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1.
Cureus ; 16(2): e53773, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38327723

ABSTRACT

Introduction Haemorrhoids and anal fissures (HAF) are common in pregnancy and can severely affect the quality of life of those suffering from them. Despite the condition being common, there is limited evidence, formal guidelines or recommendations on treatment, and little is known about the natural course during pregnancy. Methods This was a prospective, observational cohort study conducted at a tertiary-referral university maternity hospital (The National Maternity Hospital, Dublin), conducted over a nine-month period. The first part of the study was a case-control study of antenatal patients over 34 weeks' gestation. The second part of the study involved a cohort of postnatal patients. Anonymous patient surveys were performed and analysed. Results Two hundred and fifty-eight patients were recruited into the study from the outpatient clinics and wards of one maternity hospital from April to December 2021. Of the antenatal patients, 82/184 (45%) of these patients had symptoms of HAF and 102/184 (55%) antenatal patients were unaffected, acting as controls. In addition, 74 affected postnatal patients were also included. In the affected antenatal group, 36/82 (44%) of patients had self-reported HAF (symptoms or signs of HAF); 50/82 (61%) of patients diagnosed with HAF on their own. 12/82 (15%) noticed symptoms in the first trimester, 25/82 (30%) in the second and 45/82 (55%) in the third. 142/184 (77%) of antenatal patients used conservative methods to manage their symptoms, including an increase in dietary fibre. 144/184 (78%) used medical treatments including suppositories. Only one patient had surgery. 70/156 (45%) of postnatal patients' symptoms resolved within days, 42/156 (27%) in weeks and 44/156 (28%) within months. Conclusion HAF affect almost half of the pregnancies. Age over 35 was significantly associated with antenatal haemorrhoids or anal fissures. Concerningly, the majority of patients (64%) self-diagnose and manage the condition without either seeking or receiving guidance from medical professionals. In terms of the natural course of the disease, it was encouraging that 45% of patients' symptoms resolved within a few days. This will help when counselling patients with distressing symptoms. Conservative measures such as increased dietary fibre, increased fluid intake and bath salts were effective in relieving symptoms for the majority of patients.

2.
Ir J Med Sci ; 193(2): 797-812, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37715828

ABSTRACT

BACKGROUND: Migration due to environmental factors is an international crisis affecting many nations globally. Pregnant people are a vulnerable subgroup of migrants. AIM: This article explores the potential effects of environmental migration on pregnancy and aims to draw attention to this rising concern. METHODS: Based on the study aim, a semi-structured literature review was performed. The following databases were searched: MEDLine (PubMed) and Google Scholar. The search was originally conducted on 31st January 2021 and repeated on 22nd September 2022. RESULTS: Pregnant migrants are at increased risk of mental health disorders, congenital anomalies, preterm birth, and maternal mortality. Pregnancies exposed to natural disasters are at risk of low birth weight, preterm birth, hypertensive disorders, gestational diabetes, and mental health morbidity. Along with the health risks, there are additional complex social factors affecting healthcare engagement in this population. CONCLUSION: Maternity healthcare providers are likely to provide care for environmental migrants over the coming years. Environmental disasters and migration as individual factors have complex effects on perinatal health, and environmental migrants may be at risk of specific perinatal complications. Obstetricians and maternity healthcare workers should be aware of these challenges and appreciate the individualised and specialised care that these patients require.


Subject(s)
Premature Birth , Transients and Migrants , Pregnancy , Humans , Infant, Newborn , Female , Premature Birth/epidemiology , Infant, Low Birth Weight , Parturition
3.
Am J Obstet Gynecol ; 2023 Dec 06.
Article in English | MEDLINE | ID: mdl-38065377

ABSTRACT

Transabdominal cerclage is an effective surgical intervention for preterm birth prevention. Placement of cervical sutures using a port closure device for prepregnancy laparoscopic abdominal cerclage has been used at our unit in recent years. We report the operative and pregnancy outcomes for prepregnancy laparoscopic abdominal cerclage using the port closure device and compare it with the outcomes of the traditional approach. For prepregnancy laparoscopic transabdominal cerclage (n=52), the port closure device approach was associated with less blood loss during surgery (0.95±4.4 mL vs 5.4±15.7 mL; P=.007) and a shorter hospital length of stay (0.0; 0.0-0.0 days vs 1.0; 0.0-1.0 days; P<.001). There were also trends toward shorter operating times (41.4±15.3 minutes vs 50.1±18.0 minutes; P=.167) and lower perioperative complication rates (0.0%; 0/21 vs 16.1%; 5/31; P=.065) when compared with the traditional technique. There was no significant difference between the port closure device technique and the traditional approach in the rate of preterm birth in a subsequent pregnancy (0.0%; 0/9 vs 22.6%; 7/39; P=.248). Use of the port closure device for suture placement during prepregnancy laparoscopic cerclage for preterm birth prevention was reported. This technique was associated with less blood loss and a shorter hospital length of stay, had trends toward shorter operating times and lower perioperative complication rates, and had similar rates of preterm birth.

4.
Obstet Gynecol ; 141(4): 854-856, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36897156

ABSTRACT

Uterine rupture is a rare obstetric complication that is associated with maternal and neonatal morbidity and mortality. The aim of this study was to examine uterine rupture and its outcomes in the setting of the unscarred compared with the scarred uterus. A retrospective observational cohort study was performed examining all cases of uterine rupture in three tertiary care hospitals in Dublin, Ireland, over a 20-year period. The primary outcome was perinatal mortality rate with uterine rupture, which was 11.02% (95% CI 6.5-17.3). There was no significant difference in perinatal mortality between cases of scarred and unscarred uterine rupture. Unscarred uterine rupture was associated with higher maternal morbidity , defined as major obstetric hemorrhage or hysterectomy.


Subject(s)
Perinatal Death , Uterine Rupture , Pregnancy , Infant, Newborn , Female , Humans , Uterine Rupture/etiology , Uterine Rupture/surgery , Pregnancy Outcome , Retrospective Studies , Uterus , Hysterectomy/adverse effects
5.
Eur J Obstet Gynecol Reprod Biol ; 282: 24-30, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36621262

ABSTRACT

OBJECTIVE: The aim of this study was to present contemporary trends in opiate use disorder (OUD) and substance use in pregnancy in Ireland, with associated obstetric outcomes, over the last ten years. STUDY DESIGN: This retrospective observational cohort study was conducted at an Irish tertiary maternity unit. All women with OUD or substance use in pregnancy delivered under this service between 2010 and 2019 were included. Drug-exposure was self-reported. Data was collected by combining electronic and hand-held patient records. Trends and outcomes were analysed by year of delivery. Approval for the study was granted by the institution's clinical governance committee. RESULTS: Of the 82,669 women delivered, 525 had OUD or substance use in pregnancy (1 in every 160 women booking). 11.6% were homeless, 20.0% were in full-time employment and 91.0% smoked tobacco in pregnancy. 66.3% had a history of psychiatric disorders. Over the ten years, there was a significant reduction in women delivered with OUD or substance use in pregnancy (0.8 % to 0.4 %, RR 0.55, 95 % CI 0.36-0.85), significant reduction in the proportion of women on Opioid-Substitute-Treatment (OST, RR 0.66 95 % CI 0.51-0.87) and an increase in mean maternal age (30.7to32.0 years). Rates of cocaine and cannabis consumption increased (20.6 %, RR 3.8, 95 % CI 1.57-9.44: 24.0 %, RR 3.7, 95 % CI 1.58-8.86 respectively). The maternal mortality rate was 380.9:100,000 births. The perinatal mortality rate was 15.6:1000 births. The preterm birth rate was 17.9 %, with a mean birth weight of 2832 g. The rate of NICU admission was 52.0 % and the mean length of stay was 22.4 days. Amongst the smaller OUD population, the rate of NICU admission for Neonatal Abstinence Syndrome (NAS) and treatment for NAS increased over the study timeframe (36.0 %, RR 2.97, 95 % CI 1.86-4.75: 28.5 %, RR 2.92, 95 % CI 1.70-5.0 respectively). CONCLUSIONS: The obstetric population attending an Irish antenatal service with opiate use disorder or substance exposure is reducing in size with older patients, less opioid substitute therapy and increasing cocaine and cannabis use. These women have high rates of maternal and perinatal morbidity and mortality. Specialist antenatal addiction services, coordinated by the drug-liaison midwife, are critical in adapting care to respond to this dynamic and vulnerable patient cohort.


Subject(s)
Cocaine , Opiate Alkaloids , Premature Birth , Substance-Related Disorders , Pregnancy , Infant, Newborn , Female , Humans , Adult , Premature Birth/epidemiology , Analgesics, Opioid/therapeutic use , Retrospective Studies , Ireland/epidemiology , Substance-Related Disorders/epidemiology
6.
Ir J Med Sci ; 192(3): 1249-1257, 2023 Jun.
Article in English | MEDLINE | ID: mdl-35781860

ABSTRACT

BACKGROUND: Macrosomia in the absence of diabetes can be associated with increased neonatal and maternal morbidity. Management is usually undertaken on a case-by-case basis. AIMS: In order to inform local practice, this study aimed to evaluate the outcomes of the management of non-diabetic macrosomia in an Irish tertiary center. METHODS: A retrospective observational study was performed on all women with estimated fetal weight over 4000 g after 37 weeks' gestation. Maternal demographics and obstetric and neonatal outcomes were recorded using the hospital information system. Women with diabetes, previous caesarean section, non-cephalic presentation, or any other complicating condition were excluded. Women were divided into two groups: 1. Active management: Elective delivery for macrosomia-between 38 + 0 and 40 + 6 weeks' gestation 2. Expectant management: with induction of labour offered after 41 weeks' gestation RESULTS: There were 397 women included, 188 with active and 209 with expectant management. There was no difference in adverse neonatal outcomes, major maternal morbidity, or mode of delivery, after exclusion of pre-labor caesarean section. Women with expectant management were more likely to go into spontaneous labor (46.9 vs 1.6%, p < 0.001) and to have a favorable cervix at the onset of induction of labor if nulliparous (86.1 vs 70.0%, p = 0.021), but have higher rates of episiotomy (28.6 vs 18.2%, p = 0.021). With active management, nulliparas with an unfavorable cervix had increased risk of anal sphincter injury (6.5 vs 0.0%, p = 0.007) and postpartum hemorrhage (59.0 vs 35.5%, p = 0.003). CONCLUSIONS: Overall, there was no difference in major maternal or neonatal outcomes between management options for fetal macrosomia. However, inducing nulliparas with an unfavorable cervix for non-diabetic macrosomia was associated with obstetric anal sphincter injury and postpartum hemorrhage.


Subject(s)
Cesarean Section , Postpartum Hemorrhage , Infant, Newborn , Pregnancy , Female , Humans , Fetal Macrosomia/epidemiology , Watchful Waiting , Postpartum Hemorrhage/etiology , Labor, Induced/adverse effects
8.
Eur J Obstet Gynecol Reprod Biol ; 274: 142-147, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35640443

ABSTRACT

OBJECTIVES: The objective of this study was to: 1. Establish the median gestational age of spontaneous labour for low-risk nulliparas. 2. Examine the variation in mode of delivery and short-term neonatal outcomes with gestation at onset of spontaneous labour. STUDY DESIGN: This is a retrospective observational cohort study conducted at a tertiary obstetric unit. The study population was 12, 323 low risk nulliparous women with singleton pregnancies who experienced spontaneous onset of labour. The study period was over seven years, from Jan 1st 2011 to 31st Dec 2017. Exclusion criteria were multiparity, multi-fetal pregnancy, booking after 14 weeks gestation, antepartum or intrapartum death, or any obstetric or fetal indication for delivery with the exception of post-maturity. Gestation of onset of spontaneous labour, demographic variables and maternal and neonatal outcomes were collected. The primary outcome was median gestational age at onset of spontaneous labour and its distribution at term. Secondary outcomes were mode of delivery and neonatal outcomes including low-apgar score and NICU admission. RESULTS: 12, 323 patients were eligible for inclusion. Median gestation for onset of labour was 40.1 weeks gestation, with 80.5% of spontaneous labour occurs by 41 + 0 weeks gestation. The risk of assisted delivery (RR 1.32, 95% CI 1.23 - 1.42), caesarean section (RR 2.17, 95% CI 1.88-2.51) and low-apgar scores (RR 3.13 95% CI 1.50-6.55) increased significantly with spontaneous labour after 41 weeks' gestation. CONCLUSIONS: Nulliparous women with low-risk pregnancies are most likely to experience spontaneous labour between 40 + 0 and 40 + 6. 80.5% of spontaneous labour occurred by 41 + 0 weeks gestation. Assisted vaginal delivery, caesarean section and low-apgar scores were significantly more likely with spontaneous labour after 41 weeks' gestation.


Subject(s)
Cesarean Section , Delivery, Obstetric , Cohort Studies , Female , Gestational Age , Humans , Infant, Newborn , Parity , Pregnancy
9.
Int J Gynaecol Obstet ; 157(3): 489-501, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35122246

ABSTRACT

BACKGROUND: Endocrine disrupting chemicals have harmful effects on reproductive, perinatal, and obstetric outcomes. OBJECTIVE: To analyze the evidence on nutritional interventions to reduce the negative effects of endocrine disruptors on reproductive, perinatal, and obstetric outcomes. SEARCH STRATEGY: A search of MEDLINE (PubMed), Allied Health Literature (CINAHL), EMBASE, Web of Science, and the Cochrane Database was conducted from inception to May 2021. SELECTION CRITERIA: Experimental studies on human populations. DATA COLLECTION AND ANALYSIS: Data were collected from eligible studies. Risk of bias assessment was completed using the Cochrane risk of bias tool and the ROBINS-I Tool. RESULTS: Database searches yielded 15 362 articles. Removing 11 181 duplicates, 4181 articles underwent abstract screening, 26 articles were eligible for full manuscript review, and 16 met full inclusion criteria. Several interventions were found to be effective in reducing exposure to endocrine disruptors: avoidance of plastic containers, bottles, and packaging; avoidance of canned food/beverages; consumption of fresh and organic food; avoidance of fast/processed foods; and supplementation with vitamin C, iodine, and folic acid. There were some interventional studies examining therapies to improve clinical outcomes related to endocrine disruptors. CONCLUSION: Dietary alterations can reduce exposure to endocrine disruptors, with limited data on interventions to improve endocrine-disruptor-related clinical outcomes. This review provides useful instruction to women, their families, healthcare providers, and regulatory bodies.


Subject(s)
Endocrine Disruptors , Endocrine Disruptors/adverse effects , Female , Humans , Pregnancy , Reproductive Health , Vitamins
12.
Eur J Obstet Gynecol Reprod Biol X ; 13: 100137, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34825174

ABSTRACT

OBJECTIVE: This study examines Irish obstetrics and gynaecology trainees' experiences with and opinions of termination of pregnancy (ToP) after legal change. STUDY DESIGN: We invited obstetrics & gynaecology non-consultant hospital doctors (NCHDs) to participate in a web-based survey through a professional e-mail listserv. We conducted descriptive statistical analyses of responses using Stata SE Version 16. RESULTS: A total of 102/202 (50.5%) trainees responded to the survey. Of these, 61.8% believed that ToP should be allowed on request up to 12 weeks and in limited circumstances thereafter (in line with current law), and 19.6% believe ToP should be allowed on request even after 12 weeks. Knowledge about the abortion law was high (70.6% achieved a perfect knowledge score). Since the new law came into effect, 61.8% of trainees reported participation in abortion care, though only 25.5% had performed surgical procedures. More than 75% of respondents would like to receive more training in all clinical skills related to ToP. In the future, 67.6% of respondents would be willing to provide TOP in all circumstances allowed by law. CONCLUSION: Irish obstetrics & gynaecology NCHDs are generally supportive of the legislation. Few trainees have performed surgical abortions, and most would like to receive additional clinical training related to ToP.

13.
J Obstet Gynaecol India ; 71(1): 33-37, 2021 Feb.
Article in English | MEDLINE | ID: mdl-32989348

ABSTRACT

INTRODUCTION: Medical students are known to have high levels of depression, anxiety and stress from the high-pressure environments that they study and train in. The coronavirus pandemic presents source of stress and anxiety to large populations in general, and to healthcare professionals in particular. This study was undertaken to assess the psychological effects of this pandemic on the mental health of medical students and trainees. MATERIALS AND METHODS: An online questionnaire was designed to capture information on the participant's anxieties related to the pandemic and included a validated tool for the assessment of anxiety and depression symptoms (GAD-7 and PHQ-9, respectively). The questionnaire was prepared on Google Forms, and the link to the questionnaire was disseminated to 113 medical students and junior doctors on 19 April 2020, and the survey closed on 22 April 2020 midnight. RESULTS: The survey was sent to 113 students, and 83 students participated. Of the participants, 47 (56.6%) were female and 36 (43.4%) were male, and 80 (96.4%) were aged less than 30 years old. Formal anxiety and depression scores using the GAD-7 and PHQ-9 tools indicated 15/82 (18.3%) had anxiety scores of 0 (lowest possible) and 21/82 (25.6%) had the lowest possible depression score of 0. However, 6/82 (7.3%) had scores that were classified as severe depression. Females had significantly higher median anxiety (5 v 2, p < 0.002) and depression scores (5 v 3, p = 0.025) than male participants. Direct patient care and care of patients with Covid-19 did not result in significant deterioration in anxiety and depression. CONCLUSION: Female students/junior doctors showed higher anxiety and depression scores than males. Direct patient care and care of patients with Covid-19 did not result in a measurable deterioration in anxiety and depression in this study. In this stressful pandemic situation, it is imperative to look after the mental health of healthcare workers as well as patients.

14.
J Healthc Qual ; 43(2): 67-75, 2021.
Article in English | MEDLINE | ID: mdl-32568811

ABSTRACT

OBJECTIVE: Caesarean section surgical site infection (SSI) is a surgical wound site infection occurring within 30 days of surgery with a reported incidence of 3-15%. This quality improvement (QI) project aimed to reduce caesarean section SSI by 50% in a tertiary maternity center. METHODS: Using multidisciplinary team approach, the project was designed with evidence-based interventions. The Royal College of Physicians of Ireland/Royal College of Surgeons in Ireland "Preventing Surgical Site Infections Key Recommendations for Practice" guideline was used as standard perioperative care. A care bundle was designed targeting preoperative personal patient preparation, preoperative prophylactic antibiotics, and strict skin preparation technique, all measured using a patient survey. The rate of SSI was followed for 14 months. The Model for Improvement methodology was used to implement change. RESULTS: Surgical site infection rate decreased from 6.7% (n = 684 caesarean sections, n = 46 SSI) to 3.45% (n = 3,206 caesarean sections, n = 110 SSI), p = .0006. Reduction occurred in both elective (4.4%-2.7%) and emergency (9.1%-4.1%) caesarean section groups. There was excellent adherence to all three elements of the care bundle. The 50% reduction in caesarean section SSI was sustained over the 14-month period, significantly reducing maternal morbidity. CONCLUSIONS: The success of this QI project is attributable to frontline ownership and empowerment of patients and staff.


Subject(s)
Cesarean Section , Surgical Wound Infection , Female , Humans , Perioperative Care , Pregnancy , Quality Improvement , Surgical Wound Infection/prevention & control
15.
J Perinat Med ; 48(9): 971-976, 2020 Nov 26.
Article in English | MEDLINE | ID: mdl-32975206

ABSTRACT

Objectives The physical health impact of the coronavirus disease infection (COVID-19) has received attention worldwide; however, data around the psychological impact of the pandemic is still emerging and little has been reported on psychological effects among vulnerable groups. This study was undertaken with the aim of studying the impact of the COVID-19 pandemic and related restrictions on perinatal mental health among women in Qatar. Methods A cross- sectional survey of women accessing maternity services in Qatar was carried out during the months of June and July 2020 at the local peak of the pandemic. Background data including relevant demographic details, pregnancy and mental health history, concerns, as well as helpful stress-reducing factors reported by women was collected. Depression and anxiety symptomatology was studied using the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS). Results The survey results revealed a high prevalence of anxiety and Depressive symptomatology (34.4 and 39.2% respectively), based on PHQ-ADS scoring. These rates appeared much higher than the reported pre-pandemic prevalence and were not affected by occupation, previous mental health problems or pregnancy complications. Women's most commonly reported concerns as well as coping factors are discussed. Conclusions Results indicate a marked increase in anxiety and depressive symptoms during the COVID-19 pandemic, among pregnant and puerperal individuals, who constitute a vulnerable group with respect to mental health morbidity. These findings can be used to inform public health interventions, among which, consideration should be given to routine mental health screening of vulnerable groups during major health crises.


Subject(s)
Betacoronavirus , Coronavirus Infections/psychology , Mental Health/statistics & numerical data , Pandemics , Pneumonia, Viral/psychology , Pregnancy Complications/psychology , Stress, Psychological/epidemiology , Anxiety/epidemiology , COVID-19 , Cross-Sectional Studies , Depression/epidemiology , Female , Humans , Pregnancy , Qatar/epidemiology , SARS-CoV-2 , Surveys and Questionnaires
19.
Lancet ; 395(10232): 1278-1291, 2020 04 18.
Article in English | MEDLINE | ID: mdl-32305093

ABSTRACT

BACKGROUND: Acalabrutinib is a selective, covalent Bruton tyrosine-kinase inhibitor with activity in chronic lymphocytic leukaemia. We compare the efficacy of acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab in patients with treatment-naive chronic lymphocytic leukaemia. METHODS: ELEVATE TN is a global, phase 3, multicentre, open-label study in patients with treatment-naive chronic lymphocytic leukaemia done at 142 academic and community hospitals in 18 countries. Eligible patients had untreated chronic lymphocytic leukaemia and were aged 65 years or older, or older than 18 years and younger than 65 years with creatinine clearance of 30-69 mL/min (calculated by use of the Cockcroft-Gault equation) or Cumulative Illness Rating Scale for Geriatrics score greater than 6. Additional criteria included an Eastern Cooperative Oncology Group performance status score of 2 or less and adequate haematologic, hepatic, and renal function. Patients with significant cardiovascular disease were excluded, and concomitant treatment with warfarin or equivalent vitamin K antagonists was prohibited. Patients were randomly assigned (1:1:1) centrally via an interactive voice or web response system to receive acalabrutinib and obinutuzumab, acalabrutinib monotherapy, or obinutuzumab and oral chlorambucil. Treatments were administered in 28-day cycles. To reduce infusion-related reactions, acalabrutinib was administered for one cycle before obinutuzumab administration. Oral acalabrutinib was administered (100 mg) twice a day until progressive disease or unacceptable toxic effects occurred. In the acalabrutinib-obinutuzumab group, intravenous obinutuzumab was given on days 1 (100 mg), 2 (900 mg), 8 (1000 mg), and 15 (1000 mg) of cycle 2 and on day 1 (1000 mg) of cycles 3-7. In the obinutuzumab-chlorambucil group, intravenous obinutuzumab was given on days 1 (100 mg), 2 (900 mg), 8 (1000 mg), and 15 (1000 mg) of cycle 1 and on day 1 (1000 mg) of cycles 2-6. Oral chlorambucil was given (0·5 mg/kg) on days 1 and 15 of each cycle, for six cycles. The primary endpoint was progression-free survival between the two combination-therapy groups, assessed by independent review committee. Crossover to acalabrutinib was allowed in patients who progressed on obinutuzumab-chlorambucil. Safety was assessed in all patients who received at least one dose of treatment. Enrolment for this trial is complete, and the study is registered at ClinicalTrials.gov, NCT02475681. FINDINGS: Between Sept 14, 2015, and Feb 8, 2017, we recruited 675 patients for assessment. 140 patients did not meet eligibility criteria, and 535 patients were randomly assigned to treatment. 179 patients were assigned to receive acalabrutinib-obinutuzumab, 179 patients were assigned to receive acalabrutinib monotherapy, and 177 patients were assigned to receive obinutuzumab-chlorambucil. At median follow-up of 28·3 months (IQR 25·6-33·1), median progression-free survival was longer with acalabrutinib-obinutuzumab and acalabrutinib monotherapy, compared with obinutuzumab-chlorambucil (median not reached with acalabrutinib and obinutuzumab vs 22·6 months with obinutuzumab, hazard ratio [HR] 0·1; 95% CI 0·06-0·17, p<0·0001; and not reached with acalabrutinib monotherapy vs 22·6 months with obinutuzumab, 0·20; 0·13-0·3, p<0·0001). Estimated progression-free survival at 24 months was 93% with acalabrutinib-obinutuzumab (95% CI 87-96%), 87% with acalabrutinib monotherapy (81-92%), and 47% with obinutuzumab-chlorambucil (39-55%). The most common grade 3 or higher adverse event across groups was neutropenia (53 [30%] of 178 patients in the acalabrutinib-obinutuzumab group, 17 [9%] of 179 patients in the acalabrutinib group, and 70 [41%] of 169 patients in the obinutuzumab-chlorambucil group). All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients). Grade 3 or higher infections occurred in 37 (21%) patients given acalabrutinib-obinutuzumab, 25 (14%) patients given acalabrutinib monotherapy, and 14 (8%) patients given obinutuzumab-chlorambucil. Deaths occurred in eight (4%) patients given acalabrutinib-obinutuzumab, 12 (7%) patients given acalabrutinib, and 15 (9%) patients given obinutuzumab-chlorambucil. INTERPRETATION: Acalabrutinib with or without obinutuzumab significantly improved progression-free survival over obinutuzumab-chlorambucil chemoimmunotherapy, providing a chemotherapy-free treatment option with an acceptable side-effect profile that was consistent with previous studies. These data support the use of acalabrutinib in combination with obinutuzumab or alone as a new treatment option for patients with treatment-naive symptomatic chronic lymphocytic leukaemia. FUNDING: Acerta Pharma, a member of the AstraZeneca Group, and R35 CA198183 (to JCB).


Subject(s)
Agammaglobulinaemia Tyrosine Kinase/antagonists & inhibitors , Antibodies, Monoclonal, Humanized/administration & dosage , Benzamides/administration & dosage , Chlorambucil/administration & dosage , Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy , Pyrazines/administration & dosage , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized/adverse effects , Antineoplastic Agents, Immunological , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Benzamides/adverse effects , Chlorambucil/adverse effects , Female , Humans , Male , Middle Aged , Progression-Free Survival , Pyrazines/adverse effects
20.
BMJ Case Rep ; 13(3)2020 Mar 12.
Article in English | MEDLINE | ID: mdl-32169987

ABSTRACT

Intravenous leiomyomatosis is extremely rare. This case describes a 42-year-old woman who presented with abdominal distension, cyclical bloating and urinary retention. Preoperative imaging showed a multilobulated uterine mass. Following multidisciplinary team discussion, a complete staging surgery consisting of midline laparotomy, total hysterectomy and bilateral salpingo-oophrectomy was performed. Intraoperatively, a large multilobulated uterine mass was noted with engorgement of the infundibulopelvic ligaments due to intravascular extension of tumour. On removal of the uterus, the patient desaturated and became hypotensive. Intraoperative transoesophageal echocardiography revealed mass extending from the inferior vena cava (IVC) into the right atrium (RA). The cardiothoracic surgical team retrieved a worm-like mass extending from the IVC into the RA. Histopathological examination diagnosed a large uterine leiomyoma with intravenous leiomyomatosis. The mass from the RA was a bland spindle cell tumour which matched the uterine mass histopathologically. Intravenous leiomyomatosis is a rare variant of uterine leiomyoma. Although intracardiac extension has been described, this is the first case of intraoperative embolisation of pelvic tumour to the RA at hysterectomy.


Subject(s)
Embolization, Therapeutic/methods , Heart Atria/pathology , Leiomyomatosis/surgery , Vascular Diseases/pathology , Vena Cava, Inferior/pathology , Adult , Echocardiography, Transesophageal/methods , Female , Heart Atria/diagnostic imaging , Heart Neoplasms/pathology , Humans , Hysterectomy/methods , Intraoperative Period , Laparotomy/methods , Salpingo-oophorectomy/methods , Treatment Outcome , Uterine Neoplasms/diagnostic imaging , Uterine Neoplasms/pathology , Vascular Neoplasms/pathology , Vena Cava, Inferior/diagnostic imaging
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