Agents In Pregnancy Research Articles

Association between maternal dupilumab exposure and pregnancy outcomes in patients with moderate-to-severe atopic dermatitis: A nationwide retrospective cohort study.

There is limited epidemiological evidence on outcomes associated with dupilumab exposure during pregnancy; monitoring pregnancy outcomes in large populations is required. To investigate the potential association between exposure to dupilumab in pregnant women with atopic dermatitis and any adverse pregnancy, neonatal, congenital and post-partum outcomes. We performed a multicentre retrospective cohort study across 19 Italian tertiary referral hospital. Childbearing women were eligible if aged 18-49 years and carried out the pregnancy between 1 October 2018 and 1 September 2022. We retrospectively screened records of 5062 patients receiving dupilumab regardless of age and gender, identifying 951 female atopic dermatitis patients of childbearing age, 29 of whom had been exposed to the drug during pregnancy (3%). The median duration of dupilumab treatment prior to conception was 22.5 weeks (range: 3-118). The median time of exposure to the drug during pregnancy was 6 weeks (range: 2-24). All the documented pregnancies were unplanned, and the drug was discontinued in all cases once pregnancy status was reported. The comparison of the study cohort and the control group found no significant drug-associated risk for adverse pregnancy, congenital, neonatal or post-partum outcomes. The absence of a statistically significant effect of exposure on the event was confirmed by bivariate analysis and multivariate analysis adjusted for other confounding factors. This cohort of pregnant patients exposed to dupilumab adds to the existing evidence concerning the safety of biologic agents in pregnancy. No safety issues were identified regarding the primary outcome assessed. In clinical practice, these data provide reassurance in case of dupilumab exposure during the first trimester. However, the continuous use of dupilumab throughout pregnancy warrants further research.

Effects of repeated doses of paracetamol administration during pregnancy on lung, kidney, and liver tissues of pregnant rats.

Paracetamol is one of the most widely used analgesics and antipyretics in the world. It is the most commonly used analgesic and antipyretic agent in pregnancy. Paracetamol is known to have toxic effects on the liver, lung, and kidney. In this study, we investigated the effects of long-term chronic paracetamol exposure on the lung, liver, and kidney in newborn rats at different trimesters of pregnancy. In our study, we formed control (group C), first trimester (group A), and third trimester (group B) groups. Group A had the first seven days of pregnancy and group B had days 15-21. Paracetamol was given orally during the specified periods. On the third postnatal day, pups were euthanized by applying 50 mg/kg ketamine intraperitoneally, and then lung, liver, and kidney tissues were kept under appropriate conditions for examination. A total of 70 pups underwent histopathological examination. The lung revealed congestion (p<0.0001), and erythrocytes (p<0.0001), the liver revealed significant histopathological findings in terms of the presence of inflammation (p<0.0001), vacuolar degeneration (p<0.0001), and sinusoidal dilatation in groups A and B compared to the control group under light microscopy. MDA and free radical metabolism enzyme activities, CAT, GSH, and SOD were evaluated. While there were no significant differences between the groups in lung and kidney tissues, oxidant parameters were significant in liver tissues. Our data point out that subacute doses of paracetamol used chronically in different trimesters caused damage to the lung, liver, and kidney tissues of pups.

Efficacy, Safety, and Tolerability of Iron Infusions in Pregnant Women: A Retrospective Chart Review

Background: Iron deficiency (ID) is the most common nutritional deficiency in pregnancy. Iron deficiency anemia (IDA) is also known to be a common problem among pregnant women, and it has been associated with maternal morbidity, peripartum complications, and impaired infant development. Pregnant women who have ID or IDA may benefit from iron infusions to optimize their iron stores more rapidly prior to delivery, however per the American College of Obstetricians and Gynecologists, oral iron is recommended first-line agent for IDA in pregnancy and treating ID without anemia (IDWA) in pregnancy is not currently recommended. IV iron for IDA is considered a second-line agent in pregnancy for many reasons: lack of data on the experience of iron infusions in U.S. pregnant women, lack of randomized trials in pregnant women, and FDA prescribing information labels for all iron formulations containing warnings about possible adverse effects. Also, there has been reluctance to prescribe newer iron formulations including Ferric Carboxymaltose (FCM), Ferumoxytol (FM), and Ferric Derisomaltose (FDI). Methods: In this single center case series, pregnant women in their 2nd or 3rd trimesters who had IDWA or IDA received iron infusions in an outpatient infusion center with nurses trained to monitor pregnant patients carefully for infusion reactions. Before the infusions, the women were assessed in a hematology consult for symptoms of ID, including shortness of breath, fatigue, and ice craving/ice chewing, as well as lab testing consistent with ID (ferritin&amp;lt;30 or iron saturation &amp;lt;16%) and anemia (hemoglobin&amp;lt;12). The iron formulation each woman received was determined by her health plan coverage and, in some cases, by her experience with prior iron infusions. Most women with IDWA were prescribed 400-500mg iron and most women with IDA were prescribed 1000mg iron. Two weeks after the final infusion, follow-up iron and blood counts were measured, and symptoms were re-assessed in a follow-up visit. Safety of iron infusions was determined by reviewing frequency of reactions that occurred during infusions (observed) including complement activation-related pseudoallergy (CARPA) and immune-mediated hypersensitivity reactions, as well as transient discomfort within the first few days after iron infusions (assessed by self-reports or reported during follow-up visits), as well as frequency of discontinuing the infusions. Results: 1,383 pregnant women with IDWA (n=69) or IDA (n=1,314) received a total of 2,971 iron infusions between June 2021 and June 2023, including Ferric Derisomaltose (FDI) 1000 mg single dose (n=417), two Ferumoxytol (FM) 510 mg doses (n=510), four Iron Sucrose (IS) 200 mg doses (n=1,661) or two IS 400 mg doses (n=383). No routine pre-medications were used. Among these pregnant women who received iron infusions, 94% reported improvement of one or more symptoms (shortness of breath, fatigue, or ice craving/ice chewing). Two weeks after the final infusion, 87% were found to have iron saturation greater than 15%, 83% were found to have ferritin above 30, and 88% were found to have increased hemoglobin compared to their pre-infusion hemoglobin. The average hemoglobin increase was 1.2 g/dL. IDA patients had higher hemoglobin increases than IDWA patients but similar increases in iron saturation and ferritin, regardless of iron formulation received. Iron infusions were usually well tolerated. The overall incidence of infusion reactions occurring during infusions, including CARPA reactions, was 4.5% (9.8% for FDI, 4.9% for FM, 1.4% for IS 200 mg doses, and 0.5% for IS 400mg doses). Five pregnant women (0.17%) discontinued iron treatments because of infusion reactions. The overall incidence of post-infusion discomfort symptoms was 22.5% (9.5% for FDI, 18.8% for FM, 31.3% for IS 200 mg doses, and 26.7% for IS 400 mg doses), including tiredness, headache, low back pain, leg swelling, or shortness of breath. Two women were evaluated in hospital ER's, one for hypotension during an iron infusion and one for hives after an iron infusion. There were no adverse events that impacted a woman's pregnancy. Conclusions: Iron infusions in pregnant women are effective, safe, and well-tolerated when administered in an outpatient infusion center that has nurses trained to monitor pregnant patients carefully for infusion reactions. For pregnant women who have IDWA or IDA, the benefits of iron infusions likely outweigh the risks.

Medications for Managing Preexisting and Gestational Diabetes in Pregnancy

Persons with gestational and pregestational diabetes during pregnancy may require pharmacologic agents to achieve pregnancy glycemic targets, and the available medications for use in pregnancy are limited. Insulin is the only FDA-approved medication for use in pregnancy and has the greatest evidence for safety and efficacy. Metformin and glyburide are the most commonly used oral agents in pregnancy. Understanding each medication's unique pharmacokinetics, potential side effects, fetal or childhood risks, gestational age of medication initiation and patient's diabetes care barriers are important aspects of shared decision-making and choosing a regimen that will achieve glycemic and pregnancy goals.

Considerations for the Use of Long-Acting and Extended-Release Agents During Pregnancy and Lactation.

Long-acting agents hold significant promise for treating and preventing common illnesses, including infections. Pharmacokinetic and safety data during pregnancy and lactation are often unavailable for new drugs; these data are vital to facilitate optimal drug use by pregnant and lactating women and women who may conceive. In this commentary, we summarize the circumstances in which pregnant and lactating women are likely to use and benefit from long-acting agents. We focus on long-acting formulations of small molecules (rather than biologics such as monoclonal antibodies) and on several infections of global importance (human immunodeficiency virus, tuberculosis, malaria, and hepatitis C). We discuss pregnancy pharmacokinetic/pharmacodynamic and potential safety and efficacy considerations pertaining to the use of long-acting agents in pregnancy and lactation. Finally, we summarize existing preclinical and pregnancy pharmacokinetic data that are available (or expected in the near future) for several agents that are under development or approved, and how key research gaps may be addressed.

Drug-Induced Microbiome Changes: Considerations in Pregnancy.

During pregnancy, the maternal microbiome is associated with both the health of the mother as well as the developing fetus. Several classes of drugs are known to influence the microbiome and their use in pregnancy may impact maternal/fetal outcomes and long-term health of offspring. The drug-microbiome interactions of antibiotics, proton pump inhibitors, laxatives, metformin, and probiotics will be described, along with considerations for use of these agents in pregnancy.

Retrospective Assessment of the Use of Pharmacotherapeutic Agents in Pregnancy with Potential Impact on Neonatal Health

Abstract This study focuses on the role of a clinical pharmacist in the optimisation of pharmacotherapy in the case of patients during pregnancy and its importance within the hospital sector in Slovakia. Retrospective evaluation of pharmacotherapy in pregnant patients with a focus on teratogenicity and appropriate drug selection was used. The hospital data were collected during 24 months from 22 female patients. The main observed outcome was health condition of the newborn, and it was expressed as healthy newborn, illness of the newborn, any congenital defect or malformation, spontaneous abortion, or unspecified information about the newborn. Based on a foetal risk assessment of used therapeutic agents from the Summary of Product Characteristics (SmPC), basal foetal and neonatal risk assessment (Briggs et al., 2017), and recommendations and related human past reports and supporting evidence studies, drugs were divided into two groups: confirmed foetal risk drugs and negative (nonconfirmed) foetal risk drugs. A total of 36.3% of the patients used two drugs. Patients most frequently used drugs during the first trimester (81.8%). During pregnancy, the most used drugs were for the nervous system (25.5%), anti-infective agents (23.6%), and respiratory therapeutic agents (14.5%). Of the 22 patients, 16 (73%) had healthy newborns, despite the use of therapeutic agents with different foetal-risk variations. In the group of therapeutic agents with confirmed risk, in some, negative effect on the newborn's health was clinically manifested. Spontaneous abortion was present after using norethisterone acetate and valproic acid; birth defect (unspecified) was present after usage of interferon β-1a and methylprednisolone sodium succinate. An illness (heart murmur) was present after the use of monohydrate sodium salt of metamizole. Another illness (Wilm's tumour) was present after the use of budesonide. Unspecified information about the newborn was observed in four cases after the use of prednisone, allopurinol, nadroparin, and fluvastatin.

Approaches to accelerating the study of new antiretrovirals in pregnancy.

IntroductionWomen who are pregnant or who could become pregnant experience delayed access to or underinformed use of important new antiretroviral (ARV) drugs because of traditional drug development processes that ostensibly aim to reduce potential harm but effectively fail to ensure that timely information about safe and effective use in pregnancy is available.DiscussionThe World Health Organization and International Maternal, Pediatric, Adolescent Antiretroviral Clinical Trials Network convened a year‐long workshop on “Approaches to Enhance and Accelerate Study of New Drugs for HIV and Associated Infections in Pregnant Women.” Workshop participants were tasked with defining key principles and optimal approaches to including pregnant women in pre‐ and post‐licensure trials in order to accelerate the availability of pharmacokinetic and safety data for new ARV agents in pregnancy. ARV efficacy in pregnancy and ARV efficacy for prevention of vertical transmission can be extrapolated from proof of efficacy in non‐pregnant adults, provided that drug levels in pregnancy are similar. However, short‐term safety and pharmacokinetics must be studied directly in pregnant women and should be conducted and included in initial licensure for all new ARVs. Accelerating the timeline for completion of pre‐clinical studies is essential for pregnancy short‐term safety and pharmacokinetic studies to be safely completed by the time a drug is licensed. Composite key pregnancy, birth and neonatal outcomes are critical for drugs expected to have broad use, and studies should be initiated at or soon after drug licensure. Teratogenicity risk cannot be feasibly assessed before drug licensure and will depend on robust post‐marketing surveillance systems. With some modifications, these principles will apply to ARVs used for prevention, two‐drug regimens, long‐acting ARVs and ARVs administered through novel delivery systems.ConclusionsImplementation of the proposed principles and framework will enhance and accelerate the study of new ARVs in pregnancy, resulting in more timely, equitable and informed access to new ARVs for pregnant women.

The Perioperative Management of Antiplatelet and Anticoagulant Drugs in Hip Fractures: Do the Surgery as Early as Possible.

Hip fractures are among the most common fractures operated by orthopedic surgeons. Many elderly patients, who account for a significant percentage of hip fractures, suffer from medical conditions requiring antiplatelet and anticoagulant administration. Meanwhile, considerable evidence recommends early surgery within 48b hours of admission. We aim to review the existing evidence regarding the perioperative management of antiplatelet and anticoagulant drugs in hip fractures. It was concluded that surgery for hip fractures in patients with antiplatelet drug consumption should not be delayed unless a clear contraindication exists. Active reversal strategies are indicated for patients with hip fractures and warfarin therapy. However, evidence for the safety of these agents in pregnancy, breastfeeding state, and adolescence has not yet been established. Little data exists about perioperative management of direct-acting oral anticoagulants in hip fractures. Early surgery after 12-24 hours of drug cessation has been suggested in studies; however, it should be employed cautiously. Despite extensive research, the importance of the issue necessitates additional higher-quality studies.

How Could Nanomedicine Improve the Safety of Contrast Agents for MRI during Pregnancy?

Pregnancy is a delicate state, during which timely investigation of possible physiological anomalies is essential to reduce the risk of maternal and fetal complications. Medical imaging encompasses different technologies to image the human body for the diagnosis, course of treatment management, and follow-up of diseases. Ultrasound (US) is currently the imaging system of choice for pregnant patients. However, sonographic evaluations can be non-effective or give ambiguous results. Therefore, magnetic resonance imaging (MRI), due to its excellent tissue penetration, the possibility of acquisition of three-dimensional anatomical information, and its high spatial resolution, is considered a valid diagnostical alternative. Nevertheless, currently employed contrast agents to improve the MRI image quality are harmful to the fetus. Because of their ability to cross the placenta, their use on pregnant patients is avoided. This review will firstly recapitulate the most common non-obstetrical, obstetrical, and fetal indications for magnetic resonance imaging on pregnant women. Fetal safety risks, due to the use of strong magnetic fields and exogenous contrast agents, will be presented. Then, possible advantages of nanostructured contrast agents compared to current molecular ones are explored. Nanosystems’ characteristics affecting contrast efficiency, and their potential for improving contrast-enhanced MRI’s safety in pregnant women, are discussed. Lastly, promising examples of nanoparticles as safer alternatives to current MRI contrast agents in pregnancy are discussed.

Does hemoglobin A1c level predict need for hypoglycemic agents in gestational diabetes?

There is minimal data regarding the clinical utility of hemoglobin A1c (HbA1c) to predict the severity of gestational diabetes mellitus (GDM). We evaluated whether HbA1c level at time of GDM diagnosis predicted need for hypoglycemic agents in pregnancy.

Dynamic contrast enhanced magnetic resonance imaging: A review of its application in the assessment of placental function.

It is important to develop a better understanding of placental insufficiency given its role in common maternofetal complications such as preeclampsia and fetal growth restriction. Functional magnetic resonance imaging offers unprecedented techniques for exploring the placenta under both normal and pathological physiological conditions. Dynamic contrast-enhanced magnetic resonance imaging (DCE MRI) is an established and very robust method to investigate the microcirculatory parameters of an organ and more specifically its perfusion. It is currently a gold standard in the physiological and circulatory evaluation of an organ. Its application to the human placenta could enable to access many microcirculatory parameters relevant to the placental function such as organ blood flow, fractional blood volume, and permeability surface area, by the acquisition of serial images, before, during, and after administration of an intravenous contrast agent. Widely used in animal models with gadolinium-based contrast agents, its application to the human placenta could be possible if the safety of contrast agents in pregnancy is established or they are confirmed to not cross the placenta.

Safety of anti-TNF agents in pregnancy

Safety of anti-TNF agents in pregnancy

Placental transfer of doravirine, a recent HIV-1 NNRTI in the ex vivo human cotyledon perfusion model.

The recent HIV-1 NNRTI doravirine is likely to be used in pregnant women despite the complete lack of data on safety and exposure in the fetus. The objective of this study was to determine its placental transfer. Maternal-to-fetal transfer was investigated using the open-circuit ex vivo dually perfused human cotyledon model. Doravirine was added to a maternal perfusate (theoretical doravirine concentration of 250 ng/mL) containing 2 g/L human albumin and 20 g/L antipyrine, a marker to validate the cotyledon's viability, and cotyledons were dually perfused for up to 90 min. In five experiments, the median (IQR) doravirine concentrations in the maternal and fetal compartments were, respectively, 303 (178-420) and 40 (30-54) ng/mL, the fetal-to-maternal ratio was 16% (12%-18%) and the clearance index (in comparison with antipyrine transfer) was 48% (35%-64%). The median accumulation index in cotyledon tissue was 39% (range 10%-66%). Doravirine both crosses and accumulates in the placenta. This may be useful as pre/post-exposure prophylaxis to reduce the risk of vertical HIV transmission but carries the potential for fetal toxicities. Further investigation is required to determine the safety and efficacy of this new antiretroviral agent in pregnancy.

N-acetylcysteine, xCT and suppression of Maxi-chloride channel activity in human placenta

IntroductionPlacental oxidative stress features in pregnancy pathologies but in clinical trials antioxidant supplementation has not improved outcomes. N-acetylcysteine (NAC) stimulates glutathione production and is proposed as a therapeutic agent in pregnancy. However, key elements of N-acetylcysteine biology, including its cellular uptake mechanism, remains unclear. This study explores how the cystine/glutamate transporter xCT may mediate N-acetylcysteine uptake and how N-acetylcysteine alters placental redox status. MethodsThe involvement of xCT in NAC uptake by the human placenta was studied in perfused placenta and Xenopus oocytes. The effect of short-term N-acetylcysteine exposure on the placental villous proteome was determined using LC-MS. The effect of N-acetylcysteine on Maxi-chloride channel activity was investigated in perfused placenta, villous fragments and cell culture. ResultsMaternoplacental N-acetylcysteine administration stimulated intracellular glutamate efflux suggesting a role of the exchange transporter xCT, which was localised to the microvillous membrane of the placental syncytiotrophoblast. Placental exposure to a bolus of N-acetylcysteine inhibited subsequent activation of the redox sensitive Maxi-chloride channel independently of glutathione synthesis. Stable isotope quantitative proteomics of placental villi treated with N-acetylcysteine demonstrated changes in pathways associated with oxidative stress, apoptosis and the acute phase response. DiscussionThis study suggests that xCT mediates N-acetylcysteine uptake into the placenta and that N-acetylcysteine treatment of placental tissue alters the placental proteome while regulating the redox sensitive Maxi-chloride channel. Interestingly N-acetylcysteine had antioxidant effects independent of the glutathione pathway. Effective placental antioxidant therapy in pregnancy may require maintaining the balance between normalising redox status without inhibiting physiological redox signalling.

POS-186 AMLODIPINE AS AN ALTERNATIVE ANTIHYPERTENSIVE IN PREGNANCY: A SYSTEMATIC REVIEW

Hypertension complicates up to 10% of UK pregnancies and is associated with three to five-fold increased risk of pre-eclampsia and adverse perinatal outcome with associated long-term increased risk of cardiovascular disease. The selection of antihypertensive agents in pregnancy is restricted due to concerns over potential adverse effects on the fetus. Amlodipine is used as a first line agent to manage hypertension in many settings outside pregnancy but its safety in human pregnancy is uncertain.Our objective was perform a systematic review of amlodipine use in pregnancy and its association with adverse maternal and perinatal outcome.

Gelingt das Screening von Schwangeren auf HIV, Syphilis und Hepatitis\xa0B in Deutschland? Eine Analyse auf Basis von Routinedaten

ZusammenfassungHintergrundInfektionen in der Schwangerschaft sind weltweit eine der führenden Ursachen für erhöhte Morbidität und Mortalität bei Müttern und ihren Neugeborenen. In Deutschland gibt es seit mehr als 50 Jahren eine standardisierte Gesundheitsvorsorge in der Schwangerschaft. Die Mutterschafts-Richtlinien des Gemeinsamen Bundesausschusses bilden hierzu den gesetzlichen Rahmen und umfassen unter anderem das Screening von Schwangeren auf HIV, Syphilis und Hepatitis B.Ziel der ArbeitIm Rahmen dieser Arbeit soll eruiert werden, wie hoch die Abdeckung des Screenings in der deutschen Bevölkerung ist.Material und MethodenMithilfe von anonymisierten Routinedaten von gesetzlich Versicherten, die dem Institut für angewandte Gesundheitsforschung Berlin GmbH (InGef) aus den Jahren 2011 bis 2015 vorliegen, wurde mithilfe von verschiedenen Internationale statistische Klassifikationsziffern der Krankheiten und verwandter Gesundheitsprobleme(ICD-10)- und Einheitlicher Bewertungsmaßstab(EBM)-Ziffern eine Definition für Schwangerschaft entwickelt und eine erste Auswertung zur Inanspruchnahme von Testungen auf Infektionserreger in der Schwangerschaft vorgenommen.ErgebnisseDer hohe Anteil von Frauen, die im Rahmen der Schwangerschaft auf Syphilis (95,3 %) und Hepatitis B (91,6 %) getestet werden, spricht für eine sehr gute Erreichbarkeit und Inanspruchnahme von vorgeburtlichen Screeningangeboten. Bei HIV ist der Anteil an getesteten Frauen deutlich niedriger (84,9 %).DiskussionOb Schwangere einen HIV-Test ablehnen, der Test anderweitig durchgeführt oder nicht durch das ärztliche Personal empfohlen wurde, lässt sich anhand der vorliegenden Datenlage nicht klären. Angesichts der hochwirksamen medizinischen Interventionsmöglichkeiten für Syphilis, HIV und Hepatitis B ist eine möglichst vollständige Testung von Schwangeren in Deutschland anzustreben. Die Gründe für fehlende Screeninguntersuchungen müssen weiter eruiert und Ansatzpunkte für eine Steigerung der Inanspruchnahme identifiziert werden.

The Moral Imperative to Include Pregnant Women in Clinical Trials of Interventions for COVID-19

Although the number of clinical trials for patients with COVID-19 is increasing, many exclude pregnant women as participants or do not address pregnancy. This commentary discuss why pregnancy women should be included in clinical trials of interventions for COVID-19.

An Unusual Type of Lymphomatoid Papulosis Presenting in Pregnancy: Risk-Benefit Analysis of Antepartum Treatment [18H

INTRODUCTION: Lymphomatoid papulosis (LyP) has an incidence of 2 per 1,000,000 and is associated with lymphoproliferative disorders. Type E, characterized by angioinvasion, is the rarest subtype and is associated with CD30 and CD8 expression. LyP is associated with immune compromising disorders, making pregnancy a potential setting for presentation. We present one of the first cases of LyP type E in pregnancy. METHODS: Case: 30-year-old G5P3, with a pregnancy complicated by a history of hemolysis, elevated liver enzymes and low platelet count syndrome in a previous pregnancy, presented in early pregnancy with a two month history of diffuse painful skin lesions. As the pregnancy progressed, the lesions spread and would blister and ulcerate before resolving. Biopsy returned with CD30+ angioinvasive LyP type E. Prednisone and topical steroids provided minimal symptomatic improvement. Peginterferon alfa-2a was offered as an alternative therapy; however, was deferred until after delivery. CONCLUSION: Appropriate diagnosis of LyP and subtype as well as multi-disciplinary follow-up is essential given possible associated lymphoproliferative disorders. Treatment may involve more risk than benefit and has not been proven to prevent associated malignancy necessitating individualized risk-benefit analysis. Conservative treatment is preferred, even in significantly symptomatic pregnant patients. In some severely symptomatic patients, peginterferon alfa-2a may be considered with a better safety profile compared to other agents in pregnancy. The angiodestructive nature of type E may be associated with pregnancy complications including those on the preeclampsia spectrum. These pregnancies may require closer monitoring and the consideration of aspirin prophylaxis. Early diagnostic biopsy will allow for timely intervention.

Multidrug Therapy for Refractory Immune Thrombocytopenia in Pregnancy

Severe immune thrombocytopenia complicating pregnancy may require treatment beyond first-line medications (intravenous immunoglobulins or corticosteroids), but there is a paucity of literature on the use of such second-line agents in pregnancy. The patient is a 29-year-old woman with early-onset severe immune thrombocytopenia at 13 weeks of gestation. Maternal platelet counts reached a nadir of less than 5×10/L. The thrombocytopenia persisted despite first-line medications. Romiplostim, rituximab, and azathioprine were added to the therapeutic regimen. Platelet counts eventually stabilized at greater than 150×10/L before delivery. After delivery at term, the neonate had transient B-cell suppression, which was presumed to be secondary to rituximab, but was otherwise doing well and meeting all milestones at 7 months of age. The addition of second-line agents was associated with sustained elevation in maternal platelet counts and may have obviated the need for splenectomy.