Obstetrics and gynecology最新文献

Objective: To assess the efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in menopausal women.

Data sources: MEDLINE, EMBASE, and Cochrane databases were systematically searched until August 22, 2024. Because the Cochrane Library included all the identified randomized controlled trials (RCTs), it was unnecessary to search ClinicalTrials.gov . The following words made up the search strategy, which was applied to the three databases: fezolinetant, elinzanetant, vasomotor symptoms, and menopause.

Methods of study selection: Only RCTs comparing fezolinetant and elinzanetant with placebo for vasomotor symptoms in menopausal women were included.

Tabulation, integration, and results: We extracted the number of patients, mean age, body mass index (BMI), and number of patients who underwent oophorectomy. Data were examined with the Mantel-Haenszel method and 95% CIs. Heterogeneity was assessed with I2 statistics. R 4.3.2 was used for statistical analysis. Seven RCTs with 4,087 patients were included in the analysis. Fezolinetant and elinzanetant were associated with diminished vasomotor symptom frequency: fezolinetant 30 mg (mean difference 2.16, 95% CI, 1.54-2.79, I2 =0%), fezolinetant 45 mg (mean difference 2.54, 95% CI, 1.86-3.21, I2 =0%), and elinzanetant 120 mg (mean difference 2.99, 95% CI, 1.74-4.23, I2 =0%). Both drugs also showed a decrease in vasomotor symptom severity: fezolinetant 30 mg (mean difference 0.20, 95% CI, 0.09-0.33, I2 =0%), fezolinetant 45 mg (mean difference 0.24, 95% CI, 0.13-0.34, I2 =0%), and elinzanetant 120 mg (mean difference 0.36, 95% CI, 0.26-0.46, I2 =0%). Elinzanetant 120 mg showed a significant improvement in sleep quality (mean difference 4.65, 95% CI, 3.73-5.56, I2 =0%). Elinzanetant 120 mg was associated with the occurrence of drug-related adverse events (11.70% vs 20.75%, risk ratio [RR] 0.57, 95% CI, 0.39-0.82, I2 =19%) and headache (2.54% vs 8.0%, RR 0.32, 95% CI, 0.16-0.64, I2 =0%).

Conclusion: In this meta-analysis, consistent results suggest that fezolinetant and elinzanetant are associated with beneficial outcomes in menopausal women with vasomotor symptoms. Elinzanetant provided a larger effect size in vasomotor symptom frequency and severity reduction and greatly improved sleep quality compared with fezolinetant.

Systematic review registration: PROSPERO, CRD42023469952.

The menopause transition represents a significant life phase for people assigned female at birth marked by various physical and psychological changes. For military service members and veterans, this transition can be even more complex because of unique factors related to military service. A tradition of excluding women from service before reaching the age of the menopause transition has left the Military Health System unprepared to address the specific health needs of this population. The lack of attention to menopause needs of military service members is evidenced by the absence of menopause-related research in the active-duty population and a dearth of menopause-specific research in the veteran population. White House Executive Order 14120 on Advancing Women's Health Research and Innovation has highlighted the urgent need for focused research and improved health care delivery tailored to the menopause needs of military individuals and veterans. By addressing these gaps, we can better support the health and well-being of military service members in the menopause transition, ultimately improving operational readiness and retention. Because military service members and veterans often rely on the private sector for health care, it is incumbent on all health care professionals and systems to consider their unique health care needs related to midlife and menopause.

Objective: To explore the associations between hypertensive disorders of pregnancy and the subsequent development of autoimmune diseases.

Methods: This retrospective cohort study used TriNetX, a federated network of real-world data. Using the Global Collaborative Network data, we collected electronic medical records from 102 health care organizations with 131 million patient records from 2006 to 2020. The study assessed the risk of autoimmune diseases in women aged 16-45 years. Two cohorts were compared: the pregnancy-induced hypertension cohort, which included women with gestational hypertension, preeclampsia, or eclampsia, and the normotensive pregnancy cohort. Women with preexisting autoimmune diseases or hypertension and those with complications occurring before 20 weeks of gestation were excluded. Propensity score matching was used to ensure balanced cohorts. The primary outcome was the long-term risk of autoimmune diseases during a follow-up period of up to 18 years. The secondary outcome evaluated the association between the risk of autoimmune diseases and both the patient's age and the severity of pregnancy-induced hypertension.

Results: The prevalence of pregnancy-induced hypertension was found to be 13.4%. After propensity score matching, among 289,564 women, those with pregnancy-induced hypertension demonstrated a significantly higher risk of developing autoimmune diseases during long-term follow-up. The risk of systemic lupus erythematosus was notably higher (hazard ratio 1.87, 95% CI, 1.60-2.18), along with elevated risks of multiple sclerosis, Addison disease, antiphospholipid syndrome, inflammatory bowel disease, mixed connective tissue disease, and rheumatoid arthritis. Subgroup analysis revealed that women of advanced maternal age with pregnancy-induced hypertension had a similar risk of developing autoimmune diseases compared with younger women. In addition, the risk of these autoimmune diseases increased with the severity of pregnancy-induced hypertension.

Conclusion: Women with a history of pregnancy-induced hypertension face a higher long-term risk of autoimmune diseases, emphasizing the need for ongoing monitoring and preventive care.

Objective: To evaluate the performance of a cell-free DNA (cfDNA) assay that uses next-generation sequencing with quantitative counting templates for the clinical detection of the fetal RHD genotype in a diverse RhD-negative pregnant population in the United States.

Methods: This retrospective cohort study was conducted in four U.S. health care centers. The same next-generation sequencing quantitative counting template cfDNA fetal RhD assay was offered to nonalloimmunized RhD-negative pregnant individuals as part of clinical care. Rh immune globulin (RhIG) was administered at the discretion of the clinician. The sensitivity, specificity, and accuracy of the assay were calculated considering the neonatal RhD serology results.

Results: A total of 401 nonalloimmunized RhD-negative pregnant individuals who received clinical care in the period from August 2020 to November 2023 were included in the analysis. The D antigen cfDNA result was 100% concordant with the neonatal serology, resulting in 100% sensitivity, 100% positive predictive value (95% CI, 98.6-100% for both), 100% specificity, and 100% negative predictive value (95% CI, 97.4-100% for both). There were 10 pregnant individuals in whom the cfDNA analysis identified a non-RHD gene deletion, including RhDΨ (n=5) and RHD-CE-D hybrid variants (n=5). Rh immune globulin was administered antenatally to 93.1% of pregnant individuals, with cfDNA results indicating an RhD-positive fetus compared with 75.0% of pregnant individuals with cfDNA results indicating an RhD-negative fetus, signifying that clinicians were using the cfDNA results to guide pregnancy management.

Conclusion: This next-generation sequencing with quantitative counting templates cfDNA analysis for detecting fetal RhD status is highly accurate with no false-positive or false-negative results in 401 racially and ethnically diverse pregnant individuals with 100% follow-up of all live births. This study and prior studies of this assay support a recommendation to offer cfDNA screening for fetal Rh status as an alternative option to prophylactic RhIG for all nonalloimmunized RhD-negative individuals, which will result in more efficient and targeted prenatal care with administration of RhIG only when medically indicated.

Background: Although the fundus is the most likely location of rupture in the gravid uterus, the isthmus is the weakest point, leaving it vulnerable to avulsion during blunt pelvic trauma. We describe a case of uterine avulsion in a gravid patient that was repaired in an attempt to preserve future fertility.

Case: A 19-year-old primigravid woman in her second trimester presented with uterine body avulsion from the cervix after motor vehicle collision. After evacuation of the pregnancy, repair consisted of circumferential interrupted sutures with digital confirmation of cervical patency. On follow-up imaging, normal anatomy appeared restored, with no residual abnormalities noted. We recommended the use of long-acting reversible contraception postoperatively, as well as special considerations for future pregnancies, such as prelabor caesarean delivery and maternal-fetal medicine subspecialist referral.

Conclusion: A gravid uterus may be particularly prone to avulsion at the isthmus, and similar techniques as those described previously in cases of nongravid uterine avulsion may be used in an attempt to preserve future fertility.

Our objective was to develop a prediction model for hepatitis C virus (HCV) infection perinatal transmission to improve triage for neonatal follow-up. This was a secondary analysis of HCV antibody-positive participants who were enrolled in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network multicenter observational study of HCV infection in pregnancy. Among 432 participants, the perinatal transmission rate was 6.0% (95% CI, 4.0-8.7%). The prediction model was developed and included two factors: maternal HCV RNA titer greater than 106 international units/mL and having had any antepartum bleeding. Using this model, the area under the curve for perinatal transmission was 0.76 (95% CI, 0.67-0.86). Probabilities of perinatal transmission of HCV infection ranged from 1.5% (a pregnant individual with HCV RNA 106 international units/mL or less and no antepartum bleeding) to 28.5% (a pregnant individual with an HCV RNA titer greater than 106 international units/mL and antepartum bleeding). Our results provide data to aid in clinical counseling of pregnant individuals with positive HCV antibodies. Additional research is needed to externally validate this prediction model.

Objective: To evaluate whether cannabis use during pregnancy was associated with depressive symptoms and whether ongoing use beyond the first trimester and higher amounts of cannabis use were associated with increased depressive symptoms.

Methods: This was a secondary analysis of the nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers to Be) study with participants enrolled from October 2010 to September 2013 at eight academic centers. Individuals with pregnancy outcome data who completed the EPDS (Edinburgh Postnatal Depression Scale) in the first and third trimesters and had available frozen stored urine samples were included. Cannabis exposure was ascertained by urine immunoassay for THC-COOH (11-nor-9-carboxy-delta-9-tetrahydrocannabinol); positive results were confirmed with liquid chromatography tandem mass spectrometry. Cannabis exposure groups for the primary analysis were classified as any exposure (positive urine assay at any of the three time points: 6 0/7-13 6/7 weeks of gestation, 16 0/7-21 6/7 weeks, and 22 0/7-29 6/7 weeks) or no exposure. In a secondary analysis, cannabis exposure was classified as no, only first trimester, or ongoing exposure beyond the first trimester. The primary outcome was depressive symptoms (EPDS score higher than 10) at 22-29 weeks of gestation. The association between cannabis exposure and later depressive symptoms was assessed with multivariable logistic. In an exploratory analysis, first-trimester urine THC-COOH was quantified to determine whether heavier use was associated with greater odds of depressive symptoms later in pregnancy.

Results: Of 10,038 nuMoM2b participants, 8,424 met the inclusion criteria, and 6.4% (n=535) were exposed to cannabis. Of those exposed, 32.1% (n=172) had only first-trimester exposure, and 67.9% (n=363) had ongoing exposure. Any cannabis use was not significantly associated with later depressive symptoms (adjusted odds ratio [aOR] 1.3, 95% CI, 0.97-1.6) compared with no exposure. However, ongoing exposure beyond the first trimester was associated with later depressive symptoms (aOR 1.6, 95% CI, 1.2-2.2). Higher levels of urine THC-COOH in the first trimester and across pregnancy were associated with increased odds of subsequent depressive symptoms.

Conclusion: Any cannabis exposure was not associated with later-pregnancy increased depressive symptoms. However, ongoing use beyond the first trimester and higher levels of cannabis metabolite in first-trimester urine were associated with greater odds of depressive symptoms in later pregnancy. Directionality of this association cannot be determined given the study design.

Objective: To assess the long-term changes in cardiovascular biomarkers during the WHI (Women's Health Initiative) hormone therapy (HT) clinical trials of conjugated equine estrogens (CEE) alone and CEE plus medroxyprogesterone acetate (MPA).

Methods: HT trial participants from the CEE alone (n=1,188, 0.625 mg/d CEE or placebo) and the CEE+MPA (n=1,508, 0.625 mg/d CEE plus continuous 2.5 mg/d MPA or placebo) trials provided blood samples at baseline and after 1, 3, and 6 years. Low-density lipoprotein cholesterol (LDL-C; primary endpoint), high-density lipoprotein cholesterol (HDL-C), triglycerides, total cholesterol, lipoprotein(a), glucose, insulin, and homeostatic model assessment for insulin resistance were measured. Repeated-measures regression models estimated the geometric means of each log-transformed biomarker by restricted maximum likelihood. A constant treatment effect across visits was used to estimate the overall effect, expressed as a ratio of geometric means, and was complemented with geometric means (95% CIs) by randomization group and corresponding ratios of geometric means (95% CI; HT vs placebo) at each visit.

Results: During the intervention phase of the CEE-alone trial, randomization to CEE reduced LDL-C by 11% over 6 years (ratio of geometric means 0.89, 95% CI, 0.88-0.91, P<.001). The overall reduction in LDL-C was similar for CEE+MPA relative to placebo (ratio of geometric means 0.88, 95% CI, 0.86-0.89, P<.001). Relative to placebo, HDL-C and triglycerides were 13.0% and 7.0% higher with CEE and CEE+MPA, respectively. The homeostatic model assessment for insulin resistance decreased by 14.0% and 8.0% for CEE-alone and CEE+MPA trial participants, respectively. Relative to placebo, lipoprotein(a) decreased by 15.0% and 20.0% for participants randomized to CEE alone and CEE+MPA, respectively.

Conclusion: Lipoprotein(a), LDL-C, and homeostatic model assessment for insulin resistance were lower and HDL-C levels were higher for HT compared with placebo. Triglycerides increased in both the CEE and CEE+MPA trials, however. Future research should assess whether other progestogens attenuate the effect of estrogen on HDL-C. These results may be used to counsel younger menopausal women with bothersome symptoms who are deciding whether to initiate oral HT within the context of published effects of oral HT on rates of cardiovascular events.

Clinical trial registration: ClinicalTrials.gov, NCT00000611.

Objective: To estimate the effect of Medicaid expansion on uninsurance rates and catastrophic charges from emergency surgical management of ectopic pregnancy and ovarian torsion using difference-in-difference analysis and to evaluate for racial and ethnic disparities.

Methods: We conducted a retrospective cohort analysis using 2012-2018 State Inpatient Data and State Ambulatory Surgery and Services Databases in four states: Kentucky and Maryland (expansion) and Florida and North Carolina (nonexpansion). Patients undergoing surgical management of ovarian torsion or ectopic pregnancy were included. Logistic regression models were used controlling for year and expansion type; a difference-in-difference treatment indicator was used to evaluate changes in uninsurance rates and catastrophic spending (hospital charges more than 10% of estimated annual median income) among those uninsured. We then examined race and ethnicity for those uninsured before and after expansion by state.

Results: A total of 594,116 patients were included. Before expansion, the percent of patients uninsured was higher in nonexpansion states (6.5%) compared with expansion states (5.1%). After expansion, the percent uninsured decreased from 5.1% to 2.4% in expansion states compared with 6.5% to 5.3% in nonexpansion states. The interaction between expansion year and Medicaid expansion status was significant (P<.001). Pre-expansion percent catastrophic charges among uninsured patients were higher in nonexpansion states compared with expansion states (96.7% vs 85.7%). After expansion, the percent catastrophic financial burden remained higher at 96.9% in nonexpansion states compared with 82.5% in expansion states. The interaction between expansion year and Medicaid expansion status was significant (P<.001). The uninsured gap between Black or African American and White patients in expansion states after expansion was 0.5%-relatively unchanged-compared with 11.6% for Hispanic and non-Hispanic patients, an increase from 8.3% before expansion.

Conclusion: Medicaid expansion was associated with reductions in uninsured hospitalizations and catastrophic charges after gynecologic surgical emergencies and was associated with differences between Hispanic and non-Hispanic patients.