Clinical Outcomes In Women Research Articles

Menopausal status and clinical outcomes in women with heart failure with reduced ejection fraction: the GALACTIC-HF trial

Abstract Introduction Mechanisms driving disease progression and potential responsiveness to investigational therapies may theoretically differ among women with heart failure (HF) based on menopausal status. However, few data are available describing the clinical course of premenopausal and postmenopausal women with HF. We investigated differences in baseline characteristics, clinical outcomes, and response to omecamtiv mecarbil in premenopausal and postmenopausal women participants of the GALACTIC-HF trial. Methods The GALACTIC-HF trial randomized patients with symptomatic HFrEF with LVEF of 35% or less to omecamtiv mecarbil or placebo. Menopausal status at randomization was collected. When menopausal status was unknown/unreported, menopausal status was inferred based on the expected distribution of age at menopause in the general population. The risk of the primary endpoint, worsening HF event or cardiovascular death, was compared among women by menopausal status using Cox regression models adjusted for clinical covariates, including age and baseline EF. Treatment effect heterogeneity was evaluated by menopausal status. Results Of the 8,232 patients enrolled, 1,749 (21.2%) were women. Menopausal status was available at baseline in 1,483 (84.8%). One hundred women reported being potentially childbearing (pre-menopausal) and 1,383 women reported being post-menopausal. Among the 266 patients that had unknown menopausal status, those younger than 47 years were additionally classified as pre-menopausal and those older than 56 years as post-menopausal based on estimated 10th /90th percentiles extrapolated from the general population. Compared to post-menopausal women, pre-menopausal women were younger, had higher eGFR, and had fewer comorbidities. Premenopausal women also had slightly higher BMI and lower LVEF, but lower NTproBNP and troponin at baseline compared to postmenopausal women. Premenopausal and postmenopausal women had similarly high burden of symptoms as assessed by the KCCQ-total symptoms score (median 63.5 vs. 64.6; P=0.79). During a median follow-up of 22 months, premenopausal and postmenopausal women experienced similar rates of primary and secondary outcomes (Table 1). Omecamtiv mecarbil was beneficial across the entire female cohort with no effect modification by menopausal status (Pinteraction=0.39). Sensitivity analysis excluding all women with unknown menopausal status yielded similar results. Conclusions In this high-risk HFrEF cohort, premenopausal women experienced similar rates of adverse cardiovascular outcomes as post-menopausal women despite younger age, fewer comorbidities, and lower cardiac biomarkers. Additional research is necessary to understand how risk factors unique to females might influence outcomes in those with heart failure. The benefit of omecamtiv mecarbil on reducing cardiovascular risk was consistent regardless of menopausal status.Primary/secondary outcomes by menopausal

Comparison of clinical outcomes in women with surgically treated early primary cervical cancer: Lymphadenectomy versus sentinel lymph node biopsy.

The primary objective of this study was to elucidate the impact of sentinel lymph node (SLN) mapping and biopsy techniques on the clinical outcomes of women with early primary cervical cancer. All consecutive women with clinically determined stage I-IIA cervical cancer who underwent lymph node assessment with either SLN mapping or conventional pelvic/para-aortic lymphadenectomy were reviewed. Women in the SLN group (n=33) had fewer total dissected pelvic nodes (8.3±5.9 versus 17.4±7.7, p<0.001), less intraoperative blood loss (513±332mL versus 1228±1170mL, p<0.001), a shorter length of hospital stay (7.1±2.4 versus 10.2±6.1 days, p=0.004) and a trend toward a lower incidence of lymphocysts (3% versus 14%, p=0.090) than women in the conventional lymphadenectomy group (n=74). The rates of recurrence-free survival (3-year: 87.6% vs. 82.9%) and overall survival (3-year: 100% vs. 91.0%) did not differ between the SLN group and the conventional lymphadenectomy group (p=0.846 and p=0.254, respectively). SLN biopsy does not seem to be associated with an inferior survival outcome compared with conventional lymphadenectomy in women with early primary cervical cancer. In addition, it is associated with less blood loss and a shorter length of hospital stay.

Pregnant Women Presenting to Psychiatric Emergency Services: A Retrospective Chart Review from India

Background: Managing psychiatric emergencies during pregnancy is often challenging, as the safety of both the mother and the unborn fetus needs to be considered. This study aimed to examine the nature of psychiatric emergencies in pregnancy, their management, and clinical outcomes in women presenting to a psychiatry emergency room (ER). Methods: Charts of perinatal women consulting psychiatry ER between January 2016 and June 2021 were reviewed for the nature of the psychiatric emergency, pregnancy details, psychiatric symptoms, sociodemographic information, medical comorbidities, clinical diagnosis, and care plan. Results: Among 286 perinatal women who attended psychiatry ER, 57 (19.9%) patients were pregnant. Over half ( n = 30, 52.6%) women were multiparous and in their second trimester ( n = 29, 50.9%). Bipolar disorder ( n = 22, 38.6%) was the most common diagnosis. Agitation/aggression ( n = 34, 59.6%) was the most common reason for visiting ER, with risk of self-harm ( n = 14, 24.6%) and risk of harm to the fetus ( n = 7, 12.3%) being other reasons. Emergency psychotropic medications were used in 32 (56.1%) women, with the use of haloperidol in combination with promethazine ( n = 12, 37.5%) or lorazepam ( n = 8, 25%) being the most common. Conclusion: One-fifth of women in the perinatal period presenting to the ER were pregnant. Agitation and aggression were the most common reasons. Parenteral medications were commonly used, and more than a fifth required inpatient care, emphasizing the seriousness of risk.

ASO Visual Abstract: PROMRIINE (PRe-operatory Magnetic Resonance Imaging is INEffective) Study: A Systematic Review and Meta-analysis of the Impact of Magnetic Resonance Imaging on Surgical Decisions and Clinical Outcomes in Women with Breast Cancer.

ASO Visual Abstract: PROMRIINE (PRe-operatory Magnetic Resonance Imaging is INEffective) Study: A Systematic Review and Meta-analysis of the Impact of Magnetic Resonance Imaging on Surgical Decisions and Clinical Outcomes in Women with Breast Cancer.

PROMRIINE (PRe-operatory Magnetic Resonance Imaging is INEffective) Study: A Systematic Review and Meta-analysis of the Impact of Magnetic Resonance Imaging on Surgical Decisions and Clinical Outcomes in Women with Breast Cancer

BackgroundThe purpose of this study was to review and summarize the association between preoperative magnetic resonance imaging (MRI) and surgical outcomes in women with newly diagnosed invasive breast cancer from published randomized controlled trials (RCT).Materials and MethodsTwo independent researchers conducted a systematic review through a comprehensive search of electronic databases, including PubMed, Medline, Embase, Ovid, Cochrane Library, and Web of Science. If there was disagreement between the two reviewers, a third reviewer assessed the manuscript to determine whether it should be included for data extraction. The quality of the papers was assessed using the risk of bias tool, and the evidence was analyzed using GRADE. Meta-analyses using a fixed-effects model were used to estimate the pooled risk ratio (RR) and 95% confidence interval (CI).ResultsInitially, 21 studies were identified, 15 of which were observational comparative studies. A total of five RCTs were included, and they suggested that preoperative MRI significantly reduced the rate of immediate breast-conserving surgery and increased the risk for mastectomy.ConclusionsFrom the RCT perspective, preoperative MRI for newly diagnosed invasive breast cancer did not improve surgical outcomes and may increase the risk of mastectomy.

Examining the validity and reliability of the COMcareSS (Continuity of Midwifery Care Satisfaction Survey)

BackgroundContinuity of midwifery care has been proven to show an improvement in clinical outcomes for women and greater maternal satisfaction with maternity care. Several questionnaires have been developed to measure satisfaction with maternity services although few are suitable for continuity of midwifery maternity care models, and many have not been validated. AimsThe purpose of this study was to test the reliability and validity of the newly developed Continuity of Midwifery Care Satisfaction Survey (COMcareSS) with a cohort of women who have recently experienced continuity of midwifery care. MethodsThe COMcareSS was distributed to women in Australia who had experienced a live birth within a continuity model of midwifery care and were up to two months postpartum. Factor analysis was conducted, and Cronbach’s alpha coefficient calculated for the 34-item scale. FindingsIn total 272 completed responses were recorded. Cronbach’s alpha coefficient for the scale was 0.96 suggesting some redundancy in items. There was a lack of variation in responses. In factor analysis, only one factor could feasibly be attempted. This accounted for 76 % of variation in responses. ConclusionThe COMcareSS scale is the first to be developed to measure maternal satisfaction with continuity of midwifery led care. The 34-item scale has good internal consistency. The scale may be unidimensional though the lack of variation in responses means that other possible latent constructs, were not able to be detected. Use of a standardised scale such as the COMcareSS will facilitate benchmarking between services and, comparison and meta-analysis in research studies.

Abstract PO3-27-03: PROMISE Study: Pre-Operatory MRI is not Effective. A Systematic review of impact of magnetic resonance imaging on surgery-decision and clinical outcomes in women with breast cancer

Abstract Background: The use of magnetic resonance imaging (MRI) in patients with breast cancer before surgery has been a subject of ongoing debate and discussion. The role of MRI as a preoperative tool to guide surgical decision-making remains controversial. Some studies suggest that MRI may improve the detection of additional tumors or assess the extent of disease, while others discuss that it may lead to increased false-positive findings and unnecessary interventions. The potential benefits and potential harms of incorporating MRI into the preoperative assessment of breast cancer patients continue to be topics of research and clinical interest. Clarifying the impact of preoperative MRI on surgical outcomes is crucial to inform evidence-based practices and optimize patient care. Until present, there is no pooled analyses from randomized clinical trials perspective of the clinical impact regarding the routine use of MRI. Objectives: This study aims to conduct metanalysis of randomized controlled trials (RCT) to investigate the association between preoperative MRI and surgical outcomes in women with newly diagnosed invasive breast cancer, providing evidence-based recommendations for clinical practice. Methods: A comprehensive search of electronic databases including PubMed, Medline, Embase, Ovid, Cochrane Library, and Web of Science was conducted by three independent researchers from inception to May 2023. The inclusion and exclusion criteria were based on Cochrane's principles. Relevant data from eligible studies were extracted. A systematic evaluation and meta-analysis were performed using the fixed-effects model to estimate the pooled risk ratio (RR) and 95% CI. Results: Out of 21 studies found, 6 were RCTs and 15 observational comparative studies. The results showed that in RCT preoperative MRI significantly reduce the rate of immediate breast conservative surgery (RR=0.94, 95%CI 0.91~0.96, I2=0%) and increase the mastectomy rate (RR=1.88, 95%CI 1.48~2.38, I2=86%). There wasn’t any change in reoperations rates (RR=0,87, 95%CI 0.71~1.07, I2=72%). Only 1 trial reported data on survival, showing no difference between groups. Conclusion: From RCT standpoint, the evidence suggests that preoperative MRI for newly diagnosed invasive breast cancer may not be beneficial to the patients by increasing rate of mastectomy with no survival benefit and that should be considered when offering as a routine practice to patients with breast cancer before surgery. Forest plot of mastectomy as an outcome Forest plot of re-operation as an outcome Citation Format: Andre Mattar, Andressa Amorim, Evandro Mateus, Fabio Bagnoli, Felipe Zerwes, Francisco Pimentel Cavalcante, Guilherme Novita, Lincon Mori, Marcelo Madeira, Marina Diogenes, Marcelo Antonini, Lucas Okumura. PROMISE Study: Pre-Operatory MRI is not Effective. A Systematic review of impact of magnetic resonance imaging on surgery-decision and clinical outcomes in women with breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-27-03.

The Presence of Extensive Lymphovascular Invasion is Associated With Higher Risks of Local-Regional Recurrence Compared With Usual Lymphovascular Invasion in Curatively Treated Breast Cancer Patients

Purpose/objectives: Several datasets have demonstrated a correlation between lymph-vascular invasion (LVI) and local-regional recurrence (LRR). Whether the observation of "extensive LVI" is a further and incremental determinant of LRR risk is unknown. We describe clinical outcomes in women with invasive breast cancer stratified by: 1) absence of LVI (neg), 2) LVI focal or suspicious (FS-LVI), 3) usual (non-extensive) LVI (LVI) and 4) extensive LVI (E-LVI).Materials/Methods: Between 12/2009 and 8/2021, 8837 patients with early-stage breast cancer were treated with curative intent and were evaluable. Clinical-pathological details were abstracted by retrospective review. The description of LVI was abstracted from pathology reports. Recurrence and survival outcomes were compared based on the extent of LVI. A matched propensity score analysis compared outcomes between patients with LVI vs. E-LVI.Results: Of the 8837 patients studied, 5584 were neg, 461 had FS-LVI, 2315 had LVI, and 477 had E-LVI. Patient with E-LVI had an adverse risk profile compared to the other groups.The 5- and 10-year local regional recurrence (LRR) cumulative incidence estimates in patients with E-LVI were 9.6% (95% CI: 7.1-13) and 13% (95% CI: 10-17), which were significantly higher than observed in the usual LVI group (6.8% [5.7-7.9] and 10% [8.8-12], respectively). A statistically significant difference in LRR was demonstrated on univariable (HR 1.4, 95% CI [1.03-1.89], p-value 0.029) and multivariable regression analysis (HR 1.62, 95% CI [1.15-2.27], p-value 0.005) when compared to non-extensive LVI.In an alternative approach, we performed a 2:1 propensity-matched analysis comparing LVI to E-LVI patients. The hazard ratio for LRR (HR 1.47 (CI 1.02-2.14, p=0.041) was suggestive of a higher risk with E-LVI.Conclusions: Our work suggests that patients with E-LVI are at a higher risk for LRR than those with usual LVI. For patients who are borderline candidates for regional nodal irradiation or PMRT, the finding of E-LVI might be decisive in favor of intensified treatment.

Sex differences in resting sympathetic activity and systemic inflammation in heart failure with preserved ejection fraction

Background: The prevalence of heart failure with preserved ejection fraction (HFpEF) is higher in older women than in older men, with worse clinical outcomes for older women. The underlying mechanisms are unclear, but aberrant sympathetic neural control may in part contribute. Notably, &gt;80% of patients with HFpEF, particularly women, are overweight or obese. This observation is important because obesity can augment chronic inflammation, which may lead to sympathetic overactivity. Therefore, we hypothesized that older women with HFpEF would have augmented sympathetic activity at rest compared to older men with HFpEF and similarly aged non-HFpEF controls, which would be associated with chronic inflammation. Methods: We studied 24 women with HFpEF [mean±SD; 70±7 yrs, body mass index (BMI) 39±7 kg/m2], 17 men with HFpEF (71±8 yrs, 35±6 kg/m2), 41 control women (70±7 yrs, 27±5 kg/m2), and 26 control men (71±6 yrs, 27±3 kg/m2). Mean arterial pressure (MAP), heart rate (HR), and muscle sympathetic nerve activity (MSNA, peroneal nerve microneurography) were measured during 10 minutes of supine rest. Blood samples were drawn for the measurement of C-reactive protein (CRP). Results: BMI was greater in patients with HFpEF compared with controls (p&lt;0.001). There were no differences in resting MAP between groups and sexes (87±12 and 91±16 mmHg in men and women with HFpEF vs. 94±9 and 91±10 mmHg in control men and women, Pinteraction=0.130). Patients had higher HR compared to controls (p&lt;0.001), but there were no differences between sexes (Pinteraction=0.108). Women with HFpEF had greater resting MSNA burst frequency (BF) compared to men with HFpEF (41±15 vs. 31±11 bursts/min, P=0.047) and control women (28±13 bursts/min, P=0.001); however, MSNA BF was not different between men with HFpEF and control men (31±13 bursts/min, P=0.940). All results were similar for MSNA burst incidence (Pinteraction=0.012). CRP was higher in patients than controls (P=0.002), but there were no differences between sexes (Pinteraction=0.148). However, a mediation analysis indicated that resting MSNA BF was associated with BMI rather than CRP in women. On the other hand, we did not observe any relationships between these variables in men. Conclusions: Women, but not men, with HFpEF have augmented sympathetic activity at rest, which seems to be linked to obesity rather than systemic inflammation. This sustained sympathetic overactivity may contribute to the poor clinical outcomes in women with HFpEF. Supported by the National Institutes of Health (P01HL137630) and Harry S Moss Heart Trust, Bank of America, N.A., Trustee. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Cervical Septum Incision Adversely Impacts Clinical Outcomes in Women With Complete Uterine Septum and Duplicated Cervix

To investigate the reproductive outcomes of women with complete septate uterus and duplicated cervix who either did or did not receive cervical septum incision during hysteroscopic transcervical incision of the uterine septum. Retrospective study approved by the Hospital Ethics Committee. Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China. Women with complete septate uterus and duplicated cervix who underwent hysteroscopic transcervical incision of the uterine septum in Obstetrics and Gynecology Hospital of Fudan University between January 2008 and December 2020 (n=105). Hysteroscopic incision of the septum. Included patients were grouped according to whether or not cervical septum incision was performed. Reproductive outcomes including gravidity, abortion rate, preterm birth rate, full-term birth rate, premature rupture of membranes (PROM), and cervical incompetence were assessed. In no incision group, the abortion rate (7.4%) was significantly lower than that of incision group (27.6%, p=0.01); the preterm birth rate (4.6%) was significantly lower than that of incision group (36.8%); and the full-term birth rate (95.5%) exceeded that of incision group (63.2%, p<0.01). Incidence of PROM and cervical incompetence during pregnancy was higher in incision group (15.8% and 10.5%, p<0.01 and p=0.03). Significantly improved reproductive outcomes were observed among patients with complete septate uterus and duplicated cervix whose cervical septum was preserved during the hysteroscopic transcervical incision of the uterine septum procedure.

Real world outcomes of patients with endometrial cancer from a South African radiation oncology unit

Background: Endometrial cancer adds significantly to the burden placed on the South African health care system with GLOBOCON 2020 cancer statistics ranking it as the 5th most frequently diagnosed cancer in South African women.Aim: A retrospective audit to assess real-world clinical outcomes in women with endometrial carcinoma that received radiation as a treatment modality.Setting: A radiation oncology unit at a public tertiary hospital in the Johannesburg area, Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) in South Africa.Methods: Medical records between 2010 and 2020 were evaluated for patients who received either combination external beam (EBRT) and vaginal brachytherapy (VBT) or VBT alone. Overall survival rates (OS) and progression-free survival (PFS) were assessed.Results: One hundred and two patients were analysed. Demographic profiles were 76,5% black people, 18.6% white people, 3.9% asian people and 1% mixed race. Median age was 66 years (range: 64 years—67 years).Type 1 histology in 70%.OS at 5-year was 61.75% and at 10-year was 40% with stage and histological type being significant contributors. Statisical significance in survival occurred with a combination of LVSI with greater than 50 % myometrial invasion(P=0.038) and a combination of greater than 50% myometrial invasion with positive margins (P=0.032).Radiation treatment was completed in 102 (100%) of the patients.Conclusion: Real world outcomes of overall survival rates of endometrial carcinoma are lower than projected in our developing country, although contributory high risk factors play a role in keeping with international literature and historic landmark trials.Contribution: This study contributes to the growing body of research on endometrial cancer outcomes in low- and middle-income countries (LMICs).

Sexually transmitted infections: Prevalence and clinical outcomes among pregnant women in Western Sydney.

We report the prevalence, characteristics and clinical outcomes of women with sexually transmitted infections (STIs) in pregnancy in the Western Sydney Local Health District (WSLHD) serving a large culturally and socio-economically diverse community in New South Wales (NSW), Australia, over the last 10 years. A retrospective cohort study of all pregnant women booked for antenatal care at three hospitals in WSLHD between September 2012 and August 2022 inclusive. Characteristics and birth outcomes associated with STIs diagnosed in pregnancy (chlamydia, gonorrhea, and syphilis) are reported using multivariable logistic regression adjusting for relevant confounders. During 2012-2022, there were 102 905 births and 451 women (0.44%) with an STI diagnosis during pregnancy. The number of women with a history of chlamydia prior to their current pregnancy has increased over the last 10 years (P < 0.001). STIs in pregnancy were more common in younger women aged <20 years (adjusted odds ratio [aOR] 7.30, 95% confidence interval [CI] 5.04-10.57), 20-24 years (aOR 3.12, 95% CI 2.46-3.96), and >40 years (adj OR 1.67, 95% CI 1.07-2.59), in women with body mass index >30 (aOR 1.73, 95%CI 1.37-2.19), and those who smoked (aOR 2.24, 95% CI 1.71-2.94) and consumed alcohol (aOR 3.14, 95% CI 1.88-5.23) and illicit drugs (aOR 2.10, 95% CI 1.31-3.36). STIs in pregnancy were borderline associated with stillbirth (aOR 2.19 95% CI 0.90-5.36) but did not have a significant impact on preterm birth (aOR 1.21, 95% CI 0.87-1.68), admission to neonatal intensive care unit (NICU) (aOR 1.02, 95% CI 0.77-1.34), or having a small-for-gestational-age (SGA) baby (aOR 0.97, 95% CI 0.74-1.27). Sociodemographic factors such as age, weight, smoking, and alcohol and drug use, were associated with the STI incidence in pregnancy. While the latter did not have an impact on preterm birth, NICU admission, and SGA in our cohort, there was a borderline association with stillbirth. Future research should identify barriers and facilitators to testing in a multicultural population and understanding the drivers of higher rates of STIs in certain population groups.

Early menopause is associated with abnormal diastolic function and poor clinical outcomes in women with suspected angina

Early identification of women at high risk for cardiovascular diseases (CVD), with subsequent monitoring, will allow for improved clinical outcomes and generally better quality of life. This study aimed to identify the associations between early menopause, abnormal diastolic function, and clinical outcomes. This retrospective study included 795 menopausal women from is a nationwide, multicenter, registry of patients with suspected angina visiting outpatient clinic. The patients into two groups: early and normal menopause (menopausal age ≤ 45 and > 45 years, respectively). If participants met > 50% of the diastolic function criteria, they were classified as having normal diastolic function. Multivariable-adjusted Cox models were used to test associations between menopausal age and clinical outcomes including the incidence of major adverse cardiovascular events (MACE), over a median follow-up period of 771 days. Early menopause was associated with increased waist circumference (p = 0.001), diabetes prevalence (p = 0.003), obstructive coronary artery disease (p = 0.005), abnormal diastolic function (p = 0.003) and greater incidences of MACE, acute coronary syndrome, and hospitalization for heart failure. In patients with abnormal diastolic function, early menopause increased MACE risk significantly, with no significant difference in normal diastolic function. These findings highlight early menopause and abnormal diastolic function as being potential risk markers in women for midlife CVD events.

Health impacts of new-onset diabetes in women post-gestational diabetes mellitus: Insights from Hong Kong's territory-wide data.

To determine the population health burden attributable to the development of diabetes among women with a history of gestational diabetes mellitus (GDM). We conducted a retrospective analysis of women with a history of GDM attending the Hong Kong Hospital Authority between 2000 and 2019. The time-varying population attributable fraction was calculated. A total of 76,181 women with a history of gestational diabetes mellitus were included, 6,606 of them developed diabetes during a median follow-up of 8.6 years. The respective hazard ratios (95% confidence interval) among women with GDM who developed diabetes vs those with GDM only were 2.8 (2.2, 3.7) for cardiovascular disease (CVD), 4.8 (3.0, 7.7) for end-stage kidney disease (ESKD), 2.2 (1.9, 2.6) for infection-related hospitalization, and 1.8 (1.3, 2.4) for all-cause mortality. The development of diabetes was associated with 1.3 (0.8, 1.7), 0.6 (0.3, 0.8), 3.2 (2.4, 4.0), and 0.5 (0.2, 0.9) additional incident cases per 1,000 person-years, accounting for 24.0% (13.2%, 35.9%), 42.0% (22.5%, 58.8%), 10.8% (7.1%, 14.9%), and 6.0% (-3.1%, 16.1%) of absolute number of CVD, ESKD, infection-related hospitalization, and all-cause mortality over 20 years after GDM, respectively. Diabetes is a significant contributor to the population health burden of some clinical outcomes in women with a history of gestational diabetes mellitus, but other risk factors need to be considered.

Efficient administration of a combination of nifedipine and sildenafil citrate versus only nifedipine on clinical outcomes in women with threatened preterm labor: a systematic review and meta-analysis

BackgroundPreterm labor (PTL) is a common and serious pregnancy disorder that can cause long-term neurological issues in the infant. There are conflicting studies concerning whether sildenafil citrate (SC) reduces preterm labor complications. Therefore, the meta-analysis aimed to examine the clinical outcomes in women with threatened PTL who received nifedipine plus SC therapy versus only nifedipine.MethodsFor the original articles, six databases were searched using relevant keywords without restriction on time or language until January 13, 2024. The Cochrane risk-of-bias tool for randomized trials (RoB) and the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) were both used to assess the risk of bias in randomized and non-randomized studies, and GRADE determined the quality of our evidence. Meta-analysis of all data was carried out using Review Manager (RevMan) version 5.1.ResultsSeven studies with mixed quality were included in the meta-analysis. The study found that combining nifedipine and SC resulted in more prolongation of pregnancy (MD = 6.99, 95% CI: 5.32, 8.65, p < 0.00001), a lower rate of delivery in the 1st to 3rd days after hospitalization (RR = 0.62, 95% CI: 0.50, 0.76, p < 0.00001), a higher birth weight (252.48 g vs. nifedipine alone, p = 0.02), and the risk ratio of admission to the neonatal intensive care unit (NICU) was significantly lower (RR = 0.62, 95% CI: 0.50, 0.76, p < 0.00001) compared to nifidepine alone. The evidence was high for prolongation of pregnancy, delivery rate 24–72 h after admission, and NICU admission, but low for newborn birth weight.ConclusionsGiven the effectiveness of SC plus nifedipine in increased prolongation of pregnancy and birth weight, lower delivery in the 1st to 3rd days after hospitalization, and NICU admission, Gynecologists and obstetricians are suggested to consider this strategy for PTL management, although additional article rigor is required to improve the quality of the evidence.

Comparative efficacy of different growth hormone supplementation protocols in improving clinical outcomes in women with poor ovarian response undergoing assisted reproductive therapy: a network meta-analysis

Growth hormone (GH) has a long-standing history of use as an adjunctive therapy in the treatment of poor ovarian response (POR), but the optimal dosage and timing remains unclear. The aim of this study was to evaluate and compare the efficacy of different GH supplementation protocols through a network meta-analysis (NMA) and determine the optimal treatment protocol. This study was reported based on the Preferred Reporting Items for Systematic Reviews for Network Meta-Analysis (PRISMA-NMA) statement. Databases including PubMed, Web of Science, Cochrane Library and Embase were searched until June 2023. A total of 524 records were retrieved in our search, and 23 clinical studies comprising 4889 cycles were involved. Seven different GH protocols were identified. Results showed that compared to the control group, daily administration of 4–8 IU of GH during the follicular phase of the stimulation cycle had the best comprehensive therapeutic effects on improving the number of retrieved oocytes, mature oocytes, endometrial thickness, and reducing gonadotropin requirements in POR patients undergoing assisted reproductive therapy, with a relatively brief treatment duration and a moderate total GH dose. Subgroup analysis demonstrated that this protocol could significantly improve the clinical pregnancy rate of POR patients in the randomized controlled trials (RCT) subgroup and the African subgroup. Therefore, its clinical application is suggested. Besides, the potential advantages of long-term GH supplementation protocol (using GH for at least 2 weeks before oocyte retrieval) has merit for further research. Rigorous and well-designed multi-arm RCTs are needed in the future to confirm the conclusions drawn from this study.

Impact of Restricted Treatment Duration of Metoclopramide on Clinical Outcomes in Women with Hyperemesis Gravidarum

Impact of Restricted Treatment Duration of Metoclopramide on Clinical Outcomes in Women with Hyperemesis Gravidarum

Influence of postdiagnostic aspirin use on clinical outcomes of women with breast cancer: a meta-analysis

ABSTRACT We examined the association between postdiagnostic aspirin use and recurrence and disease-specific mortality among women with breast cancer in a meta-analysis. The PubMed, Embase, and Web of Science databases were searched to identify observational studies with longitudinal follow-ups according to the aim of the meta-analysis. Combining the results was achieved using a random-effects model that included inter-study heterogeneity. Fifteen cohort studies with 131,636 women with breast cancer were included. Based on a meta-analysis, women who took aspirin after being diagnosed with breast cancer had a lower risk of breast cancer recurrence (adjusted risk ratio [RR]: 0.77, 95 percent confidence interval [CI]: 0.63 to 0.95, P = .02; I2 = 72 percent) and breast cancer specific mortality (adjusted RR: 0.73, 95 percent CI: 0.60 to 0.90, P = .004; I2 = 80 percent) than those who did not use aspirin. The certainty of the evidence was rated using the Grading of Recommendations Assessment, Development, and Evaluations scoring system showed moderate certainty for both the outcomes because significant inconsistency was observed. In conclusion, aspirin use after diagnosis might be associated with reduced recurrence and disease-specific mortality in women with breast cancer.

The Presence of Extensive Lymphovascular Invasion (LVI) is Associated with Higher Risk of Recurrence in Curatively Treated Breast Cancer Patients

Lymphovascular invasion (LVI) is a pathological feature seen in breast cancer that may be an important step in cancer metastasis. Multiple datasets have demonstrated a correlation between LVI and local-regional recurrence (LRR). Whether the extent of LVI is an incremental determinant of LRR risk is unknown. We describe clinical outcomes in women with invasive breast cancer stratified by: 1) absence of LVI (neg), 2) LVI focal or suspicious (FS-LVI), 3) usual (non-extensive) LVI (LVI) and 4) extensive LVI (E-LVI). Between December 2009 and August 2021, there were 8,837 patients with early-stage breast cancer (T1-2 and N0-2a) were treated with curative intent and were evaluable. Clinical-pathological details were abstracted by retrospective review. The description of LVI was abstracted from pathology reports. Recurrence and survival outcomes were compared based on the extent of LVI. Of the 8837 patients studied, 5584 were neg, 461 had FS-LVI, 2315 had LVI, and 477 had E-LVI. The E-LVI cohort had baseline characteristics suggestive of higher risk such as younger median age, higher proportion of grade 3, more nodal positivity, more mastectomy (67% vs 48%), and higher use of chemotherapy compared to LVI. The cumulative incidence of LRR and DM was highest in the E-LVI group. Using LVI as the reference, the presence of E-LVI, age, tumor size, ER status, grade, mastectomy, and close/positive margins were independent variables for LRR on Cox multivariable regression (Table 1). To assess the effect with an alternate statistical method, we created propensity matched cohorts (matched for age, size, receptors, grade, surgery type, margins and chemotherapy/RT use); a statistical difference in OS was noted between groups with LVI vs E-LVI (HR 1.44 (CI 1.06-1.96, p = 0.018), but not in LRR (HR 1.31 (CI 0.87-1.97, p = 0.2) or DM (HR 1.16 (CI 0.88-1.53, p = 0.3). Our work suggests that patients with E-LVI are at a higher risk for LRR compared to patients with usual LVI, despite maximal standard of care treatment. This is important because E-LVI can be determined from breast specimens, and may help define indications for RNI/PMRT when nodal information is not available.

Presence of Adenomyosis Impairs Clinical Outcomes in Women Undergoing Frozen Embryo Transfer: A Retrospective Cohort Study.

(1) Background: The presence of adenomyosis among pregnant patients has been associated with a higher incidence of miscarriage and pregnancy complications. Although the role of adenomyosis in women undergoing in vitro fertilization (IVF) was investigated in several studies and demonstrated a potentially detrimental effect on live birth rates following IVF, most of them were small studies in which the adenomyosis diagnosis was not confirmed based on solid ultrasonographic criteria. (2) Methods: 3503 patients undergoing their first blastocyst frozen transfer through a hormonal replacement (HRT) FET cycle. Among them, 140 women had a confirmed diagnosis of adenomyosis based on the MUSA criteria. (3) Results: Adenomyosis patients were more likely to proceed with deferred FET compared with no-adenomyosis women (p = 0.002) and were significantly more likely to be treated with GnRH agonist pre-treatment (2 months) (p < 0.001). The presence of adenomyosis significantly decreased the clinical pregnancy rates (aOR 0.62, 95% CI: 0.39-0.98, p = 0.040) and live birth rates (aOR 0.46, 95% CI: 0.27-0.75, p = 0.003) and significantly increased the miscarriage rates (aOR 2.13, 95% CI: 0.98-4.37, p = 0.045). Multivariable logistic regression adjusting for age, autologous or donor oocytes, PGT-A, deferred FET, serum progesterone levels the day before FET, GnRH agonist pre-treatment, number of embryos transferred, and adenomyosis demonstrated that the use of the GnRH agonist protocol did not decrease or increase the miscarriage rate, clinical pregnancy rate, or live birth rate. (4) Conclusions: The presence of adenomyosis had a significant negative impact on the clinical outcomes of patients undergoing FET and was associated with higher miscarriage, lower clinical pregnancy, and live birth rates. GnRH agonist pre-treatment does not appear to improve clinical outcomes.