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Introduction: Healthcare services for pregnant and postpartum ('perinatal') women were reconfigured significantly at the advent and for the duration of the SARS-CoV-2 pandemic, and despite the United Kingdom announcing 'Freedom Day' on 19 July 2021 (whereafter all legal lockdown-related restrictions were lifted), restrictions to maternity (antenatal, intrapartum, and postnatal) services remained. This study presents data from eight perinatal women about their experiences of psychosocial wellbeing and maternity care in the post-'Freedom Day' epoch. Methods: Semi-structured interviews were conducted virtually, with data recorded, transcribed, and analysed by hand. Grounded theory analysis was employed with the final theory assessing the reproductive injustice of the pandemic 'Freedom Day'. Results: Analysing iteratively and inductively led to four emergent themes: 'A Failing System, Failing Women'; 'Harm Caused by a State of Difference'; 'The Privileges (Not Rights) of Reproductive Autonomy, Agency, and Advocacy'; and 'Worried Women and Marginalised Mothers'. Together, these themes form the theory of 'Freedom for some, but not for Mum'. Discussion: Women experienced a lack of high-quality reliable information about the pandemic, vaccination against the virus, and the changes to, and decision-making surrounding, their perinatal care. Women recognised healthcare professionals and maternity services were stretched and that maternity services were failing but often reported hostility from staff and abandonment at times when they were unsure about how to navigate their care. The most singular injustice was the disparity between women having to accept continuing restrictions to their freedom whilst receiving maternity care and the (reckless) freedom being enacted by the general public.
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COVID-19 , Humanos , Femenino , COVID-19/psicología , COVID-19/epidemiología , Reino Unido , Embarazo , Adulto , Atención Perinatal , SARS-CoV-2 , Servicios de Salud Materna , Investigación Cualitativa , Justicia Social , Pandemias , Teoría Fundamentada , Entrevistas como AsuntoRESUMEN
BACKGROUND: Women who suffer an early pregnancy loss require specific clinical care, aftercare, and ongoing support. In the UK, the clinical management of early pregnancy complications, including loss is provided mainly through specialist Early Pregnancy Assessment Units. The COVID-19 pandemic fundamentally changed the way in which maternity and gynaecological care was delivered, as health systems moved to rapidly reconfigure and re-organise services, aiming to reduce the risk and spread of SARS-CoV-2 infection. PUDDLES is an international collaboration investigating the pandemic's impact on care for people who suffered a perinatal bereavement. Presented here are initial qualitative findings undertaken with UK-based women who suffered early pregnancy losses during the pandemic, about how they navigated the healthcare system and its restrictions, and how they were supported. METHODS: In-keeping with a qualitative research design, in-depth semi-structured interviews were undertaken with an opportunity sample of women (N = 32) who suffered any early pregnancy loss during the COVID-19 pandemic. Data were analysed using a template analysis to understand women's access to services, care, and networks of support, during the pandemic following their pregnancy loss. The thematic template was based on findings from parents who had suffered a late-miscarriage, stillbirth, or neonatal death in the UK, during the pandemic. RESULTS: All women had experienced reconfigured maternity and early pregnancy services. Data supported themes of: 1) COVID-19 Restrictions as Impractical & Impersonal; 2) Alone, with Only Staff to Support Them; 3) Reduction in Service Provision Leading to Perceived Devaluation in Care; and 4) Seeking Their Own Support. Results suggest access to early pregnancy loss services was reduced and pandemic-related restrictions were often impractical (i.e., restrictions added to burden of accessing or receiving care). Women often reported being isolated and, concerningly, aspects of early pregnancy loss services were reported as sub-optimal. CONCLUSIONS: These findings provide important insight for the recovery and rebuilding of health services in the post-pandemic period and help us prepare for providing a higher standard of care in the future and through any other health system shocks. Conclusions made can inform future policy and planning to ensure best possible support for women who experience early pregnancy loss.
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Aborto Espontáneo , COVID-19 , Investigación Cualitativa , Humanos , Femenino , COVID-19/epidemiología , COVID-19/psicología , Embarazo , Adulto , Aborto Espontáneo/psicología , Aborto Espontáneo/epidemiología , Reino Unido/epidemiología , SARS-CoV-2 , Accesibilidad a los Servicios de Salud , Servicios de Salud Materna , Aflicción , Adulto JovenRESUMEN
STUDY QUESTION: Is acute haemoperitoneum that is managed conservatively a precursor of deep endometriosis? SUMMARY ANSWER: Our study provides evidence to suggest that acute haemoperitoneum may lead to the development of deep endometriosis in a significant proportion of cases. WHAT IS KNOWN ALREADY: A recent pilot study was the first to suggest that acute haemoperitoneum could be a precursor of deep endometriosis. However, the sample size was small, and the follow-up was not standardized owing to unknown rates of clot absorption and development of endometriosis. STUDY DESIGN SIZE DURATION: This was a prospective observational cohort study conducted at a single centre over a 31-month period. A required sample size of 30 was calculated using results from a previous study, with a minimum of 15 women each in the groups with and without significant haemoperitoneum (study and control groups, respectively). A total of 59 women were recruited to the study and eight were lost to follow-up. The final sample comprised 51 women, 15 in the study group and 36 in the control group. PARTICIPANTS/MATERIALS SETTING METHODS: All non-pregnant, premenopausal women aged 18-50 years who consecutively presented to our dedicated gynaecological diagnostic unit with severe acute lower abdominal pain were eligible for this study. We only included women who were clinically stable and were suitable for conservative management. Those with prior history or evidence of endometriosis on their initial ultrasound scan, previous hysterectomy, or bilateral oophorectomy were excluded. Participants had standardized follow-up visits for 6 months, with pelvic ultrasound scans and the British Society of Gynaecological Endoscopy pelvic pain questionnaires completed at each visit. The primary outcome was the sonographically confirmed presence of newly formed endometriosis. Secondary outcomes were the presence and change of pelvic pain symptoms and health-related quality of life (HR-QOL). MAIN RESULTS AND THE ROLE OF CHANCE: After completion of follow-up, 7/15 (47%; 95% CI 21.3-71.4%) women presenting with acute haemoperitoneum (study group) developed sonographic evidence of deep endometriosis, compared to 0/36 (0%; 97.5% CI 0.0-9.7%) women in the control group. A ruptured functional haemorrhagic cyst was the most common cause of haemoperitoneum, occurring in 13/15 cases (87%). The time from the initial event to sonographic evidence of endometriosis varied from 2 to 6 months. The EuroQol visual analogue scores were not significantly different at baseline between the groups that developed and did not develop endometriosis [28 (interquartile range (IQR) 15-40, n = 6) vs 56 (IQR 35-75, n = 44), P = 0.09], while the EuroQol-5D values were lower in the endometriosis group [-0.01 (IQR -0.07 to 0.19, n = 6) vs 0.62 (IQR 0.24-0.73, n = 44), P = 0.002]. At 6 months, the EuroQol-5D scores were improved in both groups, but remained significantly lower in the endometriosis group compared to the no endometriosis group [0.69 (IQR 0.66-0.80, n = 6) vs 0.85 (IQR 0.76-1.00, n = 44), P = 0.03]. There was no clinically relevant difference in the pelvic pain scores at either time point. LIMITATIONS REASONS FOR CAUTION: It remains uncertain whether minimal, superficial endometriosis existed at commencement of the study and had a role in the development of deep endometriosis. Although the ultrasound findings were in keeping with deep endometriosis, this was not confirmed histologically. The pelvic pain and HR-QOL findings could have been influenced by the baseline scores being taken when the patient was admitted with acute pain. Also, the sample size was too small to draw reliable conclusions regarding the impact of newly developed endometriosis on QoL. WIDER IMPLICATIONS OF THE FINDINGS: Our study provides further evidence showing that significant haemoperitoneum may be a precursor of deep endometriosis. Haemodynamically stable women presenting with acute pelvic pain and significant haemoperitoneum should be counselled about the risk of developing deep endometriosis. Interventional studies should be carried out in the future to see whether laparoscopy and pelvic washout could prevent development of deep endometriosis. Preventative strategies, including treatment to suppress ovulation and formation of functional cysts, should be further investigated. This includes the combined and progesterone-only contraceptive pills. Larger future studies are also required to assess women over a longer period of time, with adjustment for confounding factors, to evaluate a possible effect on HR-QOL and pain symptoms. STUDY FUNDING/COMPETING INTERESTS: Funding was obtained from The Gynaecology Ultrasound Centre, London, UK. TT received personal fees from GE, Samsung, Medtronic, and Merck for lectures on ultrasound. TT also received a postdoctoral grant from the South-Eastern Norwegian Health Authority (grant number 2020083). TRIAL REGISTRATION NUMBER: researchregistry6472.
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OBJECTIVE: To determine whether obstetric outcomes differ between women with endometriosis and those without, where all women undergo first-trimester screening for endometriosis. DESIGN: A prospective observational cohort study. SETTING: The Early Pregnancy Unit at University College London Hospital, United Kingdom. PATIENTS: Women with a live pregnancy progressing beyond 12 weeks' gestation and concurrent endometriosis (n = 110) or no endometriosis (n = 393). INTERVENTION: All women underwent a pelvic ultrasound examination in early pregnancy to examine for the presence of endometriosis and uterine abnormalities. MAIN OUTCOME MEASURES: The primary outcome of interest was preterm birth, defined as delivery before 37 completed weeks' gestation. Secondary outcomes included late miscarriage, antepartum hemorrhage, placental site disorders, gestational diabetes, hypertensive disorders of pregnancy, neonates small for gestational age, mode of delivery, intrapartum sepsis, postpartum hemorrhage, and admission to the neonatal unit. RESULTS: Women with a diagnosis of endometriosis did not have statistically significantly higher odds of preterm delivery (adjusted odds ratio [aOR] 1.85 [95% confidence interval {CI} 0.50-6.90]), but they did have higher odds of postpartum hemorrhage during cesarean section (aOR 3.64 [95% CI 2.07-6.35]) and admission of their newborn infant to the neonatal unit (aOR 3.24 [95% CI 1.08-9.73]). Women with persistent or recurrent deep endometriosis after surgery also had higher odds of placental site disorders (aOR 8.65 [95% CI 1.17-63.71]) and intrapartum sepsis (aOR 3.47 [95% CI 1.02-11.75]). CONCLUSION: We observed that women with endometriosis do not have higher odds of preterm delivery, irrespective of their disease subtype. However, they do have higher odds of postpartum hemorrhage during the cesarean section and newborn admission to the neonatal unit.
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INTRODUCTION: Cesarean scar ectopic pregnancies (CSEPs) are associated with significant maternal morbidity and termination is often recommended in the early first trimester. Management of more advanced cases is challenging due to higher risks of major intraoperative hemorrhage. Hysterectomy is currently the intervention of choice for advanced cases. This study aimed to investigate if advanced live CSEPs could be managed effectively conservatively using suction curettage and interventional radiology. MATERIAL AND METHODS: A retrospective single-center cohort study was performed. A total of 371 women diagnosed with CSEP were identified between January 2008 and January 2023. A total of 6% (22/371) women had an advanced live CSEP with crown-rump length (CRL) of ≥40 mm (≥10 weeks' gestation). Of these, 77% (17/22) opted for surgical intervention, whilst the remaining five continued their pregnancies. A preoperative ultrasound was performed in each patient. All women underwent suction curettage under ultrasound guidance and insertion of Shirodkar cervical suture as a primary hemostatic measure combined with uterine artery embolization (UAE) if required. The primary outcome was rate of blood transfusion. Secondary outcomes were estimated intraoperative blood loss, UAE, intensive care unit admission, reintervention, hysterectomy, hospitalization duration and rate of retained products of conception. Descriptive statistics were used to describe these variables. RESULTS: Median CRL of the 17 patients included was 54.1 mm (range: 40.0-85.7) and median gestational age based on CRL was 12 + 3 weeks (range: 10 + 6-15 + 0). On preoperative ultrasound scan placental lacunae were recorded in 76% (13/17) of patients and color Doppler score was ≥3 in 67% (10/15) of patients. At surgery, Shirodkar cervical suture was used in all cases. It was successful in achieving hemostasis by tamponade in 76% (13/17) of patients. In the remaining 24% (4/17) patients tamponade failed to achieve complete hemostasis and UAE was performed to stop persistent arterial bleeding into the uterine cavity. Median intraoperative blood loss was 800 mL (range: 250-2500) and 41% (7/17) women lost >1000 mL. 35% (6/17) needed blood transfusion. No women required hysterectomy. CONCLUSIONS: Surgical evacuation with Shirodkar cervical suture and selective UAE is an effective treatment for advanced live CSEPs.
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Cesárea , Cicatriz , Preservación de la Fertilidad , Embarazo Ectópico , Embolización de la Arteria Uterina , Humanos , Femenino , Embolización de la Arteria Uterina/métodos , Embarazo , Adulto , Estudios Retrospectivos , Embarazo Ectópico/cirugía , Embarazo Ectópico/terapia , Cesárea/efectos adversos , Preservación de la Fertilidad/métodos , Legrado por Aspiración , Primer Trimestre del Embarazo , Técnicas de Sutura , Pérdida de Sangre Quirúrgica/prevención & controlRESUMEN
PROBLEM: Early pregnancy losses [EPL] are common, varied, and require different courses of management and care. BACKGROUND: In the UK, women who suspect or suffer a pregnancy loss are usually provided specialist care in early pregnancy assessment units [EPAUs]. Their configuration has recently been evaluated, but recommendations for change in-line with best practice for optimum outcomes were unable to be implemented due to the COVID-19 pandemic health system shock. AIM: To compare women's experiences of EPAUs during the pandemic to themes previously found in qualitative work undertaken with women who utilised EPAUs before the pandemic. METHODS: We conducted semi-structured virtual interviews, with women (N = 32) who suffered an early pregnancy loss during the pandemic; analysing transcripts using Template Analysis, based on findings about women's (pre-pandemic) experiences of EPAU from The VESPA Study. FINDINGS: We report on seven key themes: Barriers to Accessing Services; Communication & Information; Retention of Relational Care; Involvement in Care Decisions; Staffs' Attitude or Approach; Efficiency of Service Delivery; Sensitive Patient Management. DISCUSSION: Sensitive patient management and woman-staff interactions in EPAU settings remain a fundamental issue. Women also reported their experiences of EPAUs were comparatively worse during the pandemic. CONCLUSIONS: Women valued the care provided by EPAUs and found services to be efficient, despite pandemic-related restrictions. However, psychological recognition surrounding EPL and appropriate, sensitive, relational care and support continue to be areas in need of improvement. Our recommendation is to implement the improvements suggested by VESPA as a priority to ameliorate present sub-optimal experiences and prevent further deterioration.
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Aborto Espontáneo , Servicios de Salud Materna , Embarazo , Femenino , Humanos , Aborto Espontáneo/psicología , Pandemias , Investigación CualitativaRESUMEN
BACKGROUND: A previous term (≥37 weeks' gestation), full-dilatation cesarean delivery is associated with an increased risk for a subsequent spontaneous preterm birth. The mechanism is unknown. We hypothesized that the cesarean delivery scar characteristics and scar position relative to the internal cervical os may compromise cervical function, thereby leading to shortening of the cervical length and spontaneous preterm birth. OBJECTIVE: This study aimed to determine the relationship of cesarean delivery scar characteristics and position, assessed by transvaginal ultrasound, in pregnant women with previous full-dilatation cesarean delivery with the risk of shortening cervical length and spontaneous preterm birth. STUDY DESIGN: This was a single-center, prospective cohort study of singleton pregnant women (14 to 24 weeks' gestation) with a previous term full-dilatation cesarean delivery who attended a high-risk preterm birth surveillance clinic (2017-2021). Women underwent transvaginal ultrasound assessment of cervical length, cesarean delivery scar distance relative to the internal cervical os, and scar niche parameters using a reproducible transvaginal ultrasound technique. Spontaneous preterm birth prophylactic interventions (vaginal cervical cerclage or vaginal progesterone) were offered for short cervical length (≤25 mm) and to women with a history of spontaneous preterm birth or late miscarriage after full-dilatation cesarean delivery. The primary outcome was spontaneous preterm birth; secondary outcomes included short cervical length and a need for prophylactic interventions. A multivariable logistic regression analysis was used to develop multiparameter models that combined cesarean delivery scar parameters, cervical length, history of full-dilatation cesarean delivery, and maternal characteristics. The predictive performance of models was examined using the area under the receiver operating characteristics curve and the detection rate at various fixed false positive rates. The optimal cutoff for cesarean delivery scar distance to best predict a short cervical length and spontaneous preterm birth was analyzed. RESULTS: Cesarean delivery scars were visualized in 90.5% (220/243) of the included women. The spontaneous preterm birth rate was 4.1% (10/243), and 12.8% (31/243) of women developed a short cervical length. A history- (n=4) or ultrasound-indicated (n=19) cervical cerclage was performed in 23 of 243 (9.5%) women; among those, 2 (8.7%) spontaneously delivered prematurely. A multiparameter model based on absolute scar distance from the internal os best predicted spontaneous preterm birth (area under the receiver operating characteristics curve, 0.73; 95% confidence interval, 0.57-0.89; detection rate of 60% for a fixed 25% false positive rate). Models based on the relative anatomic position of the cesarean delivery scar to the internal os and the cesarean delivery scar position with niche parameters (length, depth, and width) best predicted the development of a short cervical length (area under the receiver operating characteristics curve, 0.79 [95% confidence interval, 0.71-0.87]; and 0.81 [95% confidence interval, 0.73-0.89], respectively; detection rate of 73% at a fixed 25% false positive rate). Spontaneous preterm birth was significantly more likely when the cesarean delivery scar was <5.0 mm above or below the internal os (adjusted odds ratio, 6.87; 95% confidence interval, 1.34-58; P =.035). CONCLUSION: In pregnancies following a full-dilatation cesarean delivery, cesarean delivery scar characteristics and distance from the internal os identified women who were at risk for spontaneous preterm birth and developing short cervical length. Overall, the spontaneous preterm birth rate was low, but it was significantly increased among women with a scar located <5.0 mm above or below the internal cervical os. Shortening of cervical length was strongly associated with a low scar position. Our novel findings indicate that a low cesarean delivery scar can compromise the functional integrity of the internal cervical os, leading to cervical shortening and/or spontaneous preterm birth. Assessment of the cesarean delivery scar characteristics and position seem to have use in preterm birth clinical surveillance among women with a previous, full-dilatation cesarean delivery and could better identify women who would benefit from prophylactic interventions.
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Nacimiento Prematuro , Recién Nacido , Embarazo , Femenino , Humanos , Nacimiento Prematuro/diagnóstico , Nacimiento Prematuro/epidemiología , Nacimiento Prematuro/etiología , Estudios Prospectivos , Cicatriz/etiología , Cicatriz/complicaciones , Dilatación/efectos adversos , Medición de Longitud Cervical/efectos adversos , Medición de Longitud Cervical/métodosRESUMEN
Obstetrics and gynecology (OB/GYN) are areas of medicine that specialize in the care of women during pregnancy and childbirth and in the diagnosis of diseases of the female reproductive system. Ultrasound scanning has become ubiquitous in these branches of medicine, as breast or fetal ultrasound images can lead the sonographer and guide him through his diagnosis. However, ultrasound scan images require a lot of resources to annotate and are often unavailable for training purposes because of confidentiality reasons, which explains why deep learning methods are still not as commonly used to solve OB/GYN tasks as in other computer vision tasks. In order to tackle this lack of data for training deep neural networks in this context, we propose Prior-Guided Attribution (PGA), a novel method that takes advantage of prior spatial information during training by guiding part of its attribution towards these salient areas. Furthermore, we introduce a novel prior allocation strategy method to take into account several spatial priors at the same time while providing the model enough degrees of liberty to learn relevant features by itself. The proposed method only uses the additional information during training, without needing it during inference. After validating the different elements of the method as well as its genericity on a facial analysis problem, we demonstrate that the proposed PGA method constantly outperforms existing baselines on two ultrasound imaging OB/GYN tasks: breast cancer detection and scan plane detection with segmentation prior maps.
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Ginecología , Internado y Residencia , Obstetricia , Humanos , Embarazo , Masculino , Femenino , Ginecología/educación , Obstetricia/educación , Mama , Redes Neurales de la ComputaciónRESUMEN
BACKGROUND: To detect uterine cancer, simpler and more specific index tests are needed to triage women with abnormal uterine bleeding to a reference histology test. We aimed to compare the performance of conventional index imaging tests with the novel WID-qEC DNA methylation test in terms of detecting the presence or absence of uterine cancers in women with abnormal uterine bleeding. METHODS: EPI-SURE was a prospective, observational study that invited all women aged 45 years and older with abnormal uterine bleeding attending a tertiary gynaecological diagnostic referral centre at University College London Hospital (London, UK) to participate. Women meeting these inclusion criteria who consented to participate were included. Pregnant women and those with previous hysterectomy were excluded. A cervicovaginal sample for the WID-qEC test was obtained before standard assessment using index imaging tests (ie, ultrasound) and, where applicable, reference histology (ie, biopsy, hysteroscopy, or both) was performed. Technicians performing the WID-qEC test were masked to the final clinical outcome. The result of the WID-qEC test is defined as the sum of the percentage of fully methylated reference (ΣPMR) of the ZSCAN12 and GYPC regions. Patients were followed until diagnostic resolution or until June 12, 2023. The primary outcome was to assess the real-world performance of the WID-qEC test in comparison with ultrasound with regard to the area under the receiver-operating-characteristic curve (AUC), sensitivity, specificity, and positive and negative predictive values. EPI-SURE is registered with ISRCTN (16815568). FINDINGS: From June 1, 2022, to Nov 24, 2022, 474 women were deemed eligible to participate. 74 did not accept the invitation to participate, and one woman withdrew after providing consent. 399 women were included in the primary analysis cohort. Based on 603 index imaging tests, 186 (47%) women were recommended for a reference histology test (ie, biopsy, hysteroscopy, or both). 12 women were diagnosed with cancer, 375 were not diagnosed with cancer, and 12 had inconclusive clinical outcomes and were considered study dropouts. 198 reference histology test procedures detected nine cases of cancer and missed two; one further cancer was directly diagnosed at hysterectomy without a previous reference test. The AUC for detection of uterine cancer based on endometrial thickness in mm was 87·2% (95% CI 71·1-100·0) versus 94·3% (84·7-100·0) based on WID-qEC (p=0·48). Endometrial thickness assessment on ultrasound scan was possible in 379 (95%) of the 399 women and a prespecified cut-off of 4·5 mm or more showed a sensitivity of 90·9% (95% CI 62·3-98·4), a specificity of 79·1% (74·5-82·9), a positive predictive value of 11·8% (6·5-20·3), and a negative predictive value of 99·6% (98·0-99·9). The WID-qEC test was possible in 390 (98%) of the 399 patients with a sensitivity of 90·9% (95% CI 62·3-98·4), a specificity of 92·1% (88·9-94·4), a positive predictive value of 25·6% (14·6-41·1), and a negative predictive value of 99·7% (98·3-99·9), when the prespecified threshold of 0·03 ΣPMR or more was applied. When a higher threshold (≥0·3 ΣPMR) was applied the specificity increased to 97·3% (95% CI 95·1-98·5) without a change in sensitivity. INTERPRETATION: The WID-qEC test delivers fast results and shows improved performance compared with a combination of imaging index tests. Triage of women with abnormal uterine bleeding using the WID-qEC test could reduce the number of women requiring histological assessments for identification of potential malignancy and specifically reduce the false positive rate. FUNDING: The Eve Appeal, Land Tirol, and the European Research Council under the European Union's Horizon 2020 Research and Innovation Programme.
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Neoplasias Uterinas , Femenino , Humanos , Embarazo , Estudios Prospectivos , Sensibilidad y Especificidad , Reino Unido , Hemorragia Uterina/diagnóstico por imagen , Hemorragia Uterina/etiología , Hemorragia Uterina/patología , Neoplasias Uterinas/diagnóstico por imagenRESUMEN
BACKGROUND: A cesarean scar pregnancy is an iatrogenic consequence of a previous cesarean delivery. The gestational sac implants into a niche created by the incision of the previous cesarean delivery, and this carries a substantial risk for major maternal complications. The aim of this study was to report, analyze, and compare the effectiveness and safety of different treatments options for cesarean scar pregnancies managed in the first trimester through a registry. OBJECTIVE: This study aimed to evaluated the ultrasound findings, disease behavior, and management of first-trimester cesarean scar pregnancies. STUDY DESIGN: We created an international registry of cesarean scar pregnancy cases to study the ultrasound findings, disease behavior, and management of cesarean scar pregnancies. The Cesarean Scar Pregnancy Registry collects anonymized ultrasound and clinical data of individual patients with a cesarean scar pregnancy on a secure, digital information platform. Cases were uploaded by 31 participating centers across 19 countries. In this study, we only included live and failing cesarean scar pregnancies (with or without a positive fetal heart beat) that received active treatment (medical or surgical) before 12+6 weeks' gestation to evaluate the effectiveness and safety of the different management options. Patients managed expectantly were not included in this study and will be reported separately. Treatment was classified as successful if it led to a complete resolution of the pregnancy without the need for any additional medical interventions. RESULTS: Between August 29, 2018, and February 28, 2023, we recorded 460 patients with cesarean scar pregnancies (281 live, 179 failing cesarean scar pregnancy) who fulfilled the inclusion criteria and were registered. A total of 270 of 460 (58.7%) patients were managed surgically, 123 of 460 (26.7%) patients underwent medical management, 46 of 460 (10%) patients underwent balloon management, and 21 of 460 (4.6%) patients received other, less frequently used treatment options. Suction evacuation was very effective with a success rate of 202 of 221 (91.5%; 95% confidence interval, 87.8-95.2), whereas systemic methotrexate was least effective with only 38 of 64 (59.4%; 95% confidence interval, 48.4-70.4) patients not requiring additional treatment. Overall, surgical treatment of cesarean scar pregnancies was successful in 236 of 258 (91.5%, 95% confidence interval, 88.4-94.5) patients and complications were observed in 24 of 258 patients (9.3%; 95% confidence interval, 6.6-11.9). CONCLUSION: A cesarean scar pregnancy can be managed effectively in the first trimester of pregnancy in more than 90% of cases with either suction evacuation, balloon treatment, or surgical excision. The effectiveness of all treatment options decreases with advancing gestational age, and cesarean scar pregnancies should be treated as early as possible after confirmation of the diagnosis. Local medical treatment with potassium chloride or methotrexate is less efficient and has higher rates of complications than the other treatment options. Systemic methotrexate has a substantial risk of failing and a higher complication rate and should not be recommended as first-line treatment.
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Dolor Crónico , Dolor Pélvico , Humanos , Femenino , Dolor Pélvico/diagnóstico , Dolor Pélvico/etiología , Dolor Pélvico/terapiaRESUMEN
INTRODUCTION: The number and invasion depth of endometriotic bowel lesions, total length of bowel affected by endometriosis, lesion-to-anal verge distance, and extent of pouch of Douglas obliteration are important factors in preoperatively determining risk and complexity of endometriosis surgery. The intra- and interobserver reproducibility of transvaginal ultrasound in the evaluation of many of these parameters has not yet been investigated. Our study aimed to assess the intra- and interobserver reproducibility of transvaginal ultrasound between an experienced and less experienced examiner for all of these parameters. MATERIAL AND METHODS: This prospective observational cross-sectional study was conducted between July 2019 and November 2020. Fifty consecutive premenopausal women who underwent transvaginal ultrasound examination in our clinic for the first time, were examined by the same two operators during the same attendance. Outcomes of interest were the inter-rater reproducibility of transvaginal ultrasound for detecting the presence, number, depth and size of bowel endometriotic nodules, lesion-to-anal-verge distance, total length of bowel affected, and pouch of Douglas obliteration. The intraobserver reproducibility was assessed for the continuous parameters. Cohen's kappa (κ) statistic, Cohen's weighted kappa (κ), proportions of agreement, intraclass correlation coefficient (ICC) and Bland-Altman limits of agreement were used to assess the reproducibility of the parameters. RESULTS: The inter-rater agreement and reliability were very good for identifying bowel endometriosis, the number and invasion depth of bowel nodules, determining whether the maximum nodule length was <3 cm, and lesion-to-anal-verge distance <8 cm (proportion of agreement 0.92, 0.94, 0.97, 0.94, 0.96; κ 0.92, 0.91, 0.92, 0.82, 0.89). The inter-rater agreement and reliability were good for assessing pouch of Douglas obliteration (proportion of agreement 0.86, κ 0.80). The intra-rater reliability for the mean nodule diameter (ICC 0.93 and 0.97) and total length of bowel affected (ICC 0.94 and 0.91) were excellent for operators A and B, respectively. The inter-rater reliability for the mean nodule diameter was good (ICC 0.80), and moderate for the total length of bowel affected (ICC 0.70). The Bland-Altman limits of agreement demonstrated clinically acceptable ranges for these two parameters. CONCLUSIONS: This study demonstrated a high intra- and inter-rater reproducibility of transvaginal ultrasound in the diagnosis of bowel endometriosis and measurement of its various components.
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Endometriosis , Humanos , Femenino , Endometriosis/cirugía , Reproducibilidad de los Resultados , Estudios Transversales , Ultrasonografía , Intestinos , Variaciones Dependientes del ObservadorRESUMEN
INTRODUCTION: Ectopic pregnancy is an important health condition which affects up to 1 in 100 women. Women who present with mild symptoms and low serum human chorionic gonadotrophin (hCG) are often treated with methotrexate (MTX), but expectant management with close monitoring is a feasible alternative. Studies comparing the two treatments have not shown a statistically significant difference in uneventful resolution of ectopic pregnancy, but these studies were too small to define whether certain subgroups could benefit more from either treatment. MATERIAL AND METHODS: We performed a systematic review and individual participant data meta-analysis (IPD-MA) of randomized controlled trials comparing systemic MTX and expectant management in women with tubal ectopic pregnancy and low hCG (<2000 IU/L). A one-stage IPD-MA was performed to assess overall treatment effects of MTX and expectant management to generate a pooled intervention effect. Subgroup analyses and exploratory multivariable analyses were undertaken according to baseline serum hCG and progesterone levels. Primary outcome was treatment success, defined as resolution of clinical symptoms and decline in level of serum hCG to <20 IU/L, or a negative urine pregnancy test by the initial intervention strategy, without any additional treatment. Secondary outcomes were need for blood transfusion, surgical intervention, additional MTX side-effects and hCG resolution times. TRIAL REGISTRATION NUMBER: PROSPERO: CRD42021214093. RESULTS: 1547 studies reviewed and 821 remained after duplicates removed. Five studies screened for eligibility and three IPD requested. Two randomized controlled trials supplied IPD, leading to 153 participants for analysis. Treatment success rate was 65/82 (79.3%) after MTX and 48/70 (68.6%) after expectant management (IPD risk ratio [RR] 1.16, 95% confidence interval [CI] 0.95-1.40). Surgical intervention rates were not significantly different: 8/82 (9.8%) vs 13/70 (18.6%) (RR 0.65, 95% CI 0.23-1.14). Mean time to success was 19.7 days (95% CI 17.4-22.3) after MTX and 21.2 days (95% CI 17.8-25.2) after expectant management (P = 0.25). MTX specific side-effects were reported in 33 MTX compared to four in the expectant group. CONCLUSIONS: Our IPD-MA showed no statistically significant difference in treatment efficacy between MTX and expectant management in women with tubal ectopic pregnancy with low hCG. Initial expectant management could be the preferred strategy due to fewer side-effects.
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Abortivos no Esteroideos , Embarazo Ectópico , Embarazo Tubario , Embarazo , Humanos , Femenino , Metotrexato/uso terapéutico , Espera Vigilante , Embarazo Tubario/tratamiento farmacológico , Embarazo Ectópico/tratamiento farmacológico , Gonadotropina Coriónica , Abortivos no Esteroideos/uso terapéutico , Estudios RetrospectivosRESUMEN
Cesarean scar ectopic pregnancy is associated with significant maternal morbidity, including severe hemorrhage, need for the blood transfusion and hysterectomy. Early diagnosis is therefore key in ensuring timely management, with consensus being that treatment before 9 weeks of gestation leads to reduced morbidity. There is no universally adopted management protocol for cesarean scar ectopic pregnancy, but surgical management generally has a higher success rate than medical management. The primary surgical treatment modalities are suction evacuation versus resection of the pregnancy via multiple routes. Adjuncts that have been shown to successfully minimize bleeding with surgical management include cervical cerclage, balloon catheter, and uterine artery embolization. However, there remains a lack of high-quality evidence regarding what is the best surgical treatment option for cesarean scar ectopic pregnancy, and therefore it is essential that clinicians provide tailored management to patients considering the presenting symptoms and local expertise with various surgical techniques.
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Embarazo Ectópico , Embolización de la Arteria Uterina , Embarazo , Femenino , Humanos , Cicatriz/complicaciones , Cicatriz/cirugía , Cesárea/efectos adversos , Embarazo Ectópico/etiología , Embarazo Ectópico/cirugía , Embarazo Ectópico/diagnóstico , Histerectomía/efectos adversosRESUMEN
Cesarean scar ectopic pregnancy is a rare type of ectopic pregnancy, where the pregnancy implants into a myometrial defect caused by a cesarean scar. Its incidence is predicted to increase, given the global increase in cesarean deliveries. As most cesarean scar ectopic pregnancies present as failing pregnancies or patients choose termination of pregnancy, there are limited data on their natural history. However, early first trimester diagnosis is essential, given the associated significant maternal morbidity. Transvaginal sonography is generally considered to be the optimal method for diagnosing cesarean scar ectopic pregnancy. There is no evidence that MRI adds to the diagnostic accuracy, and it is therefore not recommended for routine evaluation of cesarean scar ectopic pregnancy. There is no agreed reference standard for the diagnosis of cesarean scar ectopic pregnancy; therefore, the validity of several proposed sonographic diagnostic criteria reported by different authors remains unknown. There are also various suggested classification systems for cesarean scar ectopic pregnancy, which divide them in differet types. However, the proposals are very heterogeneous, and superiority of one classification system over another is yet to be established.
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Cicatriz , Embarazo Ectópico , Embarazo , Femenino , Humanos , Cicatriz/diagnóstico por imagen , Cicatriz/etiología , Cicatriz/patología , Embarazo Ectópico/diagnóstico por imagen , Embarazo Ectópico/etiología , Cesárea/efectos adversos , Primer Trimestre del Embarazo , UltrasonografíaRESUMEN
BACKGROUND: Transvaginal ultrasound imaging has become an essential tool in the prenatal evaluation of the lower uterine segment and anatomy of the cervix, but there are only limited data on the role of transvaginal ultrasound in the management of patients at high risk of placenta accreta spectrum at birth. OBJECTIVE: This study aimed to evaluate the role of transvaginal sonography in the third trimester of pregnancy in predicting outcomes in patients with a high probability of placenta accreta spectrum at birth. STUDY DESIGN: This was a retrospective analysis of prospectively collected data of patients presenting with a singleton pregnancy and a history of at least 1 previous cesarean delivery and patients diagnosed prenatally with an anterior low-lying placenta or placenta previa delivered electively after 32 weeks of gestation. All patients had a least 1 detailed ultrasound examination, including transabdominal and transvaginal scans, within 2 weeks before delivery. Of note, 2 experienced operators, blinded to the clinical data, were asked to make a judgment on the likelihood of placenta accreta spectrum as a binary, low or high-probability of placenta accreta spectrum, and to predict the main surgical outcome (conservative vs peripartum hysterectomy). The diagnosis of accreta placentation was confirmed when one or more placental cotyledons could not be digitally separated from the uterine wall at delivery or during the gross examination of the hysterectomy or partial myometrial resection specimens. RESULTS: A total of 111 patients were included in the study. Abnormal placental tissue attachment was found in 76 patients (68.5%) at birth, and histologic examination confirmed superficial villous attachment (creta) and deep villous attachment (increta) in 11 and 65 cases, respectively. Of note, 72 patients (64.9%) had a peripartum hysterectomy, including 13 cases with no evidence of placenta accreta spectrum at birth because of failure to reconstruct the lower uterine segment and/or excessive bleeding. There was a significant difference in the distribution of placental location (X2=12.66; P=.002) between transabdominal and transvaginal ultrasound examinations, but both ultrasound techniques had similar likelihood scores in identifying accreta placentation that was confirmed at birth. On transabdominal scan, only a high lacuna score was significantly associated (P=.02) with an increased chance of hysterectomy, whereas on transvaginal scan, significant associations were found between the need for hysterectomy and the thickness of the distal part of the lower uterine segment (P=.003), changes in the cervix structure (P=.01), cervix increased vascularity (P=.001), and the presence of placental lacunae (P=.005). The odds ratio for peripartum hysterectomy were 5.01 (95% confidence interval, 1.25-20.1) for a very thin (<1-mm) distal lower uterine segment and 5.62 (95% confidence interval, 1.41-22.5) for a lacuna score of 3+. CONCLUSION: Transvaginal ultrasound examination contributes to both prenatal management and the prediction of surgical outcomes in patients with a history of previous cesarean delivery with and without ultrasound signs suggestive of placenta accreta spectrum. Transvaginal ultrasound examination of the lower uterine segment and cervix should be included in clinical protocols for the preoperative evaluation of patients at risk of complex cesarean delivery.
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Placenta Accreta , Placenta Previa , Recién Nacido , Embarazo , Humanos , Femenino , Placenta Accreta/cirugía , Tercer Trimestre del Embarazo , Placenta/diagnóstico por imagen , Placenta/patología , Estudios Retrospectivos , Ultrasonografía Prenatal , Ultrasonografía , Placenta Previa/cirugíaRESUMEN
INTRODUCTION: The natural history of endometriosis is poorly understood, and despite numerous studies, the rate of the disease progression and optimal treatment planning in women who are asymptomatic or experience mild symptoms not requiring treatment are unknown. The aim of this study was to assess the behavior of deep endometriosis in women who are managed expectantly without any medical or surgical intervention. MATERIAL AND METHODS: A retrospective cohort study of women diagnosed with deep endometriosis on transvaginal ultrasound scan at the Department of Gynecology, University College London Hospitals and The Gynecology Ultrasound Centre, London, UK, from April 2007 to April 2022. All women attended for at least two ultrasound scans which were carried out by a single expert ultrasound examiner and at least 6 months apart. The number and position of endometriotic nodules were recorded, and the mean diameter of each nodule was calculated from measurements taken in three orthogonal planes. RESULTS: During the study period, 1922 women were found to have moderate or severe deep endometriosis on pelvic ultrasound examination. A total of 135 premenopausal women who were managed expectantly fitted the inclusion criteria. The median number of endometriotic nodules per woman at the initial visit was 2 (range: 0-7), and the median follow-up time was 666 days (181-2984). In the follow-up period, 50/135 women (37%, 95% CI: 29-46) developed additional nodules or experienced an increase in nodule size, and 17/135 women (13%, 95% CI: 8-19) had a regression in the number or size of the nodules. In the remaining 68/135 women (50%, 95% CI: 42-59) the disease remained static during the follow-up. The median change in mean diameter of nodules during the study period per woman was +0.13 mm (-11.67 - +5.83), with an annual growth rate of +0.09 mm/year (-6.65 - +6.45). CONCLUSIONS: In our study we found evidence of deep endometriosis progression in just over a third of women. In view of this, asymptomatic or mildly symptomatic women diagnosed with deep endometriosis could be reassured that their disease is unlikely to worsen with time.
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Endometriosis , Femenino , Humanos , Endometriosis/cirugía , Estudios Retrospectivos , Espera Vigilante , Pelvis , UltrasonografíaRESUMEN
OBJECTIVE: To develop core outcome sets (COS) for miscarriage management and prevention. DESIGN: Modified Delphi survey combined with a consensus development meeting. SETTING: International. POPULATION: Stakeholder groups included healthcare providers, international experts, researchers, charities and couples with lived experience of miscarriage from 15 countries: 129 stakeholders for miscarriage management and 437 for miscarriage prevention. METHODS: Modified Delphi method and modified nominal group technique. RESULTS: The final COS for miscarriage management comprises six outcomes: efficacy of treatment, heavy vaginal bleeding, pelvic infection, maternal death, treatment or procedure-related complications, and patient satisfaction. The final COS for miscarriage prevention comprises 12 outcomes: pregnancy loss <24 weeks' gestation, live birth, gestation at birth, pre-term birth, congenital abnormalities, fetal growth restriction, maternal (antenatal) complications, compliance with intervention, patient satisfaction, maternal hospitalisation, neonatal or infant hospitalisation, and neonatal or infant death. Other outcomes identified as important were mental health-related outcomes, future fertility and health economic outcomes. CONCLUSIONS: This study has developed two core outcome sets, through robust methodology, that should be implemented across future randomised trials and systematic reviews in miscarriage management and prevention. This work will help to standardise outcome selection, collection and reporting, and improve the quality and safety of future studies in miscarriage.
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Aborto Espontáneo , Muerte Materna , Recién Nacido , Embarazo , Humanos , Femenino , Aborto Espontáneo/prevención & control , Consenso , Retardo del Crecimiento Fetal/terapia , Proyectos de Investigación , Técnica Delphi , Evaluación de Resultado en la Atención de Salud , Resultado del TratamientoRESUMEN
OBJECTIVE: To address methodological deficiencies in published randomized controlled trials and systematic reviews, this study has developed a core outcome set to guide future research in ectopic pregnancy (EP). DESIGN: To identify potential outcomes, we performed a comprehensive literature review and interviews with individuals with lived experience in EP. Potential core outcomes were then entered into a 3-round Delphi survey. A total of 154 participants from 6 continents, comprising health care professionals, researchers, and individuals with lived experience in EP, completed all 3 rounds of the Delphi survey. Outcomes were prioritized at 3 consensus development meetings, and recommendations were developed on how to report these outcomes where possible. SETTING: Not applicable. PATIENT(S): Health care professionals, researchers, and individuals with lived experience in EP. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Consensus for inclusion in core outcome set. RESULT(S): Six outcomes reached full consensus, including treatment success, resolution time, the number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction. CONCLUSION(S): The core outcome set with 6 outcomes for EP will help standardize reporting of clinical trials, facilitate implementation of findings into clinical practice, and enhance patient-centered care.
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Embarazo Ectópico , Proyectos de Investigación , Embarazo , Femenino , Humanos , Consenso , Técnica Delphi , Resultado del Tratamiento , Embarazo Ectópico/diagnóstico , Embarazo Ectópico/epidemiología , Embarazo Ectópico/terapia , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Tubal ectopic pregnancies can cause substantial morbidity or even death. Current treatment is with methotrexate or surgery. Methotrexate treatment fails in approximately 30% of women who subsequently require rescue surgery. Gefitinib, an epidermal growth factor receptor inhibitor, might improve the effects of methotrexate. We assessed the efficacy of oral gefitinib with methotrexate, versus methotrexate alone, to treat tubal ectopic pregnancy. METHODS: We performed a multicentre, randomised, double-blind, placebo-controlled trial across 50 UK hospitals. Participants diagnosed with tubal ectopic pregnancy were administered a single dose of intramuscular methotrexate (50 mg/m2) and randomised (1:1 ratio) to 7 days of additional oral gefitinib (250 mg daily) or placebo. The primary outcome, analysed by intention to treat, was surgical intervention to resolve the ectopic pregnancy. Secondary outcomes included time to resolution of ectopic pregnancy and serious adverse events. This trial is registered at the ISRCTN registry, ISCRTN 67795930. FINDINGS: Between Nov 2, 2016, and Oct 6, 2021, 328 participants were allocated to methotrexate and gefitinib (n=165) or methotrexate and placebo (n=163). Three participants in the placebo group withdrew. Surgical intervention occurred in 50 (30%) of 165 participants in the gefitinib group and in 47 (29%) of 160 participants in the placebo group (adjusted risk ratio 1·15, 95% CI 0·85 to 1·58; adjusted risk difference -0·01, 95% CI -0·10 to 0·09; p=0·37). Without surgical intervention, median time to resolution was 28·0 days in the gefitinib group and 28·0 days in the placebo group (subdistribution hazard ratio 1·03, 95% CI 0·75 to 1·40). Serious adverse events occurred in five (3%) of 165 participants in the gefitinib group and in six (4%) of 162 participants in the placebo group. Diarrhoea and rash were more common in the gefitinib group. INTERPRETATION: In women with a tubal ectopic pregnancy, adding oral gefitinib to parenteral methotrexate does not offer clinical benefit over methotrexate and increases minor adverse reactions. FUNDING: National Institute of Health Research.