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8,574 result(s) for "Pregnancy Complications - drug therapy"
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EULAR recommendations for women's health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome
ObjectivesDevelop recommendations for women's health issues and family planning in systemic lupus erythematosus (SLE) and/or antiphospholipid syndrome (APS).MethodsSystematic review of evidence followed by modified Delphi method to compile questions, elicit expert opinions and reach consensus.ResultsFamily planning should be discussed as early as possible after diagnosis. Most women can have successful pregnancies and measures can be taken to reduce the risks of adverse maternal or fetal outcomes. Risk stratification includes disease activity, autoantibody profile, previous vascular and pregnancy morbidity, hypertension and the use of drugs (emphasis on benefits from hydroxychloroquine and antiplatelets/anticoagulants). Hormonal contraception and menopause replacement therapy can be used in patients with stable/inactive disease and low risk of thrombosis. Fertility preservation with gonadotropin-releasing hormone analogues should be considered prior to the use of alkylating agents. Assisted reproduction techniques can be safely used in patients with stable/inactive disease; patients with positive antiphospholipid antibodies/APS should receive anticoagulation and/or low-dose aspirin. Assessment of disease activity, renal function and serological markers is important for diagnosing disease flares and monitoring for obstetrical adverse outcomes. Fetal monitoring includes Doppler ultrasonography and fetal biometry, particularly in the third trimester, to screen for placental insufficiency and small for gestational age fetuses. Screening for gynaecological malignancies is similar to the general population, with increased vigilance for cervical premalignant lesions if exposed to immunosuppressive drugs. Human papillomavirus immunisation can be used in women with stable/inactive disease.ConclusionsRecommendations for women's health issues in SLE and/or APS were developed using an evidence-based approach followed by expert consensus.
Safety and efficacy of dihydroartemisinin–piperaquine for intermittent preventive treatment of malaria in pregnant women with HIV from Gabon and Mozambique: a randomised, double-blind, placebo-controlled trial
The cornerstone of malaria prevention in pregnancy, intermittent preventive treatment (IPTp) with sulfadoxine–pyrimethamine, is contraindicated in women with HIV who are receiving co-trimoxazole prophylaxis. We assessed whether IPTp with dihydroartemisinin–piperaquine is safe and effective in reducing the risk of malaria infection in women with HIV receiving co-trimoxazole prophylaxis and antiretroviral drugs. For this randomised, double-blind, placebo-controlled clinical trial, women with HIV attending the first antenatal care clinic visit, resident in the study area, and with a gestational age up to 28 weeks were enrolled at five sites in Gabon and Mozambique. Participants were randomly assigned (1:1) to receive either IPTp with dihydroartemisinin–piperaquine at each scheduled antenatal care visit plus daily co-trimoxazole (intervention group) or placebo at each scheduled antenatal care visit plus daily co-trimoxazole (control group). Randomisation was done centrally via block randomisation (block sizes of eight), stratified by country. IPTp was given over 3 days under direct observation by masked study personnel. The number of daily IPTp tablets was based on bodyweight and according to the treatment guidelines set by WHO (target dose of 4 mg/kg per day [range 2–10 mg/kg per day] of dihydroartemisinin and 18 mg/kg per day [range 16–27 mg/kg per day] of piperaquine given once a day for 3 days). At enrolment, all participants received co-trimoxazole (fixed combination drug containing 800 mg trimethoprim and 160 mg sulfamethoxazole) for daily intake. The primary study outcome was prevalence of peripheral parasitaemia detected by microscopy at delivery. The modified intention-to-treat population included all randomly assigned women who had data for the primary outcome. Secondary outcomes included frequency of adverse events, incidence of clinical malaria during pregnancy, and frequency of poor pregnancy outcomes. All study personnel, investigators, outcome assessors, data analysts, and participants were masked to treatment assignment. This study is registered with ClinicalTrials.gov, NCT03671109. From Sept 18, 2019, to Nov 26, 2021, 666 women (mean age 28·5 years [SD 6·4]) were enrolled and randomly assigned to the intervention (n=332) and control (n=334) groups. 294 women in the intervention group and 308 women in the control group had peripheral blood samples taken at delivery and were included in the primary analysis. Peripheral parasitaemia at delivery was detected in one (<1%) of 294 women in the intervention group and none of 308 women in the control group. The incidence of clinical malaria during pregnancy was lower in the intervention group than in the control group (one episode in the intervention group vs six in the control group; relative risk [RR] 0·12, 95% CI 0·03–0·52, p=0·045). In a post-hoc analysis, the composite outcome of overall malaria infection (detected by any diagnostic test during pregnancy or delivery) was lower in the intervention group than in the control group (14 [5%] of 311 women vs 31 [10%] of 320 women; RR 0·48, 95% CI 0·27–0·84, p=0·010). The frequency of serious adverse events and poor pregnancy outcomes (such as miscarriages, stillbirths, premature births, and congenital malformations) did not differ between groups. The most frequently reported drug-related adverse events were gastrointestinal disorder (reported in less than 4% of participants) and headache (reported in less than 2% of participants), with no differences between study groups. In the context of low malaria transmission, the addition of IPTp with dihydroartemisinin–piperaquine to co-trimoxazole prophylaxis in pregnant women with HIV did not reduce peripheral parasitaemia at delivery. However, the intervention was safe and associated with a decreased risk of clinical malaria and overall Plasmodium falciparum infection, so it should be considered as a strategy to protect pregnant women with HIV from malaria. European and Developing Countries Clinical Trials Partnership 2 (EDCTP2) and Medicines for Malaria Venture. For the Portuguese and French translations of the abstract see Supplementary Materials section.
Impact of Inherited Thrombophilia on Pregnancy Complications and the Role of Low-Molecular-Weight Heparin Therapy: A Case–Control Study
Background and Objectives: Inherited thrombophilia (IT) increases the risk of adverse pregnancy outcomes, but the benefit of low-molecular-weight heparin (LMWH) prophylaxis remains debated. This study aimed evaluate the effect of LMWH by analyzing outcomes in women with IT who received LMWH versus those who did not and also compare pregnancy complication rates before and after inherited thrombophilia diagnosis. Materials and Methods: We conducted a retrospective case–control study including 276 pregnant women with inherited thrombophilia and prior pregnancy complications and 276 healthy pregnant controls on delivery. The main outcome was the incidence of complications: preterm rupture of membranes, oligohydramnios, fetal growth restriction, preterm delivery, stillbirth, HELLP syndrome, gestational hypertension, deep vein thrombosis, and recurrent pregnancy loss. The effect of LMWH was assessed by comparing complication rates among inherited thrombophilia patients who received therapy versus those who did not. Results: Women with IT were older, had higher BMI, delivered earlier, and had neonates with lower birth weight compared to controls. In current pregnancies, LMWH was associated with reduced rates of preterm delivery, fetal growth restriction, gestational hypertension, and recurrent pregnancy loss, especially in factor V Leiden carriers. LMWH had little effect on low-risk genotypes and was not independently associated with outcome reduction. Conclusions: LMWH prophylaxis should be reserved for high-risk women with IT. Routine use in all IT pregnancies is not justified and may cause unnecessary risks and costs. Early screening, risk stratification, and individualized care are essential to optimize outcomes.
Impact of Microscopic and Submicroscopic Parasitemia During Pregnancy on Placental Malaria in a High-Transmission Setting in Uganda
In pregnant women assessed for parasitemia every 28 days, the risk of placental malaria increased in a dose-response relationship with both increasing frequency and density of parasitemia; however, even women with only submicroscopic parasitemia were at risk for placental malaria.
Triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV-1 (Kesho Bora study): a randomised controlled trial
Breastfeeding is essential for child health and development in low-resource settings but carries a significant risk of transmission of HIV-1, especially in late stages of maternal disease. We aimed to assess the efficacy and safety of triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis in pregnant women infected with HIV. Pregnant women with WHO stage 1, 2, or 3 HIV-1 infection who had CD4 cell counts of 200–500 cells per μL were enrolled at five study sites in Burkina Faso, Kenya, and South Africa to start study treatment at 28–36 weeks' gestation. Women were randomly assigned (1:1) by a computer generated random sequence to either triple antiretroviral prophylaxis (a combination of 300 mg zidovudine, 150 mg lamivudine, and 400 mg lopinavir plus 100 mg ritonavir twice daily until cessation of breastfeeding to a maximum of 6·5 months post partum) or zidovudine and single-dose nevirapine (300 mg zidovudine twice daily until delivery and a dose of 600 mg zidovudine plus 200 mg nevirapine at the onset of labour and, after a protocol amendment in December, 2006, 1 week post-partum zidovudine 300 mg twice daily and lamivudine 150 mg twice daily). All infants received a 0·6 mL dose of nevirapine at birth and, from December, 2006, 4 mg/kg twice daily of zidovudine for 1 week after birth. Patients and investigators were not masked to treatment. The primary endpoints were HIV-free infant survival at 6 weeks and 12 months; HIV-free survival at 12 months in infants who were ever breastfed; AIDS-free survival in mothers at 18 months; and serious adverse events in mothers and babies. Analysis was by intention to treat. This trial is registered with Current Controlled Trials, ISRCTN71468401. From June, 2005, to August, 2008, 882 women were enrolled, 824 of whom were randomised and gave birth to 805 singleton or first, liveborn infants. The cumulative rate of HIV transmission at 6 weeks was 3·3% (95% CI 1·9–5·6%) in the triple antiretroviral group compared with 5·0% (3·3–7·7%) in the zidovudine and single-dose nevirapine group, and at 12 months was 5·4% (3·6–8·1%) in the triple antiretroviral group compared with 9·5% (7·0–12·9%) in the zidovudine and single-dose nevirapine group (p=0·029). The cumulative rate of HIV transmission or death at 12 months was 10·2% (95% CI 7·6–13·6%) in the triple antiretroviral group compared with 16·0% (12·7–20·0%) in the zidovudine and single-dose nevirapine group (p=0·017). In infants whose mothers declared they intended to breastfeed, the cumulative rate of HIV transmission at 12 months was 5·6% (95% CI 3·4–8·9%) in the triple antiretroviral group compared with 10·7% (7·6–14·8%) in the zidovudine and single-dose nevirapine group (p=0·02). AIDS-free survival in mothers at 18 months will be reported in a different publication. The incidence of laboratory and clinical serious adverse events in both mothers and their babies was similar between groups. Triple antiretroviral prophylaxis during pregnancy and breastfeeding is safe and reduces the risk of HIV transmission to infants. Revised WHO guidelines now recommend antiretroviral prophylaxis (either to the mother or to the baby) during breastfeeding if the mother is not already receiving antiretroviral treatment for her own health. Agence nationale de recherches sur le sida et les hépatites virales, Department for International Development, European and Developing Countries Clinical Trials Partnership, Thrasher Research Fund, Belgian Directorate General for International Cooperation, Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and UNDP/UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction.
Considerations in the management of ocular toxoplasmosis in pregnancy: a review of literature
Ocular toxoplasmosis is the most common cause of infectious posterior uveitis. Available literature is still conflicting regarding the incidence of recurrence during pregnancy as various calculations were employed in the different published studies. Although earlier reports have suggested a difference in presentation and an increase in severity during pregnancy, newer studies appear to show otherwise. Further diagnostic testing, including serologic and intraocular fluid sampling, may be indicated to increase the diagnostic accuracy in this special population of patients. The management of ocular toxoplasmosis during pregnancy is challenging as the foetus is additionally considered in the choice of treatment. Traditionally preferred anti-toxoplasmosis regimens containing antifolate drugs, such as pyrimethamine and trimethoprim-sulfamethoxazole, cannot be used routinely in pregnant patients, especially during the first trimester. This review includes literature on alternative treatments for ocular toxoplasmosis during pregnancy, including spiramycin and intravitreal treatment options.
Evaluation of Medication-mediated Effects in Pharmacoepidemiology
Medical conditions such as epilepsy or infection with human immunodeficiency virus (HIV) are known to be associated with a spectrum of adverse health outcomes if not appropriately managed by efficacious treatment and care. Medications for such conditions can be potent, and their use might sometimes have unintended health consequences. Prominent examples have emerged in HIV perinatal research in which use of antiretroviral treatment during pregnancy to treat maternal HIV infection and prevent transmission of the virus to the fetus have been shown to be associated with adverse birth outcomes. Likewise, use of antiepileptic drugs during pregnancy to treat maternal epilepsy has been shown to increase the risk of birth defects. Pharmacoepidemiology studies routinely aim to quantify the extent to which, in such settings, an observed association between an underlying medical condition and certain health outcomes can be attributed to the natural progression of the disease, and the extent to which it might be mediated by medication used to slow disease progression. We describe a simple yet principled methodology to quantify medication-mediated effects to address these types of queries. While methods for causal mediation analysis abound, there also has been much criticism of these methods as relying on untestable and sometimes unrealistic assumptions. In contrast, here we show that when the disease-free control group is also medication-free, mediated effects of the type described above are nonparametrically identified under standard no-unobserved confounding conditions, thus establishing that such effects are in a sense immune to recent criticism leveled at causal mediation methodology.
Coronavirus disease 2019 (COVID-19) in a pregnant women with treatment resistance thrombocytopenic purpura with and suspicion to HELLP syndrome: a case report
Background Coronavirus disease 2019 (COVID-19) still is a global emergency. According to the studies, pregnant women are of the at risk populations and any underlying disease(s) might even worsen their condition. The aim of this study is reporting a complex case of immune thrombocytopenic purpura (ITP) during pregnancy who has been diagnosed with COVID-19 as well as suspicion of HELLP syndrome. Case presentation A 24-year-old woman with a platelet count of 6000/mL and resistance to conventional therapies was referred. A day after starting 0.5 g/day of methylprednisolone for her, fever and a decrease in SpO2 presented. According to the paraclinical investigations, COVID-19 was diagnosed and the conventional COVID-19 treatments started for her (the methylprednisolone pulse stopped). Due to the increased liver enzymes and low platelet count, with suspicion of HELLP syndrome, cesarean section surgery was performed which resulted in a healthy neonate. Then, the methylprednisolone pulse was restarted for and she developed an increase in the platelet count. Conclusion It is not clear how COVID-19 and pregnancy affected the patient’s condition and the underlying disease; however, it seems the delivery and/or restarting the methylprednisolone pulses caused improvement in her condition.
Omega-3 fatty acids for the treatment of hypertriglyceridemia during the second trimester
Serum triacylglycerol (TG) levels increase during pregnancy. High serum TG levels may elicit acute pancreatitis; therefore, it is important that pregnant women are managed well to abrogate the rapid rise of TG levels in pregnancy. The aim of this study was to report on the effect of eicosapentaenoic acid administration on pregnant women with hypertriacylglycerolemia in the second trimester. We report on four patients who presented to Kumamoto University Hospital from January 2005 to March 2013. All four patients delivered neonates at term without complicating acute pancreatitis. Additionally, in three cases of multipara, the maximum serum TG levels were decreased to 10% to 49% of their preceding pregnancy. Oral eicosapentaenoic acid administration might be a safe and useful treatment for hypertriacylglycerolemia during pregnancy and may prevent the development of acute pancreatitis.
Epilepsy in pregnancy and reproductive outcomes: a systematic review and meta-analysis
Antenatal care of women with epilepsy is varied. The association of epilepsy and antiepileptic drug exposure with pregnancy outcomes needs to be quantified to guide management. We did a systematic review and meta-analysis to investigate the association between epilepsy and reproductive outcomes, with or without exposure to antiepileptic drugs. We searched MEDLINE, Embase, Cochrane, AMED, and CINAHL between Jan 1, 1990, and Jan 21, 2015, with no language or regional restrictions, for observational studies of pregnant women with epilepsy, which assessed the risk of obstetric complications in the antenatal, intrapartum, or postnatal period, and any neonatal complications. We used the Newcastle-Ottawa Scale to assess the methodological quality of the included studies, risk of bias in the selection and comparability of cohorts, and outcome. We assessed the odds of maternal and fetal complications (excluding congenital malformations) by comparing pregnant women with and without epilepsy and undertook subgroup analysis based on antiepileptic drug exposure in women with epilepsy. We summarised the association as odds ratio (OR; 95% CI) using random effects meta-analysis. The PROSPERO ID of this Systematic Review's protocol is CRD42014007547. Of 7050 citations identified, 38 studies from low-income and high-income countries met our inclusion criteria (39 articles including 2 837 325 pregnancies). Women with epilepsy versus those without (2 809 984 pregnancies) had increased odds of spontaneous miscarriage (OR 1·54, 95% CI 1·02–2·32; I2=67%), antepartum haemorrhage (1·49, 1·01–2·20; I2=37%), post-partum haemorrhage (1·29, 1·13–1·49; I2=41%), hypertensive disorders (1·37, 1·21–1·55; I2=23%), induction of labour (1·67, 1·31–2·11; I2=64%), caesarean section (1·40, 1·23–1·58; I2=66%), any preterm birth (<37 weeks of gestation; 1·16, 1·01–1·34; I2=64%), and fetal growth restriction (1·26, 1·20–1·33; I2=1%). The odds of early preterm birth, gestational diabetes, fetal death or stillbirth, perinatal death, or admission to neonatal intensive care unit did not differ between women with epilepsy and those without the disorder. A small but significant association of epilepsy, exposure to antiepileptic drugs, and adverse outcomes exists in pregnancy. This increased risk should be taken into account when counselling women with epilepsy. EBM CONNECT Collaboration.