Pregnancy outcome following first trimester exposure to sumatriptan

We prospectively compared pregnancy outcome after exposure to sumatriptan with that of disease-matched controls and nonteratogen controls. There were no differences in the rates of live births, spontaneous abortions, therapeutic abortions, or major birth defects among the three groups. This first prospective report suggests that the use of sumatriptan during organogenesis is not associated with an apparent increased risk of major birth defects.

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Congenital Bands with Intestinal Malrotation after Propylthiouracil Exposure in Early Pregnancy

Case Reports in Endocrinology ◽

10.1155/2015/789762 ◽

2015 ◽

Vol 2015 ◽

pp. 1-4 ◽

Cited By ~ 2

Author(s):

Alexander A. Leung ◽

Jennifer Yamamoto ◽

Paola Luca ◽

Paul Beaudry ◽

Julie McKeen

Keyword(s):

Birth Defects ◽

Early Pregnancy ◽

First Trimester ◽

Careful Consideration ◽

Intestinal Malrotation ◽

Graves Disease ◽

Increased Risk ◽

Acute Small Bowel Obstruction ◽

Trimester Exposure ◽

Duration Of Pregnancy

Exposure to propylthiouracil in early pregnancy may be associated with an increased risk of birth defects. But the spectrum of associated congenital anomalies is not yet well defined. While preliminary reports suggest that most cases of propylthiouracil-associated birth defects are restricted to the preauricular and urinary systems, careful consideration should be given to other possible manifestations of teratogenicity. We propose that congenital bands may potentially represent a rare yet serious complication of propylthiouracil exposure in early pregnancy, possibly arising from an early mesenteric developmental anomaly. We report a case of a 17-day-old girl that presented with acute small bowel obstruction associated with intestinal malrotation arising from several anomalous congenital bands. Her mother was treated for Graves’ disease during pregnancy with first trimester exposure to propylthiouracil but remained clinically and biochemically euthyroid at conception and throughout the duration of pregnancy. This case suggests that the use of propylthiouracil in early pregnancy may be associated with congenital bands and intestinal malrotation. More reports are needed to further support this association.

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Ulipristal acetate and pregnancy outcome—an observational study

Human Reproduction ◽

10.1093/humrep/deaa024 ◽

2020 ◽

Vol 35 (4) ◽

pp. 751-758

Author(s):

Jenny Katharina Wagner ◽

Katarina Dathe ◽

Christof Schaefer ◽

Maria Hoeltzenbein

Keyword(s):

Observational Study ◽

Pregnancy Outcome ◽

Birth Defects ◽

Pregnancy Outcomes ◽

Conflicts Of Interest ◽

Termination Of Pregnancy ◽

Ulipristal Acetate ◽

Live Births ◽

Increased Risk ◽

In Pregnancy

Abstract STUDY QUESTION Is the failure of the selective progesterone receptor modulator ulipristal acetate (UPA) as emergency contraception (EC; 30 mg, single) or inadvertent exposure for myoma treatment (5 mg/d) in pregnancy associated with a higher risk of birth defects, spontaneous abortion (SAB) or elective termination of pregnancy (ETOP)? SUMMARY ANSWER We did not find an increased risk for birth defects, SABs or ETOPs after UPA exposure during implantation and early embryogenesis. WHAT IS KNOWN ALREADY Pregnancy outcome data after exposure to UPA are very limited. In cases of EC failure or unplanned pregnancy during myoma treatment, women need well-grounded risk assessment to minimize anxiety and prevent unjustified termination of pregnancy. STUDY DESIGN, SIZE, DURATION Observational study of prospectively ascertained pregnancies from the German Embryotox institute with UPA exposure (EC, n = 95; myoma, n = 7). Four retrospectively reported pregnancy outcomes were evaluated separately. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 226 requests on ulipristal were directed to the German Embryotox institute during the study period 2010–2018. Outcomes of pregnancies exposed—(i) precycle, (ii) preconceptional or (iii) first trimester—were ascertained using standardized questionnaires. Descriptive statistics were applied. MAIN RESULTS AND THE ROLE OF CHANCE Failed EC with UPA resulted in 95 prospectively ascertained pregnancies, of which 56 had completed follow-up: 37 live births, 7 SABs and 12 ETOPs. There was no major birth defect. Just 34% of women had taken UPA during the fertile window. Seven prospectively enrolled pregnancies were treated for myoma and had known pregnancy outcomes: five healthy live births and two SABs. Among the four retrospectively reported pregnancies after EC, there was one child diagnosed with Beckwith-Wiedemann syndrome (BWS). LIMITATIONS, REASONS FOR CAUTION Our limited sample size does not allow concluding safety of UPA use in pregnancy. WIDER IMPLICATIONS OF THE FINDINGS We provide a preliminary basis for reassuring women who wish to carry their pregnancy to term after EC or myoma treatment with UPA. However, because of the report of a BWS after UPA exposure, a possible epigenetic effect could not be excluded and requires further evaluation. STUDY FUNDING/COMPETING INTEREST(S) This work was performed with financial support from the German Federal Institute for Drugs and Medical Devices (BfArM). All authors declare that they have no conflicts of interest. TRIAL REGISTRATION NUMBER Registered with the German Clinical Trial Register (DRKS00015155).

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Leflunomide use during pregnancy and the risk of adverse pregnancy outcomes

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2017-212078 ◽

2017 ◽

Vol 77 (4) ◽

pp. 500-509 ◽

Cited By ~ 23

Author(s):

Anick Bérard ◽

Jin-Ping Zhao ◽

Irene Shui ◽

Susan Colilla

Keyword(s):

Spontaneous Abortion ◽

First Trimester ◽

Spontaneous Abortions ◽

Third Trimester ◽

Increased Risk ◽

First Trimester Of Pregnancy ◽

Exposure During Pregnancy ◽

Trimester Exposure ◽

Adverse Pregnancy ◽

Generalised Estimating Equations

ObjectivesLeflunomide is known to be embryotoxic and teratogenic in rodents. However, there is less evidence in humans. We quantified the risk of major congenital malformation (MCM), prematurity, low birth weight (LBW) and spontaneous abortion associated with leflunomide exposure during pregnancy in humans.MethodsFrom a cohort of 289 688 pregnancies in Montreal, Quebec, Canada, from 1998 to 2015, first-trimester leflunomide exposure and other antirheumatic drug exposures were studied for their association with MCM and spontaneous abortions. Also second or third-trimester leflunomide exposures were examined for associations with prematurity and LBW. Logistic regression model-based generalised estimating equations were used.Results51 pregnancies were exposed to leflunomide during the first trimester, and 21 during the second/third trimesters. Adjusting for potential confounders, use of leflunomide during the first trimester of pregnancy was not associated with the risk of MCM (adjusted OR (aOR) 0.97, 95% CI 0.81 to 1.16; 5 exposed cases). No association was found between second/third-trimester exposure to leflunomide and the risk of prematurity (aOR 4.03, 95% CI 0.91 to 17.85; 7 exposed cases) nor LBW (aOR 1.06, 95%CI 0.90 to 1.25; 8 exposed cases). Pregnancy exposure to leflunomide was also not associated with the risk of spontaneous abortion (aOR 1.09, 95% CI 0.90 to 1.32; 11 exposed cases).ConclusionsMaternal exposure to leflunomide during pregnancy was not associated with statistically significant increased risk of MCMs, prematurity, LBW or spontaneous abortions. However, given that relatively few women were exposed to leflunomide during pregnancy in this cohort, caution remains warranted.

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New Study Finds Increased Risk of Birth Defects Related to First Trimester Use of ACE Inhibitors

PsycEXTRA Dataset ◽

10.1037/e555082006-001 ◽

2006 ◽

Keyword(s):

Birth Defects ◽

Ace Inhibitors ◽

First Trimester ◽

Increased Risk

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P599 Trimester exposure and pregnancy outcomes in women exposed to golimumab: Results from the company pharmacovigilance database

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.727 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S500-S501

Author(s):

S Esslinger ◽

M Otero-Lobato ◽

S Gabriel ◽

M Clark ◽

P Sheridan ◽

...

Keyword(s):

Pregnancy Outcome ◽

Birth Outcomes ◽

Pregnancy Outcomes ◽

Spontaneous Abortions ◽

Live Births ◽

Elective Abortion ◽

Induced Abortions ◽

Pharmacovigilance Database ◽

Inflammatory Bowel ◽

Twin Pregnancies

Abstract Background Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatological indications and ulcerative colitis (UC). To characterise pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented. Methods These dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries. Results Two hundred eight pregnancy cases (131 rheumatological; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Three cases reported twin pregnancies. Of the 208 pregnancy cases, 119 were prospective and 89 were retrospective (Table 1). Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective/7 retrospective cases). For 183 of the 208 pregnancy cases with-reported outcomes, the trimester of exposure to GLM was known (Table 2). Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM throughout pregnancy (first, second and third trimester) and all resulted in live births. Conclusion The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare, but not associated with apparent clinical sequelae. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.

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Pregnancy outcome after first-trimester exposure to fosfomycin for the treatment of urinary tract infection: an observational cohort study

Infection ◽

10.1007/s15010-019-01342-1 ◽

2019 ◽

Vol 48 (1) ◽

pp. 57-64 ◽

Cited By ~ 1

Author(s):

Wayan Philipps ◽

Anne-Katrin Fietz ◽

Katja Meixner ◽

Tobias Bluhmki ◽

Reinhard Meister ◽

...

Keyword(s):

Urinary Tract Infection ◽

Cohort Study ◽

Urinary Tract ◽

Tract Infection ◽

Pregnancy Outcome ◽

First Trimester ◽

Observational Cohort Study ◽

Observational Cohort ◽

Trimester Exposure

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Pregnancy outcome in chronic myeloid leukemia patients on imatinib therapy.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.7114 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 7114-7114

Author(s):

Swati Dasgupta ◽

Ashis Mukhopadhyay ◽

Ujjal Kanti Ray ◽

Firoj Hossain Gharami ◽

Chinmay Kumar Basu ◽

...

Keyword(s):

Congenital Anomaly ◽

Chronic Myeloid Leukemia ◽

Myeloid Leukemia ◽

Unplanned Pregnancy ◽

First Trimester ◽

Imatinib Therapy ◽

Spontaneous Abortions ◽

Male And Female ◽

Increased Risk ◽

Male Patients

7114 Background: Now that imatinib is being used to treat thousands of chronic myeloid leukemia (CML) patients for more than 10 year it is highly probable that many patients will get pregnant during its use. Company warns against any such use. But the fact remains that there is need for planned pregnancies in indicated cases. So we selected few cases both male and female for such pregnancies by interrupting treatment and following the pregnancy closely. Their outcome was studied so that we have an idea about what best could be suggested in such instance. Methods: From November 2002 to May 2010, 634 patients with CML in any stage of the disease were treated with imatinib at our tertiary cancer research institute. We selected 22 (12 females and 10 males) cases of pregnancies by interrupting treatment. We reported 9 accidental pregnancies and 13 planned pregnancies involving 22 patients who or their wives conceived while receiving imatinib for the treatment of CML. Results: Among 22 pregnancies there were 3 spontaneous abortions and 4 elective abortions. In case of 7 female patients, 3 and 4 were male and female babies respectably and in case of six male patients 4 and 4 were male and female babies. Two babies were with congenital anomaly such as one Hypospandium and one Mild-Hydrocephalus (in case of unplanned pregnancies and imatinib exposure during the first trimester of organogenesis). Conclusions: In conclusion, exposure to Imatinib during pregnancy might result in an increased risk of serious fetal abnormalities or spontaneous abortions. Women of childbearing potential should use adequate contraception while using Imatinib. We can suggest that planned pregnancy during therapy should be encouraged but imatinib therapy in unplanned pregnancy can cause spontaneous abortion or minor congenital anomaly.

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