Women's experiences of early pregnancy loss services during the pandemic: A qualitative investigation.

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.

A core outcome set for future research in ectopic pregnancy: an international consensus development study.

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.

Emotional experiences of women who access early pregnancy assessment units: a qualitative investigation.

Purpose: Early pregnancy complications are common and often result in pregnancy loss, which can be emotionally challenging for women. Research on the emotional experiences of those attending Early Pregnancy Assessment Units [EPAUs] is scarce. This analysis explored the emotions which women spontaneously reported when being interviewed about their experiences of using EPAU services.Materials and methods: Semi-structured telephone interviews were conducted with a purposive sample of 38 women. Using Thematic Framework Analysis, we identified six unique emotional typologies which mapped onto women's clinical journeys.Results: Women with ongoing pregnancies were characterized as having: "Anxious Presentation" or "Sustained Anxiety due to Diagnostic Uncertainty", dependent on whether their initial scan result was inconclusive. Women with pregnancy loss had one of four emotional typologies, varying by diagnostic timing and required interventions: "Anxious-Upset"; "Anxious-Upset after Diagnostic Uncertainty"; "Anxious-Upset with Procedural Uncertainty"; "Anxious with Sustained Uncertainty".Conclusions: We provide insights into the distinct emotions associated with different clinical pathways through EPAU services. Our findings could be used to facilitate wider recognition of women's emotional journeys through early pregnancy complications and stimulate research into how best to support women and their partners, in these difficult times.

An observational cohort study of health outcomes and costs associated with early pregnancy assessment units in the UK.

BACKGROUND: The objective of this study was to assess the impact of consultant presence, volume of patients seen and weekend opening on the health and cost-related outcomes associated with different Early Pregnancy Assessment Unit (EPAU) configurations. METHODS: This was an observational study with a prospective cohort design. Six thousand six hundred six pregnant women (16 years of age and over) attending EPAUs because of suspected early pregnancy complications were recruited from 44 EPAUs across the UK. The main outcome measures were quality of life, costs, and anxiety. RESULTS: Costs, quality of life and anxiety scores were similar across configurations with little evidence to suggest an impact of consultant presence, weekend opening or volume of patients seen. Mean overall costs varied from £92 (95% CI £85 - £98) for a diagnosis of normally developing pregnancy to £1793 (95% CI £1346 - £2240) for a molar pregnancy. EQ-5D-5L score increased from 0.85 (95% CI 0.84-0.86) at baseline to 0.91 (95% CI 0.90-0.92) at 4 weeks for the 573 women who completed questionnaires at both time points, largely due to improvements in the pain/discomfort and anxiety/depression dimensions. 78% of women reported a decrease in their anxiety score immediately following their EPAU appointment. CONCLUSIONS: EPAU configuration, as specified in this study, had limited impact on any of the outcomes examined. However, it is clear that care provided in the EPAU has a positive overall effect on women's health and emotional wellbeing, with significant improvements in EQ-5D and anxiety shown following an EPAU visit.

The risk of venous thromboembolism in early pregnancy loss: Review of the literature and current guidelines and the need for guidance - Communication from the SSC on Women's Health Issues for thrombosis and haemostasis.

BACKGROUND: Thromboembolic disease is one of the major causes of mortality and morbidity in pregnancy and the puerperium, with 1 death per 100 000 births attributed to venous thromboembolism (VTE). Factors associated with development of thrombosis are all present in pregnancy, with some of these changes seen from conception. OBJECTIVE: Given how common early pregnancy loss is, the aim of this review is to evaluate the uncertainty surrounding the risk of VTE following early pregnancy loss and termination of pregnancy. METHODS: A structured literature search was conducted to identify existing evidence as well as international pregnancy-specific guidelines regarding assessment and prevention of VTE risk in pregnant women. This review was reviewed, critiqued, and approved by all members of the International Society on Thrombosis and Haemostasis subcommittee for Women's Health Issues in Thrombosis and Haemostasis. RESULTS: Four published original research studies, one clinical comment paper, and six guidelines were reviewed. Despite clear evidence of the increased risk of VTE in pregnancy, there is a lack of guidance regarding evaluation and management after early pregnancy loss. CONCLUSION: International collaborative research to determine the risk of VTE and its prevention in women undergoing surgical termination of pregnancy or following surgical management of early pregnancy loss is urgently needed. Pregnancy-specific risk assessment taking into account preexisting risk factors is advocated. Education of health care professionals involved in early pregnancy care and guidance on management, albeit based on limited existing evidence, are necessary to highlight the need for individualized care.

A protocol for developing a core outcome set for ectopic pregnancy.

BACKGROUND: Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. STUDY AIM: To develop and implement a core outcome set to guide future research in ectopic pregnancy. METHODS AND ANALYSIS: We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus 'core' outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. TRIAL REGISTRATION: COMET 1492 . Registered in November 2019.

Differences in the organisation of early pregnancy units and the effect of senior clinician presence, volume of patients and weekend opening on emergency hospital admissions: Findings from the VESPA Study.

OBJECTIVE: To determine whether the participation of consultant gynaecologists in delivering early pregnancy care results in a lower rate of acute hospital admissions. DESIGN: Prospective cohort study and emergency hospital care audit; data were collected as part of the national prospective mixed-methods VESPA study on the "Variations in the organization of EPAUs in the UK and their effects on clinical, Service and PAtient-centred outcomes". SETTING: 44 Early Pregnancy Assessment Units (EPAUs) across the UK randomly selected in balanced numbers from eight pre-defined mutually exclusive strata. PARTICIPANTS: 6606 pregnant women (≥16 years old) with suspected first trimester pregnancy complications attending the participating EPAUs or Emergency Departments (ED) from December 2016 to July 2017. EXPOSURES: Planned and actual senior clinician presence, unit size, and weekend opening. MAIN OUTCOME MEASURES: Unplanned admissions to hospital following any visit for investigations or treatment for first trimester complications as a proportion of women attending EPAUs. RESULTS: 205/6397 (3.2%; 95% CI 2.8-3.7) women were admitted following their EPAU attendance. The admission rate among 44 units ranged from 0% to 13.7% (median 2.8). Neither planned senior clinician presence (p = 0.874) nor unit volume (p = 0.247) were associated with lower admission rates from EPAU, whilst EPAU opening over the weekend resulted in lower admission rates (p = 0.027). 1445/5464 (26.4%; 95%CI 25.3 to 27.6) women were admitted from ED. There was little evidence of an association with planned senior clinician time (p = 0.280) or unit volume (p = 0.647). Keeping an EPAU open over the weekend for an additional hour was associated with 2.4% (95% CI 0.1% to 4.7%) lower odds of an emergency admission from ED. CONCLUSIONS: Involvement of senior clinicians in delivering early pregnancy care has no significant impact on emergency hospital admissions for early pregnancy complications. Weekend opening, however, may be an effective way of reducing emergency admissions from ED.

Diagnosis and outcome of hydatidiform moles in missed-miscarriage: a cohort-study, systematic review and meta-analysis.

OBJECTIVE: To evaluate the ultrasound diagnostic rates of complete hydatidiform moles (CHM) and partial hydatidiform moles (PHM) in women presenting with a missed miscarriage, the clinical complications at diagnosis and the risk of gestational trophoblastic neoplasia (GTN) after surgical evacuation and to compare our findings with those of the published literature by completing a systematic review and meta-analysis STUDY DESIGN: Retrospective review of the data of 295 women diagnosed with a histologically confirmed hydatidiform moles (HM) over a 15-year period, including 128 CHM and 167 PHM. All women were referred to a regional specialist centre for follow-up and further management. An electronic search of PubMed, Google Scholar and MEDLINE was performed for studies published between September 1973 and September 2017 reporting on the early ultrasound diagnosis of hydatidiform mole. Only cohort studies which provided ultrasound data confirmed by histopathology were included. RESULTS: In the cohort study, ultrasound imaging diagnosed a significantly (p < 0.001) higher number of CHM (95/128 (74.2%) than PHM (68/167 (40.7%). Ovarian theca lutea cysts were observed in three CHM and one PHM. There were no cases of pre-eclampsia or thyrotoxicosis at the time of diagnosis. Maternal serum ß-human chorionic gonadotrophin levels were abnormally low (< 0.5 MoM) in 5/51 (10%) CHM and 23/43 (53%) PHM and abnormally high (> 2.0 MoM) in 20/51 (39%) CHM and 2/43 (5%) PHM. Seventeen (12.3%) CHM and two (1.4%) PHM developed a GTN requiring treatment. In the literature the proportion of histologically diagnosed HM, suspected on ultrasound in early pregnancy, ranged between 34.2 and 90.2% for HM, 57.8 and 95% for CHM and 17.6 and 51.6% for PHM. The meta-analysis indicated substantial heterogeneity in the overall ultrasound diagnosis of HM and in the differential diagnosis between CHM and PHM. CONCLUSION(S): As around a third of CHM and two thirds of PHM are not diagnosed on ultrasound in cases of missed miscarriage, histopathological examination of all products of conception in case of early pregnancy failure is essential to detect molar changes. This is particularly important for the management of women with CHM who have a higher risk of developing a GTN.

Ultrasound diagnosis of complete and partial hydatidiform moles in early pregnancy failure: An inter-observer study.

We evaluated the accuracy of the ultrasound signs suggestive of complete hydatidiform mole (CHM) and partial hydatidiform mole (PHM) in a cohort of women with histologically confirmed hydatidiform mole (HM) who presented with early pregnancy failure, including 103 CHM and 95 PHM for which ultrasound images were available. The accuracy of the differential diagnosis was significantly (p < 0.001) greater during secondary examination of ultrasound images compared with the original primary ultrasound examination. The interobserver agreement analysis indicated only a fair to moderate agreement between the two examinations (kappa value 0.41; 95% CI 0.29-0.53). Most HM present as early pregnancy failure and identification of early ultrasound signs can improve the differential diagnosis between CHM and PHM.

Physical resolution of tubal ectopic pregnancy on ultrasound imaging following successful expectant management.

RESEARCH QUESTION: What is the time required for complete physical resolution of tubal ectopic pregnancies diagnosed on ultrasound imaging in women undergoing successful expectant management? DESIGN: A prospective observational cohort study of 177 women who had successful expectant management of tubal ectopic pregnancy, who attended a single Early Pregnancy Unit between January 2014 and December 2018. All participants were monitored until their serum beta-human chorionic gonadotrophin (beta-HCG) dropped to non-pregnant concentrations and with 2-weekly follow-up ultrasound scans until resolution of the pregnancy. RESULTS: A total of 112/177 (63.3%, 95% confidence interval [CI] 55.7-70.4) of tubal ectopic pregnancies were indiscernible on ultrasound 2 weeks after serum beta-HCG had returned to non-pregnant concentrations. In 8/177 (4.5%, 95% CI 2.0-8.7), physical resolution took longer than 78 days. There was a positive correlation between biochemical and physical resolution of tubal ectopic pregnancy (r = 0.21, P = 0.006). CONCLUSIONS: Physical resolution of tubal ectopic pregnancy is often prolonged and is positively correlated with initial and maximum beta-HCG concentrations. Results of this study indicate that beta-HCG resolution cannot be used as the end-point of expectant management of tubal ectopic pregnancy, which should be considered when counselling women and planning for future pregnancies.

Evaluation of maternal serum biomarkers in predicting outcome of successful expectant management of tubal ectopic pregnancies.

OBJECTIVE: To assess the value of multiple serum biomarkers for the prediction of successful outcome of expectant management in women with tubal ectopic pregnancy (TEP). STUDY DESIGN: Women with a conclusive ultrasound diagnosis of TEP had a blood test to measure ß-human chorionic gonadotropin (ß-hCG), progesterone, inhibin A, activin A and high sensitivity C-reactive protein (hsCRP) at the initial visit. Women presenting with pain, serum ß-hCG ≥ 1500 IU, evidence of a live ectopic pregnancy or a significant haemoperitoneum were advised to have emergency surgery. Women eligible for expectant management were followed-up prospectively until serum ß-hCG declined to non-pregnant level or surgical treatment was required. RESULTS: A total of 93 women with a TEP were included in the final cohort. Emergency surgery was carried out in 42/93 (45 %) of women whilst 51/93 (55 %) were managed expectantly. Of the latter group, 42/51 (82 %) had successful expectant management and 9/51(18 %) required surgical procedure after a period of follow up. On multi-variable analysis, only higher values of serum ß-hCG and progesterone at the initial visit were associated with a lower chance of successful expectant management of TEP. A one-unit increase in either variable on the log-scale was associated with an approximate 20-fold reduction in the odds of a successful outcome. CONCLUSION(S): Serum ß-hCG and progesterone were significantly lower in women who had successful expectant management of TEP. Other biomarkers under consideration were not significantly different in women with successful and failed expectant management.

New insights in the pathophysiology of complete hydatidiform mole.

OBJECTIVE: The majority of complete hydatidiform moles (CHM) are detected on ultrasound examination by the end of the first trimester when they present as multiple sonolucent cysts. To better understand the pathophysiology of this unique placental pathology and improve its prenatal diagnosis and management we have reviewed the ultrasound features of CHM before the appearance of cystic changes. STUDY DESIGN: We searched our database to identify all women diagnosed with a complete hydatidiform mole confirmed by histopathology who had an ultrasound examination before 9 weeks' gestation. We reviewed their ultrasound reports and all the corresponding images. RESULTS: The study group included 39 women with a positive pregnancy test and vaginal bleeding, 36 of whom had at least two ultrasound examinations before 9 weeks' gestation. At the first scan (mean gestation age 7 + 1 weeks; SD 1.1), 29 out 39 (74.4%) of CHM presented as a heterogeneous hyperechogenic mass with or without gestational sac and the remaining ten (25.6%) cases as a regular 4-week gestational sac. Cystic molar changes became apparent from the end of the second month of gestation. CONCLUSION: The development of a CHM follows a well-defined pattern starting with a macroscopically normal gestation sac at 4 weeks, which transforms into a polypoid mass between 5 and 7 weeks of gestation. The hydropic changes of the villous tissue is progressive and rarely visible in utero on ultrasound before 8 weeks of gestation. These findings should allow an earlier diagnosis and assist in the management counselling of women with CHM.

Maternal serum markers in predicting successful outcome in expectant management of missed miscarriage.

The aim of this study was to evaluate the use of biological serum markers, available routinely in most hospital clinical laboratories, in predicting successful outcomes of expectant management in women presenting with a missed miscarriage. This is a single centre observational prospective study over a 16-month period. Among the 490 women who consented to the study protocol, 83 presented with missed miscarriage during the first trimester of pregnancy and opted for expectant management. The mean gestation sac diameter and volume of the gestation sac were recorded during ultrasound examination. Maternal serum samples were obtained in each case and assayed for human chorionic gonadotrophin, progesterone, pregnancy associated plasma protein A (PAPP-A) and high-sensitivity C-reactive protein using commercial assays. When examined individually, maternal age (P = 0.01), progesterone (P = 0.03) and PAPP-A (P = 0.02) were all significantly associated with successful expectant management. Increased maternal age was associated with an increased chance of success with the odds of success increased by around 75% for a 5-year increase in age. Higher values of progesterone and PAPP-A were associated with a reduced chance of successful management. Low maternal serum progesterone concentration was the strongest parameter associated with a successful spontaneous completion of miscarriage.

Application of uterine compression suture in association with intrauterine balloon tamponade ('uterine sandwich') for postpartum hemorrhage.

We evaluated in a prospective observational study the use of a 'uterine sandwich' technique (uterine compression sutures in association with intrauterine tamponade) in women who had had unsuccessful medical treatment for postpartum hemorrhage. Ten of the 11 patients had cesarean sections (complicated by placenta previa and uterine atony) and one had a normal delivery. The median estimated blood loss and units of blood transfused were 1500ml (range 750-4000ml) and two units (range 0-9), respectively. B-Lynch sutures were placed in two patients and Hayman's modification was used in nine. Bakri balloon tamponade was in place for a median of 22 hours (range 17-27 hours), while the median volume infused in the balloon was 300ml (range 150-350ml). The combined technique was successful in avoiding hysterectomy in all cases, and there was no documented postpartum morbidity. This is a simple and quick surgical technique that can be used to treat atonic postpartum hemorrhage, particularly in conjunction with placenta previa.

Complications associated with uterine artery embolisation for fibroids.

Uterine artery embolisation (UAE) is a relative newcomer to the mainstream treatment modalities available for fibroid-related problems. The efficacy of UAE is indisputable and has been shown to be comparable to hysterectomy in the short term in large-scale trials. Moreover, compared with hysterectomy, UAE is less invasive, carries a superior risk profile, and, importantly, preserves the uterus. UAE therefore offers patients symptom relief whilst at the same time retaining reproductive potential. Notably however, although women can have successful pregnancies following UAE, it is becoming increasingly evident that pregnancies after UAE are more risky especially during the early stages. Long-term outcome data from randomised trials involving UAE have very recently become available and show that whilst high satisfaction rates previously identified during early-stage followup are sustained, one notable drawback is a substantial risk of reintervention. It remains to be seen how this facet of UAE will impact on its future uptake.