Contraceptive Recommendations for Women with Immune-Mediated Inflammatory Diseases: A Delphi Consensus.

INTRODUCTION: Immune-mediated inflammatory diseases (IMID) are a group of disorders characterized by chronic inflammation caused by an altered immune regulation in targeted organs or systems. IMID itself could have an implied increased risk of venous thromboembolism (VTE) and this risk varies throughout the course of the disease as well as with some contraceptive methods and treatments. The aim of this study was to present some key considerations in relation to contraception in women with IMID. METHODS: This was an exploratory study conducted in Spain following the online modified Delphi methodology with two rounds of participation. Four questionnaires were designed for each medical specialty: gastroenterology, rheumatology, dermatology, and gynecology. Each questionnaire was divided in three domains: general recommendations about IMID, specific recommendations, and contraceptive methods for patients with IMID. A 5-point Likert scale measured agreement with each statement, with an 80% agreement threshold. Following the first round, the percentage of each response was calculated for every item. Subsequently, a second round was conducted to reach a consensus on the items for which discrepancies were observed. RESULTS: A total of 52 and 50 experts participated in the first and second round, respectively. Participants agreed on the existence of a higher risk of VTE in inflammatory bowel diseases, psoriasis, and rheumatoid arthritis diseases. Regarding recommendations for contraceptive methods in patients with IMID, experts considered the hormonal intrauterine device (IUD) as a first-line contraceptive (80.0%) and low doses of progesterone-only pills if the latter is not recommended (88.0%). Most of the interviewees concurred on the importance of the patients' contraceptive needs during the disease course (98.1%). CONCLUSION: Raising awareness and promoting a multidisciplinary relationship among the physicians involved in the therapeutic decisions by considering all the risk factors when prescribing a contraceptive method is important to prevent VTE in women with IMID.

SARS-CoV-2 Infection and Preeclampsia-How an Infection Can Help Us to Know More about an Obstetric Condition.

Pregnant women with SARS-CoV-2 infection have a significantly higher risk of maternal death, ICU admission, preterm delivery, and stillbirth compared to those without infection. Additionally, the risk of preeclampsia (PE) increases in pregnant women infected with SARS-CoV-2, particularly in severe cases. The association between COVID-19 and PE is likely attributed to various mechanisms, including direct effects of the virus on trophoblast function and the arterial wall, exaggerated inflammatory response in pregnant women, local inflammation leading to placental ischemia, SARS-CoV-2-related myocardial injury, cytokine storm, and thrombotic microangiopathy. This paper aims to explore the similarities between PE and SARS-CoV-2 infection, considering COVID-19 as a valuable study model. By examining these parallels, we can enhance our knowledge and comprehension of PE. We wish to emphasize the potential for COVID-19-induced myocardial injury in pregnant women and its connection to the increased maternal mortality rate.

The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations.

INTRODUCTION: The advent of the coronavirus disease 2019 (COVID-19) pandemic has led to the development of vaccines against severe acute respiratory syndrome coronavirus 2. Prospective evidence regarding safety for pregnant people and their developing fetuses is lacking. The aim of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to estimate the relative risk of obstetric, neonatal, and infant outcomes by comparing participants vaccinated against COVID-19 during pregnancy to a reference group of people enrolled in the Pregistry International Pregnancy Exposure Registry (PIPER) who remained unvaccinated during pregnancy. METHODS: The C-VIPER and the PIPER are international, non-interventional, real-world cohort studies. Participants receiving a COVID-19 vaccine during pregnancy will be matched in the analyses by country and gestational age at enrollment to unvaccinated individuals. Self-enrolled and self-consented participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after the delivery of a live infant. Where possible, outcomes are verified by medical records. The study aims to recruit at least 500 pregnancies for each approved or authorized vaccine and will last for 5 years for each product. CONCLUSIONS: By collecting data for each vaccine brand, the C-VIPER will be able to determine individual safety profiles. The study design allows for analysis of the effects of exposure to COVID-19 vaccines during specific etiologically relevant periods of gestation. Although the sample size may be too small to detect associations with rare outcomes, the study will be used to generate hypotheses for future research. Ultimately, the C-VIPER should provide data that will allow pregnant people and their healthcare providers to make informed decisions about COVID-19 vaccination. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT04705116. Registered on 12 January, 2021. EU PAS EUPAS39096. Registered on 20 January, 2021.

Incidence of obstetric brachial plexus palsy after a training program in shoulder dystocia.

INTRODUCTION: Shoulder dystocia is a nonpreventable obstetric emergency that causes severe complications, such as obstetric brachial plexus palsy. The objective of the study was to determine the incidence of obstetric brachial plexus palsy and other neonatal complications associated with shoulder dystocia in deliveries managed in a university hospital after the implementation of a simulation-based training that was offered to all the labour and delivery staff on a voluntary basis. MATERIAL AND METHODS: Retrospective observational study including all cases of shoulder dystocia and associated complications (mainly obstetric brachial plexus palsy) documented between January 2017 and December 2020, after the implementation of the training. In addition, we collected retrospective data on cases of obstetric brachial plexus palsy that developed in the hospital before the training (2008-2016). RESULTS: In the 2017-2020 period, in the total of 125 cases of shoulder dystocia (amounting to 1.38% of vaginal deliveries), there were 14 cases of obstetric brachial plexus palsy (11.2% of the cases of shoulder dystocia), 7 clavicle fractures and 1 humerus fracture; none of the cases of obstetric brachial plexus palsy was permanent or required treatment or rehabilitation past six months. In the years preceding the training, there were 7 cases of obstetric brachial plexus palsy, 2 permanent and 5 temporary (3 of which required rehabilitation). CONCLUSION: These results reflect the importance of knowing the morbidity present in the labour and delivery ward and the potential benefit of simulation-based training programmes in the resolution of these obstetric complications.

Critical Care in SARS-CoV-2 Infected Pregnant Women: A Prospective Multicenter Study.

Evidence suggests that pregnant women are at a higher risk of complications compared to the general population when infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the reasons that lead them to need intensive care are not clear. This is a prospective multicenter study of SARS-CoV-2 positive pregnant women, registered by the Spanish Obstetric Emergency Group, with the objective to define the characteristics of the mothers who were admitted to the Intensive Care Unit (ICU) and to investigate the causes and risk factors for ICU admission. A total of 1347 infected pregnant women were registered and analyzed, of whom, 35 (2.6%) were admitted to the ICU. No differences in maternal characteristics or comorbidities were observed between ICU and non-ICU patients, except for in vitro fertilization and multiple pregnancies. The main causes of admission to the ICU were non-obstetric causes (worsening of the maternal condition and respiratory failure due to SARS-CoV-2 pneumonia, 40%) and a combination of coronavirus disease 2019 (COVID-19) symptoms and obstetrical complications (31.4%). The multivariable logistic analysis confirmed a higher risk of ICU admission when pre-eclampsia or hemorrhagic events coexist with pneumonia. The incidence of thromboembolic events and disseminated intravascular coagulation were also significantly higher among patients admitted to the ICU. Therefore, surveillance and rapid intervention should be intensified in SARS-CoV-2 infected pregnant women with the mentioned risk factors and complications. Emphasis should always be placed on anticoagulant therapy in these patients due to the increased thromboembolic risk, C-section surgery and immobilization in the ICU.

SARS-CoV-2 infection in early first-trimester miscarriages: a prospective observational study.

RESEARCH QUESTION: Is there an association between SARS-CoV-2 infection and first-trimester miscarriage? DESIGN: This multicentre prospective study included a cohort of women with first-trimester miscarriages registered consecutively by seven Spanish hospitals where universal PCR screening for SARS-CoV-2 infection was implemented with both miscarriages and deliveries. The incidence of SARS-CoV-2 infection among women with first-trimester miscarriages was compared with the rate registered in women on admission to the delivery ward within the same time frame using a mixed-effects Poisson regression analysis, considering 'hospital' as random effect. The characteristics of SARS-CoV-2 positive and negative patients who miscarried were compared through two-sided univariable analyses. RESULTS: A total of 301 miscarriages were registered, 11 (3.7%) to SARS-CoV-2 infected and 290 to non-infected women. In the same time frame as the miscarriages, 1936 deliveries were registered, 44 [2.3%] of them were SARS-CoV-2 infected. No differences in terms of SARS-CoV-2 infection incidence were observed between infected miscarriages and infected deliveries (P = 0.233). Regarding the differences observed between miscarriages in SARS-CoV-2 positive and negative women, more inevitable miscarriages occurred in the group of infected women (36.4% versus 16.5% in non-infected women; P = 0.004), and there was greater surgical management of miscarriages (27.3% versus 8.2% in non-infected women; P = 0.036), probably in line with the greater number of inevitable miscarriages observed in this group. CONCLUSIONS: No association between SARS-CoV-2 infection and risk of first-trimester miscarriage was observed; however, the type of miscarriage seems to differ between SARS-CoV-2 positive and negative women, with inevitable miscarriage being more frequent among infected women.

Screening for Vaginal and Endocervical Infections in the First Trimester of Pregnancy? A Study That Ignites an Old Debate.

OBJECTIVES: Vaginal and endocervical infections are considered a global health problem, especially after recent evidence of their association with preterm delivery and other adverse obstetric outcomes. Still, there is no consensus on the efficacy of a screening strategy for these infections in the first trimester of pregnancy. This study evaluated their prevalence and whether screening and treatment resulted as effective in reducing pregnancy and perinatal complications. METHODS: A single-center prospective observational study was designed; a sample size of 400 first-trimester pregnant women was established and they were recruited between March 2016-October 2019 at the Puerta de Hierro University Hospital (Spain). They were screened for vaginal and endocervical infections and treated in case of abnormal flora. Pregnancy and delivery outcomes were compared between abnormal and normal flora groups by univariate analysis. RESULTS: 109 patients had an abnormal flora result (27.2%). The most frequently detected infection was Ureaplasma urealyticum (12.3%), followed by Candida spp. (11.8%), bacterial vaginosis (5%), Mycoplasma hominis (1.2%) and Trichomonas vaginalis (0.8%). Patients with abnormal flora had a 5-fold increased risk of preterm premature rupture of membranes (5.3% vs. 1.1% of patients with normal flora, Odds Ratio 5.11, 95% Confidence Interval 1.20-21.71, p = 0.028). No significant differences were observed regarding preterm delivery or neonatal morbidity. CONCLUSIONS: Considering the morbimortality related to prematurity and that the results of our study suggest that the early treatment of abnormal flora could improve perinatal outcomes, the implementation of a screening program during the first trimester should be considered.

SARS-CoV-2 Infection and C-Section: A Prospective Observational Study.

Pregnant women are particularly vulnerable to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. In addition to unfavorable perinatal outcomes, there has been an increase in obstetric interventions. With this study, we aimed to clarify the reasons, using Robson's classification model, and risk factors for cesarean section (C-section) in SARS-CoV-2-infected mothers and their perinatal results. This was a prospective observational study that was carried out in 79 hospitals (Spanish Obstetric Emergency Group) with a cohort of 1704 SARS-CoV-2 PCR-positive pregnant women that were registered consecutively between 26 February and 5 November 2020. The data from 1248 pregnant women who delivered vaginally (vaginal + operative vaginal) was compared with those from 456 (26.8%) who underwent a C-section. C-section patients were older with higher rates of comorbidities, in vitro fertilization and multiple pregnancies (p < 0.05) compared with women who delivered vaginally. Moreover, C-section risk was associated with the presence of pneumonia (p < 0.001) and 41.1% of C-sections in patients with pneumonia were preterm (Robson's 10th category). However, delivery care was similar between asymptomatic and mild-moderate symptomatic patients (p = 0.228) and their predisposing factors to C-section were the presence of uterine scarring (due to a previous C-section) and the induction of labor or programmed C-section for unspecified obstetric reasons. On the other hand, higher rates of hemorrhagic events, hypertensive disorders and thrombotic events were observed in the C-section group (p < 0.001 for all three outcomes), as well as for ICU admission. These findings suggest that this type of delivery was associated with the mother's clinical conditions that required a rapid and early termination of pregnancy.

Influence of the Human Development Index on the Maternal-Perinatal Morbidity and Mortality of Pregnant Women with SARS-CoV-2 Infection: Importance for Personalized Medical Care.

Coronavirus disease-19 (COVID-19) is perhaps the most worrisome pandemic in the 21st century, having entailed devastating consequences for the whole society during the last year. Different studies have displayed an existing association between pregnancy and COVID-19 severity due to the various physiological changes that occur during gestation. Recent data identified maternal country of origin as an important determinant of COVID-19 presentation in pregnant women. However, the explanation of this fact remains to be fully elucidated. Therefore, the purpose of this work is to analyze the possible relationship between Human Development Index (HDI) of maternal country of origin with the morbimortality of pregnant women and their newborns. Here, we conducted a multicentric, ambispective, observational case-control study (1:1 ratio) and compare with the HDI of each country (group 1-very high HDI, group 2-high HDI, group 3-medium HDI, and group 4-low HDI). In total, 1347 pregnant women with confirmed SARV-CoV-2 infection (cases) were enrolled, and each was paired with one control to give a total number of 2694 participants from 81 tertiary care centers. Among the women with SARS-CoV-2 infection, more cases were produced of perinatal mortality, overall maternal morbidity, COVID-19 maternal morbidity, C-sections, hypertensive maternal morbidity, and perinatal morbidity. Our results described an inverse association between HDI and maternofetal morbidity and mortality. Moreover, the countries with an HDI lower than 1 showed higher rates of patients with maternal COVID-19-related morbidity (6.0% vs. 2.4%, p < 0.001), a need for oxygen therapy (4.7% vs. 1.8%, p < 0.001), and maternal ICU admission (2.6% vs. 1.0%, p = 0.007). Compared to other risk factors such as overweight, obesity, preexisting and obstetric comorbidities, HDI emerged as an independent risk factor explaining much of the increased maternal-perinatal morbidity and mortality detected in our group of cases. Further research is needed to establish to confirm the real impact of this factor and its components on pregnancy outcomes.

Comparing Infection Profiles of Expectant Mothers with COVID-19 and Impacts on Maternal and Perinatal Outcomes between the First Two Waves of the Pandemic.

During 2020, Coronavirus Disease-19 (COVID-19) incidence fluctuated in two clear waves across the spring and autumn periods. This study was designed to compare the maternal and perinatal clinical outcomes in obstetrics patients with COVID-19 between the two waves of infection in Spain. We conducted an observational, analytical, ambispective cohort study with longitudinal follow-up of mothers with confirmed SARV-CoV-2 infection from different hospitals in our country between March-November 2020. We recruited 1295 pregnant women with SARS-CoV2 infection from 78 hospitals, 846 (65.3%) of whom were diagnosed during the first wave and 449 (34.7%) during the second wave. Our results show that patients developing COVID-19 during the first wave had more symptoms at triage, early in pregnancy with greater rates of COVID-19-related maternal morbidity; caesarean section and preterm birth in the first wave. We register two cases of maternal mortality and only during the first wave. Maternal morbidity events showed a strong link to perinatal mortality events in the first wave compared to the second wave, in which maternal morbidity was more associated with pneumonia. Likewise, maternal morbidity showed a strong correlation with perinatal morbidity events in both waves. We describe the differences between the patients' profiles and management between the two waves and related to maternal and perinatal outcomes. Differences were also observed in the management of pregnant women with COVID-19. Thus, there were fewer caesarean sections, and maternal and perinatal morbidity events were reduced in the second wave, while the impacts of respiratory symptoms and their severity, including a greater need for maternal treatment, were greater in this last period. Identifying the impact that changes in the profile as well as in the treatment have on maternal-perinatal morbidity and mortality will help improve the well-being of our patients and their newborns.

Maternal outcomes and risk factors for COVID-19 severity among pregnant women.

Pregnant women may be at higher risk of severe complications associated with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which may lead to obstetrical complications. We performed a case control study comparing pregnant women with severe coronavirus disease 19 (cases) to pregnant women with a milder form (controls) enrolled in the COVI-Preg international registry cohort between March 24 and July 26, 2020. Risk factors for severity, obstetrical and immediate neonatal outcomes were assessed. A total of 926 pregnant women with a positive test for SARS-CoV-2 were included, among which 92 (9.9%) presented with 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 caesarean section [70.7% (n = 53/75)], preterm delivery [62.7% (n = 32/51)] and newborns requiring admission to the neonatal intensive care unit [41.3% (n = 31/75)]. In this study, several risk factors for developing severe complications of SARS-CoV-2 infection among pregnant women were identified including pulmonary comorbidities, hypertensive disorders and diabetes. Obstetrical and neonatal outcomes appear to be influenced by the severity of maternal disease.

Association of ABO and Rh blood groups with obstetric outcomes in SARS-CoV-2 infected pregnancies: A prospective study with a multivariate analysis.

OBJECTIVE: To evaluate the influence of ABO and Rh blood groups on morbidity among SARS-CoV-2 infected pregnancies. DESIGN: Prospective observational study. SETTING: 78 centers of the Spanish Obstetric Emergency Group. POPULATION: Pregnant women with SARS-CoV-2 tested with polymerase-chain-reaction between 26-February and 5-November 2020. A cohort of 1278 SARS-CoV-2(+) pregnant women was analyzed and a concurrent comparison group of 1453 SARS-COV-2(-) patients was established. METHODS: Data were collected from medical charts. SARS-COV-2(+) was compared with SARS-COV-2(-) for differences in distribution of blood groups. We performed multivariate analysis, controlling for maternal age and ethnicity, to evaluate association of ABO and Rh blood groups with maternal and perinatal outcomes in SARS-CoV-2(+) patients with adjusted odds ratios (aOR) and 95% confidence intervals (CI). MAIN OUTCOMES MEASURES: Medical morbidity: Symptomatic COVID-19 and medical complications. Obstetric outcomes: caesarean delivery, preterm deliveries, preterm premature rupture of membranes (PPROM), hemorrhagic events, pre-eclampsia, maternal and neonatal mortality, stillbirth. RESULTS: Differences were noted between blood types and Rh for age and ethnicity comparing SARS-CoV-2(+) and SARS-CoV-2(-) groups (p < 0.05). Among the SARS-CoV-2(+) cohort, the odds of symptomatic COVID-19 and obstetric hemorrhagic event were higher in Rh+ vs Rh- mothers (aOR 1.48, 95% CI 1.02-2.14, p = 0.037, and aOR 8.72, 95% CI 1.20-63.57, p = 0.033, respectively), and PPROM were higher among blood type A vs non-A mothers (aOR 2.06, 95% CI 1.01-4.18, p = 0.046). CONCLUSIONS: In SARS-CoV-2(+) pregnant women, Rh- status was associated with a lower risk of symptomatic COVID-19, while Rh+ and blood group A were associated with obstetric hemorrhage and PPROM, respectively.

[Knowledge assessment of shoulder dystocia management by Spanish professionals.] / Evaluación del conocimiento en la resolución de la distocia de hombros en profesionales españoles.

OBJECTIVE: Shoulder dystocia (SD) training is recommended by diverse international healthcare organizations; however, it is not so in Spain, and there is no specific programmes. The objective of the study was to evaluate the level of knowledge and attitudes towards resolving a SD among a large sample of spanish obstetricians and midwives. METHODS: A multi-professional team carried out simulation-based training courses. Descriptive observational study where mean, standard deviation, minimum and maximum or median and interquartile intervals according to the distribution will be used for continuous variables. For the discrete variables, the number and the corresponding percentages will be reported. RESULTS: Between December 2015 and 2019, the team carried out 17 editions of SD workshop and 904 active professionals were trained in labour wards in different parts of Spain. The results showed that 64.8% of the professionals had learned to solve shoulder dystocia through books and/or 58.4% theoretical classes. 60.4% (380) of the respondents had not received any type of training in simulation in obstetrics. 87.1% (415/476) of the students had not felt prepared to face a SD when they finished the residency At the time of answering this survey, 61.8% (358) did not feel prepared to solve a SD. CONCLUSIONS: Training in Shoulder Dystocia in Spain is mainly theoretical and a high number of professionals recognize that they are not sufficiently prepared to face it with guarantees.

OBJETIVO: El entrenamiento en distocia de hombros (DH) está recomendado por numerosas sociedades médicas internacionales y, sin embargo, en España, no existen programas específicos de entrenamiento. El objetivo de este estudio fue evaluar el nivel de conocimiento y habilidades prácticas para resolver una distocia de hombros de un amplio número de matronas y ginecólogos españoles que habían realizado un curso basado en simulación. METODOS: El equipo multiprofesional de simulación obstétrica realizo talleres basados en simulación para la resolución de la DH. Estudio descriptivo observacional donde para las variables continuas se utilizará media, desviación estándar, mínimo y máximo o mediana e intervalos intercuartiles de acuerdo con la distribución. Para las variables discretas se reportarán el número y los porcentajes correspondientes. RESULTADOS: Entre diciembre de 2015 y 2019, el equipo llevo a cabo 17 ediciones del taller de DH y formo a 904 profesionales de diferentes partes de España. Los resultados mostraron que Un 64,8% de los profesionales había aprendido a solucionar la distocia de hombros a través de libros y/o un 58,4% clases teóricas. El 60,4% (380) de los encuestados, no había recibido ningún tipo de formación en simulación en obstetricia. Un 87,1% (415/476) de los alumnos no se había sentido preparado para enfrentarse a una DH cuando terminó la residencia En el momento de contestar esta encuesta, un 61,8% (358) no se sentía preparado para resolver una DH. CONCLUSIONES: La formación en distocia de hombros en España es principalmente teórica y un alto numero de profesionales reconoce que no están suficientemente preparados para afrontarla con garantías.

Pregnancy Outcomes and SARS-CoV-2 Infection: The Spanish Obstetric Emergency Group Study.

Pregnant women who are infected with SARS-CoV-2 are at an increased risk of adverse perinatal outcomes. With this study, we aimed to better understand the relationship between maternal infection and perinatal outcomes, especially preterm births, and the underlying medical and interventionist factors. This was a prospective observational study carried out in 78 centers (Spanish Obstetric Emergency Group) with a cohort of 1347 SARS-CoV-2 PCR-positive pregnant women registered consecutively between 26 February and 5 November 2020, and a concurrent sample of PCR-negative mothers. The patients' information was collected from their medical records, and the association of SARS-CoV-2 and perinatal outcomes was evaluated by univariable and multivariate analyses. The data from 1347 SARS-CoV-2-positive pregnancies were compared with those from 1607 SARS-CoV-2-negative pregnancies. Differences were observed between both groups in premature rupture of membranes (15.5% vs. 11.1%, p < 0.001); venous thrombotic events (1.5% vs. 0.2%, p < 0.001); and severe pre-eclampsia incidence (40.6 vs. 15.6%, p = 0.001), which could have been overestimated in the infected cohort due to the shared analytical signs between this hypertensive disorder and COVID-19. In addition, more preterm deliveries were observed in infected patients (11.1% vs. 5.8%, p < 0.001) mainly due to an increase in iatrogenic preterm births. The prematurity in SARS-CoV-2-affected pregnancies results from a predisposition to end the pregnancy because of maternal disease (pneumonia and pre-eclampsia, with or without COVID-19 symptoms).

Perinatal outcomes of pregnancies resulting from assisted reproduction technology in SARS-CoV-2-infected women: a prospective observational study.

OBJECTIVE: To evaluate the perinatal and maternal outcomes of pregnancies in women infected with SARS-CoV-2, comparing spontaneous and in vitro fertilization (IVF) pregnancies (with either own or donor oocytes). DESIGN: Multicenter, prospective, observational study. SETTING: 78 centers participating in the Spanish COVID19 Registry. PATIENT(S): 1,347 pregnant women with SARS-CoV-2 positive results registered consecutively between February 26 and November 5, 2020. INTERVENTION(S): The patients' information was collected from their medical records, and multivariable regression analyses were performed, controlling for maternal age and the clinical presentation of the infection. MAIN OUTCOME MEASURE(S): Obstetrics and neonatal outcomes, pregnancy comorbidities, intensive care unit admission, mechanical ventilation need, and medical conditions. RESULT(S): The IVF group included 74 (5.5%) women whereas the spontaneous pregnancy group included 1,275 (94.5%) women. The operative delivery rate was high in all patients, especially in the IVF group, where cesarean section became the most frequent method of delivery (55.4%, compared with 26.1% of the spontaneous pregnancy group). The reason for cesarean section was induction failure in 56.1% of the IVF patients. IVF women had more gestational hypertensive disorders (16.2% vs. 4.5% among spontaneous pregnancy women, adjusted odds ratio [aOR] 5.31, 95% confidence interval [CI] 2.45-10.93) irrespective of oocyte origin. The higher rate of intensive care unit admittance observed in the IVF group (8.1% vs. 2.4% in the spontaneous pregnancy group) was attributed to preeclampsia (aOR 11.82, 95% CI 5.25-25.87), not to the type of conception. CONCLUSION(S): A high rate of operative delivery was observed in pregnant women infected with SARS-CoV-2, especially in those with IVF pregnancies; method of conception did not affect fetal or maternal outcomes, except for preeclampsia. CLINICAL TRIAL REGISTRATION NUMBER: NCT04558996.

The association between SARS-CoV-2 infection and preterm delivery: a prospective study with a multivariable analysis.

BACKGROUND: To determine whether severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, the cause of COVID-19 disease) exposure in pregnancy, compared to non-exposure, is associated with infection-related obstetric morbidity. METHODS: We conducted a multicentre prospective study in pregnancy based on a universal antenatal screening program for SARS-CoV-2 infection. Throughout Spain 45 hospitals tested all women at admission on delivery ward using polymerase-chain-reaction (PCR) for COVID-19 since late March 2020. The cohort of positive mothers and the concurrent sample of negative mothers was followed up until 6-weeks post-partum. Multivariable logistic regression analysis, adjusting for known confounding variables, determined the adjusted odds ratio (aOR) with 95% confidence intervals (95% CI) of the association of SARS-CoV-2 infection and obstetric outcomes. MAIN OUTCOME MEASURES: Preterm delivery (primary), premature rupture of membranes and neonatal intensive care unit admissions. RESULTS: Among 1009 screened pregnancies, 246 were SARS-CoV-2 positive. Compared to negative mothers (763 cases), SARS-CoV-2 infection increased the odds of preterm birth (34 vs 51, 13.8% vs 6.7%, aOR 2.12, 95% CI 1.32-3.36, p = 0.002); iatrogenic preterm delivery was more frequent in infected women (4.9% vs 1.3%, p = 0.001), while the occurrence of spontaneous preterm deliveries was statistically similar (6.1% vs 4.7%). An increased risk of premature rupture of membranes at term (39 vs 75, 15.8% vs 9.8%, aOR 1.70, 95% CI 1.11-2.57, p = 0.013) and neonatal intensive care unit admissions (23 vs 18, 9.3% vs 2.4%, aOR 4.62, 95% CI 2.43-8.94, p <  0.001) was also observed in positive mothers. CONCLUSION: This prospective multicentre study demonstrated that pregnant women infected with SARS-CoV-2 have more infection-related obstetric morbidity. This hypothesis merits evaluation of a causal association in further research.

Impact of Recommended Maternal Vaccination Programs on the Clinical Presentation of SARS-CoV-2 Infection: A Prospective Observational Study.

The COVID-19 pandemic has raised questions about the possible cross immunity resulting from common vaccination programs and SARS-CoV-2 infection. Therefore, the Spanish Obstetric Emergency group performed a multicenter prospective study on the vaccination status of Influenza and Tdap (diphtheria, tetanus and pertussis vaccine boost administered in adulthood) in consecutive cases of SARS-CoV-2 infection in a pregnancy cohort, in order to assess its possible association with the clinical presentation and severity of symptoms of SARS-CoV-2 infection, as well as to determine the factors that may affect vaccination adherence. A total of 1150 SARS-CoV-2 positive pregnant women from 78 Spanish hospitals were analyzed: 183 had not received either vaccine, 23 had been vaccinated for Influenza only, 529 for Tdap only and 415 received both vaccines. No association was observed between the vaccination status and the clinical presentation of SARS-CoV-2 infection and/or the severity of symptoms. However, a lower adherence to the administration of both vaccines was observed in the Latin-American subgroup. Based on the results above, we reinforce the importance of maternal vaccination programs in the actual pandemic. Health education campaigns should be specially targeted to groups less likely to participate in these programs, as well as for a future SARS-CoV-2 vaccination campaign.

[Spanish registry of Covid-19 screening in asymptomatic pregnants.] / Registro español de cribado de Covid-19 en gestantes asintomáticas.

OBJECTIVE: The Spanish registry of Covid-19 in Spanish pregnant women, made up of 100 centers, is created in response to the need to know the morbidity that Covid-19 generates in pregnant women and their newborns, to know the real incidence of the disease in this population group and to establish and monitor the package of measures to improve their care. The aim of this paper was the creation of a registry of pregnant women with Covid-19 infection in order to establish the interventions and measures necessary to improve the care of these patients during hospital admission. METHODS: To prepare the registry, the main researcher of each center collected weekly / biweekly the number of total pregnant women screened, as well as the total number of positive and negative, sending these data to the responsible researchers so that it could be available in real time of the percentage of infected asymptomatic pregnant population and the evolution by weeks in the centers of each participating province. The data were analyzed using the linear regression test and the Mantel test. RESULTS: As of May 31stsup> 2020, 16,308 screening tests were carried out in these hospitals, in which 338 pregnant women were positive, which translates into 2.07% (95% Confidence Interval: 1.86-2.30) of the asymptomatic pregnant women we attended in our centers were carriers of the virus and could develop the disease in subsequent days. CONCLUSIONS: The Spanish epidemiological registry allows us to know the incidence of infection in pregnant women attended in the Spanish delivery centers, as well as the weekly and / or fortnightly evolution of the same, observing a significant decrease in the proportion of positive pregnant women over the total of screenings throughout this period, with an average of 6.5% in early April 2020 to an average of 0.93% positive in late May 2020.

OBJETIVO: El registro español de Covid-19 en embarazadas españolas, integrado por 100 centros, surge en respuesta a la necesidad de conocer la morbilidad que la Covid-19 genera en las gestantes y sus recién nacidos, de conocer la incidencia real de la enfermedad en este grupo poblacional y de establecer y monitorizar el paquete de medidas para mejorar su atención. El objetivo de este estudio fue la creación de un registro de gestantes con infección por Covid-19 con la finalidad de establecer y monitorizar las intervenciones y medidas necesarias para mejorar la atención de estas pacientes durante el ingreso hospitalario. METODOS: Para la elaboración del registro, el investigador principal de cada centro recogió con carácter semanal/quincenal el número de gestantes totales cribadas, así como el total de positivas y negativas, remitiendo a los investigadores responsables estos datos de manera que se pudiera disponer a tiempo real del porcentaje de población gestante asintomática infectada y de la evolución por semanas en los centros de cada provincia participante. Los datos fueron analizados mediante el Test de regresión lineal y test de Mantel. RESULTADOS: A día 31 de mayo de 2020, se realizaron en estos hospitales 16.308 test de cribado, en los cuales 338 gestantes resultaron positivas, lo que se traduce en que un 2,07% (Intervalo de Confianza del 95%: 1,86-2,30) de las gestantes asintomáticas que atendimos en nuestros centros eran portadoras del virus y podían desarrollar la enfermedad en días posteriores. CONCLUSIONES: El registro epidemiológico español permite conocer la incidencia de infección en gestantes atendidas en los paritorios españoles, así como la evolución semanal y/o quincenal de la misma, observándose un descenso significativo de la proporción de gestantes positivas sobre el total de cribadas a lo largo de este periodo, con una media del 6,5% a principios de abril de 2020 hasta una media del 0,93% de positivas a finales de mayo de 2020.

Fetal heart rate changes on the cardiotocograph trace secondary to maternal COVID-19 infection.

OBJECTIVE: To determine the cardiotocograph (CTG) changes in women with symptomatic COVID-19 infection. STUDY DESIGN: 12 anonymised CTG traces from 2 hospitals in Spain were retrospectively analysed by 2 independent assessors. CTG parameters were studied based on fetal pathophysiological responses to inflammation and hypoxia that would be expected based on the pathogenesis of COVID-19 patients. Correlation was made with perinatal outcomes (Apgar score at 5 min and umbilical cord pH). RESULTS: All fetuses showed an increased baseline FHR > 10 percent compared to the initial recording, in addition to absence of accelerations. 10 out of 12 CTG traces (83.3 percent) demonstrated late or prolonged decelerations and 7 out of 12 fetuses (58.3 percent) showed absence of cycling. Not a single case of sinusoidal pattern was observed. ZigZag pattern was found in 4 CTG traces (33 percent). Excessive uterine activity was observed in all CTG traces where uterine activity was monitored (10 out of 12). Apgar scores at 5 min were normal (>7) and absence of metabolic acidosis was found in the umbilical cord arterial pH (pH > 7.0) in the cases that were available (11 and 9, respectively). CONCLUSION: Fetuses of COVID-19 patients showed a raised baseline FHR (>10 percent), loss of accelerations, late decelerations, ZigZag pattern and absence of cycling probably due to the effects of maternal pyrexia, maternal inflammatory response and the "cytokine storm". However, the perinatal outcomes appear to be favourable. Therefore, healthcare providers should optimise the maternal environment first to rectify the reactive CTG changes instead of performing an urgent operative intervention.