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Biomedical subjects

Adrienne Einarson

Publications and source records attributed to Adrienne Einarson.

At least 37 records · Page 2Linked to original sources

Pregnancy outcome of women using atypical antipsychotic drugs: a prospective comparative study.

BACKGROUND: A substantial number of women of childbearing age suffer from schizophrenia and other mental illnesses that require the use of antipsychotic drugs. Atypical antipsychotics have been on the market since the mid-1990s, and to date there are no prospective comparative studies regarding use during pregnancy. OBJECTIVES: (1) To determine whether atypical antipsychotics increase the rate of major malformations above the 1% to 3% baseline risk seen in the general population. (2) To examine rates of spontaneous and therapeutic abortions, rates of stillbirths, birth weight, and gestational age at birth. METHOD: The cohort was composed of pregnant women who contacted the Motherisk Program in Canada or the Israeli Teratogen Information Service in Israel and women who were recruited from the Drug Safety Research Unit database in England. Women who had been exposed to atypical antipsychotics were matched to a comparison group of pregnant women who had not been exposed to these agents. RESULTS: Data were obtained on 151 pregnancy outcomes that included exposure to olanzapine (N= 60), risperidone (N = 49), quetiapine (N = 36), and clozapine (N = 6). Among women exposed to an atypical antipsychotic, there were 110 live births (72.8%), 22 spontaneous abortions (14.5%), 15 therapeutic abortions (9.9%), and 4 stillbirths (2.6%). Among babies of women in this group, there was 1 major malformation (0.9%), and the mean +/-SD birth weight was 3341 +/-685 g. There were no statistically significant differences in any of the pregnancy outcomes of interest between the exposed and comparison groups, with the exceptions of the rate of low birth weight, which was 10% in exposed babies compared with 2% in the comparison group (p = .05), and the rate of therapeutic abortions (p = .003). CONCLUSION: These results suggest that atypical antipsychotics do not appear to be associated with an increased risk for major malformations.

Abnormalities, Drug-Induced↗

How physicians perceive and utilize information from a teratogen information service: the Motherisk Program.

BACKGROUND: Teratogen information services have been developed around the world to disseminate information regarding the safety of maternal exposures during pregnancy. The Motherisk Program in Toronto, Canada, fields thousands of these inquiries per year. Our primary objective was to evaluate the perception and utilization of information received from us by physicians. Our secondary objective was to examine their information seeking behavior, in particular regarding teratogen information. METHODS: A one page survey was sent to physicians who had called Motherisk for information concerning pregnancy exposures in the previous 30 days for three months. Among the questions that were asked were demographics, which included gender, years in practice, specialty, information resources, and how they utilized the information received from Motherisk. RESULTS: We received 118/200 completed questionnaires (59% response rate). The mean age of the respondents was: 42 +/- 9 years, mean years of practice was: 14 +/- 8 years, males: 46(38%) and females 72(62%) and 95(80%) were family physicians. 56(48%) researched their question prior to calling Motherisk, 106(91%) and passed on the information received to their patient verbatim. The top four resources for information were: 1) The CPS (PDR), 2) textbooks, 3) journals and 4) colleagues. Only 8% used the Medline for gathering information. CONCLUSIONS: Physicians feel that a teratogen information service is an important component in the management of women exposed to drugs, chemicals, radiation and infections diseases etc. during pregnancy. Despite the advent of the electronic age, a minority of the physicians in our survey elected to use electronic means to seek information.

Adult↗

Prevalence of depression during pregnancy: systematic review.

OBJECTIVE: Current estimates of the prevalence of depression during pregnancy vary widely. A more precise estimate is required to identify the level of disease burden and develop strategies for managing depressive disorders. The objective of this study was to estimate the prevalence of depression during pregnancy by trimester, as detected by validated screening instruments (ie, Beck Depression Inventory, Edinburgh Postnatal Depression Score) and structured interviews, and to compare the rates among instruments. DATA SOURCES: Observational studies and surveys were searched in MEDLINE from 1966, CINAHL from 1982, EMBASE from 1980, and HealthSTAR from 1975. METHODS OF STUDY SELECTION: A validated study selection/data extraction form detailed acceptance criteria. Numbers and percentages of depressed patients, by weeks of gestation or trimester, were reported. TABULATION, INTEGRATION, AND RESULTS: Two reviewers independently extracted data; a third party resolved disagreement. Two raters assessed quality by using a 12-point checklist. A random effects meta-analytic model produced point estimates and 95% confidence intervals (CIs). Heterogeneity was examined with the chi(2) test (no systematic bias detected). Funnel plots and Begg-Mazumdar test were used to assess publication bias (none found). Of 714 articles identified, 21 (19,284 patients) met the study criteria. Quality scores averaged 62%. Prevalence rates (95% CIs) were 7.4% (2.2, 12.6), 12.8% (10.7, 14.8), and 12.0% (7.4, 16.7) for the first, second, and third trimesters, respectively. Structured interviews found lower rates than the Beck Depression Inventory but not the Edinburgh Postnatal Depression Scale. CONCLUSION: Rates of depression, especially during the second and third trimesters of pregnancy, are substantial. Clinical and economic studies to estimate maternal and fetal consequences are needed.

Depressive Disorder↗

The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study.

OBJECTIVE: Ondansetron (Zofran) is a drug used for the treatment of nausea and vomiting caused by cancer chemotherapy. Despite the fact that it is not indicated, women are being prescribed this drug for the treatment of nausea and vomiting of pregnancy (NVP). There is a paucity of information on fetal safety for this indication. The objective of this study is to determine whether this drug increases the baseline rate of major malformations. DESIGN: A prospective comparative observational study. SETTING: Teratogen Information Services (TIS). POPULATION: Pregnant women. METHODS: Our three groups included women who were exposed to ondansetron and women exposed to (1) other anti-emetics and (2) non-teratogen exposures. All of the women called either our NVP Helpline or TIS at The Motherisk Program in Toronto, Canada, or The Mothersafe Program in Sydney, Australia. MAIN OUTCOME MEASURE: Rates of major malformation. RESULTS: We have completed 176 pregnancy outcomes in each group. In the ondansetron cohort, there were 169 live births, 5 miscarriages, 2 therapeutic abortions, 6 (3.6%) major malformations and the mean birthweight was 3362 g [SD 525]. There were no statistical differences in any of the study endpoints between the ondansetron and the comparison groups. CONCLUSIONS: This drug does not appear (although the sample size is limited) to be associated with an increased risk for major malformations above baseline.

Adult↗

Perinatal risks of untreated depression during pregnancy.

OBJECTIVE: To review the literature on the perinatal risks involved in untreated depression during pregnancy. METHOD: We searched Medline and medical texts for all studies pertaining to this area up to the end of April 2003. Key phrases entered were depression and pregnancy, depression and pregnancy outcome, and depression and untreated pregnancy. We did not include bipolar depression. RESULTS: While there is wide variability in reported effects, untreated depression during pregnancy appears to carry substantial perinatal risks. These may be direct risks to the fetus and infant or risks secondary to unhealthy maternal behaviours arising from the depression. Recent human data suggest that untreated postpartum depression, not treatment with antidepressants in pregnancy, results in adverse perinatal outcome. CONCLUSION: The biological dysregulation caused by gestational depression has not received appropriate attention: most studies focus on the potential but unproven risks of psychotropic medication. No in-depth discussion of the role of psychotherapy is available. Because they are not aware of the potentially catastrophic outcome of untreated maternal depression, this imbalance may lead women suffering from depression to fear teratogenic effects and refuse treatment.

Abortion, Spontaneous↗

Significant changes in antipsychotic drug use during pregnancy.

Atypical antipsychotics are less likely to cause hyperprolactinemia-related side effects, such as infertility; hence it is predicted that more women taking antipsychotic medications will be able to become pregnant as the use of atypical antipsychotics increases. To compare the use of conventional and atypical antipsychotics, we conducted a retrospective review of the Motherisk Program clinic schedule from 1989 to 2001 comparing the proportion of appointments made for conventional and atypical antipsychotics. In 1989, 2.7% of all appointments were about the use of antipsychotic medication. In 2001, 7.4% of appointments were regarding antipsychotic drug use. This 170% increase was due to an increase in appointments for atypical antipsychotics as the number of appointments for conventional antipsychotics remained relatively constant over the 12-y period. Since the introduction of atypical antipsychotics, more women requiring antipsychotic drug therapy have been planning or becoming pregnant. This increase may have substantial public health implications.

Adult↗

Risks of untreated depression during pregnancy.

QUESTION: One of my patients who was taking an antidepressant for major depression is now pregnant and does not wish to take it any more. I believe she needs to continue her medication. She, however, is adamant about stopping it because she believes it would put her baby at risk. Is there evidence that not treating depression during pregnancy puts babies at risk? ANSWER: A growing body of literature investigating the effects of not treating depression on mother and developing fetus suggests that untreated depression is associated with adverse fetal outcomes and a higher risk of maternal morbidity, including suicide ideation and attempts, and postpartum depression.

Adult↗

New antidepressants in pregnancy.

QUESTION: I have read that fluoxetine is the drug of choice for treating depression during pregnancy. One of my patients, who did not respond to the "old" selective serotonin reuptake inhibitors, is doing well on venlafaxine and is now 6 weeks pregnant. What advice should I give her? ANSWER: Fluoxetine is recommended because to date it has the most evidence of its safety. It is important that women be treated appropriately for depression during pregnancy, and some research on the newer antidepressants, such as venlafaxine, will be useful to you and your patient in making an informed decision regarding treatment.

Abnormalities, Drug-Induced↗

Seroprevalence of Toxoplasma gondii infection among veterinary staff in Ontario, Canada (2002): implications for teratogenic risk.

BACKGROUND: Toxoplasma gondii infection is embryotoxic in humans. It is mainly transmitted through raw/undercooked meat and ingestion of oocysts in cat feces. There remains controversy about the actual risk of cats transmitting the disease to humans. Our primary objective was to determine the seroprevalence of T. gondii antibody among veterinary staff, to ascertain whether they have an increased risk through occupational exposure. Our secondary objective was to examine their practices regarding cats, toxoplasma infection, and pregnancy. METHODS: Veterinary staff attending the 2002 Annual Ontario Veterinary Medical Association Conference were invited to discuss their toxoplasma seroprevalence. Interested attendees completed a questionnaire and a physician drew blood samples to determine T. gondii titres using the ELISA IgG test. RESULTS: We collected 161 completed questionnaires, and 141 blood samples. There were 20 (14.2%, CI 95%:8.4-19.9%) reactive titres among the veterinarian staff (80% females aged 30-45). All were regularly exposed to cats, washed their hands when in contact and few wore gloves routinely. CONCLUSIONS: These findings of low positive rates may be used to reassure veterinary staff that their exposure to cats does not appear to increase their risk of contracting toxoplasma infection and that pregnant women are not at an increased risk by owning a cat.

Animals↗

Diclectin therapy for nausea and vomiting of pregnancy: effects of optimal dosing.

OBJECTIVES: (1) To quantify rates of suboptimal use of pyridoxine hydrochloride-doxylamine (Diclectin); and (2) to study responses to optimal doses of Diclectin in women previously taking a suboptimal dose. METHODS: Women who called the Motherisk NVP helpline, and were taking only Diclectin (vitamin B6 10 mg and doxylamine 10 mg), were enrolled in the study and assessed for the severity of nausea and vomiting of pregnancy (NVP) with the Motherisk-PUQE (pregnancy-unique quantification of emesis and nausea) scoring system. Their Diclectin doses were subsequently increased according to body weight and individual symptoms. A follow-up phone call occurred within 1 to 3 weeks after the intervention, at which time the overall PUQE score was repeated, along with individual scoring of symptoms of nausea, vomiting, and retching. RESULTS: Sixty-eight women were enrolled and completed the study. Despite moderate to severe NVP, defined by the validated PUQE scoring system, most women (50/68) were receiving 2 tablets a day of Diclectin instead of the recommended dose of 4 tablets a day. Following a mean doubling of the dose to 4 tablets a day, there was a significant decrease in length of nausea (from 4 to 3 hours, P < 0.001), frequency of vomiting (from mean 1.6 to 1.3 a day, P = 0.02), and overall PUQE score (from mean 7.5 to 6.1, P < 0.001). CONCLUSION: Women suffering from NVP are often given subtherapeutic doses of Diclectin. Women should receive a dosage according to their body weight and severity of their symptoms.

Adult↗

Prospective comparative study of the safety and effectiveness of ginger for the treatment of nausea and vomiting in pregnancy.

OBJECTIVES: The primary objective of our study was to examine the safety and the secondary objective was to examine the effectiveness of ginger for nausea and vomiting of pregnancy (NVP). STUDY DESIGN: Pregnant women who called the Motherisk Program who were taking ginger during the first trimester of pregnancy were enrolled in the study. The women were compared with a group of women who were exposed to nonteratogenic drugs that were not antiemetic medications. The women were followed up to ascertain the outcome of the pregnancy and the health of their infants. They were also asked on a scale of 0 to 10 how effective the ginger was for their symptoms of NVP. RESULTS: We were able to ascertain the outcome of 187 pregnancies. There were 181 live births, 2 stillbirths, 3 spontaneous abortions, and 1 therapeutic abortion. The mean birth weight was 3542+/-543 g, the mean gestational age was 39+/-2 weeks, and there were three major malformations. There were no statistical differences in the outcomes between the ginger group and the comparison group with the exception of more infants weighing less than 2500 g in the comparison group (12 vs 3, P < or =.001). There were a total of 66 completed effectiveness scores with the mean score of 3.3+/-2.9 SD. CONCLUSION: These results suggest that ginger does not appear to increase the rates of major malformations above the baseline rate of 1% to 3% and that it has a mild effect in the treatment of NVP.

Birth Weight↗

A multicentre prospective controlled study to determine the safety of trazodone and nefazodone use during pregnancy.

OBJECTIVES: Trazodone and nefazodone are phenylpiperazine antidepressants. Currently, there are no adequate, well-controlled studies on the fetal safety of these drugs. Our primary objective was to determine whether the use of trazodone or nefazodone during pregnancy is associated with an increased risk for major malformations. Secondary outcomes of interest included rates of spontaneous and therapeutic abortions, rates of premature labour, and birth weight. METHODS: Pregnant women from 5 centres who had been exposed to these drugs (n = 147) were enrolled in the study during their first trimester. We compared the women with 2 groups of women who took either other antidepressant drugs (n = 147) or nonteratogenic drugs (n = 147). All the women were followed up after delivery to ascertain pregnancy outcome and the health of the baby. RESULTS: We have completed 147 follow-ups. There were 121 (82.4%) live births, 20 (13.6%) spontaneous abortions, and 6 (4%) therapeutic abortions. Of the live births, there were 2 (1.6%) major malformations. In all cases, drug exposure occurred during the first trimester, with 52 (35%) of the women using these drugs throughout pregnancy. The mean gestational age at birth was 38 weeks (SD 4.2), and the mean birth weight was 3306.34 g (SD 655). We found no statistically significant differences among the 3 groups in any of the endpoints of interest that we examined. Of the sample, 58 women were exposed to trazodone, and 89 were exposed to nefazodone. CONCLUSION: Our results suggest that these drugs do not increase the rates of major malformations above the baseline rate of 1% to 3%.

Antidepressive Agents, Second-Generation↗

Electric shock during pregnancy.

QUESTION: A 24-year-old patient of mine, who was 23 weeks pregnant at the time, suffered a minor electric shock while using her hair dryer. She said she felt the current in her right hand and she was wearing shoes. She was observed in an emergency room for several hours and then discharged home. Is her pregnancy or fetus at risk now or later in the pregnancy? ANSWER: There are conflicting reports on how harmful electric shock is to a fetus. The clinical spectrum of electrical injury ranges from a transient unpleasant sensation felt by a mother and no effect on her fetus to fetal death either immediately or few days later. Several factors, such as the magnitude of the current and the duration of contact, are thought to affect outcome. In this case, it appears the current did not travel through her abdomen. Recommendations for fetal monitoring after electrocution have been published.

Adult↗

Trimethoprim-sulfonamide combination therapy in early pregnancy.

QUESTION: One of my patients presented with bacteriuria early in her pregnancy. Urine culture was positive for Escherichia coli. I would like to prescribe a trimethoprim-sulfamethoxazole combination because it worked well for her in the past. What is known about the safety of this medication during early pregnancy? ANSWER: Evidence-based studies report an association between trimethoprim-sulfonamide combinations in early pregnancy and several major malformations, such as neural tube defects and cardiovascular defects. If clinically possible, physicians are advised to use alternative antimicrobial medications for treatment of urinary tract infections during early pregnancy.

Abnormalities, Drug-Induced↗

The use of CAM by women suffering from nausea and vomiting during pregnancy.

BACKGROUND: Nausea and vomiting during pregnancy (NVP) affects two-thirds of pregnant women to varying degrees and over the years many modalities have been used to try to alleviate this often debilitating condition. There is a paucity of information in the literature about the use or efficacy of complementary and alternative medicine (CAM) for the treatment of this condition that affects so many women. Our primary objective was to examine the prevalence of CAM usage by women suffering from NVP. Our secondary objective was to ascertain if women had any supervision in the use of these treatments. METHODS: Women who called The Motherisk NVP helpline, were asked after the counseling session to complete a questionnaire, which included demographic data as well as information about their CAM use. RESULTS: Seventy women completed the questionnaire. 61% reported using CAM therapies, of which the three most popular were: ginger, vitamin B6 and acupressure. 21% of those who reported using CAM, had consulted CAM practitioners, 8% their physicians or pharmacists and 71% discussed the usage with family, friends and other allied health professionals. Women who did not use CAM stated they would probably use these modalities if there was more information about the safety in pregnancy. CONCLUSION: Pregnant women with NVP are mirroring the trend in the general population of the use of CAM. They are also using CAM therapies with little supervision from practitioners experienced in the use of these modalities.

Adult↗