Incidencia de parálisis braquial obstétrica tras programa de entrenamiento en distocia de hombros / Incidence of obstetric brachial plexus palsy after a training program in shoulder dystocia

Introducción: La distocia de hombros es una emergencia obstétrica no prevenible que causa graves complicaciones, como la parálisis braquial obstétrica. El objetivo del estudio fue determinar la incidencia de parálisis braquial obstétrica y de otras complicaciones neonatales asociadas a la distocia de hombros en los partos atendidos en un Hospital Universitario tras la implantación de un curso basado en simulación, de carácter voluntario y destinado a todos los profesionales en paritorio. Material y métodos: Estudio observacional retrospectivo; registro de los casos de distocia de hombros y de las complicaciones asociadas (principalmente parálisis braquial obstétrica) que tuvieron lugar entre enero del 2017 y diciembre del 2020, tras la implantación del curso. De forma paralela, se rescataron los casos de parálisis braquial obstétrica que tuvieron lugar en el hospital antes del entrenamiento (2008-2016). Resultados: En el período 2017-2020, de entre 125 distocias de hombros (lo que representa el 1,38% de los partos vaginales), hubo 14 casos de parálisis braquial obstétrica (el 11,2% de las distocias de hombros), siete fracturas de clavícula y una fractura de húmero; ninguna de las parálisis braquiales obstétricas fue permanente ni requirió tratamiento o rehabilitación más allá de los seis meses. En los años anteriores al entrenamiento, hubo siete casos de parálisis braquial obstétrica, dos permanentes y cinco transitorias (tres de las cuales necesitaron rehabilitación). Conclusión: Estos resultados reflejan la importancia de conocer la morbilidad presente en el paritorio y el posible beneficio de la formación basada en simulación para la resolución de estas complicaciones obstétricas. (AU)

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 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. (AU)

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.

[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.

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.

Breastfeeding mothers with COVID-19 infection: a case series.

BACKGROUND: The first reports of the Chinese experience in the management of newborns of mothers with SARS-CoV 2 infection did not recommend mother-baby contact or breastfeeding. At present, the most important International Societies, such as WHO and UNICEF, promote breastfeeding and mother-baby contact as long as adequate measures to control COVID-19 infection are followed. In cases where maternal general health conditions impede direct breastfeeding or in cases of separation between mother and baby, health organizations encourage and support expressing milk and safely providing it to the infants. METHODS: A series of 22 case studies of newborns to mothers with COVID-19 infection from March 14th to April 14th, 2020 was conducted. Mothers and newborns were followed for a median period of 1.8 consecutive months. RESULTS: Out of 22 mothers, 20 (90.9%) chose to breastfeed their babies during hospital admission. Timely initiation and skin to skin contact at delivery room was performed in 54.5 and 59.1%, respectively. Eighty two percent of newborns to mothers with COVID-19 were fed with breast milk after 1 month, decreasing to 77% at 1.8 months. Six of 22 (37.5%) mothers with COVID-19 required transitory complementary feeding until exclusive breastfeeding was achieved. During follow-up period, there were no major complications, and no neonates were infected during breastfeeding. CONCLUSIONS: Our experience shows that breastfeeding in newborns of mothers with COVID-19 is safe with the adequate infection control measures to avoid mother-baby contagion. Supplementing feeding with pasteurized donor human milk or infant formula may be effective, until exclusive breastfeeding is achieved.

Clinical course of coronavirus disease-2019 in pregnancy.

INTRODUCTION: The aim of this study is to report our clinical experience in the management of pregnant women infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the first 30 days of the coronavirus disease (COVID-19) pandemic. MATERIAL AND METHODS: We reviewed clinical data from the first 60 pregnant women with COVID-19 whose care was managed at Puerta de Hierro University Hospital, Madrid, Spain from 14 March to 14 April 2020. Demographic data, clinical findings, laboratory test results, imaging findings, treatment received, and outcomes were collected. An analysis of variance (Kruskal-Wallis test) was performed to compare the medians of laboratory parameters. Fisher's exact test was used to evaluate categorical variables. A correspondence analysis was used to explore associations between variables. RESULTS: A total of 60 pregnant women were diagnosed with COVID-19. The most common symptoms were fever and cough (75.5% each) followed by dyspnea (37.8%). Forty-one women (68.6%) required hospital admission (18 because of disease worsening and 23 for delivery) of whom 21 women (35%) underwent pharmacological treatment, including hydroxychloroquine, antivirals, antibiotics, and tocilizumab. No renal or cardiac failures or maternal deaths were reported. Lymphopenia (50%), thrombocytopenia (25%), and elevated C-reactive protein (CRP) (59%) were observed in the early stages of the disease. Median CRP, D-dimer, and the neutrophil/lymphocyte ratio were elevated. High CRP and D-dimer levels were the parameters most frequently associated with severe pneumonia. The neutrophil/lymphocyte ratio was found to be the most sensitive marker for disease improvement (relative risk 6.65; 95% CI 4.1-5.9). During the study period, 18 of the women (78%) delivered vaginally. All newborns tested negative for SARS-CoV-2 and none of them were infected during breastfeeding. No SARS-CoV-2 was detected in placental tissue. CONCLUSIONS: Most of the pregnant women with COVID-19 had a favorable clinical course. However, one-third of them developed pneumonia, of whom 5% presented a critical clinical status. CRP and D-dimer levels positively correlated with severe pneumonia and the neutrophil/lymphocyte ratio decreased as the patients improved clinically. Seventy-eight percent of the women had a vaginal delivery. No vertical or horizontal transmissions were diagnosed in the neonates during labor or breastfeeding.

Cervical Pessary Compared With Vaginal Progesterone for Preventing Early Preterm Birth: A Randomized Controlled Trial.

OBJECTIVE: To compare the effectiveness of a cervical pessary and vaginal progesterone to prevent spontaneous preterm births in pregnant women with cervical lengths 25 mm or less as measured by transvaginal ultrasonography. METHODS: This was a multicenter, open-label, randomized, noninferiority trial. Women with singleton pregnancies and a short cervix (25 mm or less) measured transvaginally at the second-trimester ultrasonogram were invited to participate. They were computer-randomized (one to one) into cervical pessary placement or treatment with vaginal progesterone (200 mg/24 hours). The primary outcome was spontaneous preterm delivery before 34 weeks of gestation. The noninferiority margin was set at 4% with a 0.025 one-sided α level and a statistical power of 80%. That is, if the 95% CI upper bound exceeded 4%, the pessary could not be deemed noninferior. A sample size of 254 women was required to show noninferiority of the pessary to progesterone. RESULTS: The trial was conducted from August 2012 to April 2016 with the participation of 27 Spanish hospitals. A total of 254 patients were enrolled and 246 included in the intention-to-treat analysis. Demographic and baseline characteristics were similar across groups. The rate of spontaneous delivery before 34 weeks of gestation was 14% (n=18/127) in the pessary group and 14% (n=17/119) in the progesterone group with a risk difference of -0.11% (95% CI -8.85% to 8.62%; P=.99), that is, noninferiority was not shown for the pessary. The incidence of increased vaginal discharge (87% vs 71%, P=.002) and discomfort (27% vs 3%, P<.001) was significantly higher in the pessary group. CONCLUSION: A cervical pessary was not noninferior to vaginal progesterone for preventing spontaneous birth before 34 weeks of gestation in pregnant women with short cervixes. CLINICAL TRIAL REGISTRATION: EU Clinical Trials Register, 2012-000241-13; ClinicalTrials.gov, NCT01643980.

Programa piloto de formación combinada en ecografía obstétrica y técnicas ecoguiadas basado en simulación / Simulation based obstetric ultrasonography combined with echoguided (ultrasound) techniques training. Pilot program

Introducción: La simulación es un elemento que ya se utiliza de manera profusa en el entrenamiento de obstetras y ginecólogos. Permite entrenarse en situaciones complejas con seguridad para la paciente. Presentamos un programa piloto con la aplicación de distintas técnicas de simulación al entrenamiento en ecografía obstétrica. Sujetos y métodos: Diseñamos un programa con parte presencial y no presencial destinado a 12 médicos internos residentes de ginecología y obstetricia. La parte no presencial consistió en el acceso a unos documentos en una página web. La parte presencial consistió en tres talleres con una duración total de cuatro horas: taller de ecografía en la semana 20 mediante realidad virtual, taller de técnicas invasivas con simuladores de tareas y taller de habilidades comunicativas en dar malas noticias mediante paciente estandarizado. Se les pasó a los alumnos una encuesta de satisfacción anónima (con escala de 1 a 10) al final del programa. Resultados: El resultado de la experiencia de aprendizaje fue muy satisfactorio, como así lo reflejaron los alumnos en la puntuación media global del curso, que fue de 9,1. Conclusión: En este trabajo mostramos que la simulación en el aprendizaje de la ecografía obstétrica ha sido satisfactoria para los residentes

Introduction: Simulation is an useful tool widely used among obstetrician and gynaecologist, as it allows training in complex situations increasing patient’s safety. We are introducing a brand-new simulation program based on obstetric ultrasound. Subjects and methods: It is designed half face-to-face for 12 gynecology and obstetrics residents. The non presence part of the course was online, with access to several documents at a website. The on-site modality consisted of 3 workshops that lasted 4 hours in total: the 20 th week ultrasound workshop implementing virtual reality, the invasive techniques course using mannequin simulation, and the development of bad news communicative skills with standardized patients workshop. All participants were required to fill an anonymous satisfaction survey (scale 1 to 10) at the end of the programme. Results: The learning experience was very satisfactory and the learners gave their inputs in the feedback survey. The final score was 9.1 over 10. Conclusion: In this paper we show that the use of simulation to learn obstetrical ultrasound was rewarding for the residents

Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound (PESAPRO Trial): study protocol for a randomized controlled trial.

BACKGROUND: Premature birth is considered one of the main problems in modern Obstetrics. It causes more than 50 % of neonatal mortality; it is responsible for a large proportion of infant morbidity and incurs very high economic costs. Cervical length, which can be accurately measured by ultrasound, has an inverse relationship with the risk of preterm birth. As a result, having an effective intervention for asymptomatic patients with short cervix could reduce the prematurity. Although recently published data demonstrates the effectiveness of vaginal progesterone and cervical pessary, these treatments have never been compared to one another. METHODS/DESIGN: The PESAPRO study is a noncommercial, multicenter, open-label, randomized clinical trial (RCT) in pregnant women with a short cervix as identified by transvaginal ultrasonography at 19 to 22 weeks of gestation. Patients are randomized (1:1) to either daily vaginal progesterone or cervical pessary until the 37th week of gestation or delivery; whichever comes first. During the trial, women visit every 4 weeks for routine questions and tests. The primary outcome is the proportion of spontaneous preterm deliveries before 34 weeks of gestation. A sample size of 254 pregnant women will be included at 29 participating hospitals in order to demonstrate noninferiority of placing a pessary versus vaginal progesterone. The first patient was randomized in August 2012, and recruitment of study subjects will continue until the end of December 2015. DISCUSSION: This trial assesses the comparative efficacy and safety between two accepted treatments, cervical pessary versus vaginal progesterone, and it will provide evidence in order to establish clinical recommendations. TRIAL REGISTRATION: EU Clinical Trials Register EudraCT2012-000241-13 (Date of registration: 16 January 2012); ClinicalTrials.gov Identifier NCT01643980 (Date of registration: 12 June 2012).

Prenatal diagnosis of concurrent achondroplasia and klinefelter syndrome.

Achondroplasia is the most frequent nonlethal skeletal dysplasia, with a prevalence of 1 : 5000 to 1 : 40,000 live births, and it is caused by a fibroblast growth factor receptor alteration. The combination of achondroplasia and Klinefelter syndrome is extremely rare and just four reports have been published in the literature, which were all diagnosed postnatally. We report the fifth case described of this uncommon association and its prenatal diagnosis. In cases of prenatal diagnosis of achondroplasia with additional suspicious morphological abnormalities, an invasive test such as amniocentesis must be carried out to assess the karyotype normality.

¿Cómo tratamos los cuellos ecográficamente acortados? / How are ultrasonographically-detected short cervixes treated?

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