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BACKGROUND SARS-CoV-2 positive pregnant women are at higher risk of adverse outcomes, but little evidence is available on how variants impact that risk. We aim to evaluate maternal and perinatal outcomes among unvaccinated pregnant women that tested positive for SARS-CoV-2, stratified by pre-Delta, Delta, and Omicron periods. METHODS This prospective study enrolled women from March 2020 to September 2022. Exposure to the different SARS-CoV-2 variants was defined by their periods of predominance. The primary outcome was severe maternal adverse outcome defined as either intensive care unit admission, acute respiratory distress syndrome, advanced oxygen supplementation, or maternal death. The secondary outcomes were preterm birth and other perinatal outcomes. FINDINGS Overall, 1402, 262, and 391 SARS-CoV-2 positive pregnant women were enrolled during the pre-Delta, Delta, and Omicron periods respectively. Severe maternal adverse outcome was reported in 3.4% (n = 947/1402; 95% confidence intervals (95%CI) 2.5-4.5), 6.5% (n = 7/262; 95%CI 3.8-10.2), and 1.0% (n = 4/391; 95%CI 0.3-2.6) of women during the pre-Delta, Delta, and Omicron periods. The risk of severe maternal adverse outcome was higher during the Delta vs pre-Delta period (adjusted risk ratio (aRR) = 1.8; 95%CI 1.1-3.2) and lower during the Omicron vs pre-Delta period (aRR = 0.3; 95%CI, 0.1-0.8). The risks of hospitalization for COVID-19 were 12.6% (n = 176/1402; 95%CI 10.9-14.4), 17.2% (n = 45/262; 95%CI 12.8-22.3), and 12.5% (n = 49/391; 95%CI 9.4-16.2), during the pre-Delta, Delta, and Omicron period, respectively. Pregnancy complications occurred after SARS-CoV-2 exposure in 30.0% (n = 363/1212; 95%CI 27.4-32.6), 35.2% (n = 83/236; 95%CI 29.1-41.6), and 30.3% (n = 105/347; 95%CI 25.5-35.4) of patients during the pre-Delta, Delta, and Omicron periods, respectively. Stillbirths were reported in 0.5% (n = 6/1159; 95%CI 0.2-1.1), 2.8% (n = 6/210; 95%CI 1.0-6.0), and 0.9% (n = 2/213; 95%CI 0.1-3.4) or patients during the pre-Delta, Delta, and Omicron periods respectively. INTERPRETATION The Delta period was associated with a higher risk of severe maternal adverse outcome and the Omicron period with a lower risk of severe adverse outcome compared to pre-Delta era. The reported risk of hospitalization was high during the Omicron period and should not be trivialized. FUNDING Swiss Federal Office of Public Health, Fondation CHUV.

Dank der Fortschritte bei antiretroviralen Therapien kommen vertikale HIV-Transmissionen von der Mutter wahrend Schwangerschaft, Entbindung oder Stillzeit auf das Kind bei vollstandig unterdruckter Virusreplikation fast nicht mehr vor. Auch eine vaginale Entbindung ist dann nicht unbedingt ausgeschlossen. Generell gibt es bei Muttern mit HIV aber einige Dinge zu beachten.

Background: Pregnant women represent a vulnerable population at higher risk of complications of infectious diseases. Data regarding the consequences of the emerging pandemic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy are scarce. Recent evidence suggests that pregnant women might be at higher risk of severe disease, while exposed fetuses and newborns could suffer from preterm birth, growth restriction and neonatal infections. Methods: We developed an international web registry to allow structured data collection. Pregnant women at any stage during gestation tested for SARS-CoV-2 infection were enrolled. Maternal, obstetrical and neonatal outcomes were recorded. Findings: 1033 pregnant women tested for SARS-CoV-2 were included, among which 926 tested positive and 107 tested negative. Positive pregnant women were at higher risk of severe maternal outcomes compared to negative women [aRR 5.6, 95% CI 1.4-22.7]. Risk factors for severe maternal outcomes among positive women were pulmonary comorbidities [aOR 4.3, 95% CI 1.9-9.5], hypertensive disorders [aOR 2.7, 95% CI 1.0-7.0] and diabetes [aOR2.2, 95% CI 1.1-4.5]. No difference in term of obstetrical and neonatal outcomes were observed between positive and negative women. Positive pregnant women with severe maternal outcomes were at higher risk of cesarean sections [70.7% (n=53/75)], preterm deliveries [62.7% (n= 32/51)] and newborns requiring admission to the neonatal intensive care unit [41.3% (n=31/75)]. A positive neonatal SARS-CoV-2 test was observed in 2.9% (n=11/384) of newborns with an available test at birth. Interpretation: Pregnant women, particularly those with associated comorbidities, seem to be at higher risk of severe complications of SARS-CoV-2 infection. Preliminary data regarding obstetrical and neonatal outcomes among women with a mild disease are reassuring. Funding Statement: None. Declaration of Interests: The authors declare that we have no conflicts of interest. Ethics Approval Statement: The study was approved by both the Swiss Ethical Board (CER-VD-2020-00548) and the local ethics boards at each participating center.

Background: Recent evidence suggests that pregnant women might be at higher risk of severe disease associated with the emerging pandemic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), while exposed fetuses/newborns could suffer from preterm birth, growth restriction and neonatal infections. The magnitude of this increased risk and specific risk factors for severity remains unclear. Methods: We performed a case control study comparing pregnant women with severe coronavirus disease 19 (case) to pregnant women with a milder form (controls) enrolled in COVI-Preg international registry cohort between from March 24 to July 26, 2020. Risk factors for severity, obstetrical, fetal and neonatal outcomes were assessed. Findings: A total of 926 pregnant women with a positive test for SARS-CoV-2 were included, among which 92 (9.9%) presented a severe COVID-19 disease. Risk factors for severe maternal outcomes were pulmonary comorbidities [aOR 4.3, 95% CI 1.9-9.5], hypertensive disorders [aOR 2.7, 95% CI 1.0-7.0] and diabetes [aOR2.2, 95% CI 1.1-4.5]. Pregnant women with severe maternal outcomes were at higher risk of cesarean sections [70.7% (n=53/75)], preterm deliveries [62.7% (n= 32/51)] and newborns requiring admission to the neonatal intensive care unit [41.3% (n=31/75)]. Interpretation: Pregnant women, particularly those with associated comorbidities, seem to be at higher risk of severe complications of SARS-CoV-2 infection. Obstetrical and neonatal outcomes appear to be influenced by the severity of maternal disease; complications include cesarean sections, prematurity and neonatal admission to the intensive care unit. Funding Statement: None. Declaration of Interests: The authors declare that they have no conflicts of interest. Ethics Approval Statement: The study was approved by both the Swiss Ethical Board (CER-VD- 2020-00548) and the local ethics boards at each participating center.

Der Einsatz und Erfolg der kombinierten antiretroviralen Therapie hat dazu geführt, dass heterosexuelle sowie vertikale HIV-Transmissionen nur noch selten vorkommen. HIV-infizierte Frauen werden immer häufiger schwanger und können durch präventive Maßnahmen, v. a. in den industrialisierten Ländern, HIV-negative gesunde Kinder gebären. Im nachfolgenden Artikel gehen wir auf die Bedeutung einer HIV-Infektion und auf die wichtigsten diagnostischen sowie therapeutischen Aspekte in der Schwangerschaft ein.

The use and success of antiretroviral treatment in HIV-positive people has led to a reduction of vertical transmission of HIV. Pregnancy in HIV-positive women became more common. The success of prophylactic measures has led to a dramatic change in care of HIV-positive women. Today, a HIV-positive mother giving birth to a HIV-negative child is standard of care in industrialized countries. We describe the impact of an HIV-infection in pregnancy and outline the most important diagnostic and therapeutic aspects.Der Einsatz und Erfolg der kombinierten antiretroviralen Therapie hat dazu geführt, dass heterosexuelle sowie vertikale HIV-Transmissionen nur noch selten vorkommen. HIV-infizierte Frauen werden immer häufiger schwanger und können durch präventive Maßnahmen, v. a. in den industrialisierten Ländern, HIV-negative gesunde Kinder gebären. Im nachfolgenden Artikel gehen wir auf die Bedeutung einer HIV-Infektion und auf die wichtigsten diagnostischen sowie therapeutischen Aspekte in der Schwangerschaft ein.

Introduction : HIV-infected pregnant women are very likely to engage in HIV medical care to prevent transmission of HIV to their newborn. After delivery, however, childcare and competing commitments might lead to disengagement from HIV care. The aim of this study was to quantify loss to follow-up (LTFU) from HIV care after delivery and to identify risk factors for LTFU. Methods : We used data on 719 pregnancies within the Swiss HIV Cohort Study from 1996 to 2012 and with information on follow-up visits available. Two LTFU events were defined: no clinical visit for >180 days and no visit for >360 days in the year after delivery. Logistic regression analysis was used to identify risk factors for a LTFU event after delivery. Results : Median maternal age at delivery was 32 years (IQR 28–36), 357 (49%) women were black, 280 (39%) white, 56 (8%) Asian and 4% other ethnicities. One hundred and seven (15%) women reported any history of IDU. The majority (524, 73%) of women received their HIV diagnosis before pregnancy, most of those (413, 79%) had lived with diagnosed HIV longer than three years and two-thirds (342, 65%) were already on antiretroviral therapy (ART) at time of conception. Of the 181 women diagnosed during pregnancy by a screening test, 80 (44%) were diagnosed in the first trimester, 67 (37%) in the second and 34 (19%) in the third trimester. Of 357 (69%) women who had been seen in HIV medical care during three months before conception, 93% achieved an undetectable HIV viral load (VL) at delivery. Of 62 (12%) women with the last medical visit more than six months before conception, only 72% achieved an undetectable VL (p=0.001). Overall, 247 (34%) women were LTFU over 180 days in the year after delivery and 86 (12%) women were LTFU over 360 days with 43 (50%) of those women returning. Being LTFU for 180 days was significantly associated with history of intravenous drug use (aOR 1.73, 95% CI 1.09–2.77, p=0.021) and not achieving an undetectable VL at delivery (aOR 1.79, 95% CI 1.03–3.11, p=0.040) after adjusting for maternal age, ethnicity, time of HIV diagnosis and being on ART at conception. Conclusions : Women with a history of IDU and women with a detectable VL at delivery were more likely to be LTFU after delivery. This is of concern regarding their own health, as well as risk for sexual partners and subsequent pregnancies. Further strategies should be developed to enhance retention in medical care beyond pregnancy. (Published: 2 November 2014) Citation : Abstracts of the HIV Drug Therapy Glasgow Congress 2014 Aebi-Popp K et al. Journal of the International AIDS Society 2014, 17(Suppl 3) :19535 http://www.jiasociety.org/index.php/jias/article/view/19535 | http://dx.doi.org/10.7448/IAS.17.4.19535

Purpose of the study : Mother-to-child transmission rates in Europe are below 1% in HIV-infected women on successful combined antiretroviral therapy (cART) irrespective of mode of delivery. Consequently, most national guidelines updated between 2001 and 2009 recommended vaginal deliveries for women with undetectable or very low viral load (VL). The aim of this study was to explore the impact of these new guidelines on the rates of vaginal deliveries following complete viral suppression on cART. Methods : A pooled analysis of data on HIV-1-positive women enrolled in the Swiss Mother & Child HIV Cohort Study and the European Collaborative Study with a live birth between 2000 and 2010 was carried out. Deliveries were classified as occurring pre- or post-publication of national guidelines recommending vaginal delivery in women with low/ undetectable VL for each country. Summary of results : Overall, 2527 mothers, 2848 deliveries and 2903 births were included from 10 countries. The women were mostly Caucasian (44%) or black (47%) and had a median age of 31 at the time of delivery. They were diagnosed with HIV a median of 3.3 years before pregnancy and 84% were CDC stage A with a median CD4 cell count of 450 cells/mm 3 . 17% reported a history of injecting-drug use (IDU) and 3% current IDU. 29% of women conceived on cART, 63% started in pregnancy and 8% received no antenatal ART. The most common regimen used was PI based cART (50%). Of the deliveries, elective caesarean section (CS) was carried out in 58%, emergency CS in 17% and vaginal delivery in 23%. Of 1869 women with a VL measure within the last trimester of pregnancy, only 65% had undetectable HIV-RNA. Overall, 21% of all deliveries occurring before the guideline change were vaginal, increasing to 48% subsequently. The proportion of women with undetectable VL having a CS decreased from 29% before to 13% after the guidelines update. Conclusions : Nearly half of all deliveries subsequent to European guideline changes were vaginal. Nevertheless, there are missed opportunities to achieve fully suppressed viral load at time of delivery and to deliver vaginally in HIV infected women. Further evaluation of treatment regimens, adherence data and barriers to treatment is planned within these cohorts. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Aebi-Popp K et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18141 http://www.jiasociety.org/index.php/jias/article/view/18141 | http://dx.doi.org/10.7448/IAS.15.6.18141

Background Physiological changes associated with pregnancy may alter antiretroviral plasma concentrations and might jeopardize prevention of mother-to-child HIV transmission. Lopinavir is one of the protease inhibitors more frequently prescribed during pregnancy in Europe. We described the free and total pharmacokinetics of lopinavir in HIV-infected pregnant and non-pregnant women, and evaluated whether significant alterations in its disposition and protein binding warrant systematic dosage adjustment. Methods Plasma samples were collected at first, second and third trimester of pregnancy, at delivery, in umbilical cord and postpartum. Lopinavir free and total plasma concentrations were measured by HPLC-MS/MS. Bayesian calculations were used to extrapolate total concentrations to trough (Cmin). Results A total of 42 HIV-positive pregnant women and 37 non-pregnant women on lopinavir/ritonavir were included in the study. Compared to postpartum and control values, total lopinavir Cmin was decreased moderately (31–39%) during pregnancy, and free Cmin minimally, showing significant alteration only at delivery (-35%). However, total and free Cmin remained in all patients above the target concentrations for wild-type virus of 1,000 ng/ml, and above the unbound IC50WT of 0.64–0.77 ng/ml of lopinavir, respectively. Lopinavir free fractions remained higher during pregnancy compared to post-partum and controls, and were influenced by α-1-acid-glycoprotein and albumin decrease. Free cord-to-mother ratio (0.43) was 2.7-fold higher than total cord-to-mother ratio (0.16), suggesting higher fetal exposure. Conclusions The moderate decrease of total lopinavir concentrations during pregnancy is not associated with proportional decrease in free concentrations. Both reach a nadir at delivery, albeit not to an extent that would put treatment-naive women at risk of insufficient exposure to the free, pharmacologically active concentrations of lopinavir. No dosage adjustment is therefore needed during pregnancy as it is unlikely to further enhance treatment efficacy but could potentially increase the risk of maternal and fetal toxicity. Nonetheless, in case of viral resistance in treatment-experienced pregnant women, loss of virological control or questionable adherence, it is justified to consider lopinavir dosage adjustment based on total plasma concentration measurement.

Objective Preterm labor is a common obstetric complication. Clinical evaluation of cervical ripening to predict preterm labor has a substantial inter- and intraobserver variability. We used frequency domain near-infrared spectroscopy (FD-NIRS) to non-invasively investigate the changes of the optical properties (i.e., absorption and scattering of light) in the uterine cervix during drug-induced cervical ripening. Methods Ten volunteers scheduled for abortion were examined. Optical properties of the uterine cervix were measured and physiological parameters were calculated prior to and after induction of cervical ripening using topical misoprostol. Mean relative changes, ±standard error of the mean as well as statistical significance using the t-test were calculated for oxy- and deoxyhemoglobin, total hemoglobin, oxygen-saturation, and water. The wavelength-dependent decrease of scattering (scatter power) was calculated by an exponential fit and tested with the Wilcoxon test. Results Misoprostol induced a decrease in total hemoglobin of 21±6% (P