scholarly journals Prospective, Controlled, Multicentre Study of Loperimide in Pregnancy

2000 ◽  
Vol 14 (3) ◽  
pp. 185-187 ◽  
Author(s):  
A Einarson ◽  
P Mastroiacovo ◽  
J Arnon ◽  
A Ornoy ◽  
A Addis ◽  
...  

BACKGROUND: Loperamide is a synthetic piperidine derivative used for the treatment of both acute and chronic diarrhea. Little is known about its safety and risk in pregnancy. Human data are limited to one surveillance study of Michigan Medicaid patients, with 108 women exposed in the first trimester. In this study there were six major birth defects, three of which were cardiovascular anomalies.OBJECTIVES: To determine whether loperamide use in pregnancy is associated with an increased risk of major malformations. The secondary end points were rates of minor malformations, spontaneous and therapeutic abortions, and premature births, and mean birth weights.PATIENTS AND METHODS: Women counselled by five teratogen information centres on the safety and risk of loperamide in pregnancy were followed after delivery and compared with a similar group of women matched for age, smoking, alcohol and other exposures.RESULTS: One hundred and five follow-ups were completed; 89 of the women were exposed to loperamide in the first trimester of pregnancy. There were no statistically significant differences between the study group and the control group in any of the end points that were analyzed. However, of women who took loperamide throughout their pregnancy, 21 of 105 had babies who were 200 g smaller than babies in the control group.CONCLUSIONS: The results of this study suggest that the use of loperamide during pregnancy is not associated with an increased risk of major malformations.

2021 ◽  
Vol 5 (3) ◽  
Author(s):  
Ai Yoshihara ◽  
Jaeduk Yoshimura Noh ◽  
Natsuko Watanabe ◽  
Miho Fukushita ◽  
Masako Matsumoto ◽  
...  

Abstract Context Medical treatment of Graves disease during the first trimester has been the subject of controversy ever since treatment with an antithyroid drug during the first trimester was reported to possibly be associated with an increased risk of birth defects in newborns. Objective We investigated whether the incidence of birth defects among newborns born to mothers with Graves disease (GD) treated with propylthiouracil (PTU) during the first trimester of pregnancy was higher than in a control group that was not exposed to any medication. Methods We reviewed the cases of 1913 women with GD who gave birth between January 1, 2015, and May 31, 2019. Detailed information concerning the outcome of pregnancy and the presence of birth defects was collected at the first visit after the delivery and again 1 year after delivery. We classified the mothers and infants into 3 groups according to the treatment the mother had received for GD in the first trimester of pregnancy: a group in which the mothers had been treated with PTU alone (PTU group), a group in which the mothers had not been treated with any medication (control group), and a group in which the mothers had received some other medical treatment, such as thiamazole, potassium iodide, or 2 or more drugs (other treatment group). Results The incidence of malformed infant births was 5.5% (30/541 infants) in the PTU group and 5.7% (27/ 475 infants) in the control group. There were no specific birth defects in the PTU group, and there were no significant differences between PTU dosages or maternal thyroid function according to whether mothers had delivered a child with a birth defect. Conclusion The results of our retrospective study showed that treatment with PTU during the first trimester of pregnancy did not increase the incidence of birth defects among newborns.


Author(s):  
Salvatore Gizzo ◽  
Marco Noventa ◽  
Stefania Di Gangi ◽  
Carlo Saccardi ◽  
Erich Cosmi ◽  
...  

AbstractOne of the most frequent causes of maternal and perinatal morbidity is represented by hypertensive disorders during pregnancy. Women at high risk must be subjected to a more intensive antenatal surveillance and prophylactic treatments. Many genetic risk factors, clinical features and biomarkers have been proposed but none of these seems able to prevent pre-eclampsia onset. English literature review of manuscripts focused on calcium intake and hypertensive disorders during pregnancy was performed. We performed a critical analysis of evidences about maternal calcium metabolism pattern in pregnancy analyzing all possible bias affecting studies. Calcium supplementation seems to give beneficial effects on women with low calcium intake. Some evidence reported that calcium supplementation may drastically reduce the percentage of pre-eclampsia onset consequently improving the neonatal outcome. Starting from this evidence, it is intuitive that investigations on maternal calcium metabolism pattern in first trimester of pregnancy could represent a low cost, large scale tool to screen pregnant women and to identify those at increased risk of pre-eclampsia onset. We propose a biochemical screening of maternal calcium metabolism pattern in first trimester of pregnancy to discriminate patients who potentially may benefit from calcium supplementation. In a second step we propose to randomly allocate the sub-cohort of patients with calcium metabolism disorders in a treatment group (calcium supplementation) or in a control group (placebo) to define if calcium supplementation may represent a dietary mean to reduce pre-eclampsia onset and to improve pregnancy outcome.


PEDIATRICS ◽  
1993 ◽  
Vol 92 (4) ◽  
pp. 559-563
Author(s):  
Jun Zhang ◽  
Wen-wei Cai

Objective. To examine the association between the common cold with or without fever in the first 3 months of pregnancy and birth defects in offspring. Design. A case-control study. Setting. Data are from the Shanghai Birth Defects Monitoring Program, conducted in 29 hospitals in Shanghai, China from October 1, 1986 to September 30, 1987. Subjects. A total of 986 birth defects cases, 990 frequency-matched live birth controls, and 159 stillbirth controls. Results. Modestly elevated risk of birth defects was identified among women who reported having a cold with or without fever in the first trimester of pregnancy. Notably increased relative risks were observed for anencephalus (odds ratio [OR] = 3.9, 95% confidence interval [CI] = 2.0 to 7.7), spina bifida (OR = 4.1, 95% CI = 1.7 to 9.7), hydrocephalus (OR = 2.3, 95 % CI = 1.1 to 5.1), cleft lip (OR = 2.2, 95 % CI = 1.4 to 3.4), and undescended testicle (OR = 1.8, 95 % CI = 1.0 to 3.0). Our study further found that the overall relative risks were consistent by using two different control groups, suggesting that this association was unlikely to be due to recall or report bias. Conclusion. Common cold in the first trimester of pregnancy may be associated with an increased risk of birth defects in offspring. However, these findings should be interpreted cautiously.


Rheumatology ◽  
2020 ◽  
Author(s):  
Niklas Worm Andersson ◽  
Lone Skov ◽  
Jon Trærup Andersen

Abstract Objective The antimalaria 4-aminoquinoline drugs chloroquine and HCQ are used in the treatment of a wide range of CTDs. Data to inform on the safety of their use in pregnancy are limited. Methods In a Danish nationwide cohort study from 1996 through 2016, we identified 4-aminoquinoline–exposed pregnancies from a cohort of 1 240 875 pregnancies to investigate the associated risks of major birth defects, preterm birth, and small size for gestational age (SGA). Distinct study cohorts of propensity-score–matched 4-aminoquinoline-exposed and unexposed pregnancies (in a 1:1 ratio) were established for each outcome analysis. The association with the outcomes was assessed by prevalence odds ratios (ORs) estimated through logistic regression. The associated risks for chloroquine and HCQ were individually assessed through additional analyses. Results A total of 1487 pregnancies exposed to 4-aminoquinolines (1184 chloroquine- and 303 HCQ-exposed) were identified. Among the 983 pregnancies exposed to 4-aminoquinolines in the first trimester, 34 infants (3.5%) were diagnosed with major birth defects as compared with 36 (3.7%) among the matched unexposed pregnancies (prevalence OR, 0.94; 95% CI: 0.59, 1.52). Exposure to 4-aminoquinolines in pregnancy was neither associated with an increased risk of preterm birth (prevalence OR, 0.97; 95% CI: 0.73, 1.28) or SGA (prevalence OR, 1.18; 95% CI: 0.93, 1.50), compared with unexposed pregnancies. No significant associations between exposure to chloroquine or HCQ individually and risk of the outcomes were identified. Conclusion Among pregnancies exposed to 4-aminoquinolines (chloroquine and HCQ), no increased risk of major birth defects, preterm birth, or SGA was identified.


2020 ◽  
Author(s):  
Daniel R. Morales ◽  
Lionel Fonkwen ◽  
Hedvig M. Nordeng

ABSTRACTBackgroundMaternal anti-thyroid drug (ATD) use during the first trimester of pregnancy has been associated with an increased risk of birth defects in offspring. Uncertainty remains on the size of this risk and how it compares to untreated hyperthyroidism due to methodological limitations of previous studies.MethodsSystematic review of MEDLINE and EMBASE identifying observational studies examining ATD use during the first trimester of pregnancy and risk of birth defects. Data were extracted on study characteristics, adjusted effect estimates and comparator groups. Effect estimates were pooled using a random-effects generic inverse variance method of analysis and absolute risk calculated.ResultsSeven cohort studies and one case–control study (involving 6212322 pregnancies and 388976 birth defects) were identified. Compared to unexposed women without hyperthyroidism, the association between ATD first trimester use and birth defects in offspring was: adjusted risk ratio [aRR] 1.16 95% CI 1.08-1.25 for propylthyoruacil (PTU); aRR 1.28 95% CI 1.06-1.54 for methimazole/carbimazole (MMI/CMZ); aRR 1.51, 95% CI 1.16-1.97 for both MMI/CMZ and PTU; and aRR 1.15 95%CI 1.02-1.29 for untreated hyperthyroidism. The risk of major birth defects per 1000 live births was: 9.6 for PTU; 16.8 for MMI/CMZ; 30.6 for both MMI/CMZ and PTU; and 9.0 for untreated hyperthyroidism.ConclusionsWhen appropriately analysed this risk of birth defects associated with ATD use in the first trimester of pregnancy is attenuated. Although still elevated, the risk of birth defects is smallest with PTU compared to use of MMI/CMZ and may be similar to that of untreated hyperthyroidism.


1962 ◽  
Vol 41 (1) ◽  
pp. 123-128 ◽  
Author(s):  
Pentti A. Järvinen ◽  
Sykkö Pesonen ◽  
Pirkko Väänänen

ABSTRACT The fractional determination of 17-ketosteroids in the daily urine was performed in nine cases of hyperemesis gravidarum and in four control cases, in the first trimester of pregnancy both before and after corticotrophin administration. The excretion of total 17-KS is similar in the two groups. Only in the hyperemesis group does the excretion of total 17-KS increase significantly after corticotrophin administration. The fractional determination reveals no difference between the two groups of patients with regard to the values of the fractions U (unidentified 17-KS), A (androsterone) and Rest (11-oxygenated 17-KS). The excretion of dehydroepiandrosterone is significantly higher in the hyperemesis group than in the control group. The excretion of androstanolone seems to be lower in the hyperemesis group than in the control group, but the difference is not statistically significant. The differences in the correlation between dehydroepiandrosterone and androstanolone in the two groups is significant. The high excretion of dehydroepiandrosterone and low excretion of androstanolone in cases of hyperemesis gravidarum is a sign of adrenal dysfunction.


Sign in / Sign up

Export Citation Format

Share Document