborate recent results suggesting a marked reduction in fecundity associated with a moderate intake of alcohol.
Adult↗
When symptoms persist: clozapine augmentation strategies.
Recent data and clinical experience confirm that, in spite of superior efficacy for treatment-refractory schizophrenia, a substantial proportion of patients receiving clozapine will continue to experience disabling symptoms. Optimizing clozapine monotherapy is the first step in the management of "clozapine nonresponders." Described here is a synthesis of the available literature on the range and efficacy of clozapine augmentation strategies that may be used when monotherapy fails. Treatment options include adjunctive antipsychotic medications, mood stabilizers, selective serotonin reuptake inhibitors, glycinergic agents, and electroconvulsive therapy. The evidence favoring one augmentation strategy over another is lacking; overall, adjunctive therapy is associated with only modest clinical improvement. Moreover, case series and open-labeled clinical trials dominate the extant literature, and there is a dearth of double-blind trials comparing these augmentation agents. Current systematic efforts to enhance the treatment of these patients with adjunctive therapies are worthy of being studied in carefully conducted clinical trials.
Antipsychotic Agents↗
The association of indicators of fetal growth with visual acuity and hearing among conscripts.
Impaired fetal growth is associated with increased susceptibility to several chronic diseases. We studied the association between birth weight, indicators of disproportional fetal growth, and impaired visual acuity and hearing in 4,300 conscripts from a well-defined region in Denmark from August 1, 1993, to July 31, 1994. From the standard health examination for conscripts, we obtained data on sight based on the Snellen's chart and data on hearing acuity based on audiometry. By means of record linkage, we obtained data on outcomes for the conscripts at birth from the Medical Birth Registry. From this registry, we have data on birth weight, gestational age, and birth length that were recorded from existing computerized registers based on the records of midwives. A birth weight of less than 3,000 gm and a body mass index at birth of less than 3.4 were associated with reduced visual acuity and impaired hearing. The results could be due to fetal brain programming or due to confounding, by early birth trauma or other factors.
Adult↗
Recall bias in a case-control surveillance system on the use of medicine during pregnancy.
It is important to study possible teratogenic effects of drugs used during pregnancy. Many studies of this type rely upon case-control designs in which drug intake is recalled by the mothers after having given birth. Recall bias in this situation may lead to spurious associations. We looked for indicators of recall bias by comparing self-reported drug intake with medically notified intake for specific diseases in the Hungarian Case-Control Surveillance System of Congenital Abnormalities, which includes 22,865 cases with congenital abnormalities and 39,151 controls. Recall error was present, especially for drugs used for a short time period. Furthermore, the timing of drug intake was reported slightly closer to the time of interview for cases compared than for controls. Severe or visible congenital abnormalities did not appear to be more conducive to recall bias than other abnormalities under study. A case-control surveillance system of this type may frequently cause spurious associations, with biased odds ratios up to a factor of 1.9.
Abnormalities, Drug-Induced↗
Do pregnant women report use of dispensed medications?
Surveillance of drug safety in pregnancy often draws on administrative prescription registries. Noncompliance in the use of prescribed medication may be frequent among pregnant women owing to their fear of fetotoxic side effects. To estimate compliance in the use of prescription drugs dispensed during pregnancy, we compared prescription data from the North Jutland Prescription Database with information on drug use provided by pregnant women to the Danish National Birth Cohort (DNBC), which is a health interview survey. We used the North Jutland Prescription Database to identify all prescription drugs dispensed during pregnancy for the 2,041 women who were enrolled in the DNBC in the County of North Jutland, Denmark. Compliance was defined as the probability of reporting drug use in DNBC after purchasing a dispensed prescription drug. The overall compliance to drugs purchased within 120 days before the interview was 43% (95% confidence interval = 40-46). Drugs used for treating chronic diseases, for example, beta-blockers, insulin, thyroid hormones, and diuretic and antiepileptic drugs, were always reported to be used, but compliance was low for drugs used for local or short-term treatment such as antihistamines, antibiotics, antacids, nonsteroid anti-inflammatory drugs, and gynecologic drugs. Thus, for the latter drug groups the prescription database may provide an incomplete identification of exposure. Neither data source is unbiased regarding actual drug intake. Nevertheless, our results indicate that for some drug groups risk assessment studies based on prescription data may produce false negative results as a result of noncompliance.
Cohort Studies↗
Higher risk of pre-eclampsia after change of partner. An effect of longer interpregnancy intervals?
Epidemiologic studies have shown that pre-eclampsia is mainly a disease of first pregnancy, possibly associated with primipaternity. The interpregnancy interval, which is strongly associated with change of partner, has received little attention. In this study, based on Danish hospital records, we evaluated whether the interpregnancy interval may confound or modify the paternal effect on pre-eclampsia. We studied the outcome of the second birth in a cohort of Danish women with pre-eclampsia in the previous birth (8,401 women) and in all women with pre-eclampsia in second (but not first) birth together with a sample of women with two births (26,596 women). A long interpregnancy interval was associated with a higher risk of pre-eclampsia in women with no previous pre-eclampsia when the father was the same. We estimated the risk of pre-eclampsia in second birth according to paternal change in different models. Although partner change was associated with an increased risk of pre-eclampsia in women with no history of pre-eclampsia, this effect disappeared after adjustment for the interpregnancy interval. We saw, however, different results when we stratified on the length of the interval. Our results indicate that the interval between births should be taken into consideration when studying the effect of changing partner on pre-eclampsia.
Adult↗
Sex ratio and twinning in women with hyperemesis or pre-eclampsia.
We examined twinning and fetal gender in births of women with a hospital diagnosis of pre-eclampsia or hyperemesis. We also investigated sex ratio in infants whose mothers had had hyperemesis or pre-eclampsia in a different pregnancy. From all the hospitalized cases in Denmark between 1980 and 1996 we extracted 6,227 births with hyperemesis and 24,764 with pre-eclampsia. Twins were more frequent in pregnancies with either condition. The male to female sex ratio was 1.04 (95%CI = 1.02-1.05) in the reference population, 0.87 (95% CI = 0.82-0.91) in births with hyperemesis, and 1.10 (95% CI = 1.07-1.12) in births with pre-eclampsia. Women with pre-eclampsia had slightly more males also in non-affected pregnancies.
Denmark↗
A population-based prescription study of asthma drugs during pregnancy: changing the intensity of asthma therapy and perinatal outcomes.
BACKGROUND: Among the goals of gestational asthma, therapy is optimisation of pulmonary function. According to the US Food and Drug Administration, no asthma drugs can be considered 'safe' during pregnancy. Fear of adverse fetal effects may thus lead to restrictive use of asthma drugs during pregnancy, and no population-based studies concerning gestational asthma therapy exist. OBJECTIVES: To examine whether asthma drugs or changing intensity of asthma therapy during pregnancy was associated with deviations from expected values of gestational age, birth weight, length at birth, or malformations. METHODS: The Birth Registry was used to identify all 15,756 primiparous women who gave birth in the County of North Jutland between 1991 and 1996. According to the North Jutland Prescription Database, 303 of these women received prescriptions for asthma drugs during pregnancy. Women who did not purchase any prescription drugs during pregnancy constituted the reference group. CONCLUSION: Women who received prescriptions for asthma drugs during pregnancy gave birth to infants with birth weight and length at birth within the expected limits. Reducing intensity of asthma treatment during pregnancy was associated with lower birth weight and length at birth. This may indicate that pregnant women chose to discontinue therapy although their disease severity justifies continuation of treatment. However, analyses did not take into account important clinical variables, and results could also be due to confounding factors or chance.
Adult↗
The Danish National Birth Cohort--its background, structure and aim.
BACKGROUND: It is well known that the time from conception to early childhood has importance for health conditions that reach into later stages of life. Recent research supports this view, and diseases such as cardiovascular morbidity, cancer, mental illnesses, asthma, and allergy may all have component causes that act early in life. Exposures in this period, which influence fetal growth, cell divisions, and organ functioning, may have long-lasting impact on health and disease susceptibility. METHODS: To investigate these issues the Danish National Birth Cohort (Better health for mother and child) was established. A large cohort of pregnant women with long-term follow-up of the offspring was the obvious choice because many of the exposures of interest cannot be reconstructed with sufficient validity back in time. The study needs to be large, and it is aimed to recruit 100,000 women early in pregnancy, and to continue follow-up for decades. The Nordic countries are better suited for this kind of research than most other countries because of their population-based registers on diseases, demography and social conditions, linkable at the individual level by means of the unique ID-number given to all citizens. Exposure information is mainly collected by computer-assisted telephone interviews with the women twice during pregnancy and when their children are six and 18 months old. Participants are also asked to fill in a self-administered food frequency questionnaire in mid-pregnancy. Furthermore, a biological bank has been set up with blood taken from the mother twice during pregnancy and blood from the umbilical cord taken shortly after birth. Data collection started in 1996 and the project covered all regions in Denmark in 1999. By August 2000. a total of 60,000 pregnant women had been recruited to the study. It is expected that a large number of gene-environmental hypotheses need to be based on case-control analyses within a cohort like this.
Cohort Studies↗
Maternal prenatal lifestyle factors and infectious disease in early childhood: a follow-up study of hospitalization within a Danish birth cohort.
OBJECTIVES: To examine whether maternal prenatal lifestyle factors were associated with the risk of hospitalization with infectious disease during early childhood and whether a possible association was modified by fetal growth reduction. METHODS: The study was based on a birth cohort of 10 400 newborns whose mothers attended the midwife centers in Odense and Aalborg, Denmark, from April 1984 to April 1987 at approximately the 36th week of gestation. Information on hospitalization with infectious disease was extracted from the National Hospital Discharge Registry, and newborns were followed up to the end of 1996. RESULTS: Among 6022 children who were hospitalized at least once, 31.4% (n = 1892) were hospitalized with infectious diseases. The cumulative incidence rate of hospitalization with infections in children from the age of 6 months to 12 years was 18.9%. The incidence rate ratio in children born to mothers smoking during pregnancy was 1.24 (95% confidence interval: 1.13-1.36) compared with those of nonsmoking mothers. Mothers whose body mass index was <18 kg/m(2) were more likely to give birth to infants who were hospitalized with infectious disease (incidence rate ratio: 1.29; 95% confidence interval: 1.05-1.59). The increased risk was present in children only up to the age of 5 years. CONCLUSIONS: The study shows that maternal smoking during pregnancy and a low prepregnancy body mass index are associated with a higher risk of hospitalization with infectious disease during early childhood. These associations are independent of fetal growth indicators.
Body Mass Index↗
The risk of limb deficiencies and other congenital abnormalities in children exposed in utero to calcium channel blockers.
AIM: Calcium channel blockers given to pregnant rats have shown an increased prevalence of digital and limb defects and their safety in pregnant women has thus been questioned. We examined the risk of malformations following exposure in utero to calcium channel blockers. METHOD: We conducted a nationwide case-control study based on the Hungarian Case-Control Surveillance of Congenital Abnormalities and identified 22,865 cases with congenital abnormalities and 31,151 population controls during the period 1980-1996. Data on drug exposure were obtained from official questionnaires and obligatory prenatal care logbooks. RESULTS: Among the cases, 586 mothers (2.6%) had been exposed to calcium channel blockers during pregnancy compared with 907 controls (2.4%). The overall prevalence ratios for 17 congenital abnormalities varied between 1.1 and 1.4, and there was no significant increased risk of limb deficiencies or other congenital abnormalities. CONCLUSION: Our data did not indicate an increased prevalence of congenital abnormalities in offspring exposed to calcium channel blockers in utero.
Abnormalities, Drug-Induced↗
A population-based case-control study of the safety of oral anti-tuberculosis drug treatment during pregnancy.
OBJECTIVE: To study the human teratogenic potential of isoniazid and other anti-tuberculosis drug treatment during pregnancy. DESIGN AND SETTING: Cases from a large population-based dataset at the Hungarian Case-Control Surveillance of Congenital Abnormalities, and controls from the National Birth Registry, between 1980 and 1996. Information on all oral anti-tuberculosis drug treatments during pregnancy was medically recorded. STUDY PARTICIPANTS: Women who had newborns or fetuses with congenital abnormalities (case group), and women who had babies with no congenital abnormality (control group). MAIN OUTCOME MEASURES: Congenital abnormalities in newborn infants and fetuses diagnosed prenatally during the second and third trimesters, and postnatally from birth to the age of one year. RESULTS: Of 38,151 controls, 29 (0.08%) were exposed to anti-tuberculosis drug treatment during pregnancy; the corresponding figures for cases were 22,865 and 11 (0.05%). The prevalence odds ratio was 0.6 (95%CI 0.3-1.3). Analysis of isoniazid and other oral antituberculosis drug use during the second and third months of gestation, i.e., in the critical period for most major congenital abnormalities, in case-control pairs did not indicate a teratogenic effect of these drugs in any group with congenital abnormality. CONCLUSION: Maternal exposure to oral anti-tuberculosis drugs during pregnancy did not show a detectable teratogenic risk to the fetus; however, the number of pregnant women who were treated with these drugs during the critical period of most major congenital abnormalities was limited (six cases vs. 21 controls).
Abnormalities, Drug-Induced↗
Avoidable deaths from cancer in the Nordic countries around the year 2000.
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Carcinogens, Environmental↗