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OBJECTIVE: To investigate whether perineal infiltration of ropivacaine after episiotomy would decrease the incidence of postpartum pain compared with placebo. DESIGN: Two-centre, double-blind, randomised, controlled trial. SETTING: Two French maternity units, October 2017 to April 2020. POPULATION: 272 women undergoing epidural analgesia with vaginal singleton delivery and mediolateral episiotomy at term (≥37 weeks) were randomly allocated perineal infiltration of ropivacaine (n = 135) or placebo (n = 137) in a 1:1 ratio before episiotomy repair. METHODS: Patients were followed at short term (12, 24, 48 h), mid-term (day 7) and long-term (3 and 6 months). MAIN OUTCOME MEASURES: The primary outcome was the rate of perineal pain, defined by a Numerical Pain Rating Scale (NPRS) exceeding 3/10, in the mid-term (day 7) postpartum period. Secondary outcomes were perineal pain (NPRS) and analgesic intake, quality of life (SF-36), postpartum depression (EPDS), pain neuropathic component (DN4) and sexual health (FSFI). RESULTS: Perineal pain occurred to an equal extent in the ropivacaine and placebo groups at day 7 (34.2% versus 30.4%, odds ratio 1.1, 95% confidence interval 0.7-1.8, p = 0.63). Similar results were recorded in the short and long term. High rates of dyspareunia and postpartum depression were documented in both groups. No differences were highlighted between the groups in terms of analgesic intake, adverse events, pain neuropathic component and postpartum quality of life. CONCLUSIONS: This study did not demonstrate any benefit of ropivacaine infiltration over placebo.
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BACKGROUND: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). METHODS AND FINDINGS: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. CONCLUSIONS: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907060.
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Maturidade Cervical/efeitos dos fármacos , Dinoprostona/farmacologia , Ocitócicos/farmacologia , Silicones/farmacologia , Adulto , Maturidade Cervical/fisiologia , Cesárea/métodos , Parto Obstétrico/métodos , Dinoprostona/administração & dosagem , Feminino , Humanos , Trabalho de Parto Induzido/métodos , Ocitócicos/administração & dosagem , Pessários , Gravidez , Gravidez Prolongada/tratamento farmacológicoRESUMO
BACKGROUND: The use of tranexamic acid reduces mortality due to postpartum hemorrhage. We investigated whether the prophylactic administration of tranexamic acid in addition to prophylactic oxytocin in women with vaginal delivery would decrease the incidence of postpartum hemorrhage. METHODS: In a multicenter, double-blind, randomized, controlled trial, we randomly assigned women in labor who had a planned vaginal delivery of a singleton live fetus at 35 or more weeks of gestation to receive 1 g of tranexamic acid or placebo, administered intravenously, in addition to prophylactic oxytocin after delivery. The primary outcome was postpartum hemorrhage, defined as blood loss of at least 500 ml, measured with a collector bag. RESULTS: Of the 4079 women who underwent randomization, 3891 had a vaginal delivery. The primary outcome occurred in 156 of 1921 women (8.1%) in the tranexamic acid group and in 188 of 1918 (9.8%) in the placebo group (relative risk, 0.83; 95% confidence interval [CI], 0.68 to 1.01; P=0.07). Women in the tranexamic acid group had a lower rate of provider-assessed clinically significant postpartum hemorrhage than those in the placebo group (7.8% vs. 10.4%; relative risk, 0.74; 95% CI, 0.61 to 0.91; P=0.004; P=0.04 after adjustment for multiple comparisons post hoc) and also received additional uterotonic agents less often (7.2% vs. 9.7%; relative risk, 0.75; 95% CI, 0.61 to 0.92; P=0.006; adjusted P=0.04). Other secondary outcomes did not differ significantly between the two groups. The incidence of thromboembolic events in the 3 months after delivery did not differ significantly between the tranexamic acid group and the placebo group (0.1% and 0.2%, respectively; relative risk, 0.25; 95% CI, 0.03 to 2.24). CONCLUSIONS: Among women with vaginal delivery who received prophylactic oxytocin, the use of tranexamic acid did not result in a rate of postpartum hemorrhage of at least 500 ml that was significantly lower than the rate with placebo. (Funded by the French Ministry of Health; TRAAP ClinicalTrials.gov number, NCT02302456 .).
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Antifibrinolíticos/uso terapêutico , Hemorragia Pós-Parto/prevenção & controle , Ácido Tranexâmico/uso terapêutico , Adulto , Antifibrinolíticos/efeitos adversos , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Injeções Intravenosas , Análise de Intenção de Tratamento , Ocitócicos/uso terapêutico , Ocitocina/uso terapêutico , Gravidez , Fatores de Risco , Tromboembolia/induzido quimicamente , Ácido Tranexâmico/efeitos adversosRESUMO
BACKGROUND: We aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA). METHODS: A list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman's history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as "not important". In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as "not important" or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study. RESULTS: Fifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women. CONCLUSION: We established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery. TRIAL REGISTRATION: The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 ( NCT04446780 ).
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Canal Anal/lesões , Parto Obstétrico/efeitos adversos , Episiotomia/métodos , Complicações do Trabalho de Parto/epidemiologia , Avaliação de Resultados em Cuidados de Saúde/normas , Consenso , Episiotomia/efeitos adversos , Feminino , Humanos , Masculino , Estudos Observacionais como Assunto/normas , Complicações do Trabalho de Parto/etiologia , Complicações do Trabalho de Parto/prevenção & controle , Obstetrícia/estatística & dados numéricos , Gravidez , Estudos Prospectivos , Projetos de Pesquisa , Participação dos Interessados , Inquéritos e Questionários/estatística & dados numéricosRESUMO
OBJECTIVES: Preterm labour is the leading cause of hospitalization during pregnancy. In France, it results in more than 60,000 births before 37 weeks of gestation every year. Recent studies suggest that detection of placental α-microglobulin-1 (PAMG-1) in vaginal secretions among women presenting symptoms of preterm labour with intact membranes has good predictive value for the onset of spontaneous preterm delivery within 7 days. The test is especially interesting, in that the repetition of antenatal corticosteroids for foetal lung maturation is no longer recommended in France and the effect of the initial administration is most beneficial in the 24 h to 7 days afterwards. METHODS: We included all studies listed in PubMed and clinicaltrials.gov with the terms "PAMG-1" and either "preterm labor" or "preterm labour", while excluding all studies on the subject of "rupture of the membranes" from 2000 through 2017. Ten studies were thus included. RESULTS: In women who had both the PAMG-1 and foetal fibronectin test, the PAMG-1 test was statistically superior to the measurement of cervical length for positive predictive value (p<0.0074), negative predictive value (p=0.0169) and specificity (p<0.001) for the prediction of spontaneous preterm delivery within 7 days. CONCLUSIONS: The use of PAMG-1 may make it possible to target the women at risk with a shortened cervix on ultrasound (<25 mm) those with an imminent preterm delivery and therefore to adapt management, especially the administration of antenatal corticosteroid therapy.
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Proteína 1 de Ligação a Fator de Crescimento Semelhante à Insulina/metabolismo , Trabalho de Parto Prematuro/diagnóstico , Biomarcadores/metabolismo , Colo do Útero/diagnóstico por imagem , Feminino , Fibronectinas/metabolismo , Humanos , Trabalho de Parto Prematuro/metabolismo , Gravidez , Ultrassonografia Pré-Natal , Esfregaço VaginalRESUMO
PURPOSE: Placental modifications observed in women with subclinical hypothyroidism (SCH) should be associated with altered fetal development in women with gestational diabetes mellitus (GDM) and worsen perinatal outcome. We aim to determine if SCH is associated with neonatal morbidity in women with GDM. METHODS: A secondary analysis of data collected for a prospective population-based cohort study including all pregnant women with singleton pregnancies at diagnosis of GDM in a tertiary care university hospital. Thyroid-stimulating hormone and free thyroxine were measured at diagnosis of GDM. Perinatal outcome was compared between two groups-women with SCH and euthyroid. Neonatal morbidity was defined by at least one of the following criteria: preterm birth, macrosomia, shoulder dystocia, respiratory distress syndrome, 5-min Apgar score < 7, pH < 7.10, and admission to the NICU (neonatal intensive-care unit) for 24 h. RESULTS: Of the total 200 women enrolled, 150 were evaluable for the study. Of whom, 9 (6%) women presented SCH. The mean gestational age at diagnosis of GDM was 21.7 ± 7.0 weeks. Maternal outcome of women with SCH was similar to euthyroid women. Neonatal morbidity occurred in 17.3% (26/150). Women with SCH had higher rate of neonatal morbidity (44.4% vs. 15.6%; p = 0.03), specifically due to admission to the NICU for 24 h (33.3% vs. 5.7%; p = 0.02). SCH in women with GDM is not associated with neonatal morbidity after controlling for gestational age at birth and admission to NICU (adjusted OR 2.02, 95% CI 0.75-10.23). CONCLUSION: Subclinical hypothyroidism is not associated with neonatal morbidity in women with gestational diabetes mellitus.
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Diabetes Gestacional/diagnóstico , Hipotireoidismo/etiologia , Mortalidade Infantil/tendências , Complicações na Gravidez/etiologia , Adulto , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Humanos , Hipotireoidismo/complicações , Lactente , Recém-Nascido , Morbidade , Gravidez , Resultado da Gravidez , Estudos Retrospectivos , Testes de Função TireóideaRESUMO
BACKGROUND: Threatened preterm delivery (TPD) is the leading cause of inpatient admissions during pregnancy. The ability to predict the risk of imminent preterm delivery is thus a major priority in obstetrics. The aim of our study is to assess the diagnostic performance of the test to detect the placental alpha microglobulin 1 (PAMG-1) for the prediction of delivery within 7 days in women with TPD. METHODS: This is a prospective multicenter diagnostic study. Inclusion criteria are singleton pregnancy, gestational age between 24 + 0 and 33 + 6 weeks inclusive, cervical measurement 25 mm or less assessed by transvaginal ultrasound (with or without uterine contractions), clinically intact membranes and cervical dilatation < 3 cm assessed by digital examination. According to the current protocol, when a women presents with TPD and the diagnosis is confirmed by transvaginal ultrasound, a vaginal sample to test for genital infection is performed. At the same time, the midwife will perform the PartoSure® test. To perform this analysis, a sample of cervicovaginal secretions is taken with the vaginal swab furnished in the test kit. The primary outcome is the specificity of the PartoSure® test of women who gave birth more than 7 days after their hospitalization for TPD. The secondary outcomes are the sensitivity, PPV, and NPV of the Partosure® test and the factors associated with false positives (with a univariate logistic regression model). Starting with the hypothesis of an anticipated specificity of 89%, if we want to estimate this specificity with a confidence interval of ± 5%, we will require 151 women who do not give birth within 7 days. We therefore decided to include 400 women over a period of two years to have a larger number of events (deliveries within 7 days). DISCUSSION: The different tests already used such as fetal fibronectin and phIGFBP-1, are not sufficiently relevant to recommend their use in daily practice. The different studies of PAMG-1 described above thus provide support for the use of this substance, tested by PartoSure®. Nonetheless, other larger studies are necessary to validate its use in daily practice and our study could answer this question. TRIAL REGISTRATION: NCT03401255 (January 15, 2018).
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Colo do Útero/química , Proteína 1 de Ligação a Fator de Crescimento Semelhante à Insulina/análise , Nascimento Prematuro/diagnóstico , Feminino , França , Hospitais , Humanos , Gravidez , Estudos Prospectivos , Medição de Risco/métodos , Sensibilidade e Especificidade , Vagina/diagnóstico por imagemRESUMO
BACKGROUND: To assess both severe maternal and neonatal mortality and morbidity after attempted operative vaginal deliveries by residents under supervision and by attending obstetricians. STUDY DESIGN: Secondary analysis of a 5-year prospective study with cross-sectional analysis including 2192 women with live singleton term fetuses in vertex presentation who underwent an attempted operative vaginal delivery in a tertiary care university hospital. Obstetricians who attempted or performed an operative vaginal delivery were classified into 2 groups according to their level of experience: attending obstetricians (who had 5 years or more of experience) and obstetric residents (who had less than 5 years of experience) under the supervision of an attending obstetrician. We used multivariate logistic regression and propensity score methods to compare outcomes associated with attending obstetricians and obstetric residents. Severe maternal morbidity was defined as third- or fourth-degree perineal laceration, perineal hematoma, cervical laceration, extended uterine incision for cesareans, postpartum hemorrhage >1500 mL, surgical hemostatic procedures, uterine artery embolization, blood transfusion, infection, thromboembolic events, admission to the intensive care unit, or maternal death; severe neonatal morbidity was defined as a 5-minute Apgar score <7, umbilical artery pH <7.00, need for resuscitation or intubation, neonatal trauma, intraventricular hemorrhage greater than grade 2, neonatal intensive care unit admission for more than 24 hours, convulsions, sepsis, or neonatal death. RESULTS: High prepregnancy body mass index, high dose of oxytocin, manual rotation, persistent occiput posterior or transverse positions, operating room delivery, midpelvic delivery, forceps, and spatulas were significantly more frequent in deliveries managed by attending obstetricians than residents whereas a second-stage pushing phase longer than 30 minutes was significantly more frequent in deliveries managed by residents. The rate of severe maternal morbidity was 7.8% (115/1475) for residents vs 9.9% (48/484) for attending obstetricians; for severe neonatal morbidity, the rates were 8.3% (123/1475) vs 15.1% (73/484), respectively. In the univariate, multivariable, and sensitivity analyses, attempted operative vaginal delivery managed by a resident was significantly and inversely associated with severe neonatal but not maternal morbidity. After propensity score matching, delivery managed by a resident was not significantly associated with severe maternal morbidity (adjusted odds ratio, 0.74; 95% confidence interval, 0.39-1.38) and was no longer associated with neonatal morbidity (adjusted odds ratio, 0.51; 95% confidence interval, 0.25-1.04). CONCLUSION: Management of attempted operative vaginal deliveries by residents under the supervision of attending obstetricians, compared with by the attending obstetricians themselves, does not appear to be associated with either maternal or neonatal morbidity. These reassuring results support the continued use of residency programs for training in operative vaginal deliveries under the supervision of attending obstetricians.
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Cesárea/estatística & dados numéricos , Extração Obstétrica , Internato e Residência , Corpo Clínico Hospitalar , Obstetrícia/educação , Adulto , Índice de Apgar , Traumatismos do Nascimento/epidemiologia , Índice de Massa Corporal , Feminino , Hematoma/epidemiologia , Humanos , Concentração de Íons de Hidrogênio , Segunda Fase do Trabalho de Parto , Lacerações/epidemiologia , Modelos Logísticos , Salas Cirúrgicas , Ocitócicos , Ocitocina , Gravidez , Pontuação de Propensão , Estudos Prospectivos , Couro Cabeludo/lesões , Artérias Umbilicais , Vácuo-ExtraçãoRESUMO
BACKGROUND: A hypothesis of preterm parturition is that the pathogenesis of spontaneous preterm birth (sPTB) may be associated with an inflammatory process. Based on this theory, we have hypothesized that an inflammatory biomarker, procalcitonin (PCT), may be a good predictive marker of sPTB at the admission for threatened preterm labour (TPL). The present study was aimed to investigate the association between serum PCT and sPTB in women with TPL and to evaluate whether PCT levels may predict sPTB in women with TPL within 7 or 14 days. METHODS: In a prospective observational laboratory-based study, women with singleton pregnancies, TPL between 24 and 36 weeks and intact membranes, were enrolled between January 2014 and June 2016. Participants received routine medical management of TPL (tocolysis with atosiban, antenatal corticosteroids, and biological tests at admission (C-reactive protein, white blood cell count, and PCT measured on electrochemiluminescence immunoassay)). The primary endpoint was sPTB before 37 weeks of gestation. The value of serum PCT levels to predict sPTB within 7 or 14 days were evaluated using receiver-operating curves (ROC) analysis. RESULTS: A total of 124 women were included in our study. PCT levels did not statistically differ between women with sPTB (n = 30, 24.2%) and controls (n = 94) (median in ng/mL [interquartile range]: 0.043 [0.02-0.07] compared to 0.042 [0.02-0.13], respectively; P = 0.56). PCT levels did not also statistically differ between women with sPTB within 7 days (n = 7, 5.6%) or 14 days (n = 12, 9.7%) after testing and controls. Moreover, subgroup analysis revealed no difference among PCT levels at admission between 24 and 28 weeks, between 28 and 32 weeks and over 32 weeks, and controls. On the basis of the receiver-operating characteristic curve, the highest sensitivity and specificity corresponded to a PCT concentration of 0.038 ng/mL, with poor predictive values for sPTB within 7 or 14 days. CONCLUSION: Serum PCT was not relevant to predict sPTB within 7 or 14 days in women admitted with TPL between 24 and 36 weeks, and thus it is not a suitable biological marker to confirm the hypothesis of an inflammatory process associated with preterm parturition. TRIAL REGISTRATION: Clinicaltrials.gov ( NCT01977079 ), Registered 24 October 2013.
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Calcitonina/sangue , Nascimento Prematuro , Adulto , Biomarcadores/sangue , Feminino , Humanos , Valor Preditivo dos Testes , Gravidez , Nascimento Prematuro/sangue , Nascimento Prematuro/diagnóstico , Nascimento Prematuro/prevenção & controle , Prognóstico , Estudos Prospectivos , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
AIMS: To describe heart rate (HR) variations in surgical residents during laparoscopy and to assess their intraoperative stress. METHODS: We performed a prospective, multicentric, observational, blinded, and comparative analysis of the HR in 75 obstetrics and gynecology residents during planned laparoscopy for infertility in five teaching hospitals with assisted reproductive technology centers. The surgical residents had neither heart disease nor were under medical treatment or using tobacco or drugs. We describe HR variations at 9 preselected operative steps using real-time noninvasive measures of the HR during laparoscopy. RESULTS: Residents performed 124 laparoscopies for unexplained infertility. Their HR increased significantly during the introduction of the Palmer needle, umbilical port and second port, and during abdominopelvic exploration and dye test compared to the baseline HR, the HR after hand washing, at the end of surgery and during skin suture (91.6 ± 1.9, 104.8 ± 2.3, 95.3 ± 2.2, 93.7 ± 2.5, 90.7 ± 1.7 vs. 83.2 ± 1.6, 88.6 ± 1.9, 87.4 ± 2.1, 88.2 ± 1.9 bpm, respectively, p < 0.02). CONCLUSION: Our results point to a potential stress for the surgeon assessed by HR variations during planned laparoscopy compared to the baseline HR before surgery. This 'static' stress can be repeated on the same day.
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Ginecologia/educação , Frequência Cardíaca/fisiologia , Internato e Residência/estatística & dados numéricos , Laparoscopia/educação , Obstetrícia/educação , Estresse Psicológico/epidemiologia , Adulto , Competência Clínica , Feminino , Hospitais de Ensino , Humanos , Infertilidade Feminina/diagnóstico , Laparoscopia/psicologia , Masculino , Gravidez , Estudos ProspectivosRESUMO
PURPOSE: Primary hyperparathyroidism (pHPT) during pregnancy is rare and associated with increased morbidity and mortality for both mother and fetus. This review aims to draw together recent thinking on pregnancy and pHPT. METHODS: We have performed a Pubmed (Medline(®)) search with no time limit using "primary hyperparathyroidism", "pregnancy" or "management" as keywords. We reviewed 37 articles in English and French languages on pHPT characteristics, clinical presentations, pregnancy complications, birth outcomes and management of pHPT during pregnancy. RESULTS: The diagnosis of pHPT is characterized by an elevated serum calcium level associated with an inappropriate increase in the parathyroid hormone level. The clinical manifestations are directly related to the calcium level. Usual techniques to detect parathyroid adenoma or hyperplasia, as computerized tomography and 99mTc-sestamibi scintigraphy, are not recommended in pregnancy. Thus, ultrasonography of the neck is the current first-line investigation during pregnancy for localization of parathyroid diseases. pHPT during pregnancy with mildly elevated calcium levels may be managed with medical treatment: intravenous or oral rehydratation, with or without forced diuresis. Few drugs are available for pHTP during pregnancy; calcitonin and cinacalcet require further study; bisphosphonate should be restricted to life-threatening hypercalcemia. Surgery is the only curative treatment and is recommended when calcium levels are above 2.75 mmol/L. It should be performed in the second trimester and considered in the third trimester if there is inadequate response to medical therapy. CONCLUSION: Early diagnosis of pHPT in a pregnant woman, followed by appropriate management and treatment, has been shown to significantly reduce maternal and fetal complications.
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Hipercalcemia/etiologia , Hiperparatireoidismo Primário/diagnóstico , Complicações na Gravidez/diagnóstico , Calcitonina/uso terapêutico , Cinacalcete , Feminino , Humanos , Hiperparatireoidismo Primário/complicações , Hiperparatireoidismo Primário/terapia , Hiperplasia/diagnóstico , Naftalenos/uso terapêutico , Neoplasias das Paratireoides/complicações , Neoplasias das Paratireoides/diagnóstico , Gravidez , Complicações na Gravidez/terapiaRESUMO
OBJECTIVE: To evaluate vaginal delivery in obese women who underwent cervical ripening at term using a dinoprostone vaginal insert or a cervical ripening balloon (CRB), and to assess maternal and neonatal morbidity according to the method. METHODS: A prospective cohort study including obese women with a live singleton fetus in cephalic presentation who required cervical ripening at term (≥37 weeks) for maternal and/or fetal disease using a dinoprostone vaginal insert or a CRB. The primary outcome was vaginal delivery. Secondary outcomes were a favorable cervix (Bishop score >6) after 24 h, the time from device insertion to delivery, and composite maternal and neonatal morbidity. RESULTS: In total, 135 consecutive women were analyzed (107 CRB, 79.3%; 28 dinoprostone vaginal insert, 20.7%). Vaginal delivery (86 [80.4%] after CRB vs 19 [67.9%] after dinoprostone vaginal insert; P = 0.248), favorable cervix within 24 h after device placement (52 [48.6%] vs 17 [60.7%]; P = 0.264), and maternal morbidity (12 [11.2%] vs 4 [14.3%]; P = 0.646) were similar between the groups. The time from device insertion to delivery also did not differ between the groups. Neonatal morbidity was significantly higher after the dinoprostone vaginal insert (11 [39.3%] vs 20 [18.7%]; P = 0.030). Cervical ripening using the dinoprostone vaginal insert, compared with the CRB, was significantly associated with neonatal morbidity (adjusted odds ratio 4.00, 95% confidence interval 1.34-12.5), but not with maternal morbidity (adjusted odds ratio 1.23, 95% confidence interval 0.30-4.38). CONCLUSIONS: Vaginal delivery, a favorable cervix after 24 h, the time from device insertion to delivery, and maternal morbidity did not significantly differ between the CRB and the dinoprostone vaginal insert for cervical ripening in obese women at term. Nevertheless, neonatal morbidity was significantly associated with the dinoprostone vaginal insert, compared with the CRB, among obese women who required cervical ripening at term.
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Maturidade Cervical , Dinoprostona , Trabalho de Parto Induzido , Obesidade , Ocitócicos , Humanos , Feminino , Gravidez , Dinoprostona/administração & dosagem , Maturidade Cervical/efeitos dos fármacos , Estudos Prospectivos , Adulto , Ocitócicos/administração & dosagem , Trabalho de Parto Induzido/métodos , Administração Intravaginal , Parto Obstétrico/métodos , Resultado da Gravidez , Recém-Nascido , Complicações na GravidezRESUMO
NAUSEA AND VOMITING IN PREGNANCY. Nausea and vomiting during pregnancy are common symptoms experienced by pregnant women. In more severe cases, known as hyperemesis gravidarum, these symptoms can become a pathological condition that can lead to significant complications in both the short and long term. Short-term complications include hydro-electrolyte imbalances, pregnancy termination, and growth retardation. Long-term complications may include anxiety disorders, depression, and post-traumatic stress disorder. Mild cases can often be alleviated through lifestyle and dietary adjustments or non-pharmacological treatments like ginger, acupuncture, or acupressure. However, moderate to severe cases require specific psychological support, anti-emetic treatments, and sometimes hospitalization with intravenous treatment and parenteral rehydration. Managing these cases is complex and challenging because it does not guarantee the complete disappearance of symptoms, which can pose difficulties for caregivers.
NAUSÉES ET VOMISSEMENTS GRAVIDIQUES. Les nausées et vomissements de la grossesse sont un symptôme classique chez la femme enceinte. Le plus souvent sans gravité, les formes modérées à sévères, appelées hyperémèse gravidique, constituent une pathologie qui peut être invalidante, source de complications de la grossesse à court terme (troubles hydroélectrolytiques, arrêt de grossesse, retard de croissance) mais aussi à long terme (troubles anxiodépressifs, état de stress post-traumatique). Les formes minimes peuvent être atténuées par des règles hygiénodiététiques ou des traitements non médicamenteux (gingembre, acupuncture, acupression). Les formes modérées à sévères nécessitent un accompagnement psychologique spécifique, des traitements antiémétiques et, parfois, une hospitalisation avec traitement par voie intraveineuse et réhydratation parentérale. Leur prise en charge est complexe et difficile car elle ne permet pas toujours une disparition des symptômes, ce qui peut mettre en difficulté les soignants.
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Hiperêmese Gravídica , Vômito , Humanos , Feminino , Gravidez , Vômito/terapia , Vômito/etiologia , Hiperêmese Gravídica/terapia , Hiperêmese Gravídica/diagnóstico , Complicações na Gravidez/terapia , Complicações na Gravidez/diagnóstico , Náusea/terapia , Náusea/etiologia , Antieméticos/uso terapêuticoRESUMO
OBJECTIVE: To determine predictors of efficacy for cervical ripening among the Bishop score criteria in nulliparous women at term. METHOD: Prospective observational study of nulliparous women with singleton term fetuses in vertex presentation, intact membranes, and an unfavorable cervix (Bishop score < 6) who underwent cervical ripening with a cervical-ripening balloon (CRB; n = 47) or dinoprostone vaginal insert (PG; n = 28). The authors analyzed Bishop score criteria (dilatation, effacement, fetal station, consistency, position) before and after device removal. Primary outcome was favorable cervix (Bishop score ≥ 6) after device removal. Secondary outcomes were vaginal delivery, modification of Bishop score criteria, and perinatal morbidity. RESULTS: Rates of favorable cervix after cervical ripening were similar between groups (66.7% with CRB vs. 59.3% with PG; P = 0.526). Vaginal delivery (76.6% vs. 78.6%; P = 0.843) and perinatal morbidity did not differ between groups. CRB appeared to be more effective than PG in increasing consistency (+0.7 ± 0.2 vs. +0.3 ± 0.2; P = 0.001) and dilatation of the cervix (+1.3 ± 0.3 vs. +0.9 ± 0.3; P = 0.005). No Bishop score criterion was found as a significant predictor for vaginal delivery. CONCLUSION: CRB seems to be more effective than PG in increasing the consistency and dilatation of the cervix. Efficacy of CRB and PG for vaginal delivery was similar.
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Ocitócicos , Gravidez , Feminino , Humanos , Trabalho de Parto Induzido , Maturidade Cervical , Dinoprostona , Parto Obstétrico , Colo do ÚteroRESUMO
The purpose of this prospective cohort study is to identify the predictive factors for vaginal delivery among women (n = 146) who underwent cervical ripening using a dinoprostone insert (PG) alone (13.7%), cervical ripening balloon (CRB) alone (52.7%), oral misoprostol (M) alone (4.1%), or repeated methods (R, 29.5%) for gestational diabetes mellitus (GDM) at term, and to analyze maternal and neonatal morbidity outcomes according to the method for cervical ripening. After cervical ripening, vaginal delivery occurred in 84.2% (n = 123) and was similar among groups (90.0% after PG, 83.1% after CRB, 83.3% after M, and 83.7% after R; p = 0.89). After a multivariable logistic regression analysis adjusted for potential confounders, the internal cervical os being open before cervical ripening was a predictor of vaginal delivery (adjusted odds ratio (OR) of 4.38, 95% confidence index (CI) of 1.62-13.3, p = 0.03), and previous cesarean delivery was a predictor of cesarean delivery (aOR of 7.67, 95% CI of 2.49-24.00, p < 0.01). Birthweight was also significantly associated with cesarean delivery (aOR of 1.15, 95% CI of 1.03-1.31, p = 0.02). The rates of maternal and neonatal morbidity outcomes were 10.9% (n = 16) and 19.9% (n = 29), respectively, and did not differ according to the mode of delivery and to the method used for cervical ripening. Identifying these specific high-risk women (previous cesarean delivery and internal cervical os being closed before cervical ripening) for cesarean delivery among women who underwent cervical ripening for GDM at term is important and practical for all physicians to make a decision in partnership with women.
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The aim of the study was to determine whether operative vaginal delivery (OVD) was associated with non-optimal neurocognitive development at the corrected age of 2 years for preterm singletons using the Loire Infant Follow-up Team (LIFT) longitudinal cohort, a French regional perinatal network and prospective, population-based cohort of preterm infants. For this study, we included women with cephalic singletons and planned vaginal delivery from 24 to 34 weeks' gestation between 2006 and 2016. The main exposure was the mode of delivery (spontaneous vaginal delivery (SVD), OVD, and cesarean delivery (CS) during labor). The primary outcome was non-optimal neurodevelopmental outcome at the corrected age of 2 years assessed by a physical examination, a neuropsychological test, and/or a parental questionnaire. Secondary outcomes were survival at discharge and survival at discharge without morbidity. We used the multivariate logistic regression and propensity score methods to compare outcomes associated with OVD. The study included 1934 infants born preterm: 1384 (71.6%) with SVD, 87 (4.5%) with OVD, and 463 (23.9%) with CS. Neonates with SVD, OVD, and CS did not differ in survival (97.0%, 97.7%, and 97.8%, respectively; p = 0.79) or in survival without morbidity (82.8%, 86.2%, and 82.7%, respectively; p = 0.71). In survived infants, 1578 (81.6%) were evaluated at age two: 279 (17.7%) were considered to have a non-optimal neurodevelopmental outcome (18.3% after SVD, 18.0% after OVD, and 15.9% after CS; p = 0.57). Propensity score analysis showed that OVD was not associated with non-optimal neurocognitive development at age two, with an adjusted odds ratio (aOR) of 0.86 and a 95% confidence interval (95% CI) of 0.47-1.69, compared with SVD; and an aOR of 0.76 and a 95% CI of 0.31-1.8, compared with CS. Operative vaginal delivery was not associated with non-optimal neurocognitive development at 2 years of corrected age for preterm singletons.
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Our aim was to identify factors associated with shoulder dystocia following an attempted operative vaginal delivery (aOVD) in a prospective cohort study and to evaluate whether these factors can be used to accurately predict shoulder dystocia by building a score of shoulder dystocia risk. This was a planned secondary analysis of a prospective cohort study of deliveries with aOVD at term from 2008-2013. Cases were defined as women with shoulder dystocia following an aOVD defined as a delivery that requires additional obstetric maneuvers following failure of gentle downward traction on the fetal head to effect delivery of the shoulders. Multivariate logistic regression analyses were performed to determine risk factors for shoulder dystocia. Shoulder dystocia occurred in 57 (2.7%) of the 2118 women included. In the whole cohort, women with shoulder dystocia more often had a history of shoulder dystocia (3.5% vs. 0.2%, p = 0.01), and there was a significant interaction between aOVD and gestational age and the duration of the second stage of labor: women with shoulder dystocia more often had a gestational age > 40 weeks and a second stage of labor longer than 3 h specifically for midpelvic aOVD. In multivariable analysis, a history of shoulder dystocia was the only factor independently associated with shoulder dystocia following aOVD (aOR 27.00, 95% CI 4.10-178.00). The AUC for the receiver operating characteristic curve generated using a multivariate model with term interaction with head station was 0.70 (95% CI 0.62-0.77). The model failed to accurately predict shoulder dystocia.
Assuntos
Distocia , Trabalho de Parto , Distocia do Ombro , Gravidez , Humanos , Feminino , Lactente , Distocia/epidemiologia , Distocia/etiologia , Estudos Prospectivos , Parto Obstétrico/efeitos adversos , Fatores de Risco , Ombro , Estudos RetrospectivosAssuntos
Parto Obstétrico , Apresentação no Trabalho de Parto , Feminino , Feto , Cabeça , Humanos , Gravidez , Ultrassonografia Pré-NatalRESUMO
UNLABELLED: Mifepristone is a progesterone receptor antagonist widely used in obstetrics. The aim of the study was to focus on free corticotrophin-releasing hormone (CRH) and also describe modulation of adrenal and placental steroid hormone concentrations induced by mifepristone. METHODS: Twenty-six women were enrolled in the study. They received mifepristone for termination of pregnancy. Maternal blood samples were retrieved before administration of mifepristone (600 mg) and 48 h after, just before induction of labor. Bound and free CRH levels were determined in maternal blood concomitantly with cortisol, estriol, progesterone and SDHEA levels. Also paired fetal cord blood samples were collected. RESULTS: Maternal plasmatic CRH level did not change after mifepristone absorption but free CRH increased significantly (0.500 ± 0.326 vs. 0.388 ± 0.303 ng/ml, p = 0.040). A significant decrease of progesterone was observed (83.6 ± 49.3 vs. 95.6 ± 54.9 ng/ml, p = 0.001) with a lower progesterone/estriol ratio (26.9 ± 15.7 vs. 40.7 ± 31.1, p = 0.004). There was a strong association between maternal and fetal free CRH (r² = 0.675, p = 0.001), cortisol (r² = 0.570, p = 0.019), and positive but modest correlation for progesterone (r² = 0.341, p = 0.046) and estriol (r² = 0.379, p = 0.025) levels. CONCLUSION: Mifepristone has an effect on free CRH level and changes the estriol-progesterone balance.