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Pregnancy Registry (pregnancy + registry)

Distribution by Scientific Domains

Medical Sciences	85%

Distribution within Medical Sciences

Neurology	41%
Obstetrics & Gynecology	16%

Selected Abstracts

Valproate teratogenicity and epilepsy syndrome

EPILEPSIA, Issue 12 2008
Edward B. Bromfield
Summary Maternal valproate (VPA) use is associated with a significant risk for congenital malformations in the exposed fetus. Since VPA is commonly used in epilepsy syndromes with a presumed genetic cause (idiopathic epilepsies), it is possible that maternal genetic background contributes to this outcome. We reviewed responses to telephone questionnaires and medical records, when available, of enrollees in the North American Antiepileptic Drug Pregnancy Registry, classifying reason for treatment as idiopathic generalized epilepsy (IGE), partial epilepsy (PE), nonclassifiable epilepsy (NCE), or not epilepsy (NE). Of 284 VPA-exposed pregnancies, 30 (11.0%) were associated with malformations: IGE = 15/126 (12%), PE = 4/28 (14%), NCE = 9/105 (9%), NE = 2/25 (8%) (p > 0.7 for all comparisons). There was a trend toward increased malformation risk with higher VPA doses (p = 0.07). VPA, and not the underlying genetic syndrome, seems to be associated with the elevated risk for malformations in the drug-exposed fetus. [source]

Australian Pregnancy Registry of Women Taking Antiepileptic Drugs

EPILEPSIA, Issue 11 2004
Frank Vajda
No abstract is available for this article. [source]

Pregnancy after liver transplantation

LIVER TRANSPLANTATION, Issue 6 2000
Vincent T. Armenti
The first known posttransplantation pregnancy was in 1958 in a renal transplant recipient who had received a kidney from her identical twin sister. The first known posttransplantation pregnancy in a liver transplant recipient was in 1978. Information available from female kidney transplant recipients helped in the decision making involved in the management of this case, as well as those that followed. Over the last 20 years, issues specific to liver transplantation and pregnancy have been identified. Similar to the kidney transplant recipient population, when prepregnancy recipient graft function is stable and adequate, pregnancy appears to be well tolerated. Also similar to kidney transplant recipients, there has been no evidence of a specific malformation pattern among the children, and although prematurity and low birth weight occur, overall newborn outcomes have been favorable. Pregnancy in the setting of recurrent liver disease, such as recurrent hepatitis C, poses a potential problem among liver transplant recipients, as well as the possible adverse effects of immunosuppression on maternal kidney function. Also of significance, peripartum graft deterioration has more severe consequences in this transplant recipient population. Therefore, pregnancy must be considered carefully in this transplant recipient group. Since 1991, the National Transplantation Pregnancy Registry (NTPR) has studied the safety of pregnancy outcomes in solid-organ transplant recipients. The purpose of this review is to catalog studies in the literature, as well as to present current data from the registry with management guidelines. [source]

Bupropion in pregnancy and the prevalence of congenital malformations,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 5 2007
J. Alexander Cole D.Sc.
Abstract Purpose Reports from the GlaxoSmithKline Bupropion Pregnancy Registry suggested an increase in cardiovascular defects following exposure to bupropion during pregnancy. We conducted a study of congenital malformations among infants born to women exposed to bupropion during their first trimester. Methods The study used data from UnitedHealthcare between January 1995 and September 2004. We calculated the prevalence of all congenital malformations and cardiovascular malformations associated with bupropion exposure in the estimated first trimester (1213 infants), compared with (1) other antidepressant exposure in the first trimester (4743 infants) and (2) bupropion exposure outside the first trimester (1049 infants). Malformation cases were confirmed through medical record abstraction. We calculated adjusted odds ratios (AORs) using the GEE form of logistic regression. Results For all congenital malformations, the prevalence associated with bupropion first trimester was 23.1 per 1000 infants. The AORs were 0.95 (95%CI 0.62,1.45) and 1.00 (95%CI 0.57,1.73) in comparison to other antidepressants (prevalence 23.2 per 1000) and bupropion outside the first trimester (prevalence 21.9 per 1000), respectively. For cardiovascular malformations, the prevalence associated with bupropion first trimester was 10.7 per 1000 infants. The AORs were 0.97 (95%CI 0.52,1.80) and 1.07 (95%CI 0.48,2.40) in comparison to other antidepressants (prevalence 10.8 per 1000) and bupropion outside the first trimester (prevalence 9.5 per 1000), respectively. Conclusions Results do not support a hypothesis of a teratogenic effect of first trimester bupropion exposure. The prevalence of malformations associated with bupropion exposure in the first trimester was not increased relative to the comparison groups. Copyright © 2006 John Wiley & Sons, Ltd. [source]

Clinical review procedures for the Antiretroviral Pregnancy Registry,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2004
Angela Scheuerle MD
Abstract The Antiretroviral Pregnancy Registry (APR) is an international pregnancy exposure registry designed to monitor prenatal antiretroviral medication exposures and detect any potential increase in the risk of major birth defects. The APR process imitates that of the Metropolitan Atlanta Congenital Defects Program (MACDP) modified to account for the differences in surveillance systems. The APR case definition attempts to separate prenatal and postnatal medication exposure, includes cases with multiple conditional defects only and collects cases diagnosed at later ages. Possible temporal association between defect pathogenesis and antiretroviral medication exposure includes a way to identify cases with known etiology,such as familial genetic conditions,and those with currently ambiguous pathogenesis,like hemangiomata and club feet. The APR also accounts for confounding factors like maternal alcohol use. Some defect reports automatically generate questions back to the reporter asking for more information. The APR incorporates procedures for managing and recording some of the more inconsistently reported malformations, such as microcephaly. Copyright © 2004 John Wiley & Sons, Ltd. [source]

Assessing teratogenicity of antiretroviral drugs: monitoring and analysis plan of the Antiretroviral Pregnancy Registry,,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2004
Deborah L. Covington DrPH
Abstract This paper describes the Antiretroviral Pregnancy Registry's (APR) monitoring and analysis plan. APR is overseen by a committee of experts in obstetrics, pediatrics, teratology, infectious diseases, epidemiology and biostatistics from academia, government and the pharmaceutical industry. APR uses a prospective exposure-registration cohort design. Clinicians voluntarily register pregnant women with prenatal exposures to any antiretroviral therapy and provide fetal/neonatal outcomes. A birth defect is any birth outcome ,20 weeks gestation with a structural or chromosomal abnormality as determined by a geneticist. The prevalence is calculated by dividing the number of defects by the total number of live births and is compared to the prevalence in the CDC's population-based surveillance system. Additionally, first trimester exposures, in which organogenesis occurs, are compared with second/third trimester exposures. Statistical inference is based on exact methods for binomial proportions. Overall, a cohort of 200 exposed newborns is required to detect a doubling of risk, with 80% power and a Type I error rate of 5%. APR uses the Rule of Three: immediate review occurs once three specific defects are reported for a specific exposure. The likelihood of finding three specific defects in a cohort of ,600 by chance alone is less than 5% for all but the most common defects. To enhance the assurance of prompt, responsible, and appropriate action in the event of a potential signal, APR employs the strategy of ,threshold'. The threshold for action is determined by the extent of certainty about the cases, driven by statistical considerations and tempered by the specifics of the cases. Copyright © 2004 John Wiley & Sons, Ltd. [source]

Prescriptions filled during pregnancy for drugs with the potential of fetal harm

BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 13 2009
S Kulaga
Objective, To assess the extent of prescriptions filled by pregnant women for drugs with recognised potential of fetal harm, and to document the outcomes of these pregnancies. Design, Cross-sectional study. Population, Quebec Pregnancy Registry. Methods, We identified women who were pregnant during a five-year period and who were insured for prescription medications under the provincial drug plan. We obtained information on prescriptions filled during pregnancy for drugs with known potential of fetal harm. Main outcome measures, Prescriptions filled for study drugs during the first, second and third trimesters of pregnancy; termination of pregnancy (TOP) or delivery, and whether the baby was diagnosed with a major congenital malformation (MCM). Results, Of 109 344 women, 56% filled at least one prescription for a medication during pregnancy; 6.3% filled at least one prescription for a drug known to pose a risk to the fetus. Overall, 47% (95% CI, 45.8,48.2) of pregnancies exposed to drugs under study ended in TOP versus 36.2% (95% CI, 35.9,36.5) of those not exposed; 8.2% (95% CI, 8.0,10.0) of live births were diagnosed with an MCM during the first year of life versus 7.1% (95% CI, 6.9,7.3) of those not exposed. Conclusions, This study documents an important level of prescriptions filled during pregnancy for drugs harmful to the developing fetus. The proportions of both TOPs and babies born with MCMs were elevated compared with the expected values. Clinicians caring for women during pregnancy should conduct a medication inventory prior to a planned pregnancy, or as soon as an unplanned pregnancy is recognised. [source]

Assessing teratogenicity of antiretroviral drugs: monitoring and analysis plan of the Antiretroviral Pregnancy Registry,,

Navigating toward Fetal and Maternal Health: The Challenge of Treating Epilepsy in Pregnancy

EPILEPSIA, Issue 10 2004
Torbjörn Tomson
Summary:, A rational approach to the treatment of women of childbearing potential with epilepsy has been hampered by the lack of conclusive data on the comparative teratogenic potential of different antiepileptic drugs (AEDs). Although, several cohort studies on birth defects associated with AED use during pregnancy have been published, these have generally failed to demonstrate differences in malformation rates between AEDs, probably mainly due to insufficient power. In particular, pregnancies with new generation AEDs have been too few. In recent years, pregnancy registries have been introduced to overcome this problem,EURAP (an international collaboration), the North American, and the U.K. AED and pregnancy registries are observational studies that prospectively assess pregnancy outcome after AED exposure using slightly different methods. Each has enlisted 3,5,000 pregnancies in women with epilepsy, and the North American and the U.K. have released preliminary observations. Thus the U.K. registry reported a higher malformation rate with valproate, 5.9% (4.3,8.2%; 95% CI), than with carbamazepine, 2.3% (1.4,3.7%), and lamotrigine, 2.1% (1.0,4.0%). Most of the more recent cohort studies have also identified a nonsignificant trend toward a higher teratogenicity with valproate. These signals need to be interpreted with some caution since none of the studies to date have fully assessed the impact of possible confounders, such as type of epilepsy, family history of birth defects, etc. However, with increasing number of pregnancies it should be possible in the near future for the pregnancy registries to take such confounding factors into account and thus make more reliable assessments of the causal relationship between exposure to specific AEDs and teratogenic risks. While awaiting more conclusive results, it appears reasonable to be cautious in prescribing valproate to women considering to become pregnant if other suitable treatment alternatives, and with less teratogenic potential, are available. Any attempt to change treatment should, however, be accomplished well before conception. The importance of maintained seizure control must also be kept in mind, and the woman who needs valproate to control her seizures should not be discouraged from pregnancy, provided that counseling at the best of available knowledge is given. [source]

Pregnancy following renal transplantation

JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 4 2003
John M. Davison
Abstract Pregnancy is not contraindicated in renal transplant recipients with stable renal function, and a successful and healthy obstetric outcome can be expected in 95% of such cases. The incidence of both maternal and fetal complications is related to the degree of graft dysfunction and/or hypertension prior to pregnancy. Poorer prognosis is associated with poorer renal function. If complications (usually hypertension, renal deterioration, and/or rejection) occur before 28 weeks, then successful obstetric outcome is reduced by 20%. More information is needed about the intrauterine effects and neonatal consequences of maternal immunosuppression, which appears harmless at maintenance levels. From the data available it seems that pregnancy does not compromise long-term transplant prognosis. In the absence of prospective controlled studies transplant pregnancy registries are the only viable means of providing clinicians with timely and relevant information on pregnancy outcomes on which to base management guidelines. [source]

Better data needed from pregnancy registries,

BIRTH DEFECTS RESEARCH, Issue 2 2009
Gerald G. Briggs
Abstract This article is a consensus position statement from the Research Committee of the Organization of Teratology Information Specialists (OTIS). The Committee believes that more specific information on the timing and dose of drug exposures from pregnancy birth defect registries sponsored by pharmaceutical companies (herein called pregnancy registries) would improve the estimation of risk for developmental toxicity (i.e., growth alteration, structural anomalies, functional/neurobehavioral deficits, or death). Specifically, the Committee believes that the exposure timing should be stated in gestational weeks and days rather than simply weeks. In addition, the Committee believes that the exposure dose should be stated in patient-specific terms, such as body weight (mg/kg) or body surface area (mg/m2) rather than simply dose strength. Although the focus of this position is pregnancy registries, it also is applicable to any source of medication-induced embryo-fetal toxicity. Birth Defects Research (Part A), 2009. © 2008 Wiley-Liss, Inc. [source]

Teratogenicity of antiepileptic drugs: role of drug metabolism and pharmacogenomics

ACTA NEUROLOGICA SCANDINAVICA, Issue 1 2007
R. Sankar
The approach to clinical decision-making pertaining to the use of antiepileptic drugs (AEDs) during pregnancy has relied on previous accumulated experience and, since the 1990s, on data from pregnancy registries. The limitations of this process are that no information regarding the chemical attributes of the AED under consideration, nor the role of a number of enzyme systems that are known to interact with foreign compounds to modify their potential for harm, are included. The role of the hepatic mixed function oxidase system may be especially important in conferring teratogenic risk. However, systems such as epoxide hydrolase, glutathione reductase, superoxide dismutase and other toxin-scavenging systems may be important modifiers that lower the risk. Knowledge is also accumulating on the interactions of AEDs with molecular targets such as histone deacetylase and peroxisome proliferator-activated receptors that may play important roles in teratogenesis. While our knowledge of these factors are incomplete, progress can be achieved by beginning to include these concepts in our discussion on the topic and by promoting research that may improve our ability to individualize the analysis of risk for a specific patient with regards to specific AEDs. [source]

Utilization of antiepileptic drugs during pregnancy: Comparative patterns in 38 countries based on data from the EURAP registry

EPILEPSIA, Issue 10 2009
The EURAP Study Group
Summary We assessed the utilization of antiepileptic drugs (AEDs), 1999,2005, in 4,798 prospective epilepsy pregnancies from 38 countries participating in EURAP, an international AED and pregnancy registry. Prominent differences in utilization patterns were observed across the various countries. Exposure to second-generation AEDs ranged from 3.5% in India and 7.3% in Italy to 75% in Denmark. Even wider variation was recorded in exposure to individual AEDs. The utilization of second-generation AEDs increased over time (for lamotrigine, from 9.9% of all pregnancies before 2001 to 29.6% after 2003). The differences in use of individual AEDs across countries probably reflect lack of evidence concerning the optimal treatment of epilepsy in women of childbearing age, as well as variation in country-specific traditions, medication costs, and drug promotion. Our observations underscore the need for comparative studies to investigate the factors influencing the prescription of AEDs during pregnancy, as well as their influence on pregnancy outcome. [source]