Obstetrics and gynecology最新文献

Objective: To use online screening and virtual patient education tools to improve the provision of hereditary cancer risk assessment.

Methods: We conducted a prospective, single-arm study in which clinicians at five U.S. community obstetrics and gynecology practices underwent an 8-week observation followed by 3-4 weeks of training on online patient screening and virtual patient education (prerecorded video with or without a genetic counselor phone call) for genetic testing-eligible patients. After a 4-week practice period, hereditary cancer risk assessment and patient education metrics were collected at 8 weeks and compared with preintervention metrics using univariate conditional logistic regression models stratified by site. The primary outcome was the change in genetic testing completion rate. Clinicians and patients were invited to complete a satisfaction survey.

Results: A total of 5,795 and 5,135 patients were seen before and after the intervention, respectively. The proportion of screened patients meeting testing guidelines increased from 21.6% before the intervention to 28.2% after the intervention (odds ratio [OR] 1.36, 95% CI, 1.26-1.47, P <.001). Guideline-eligible patients were significantly more likely to be offered genetic testing (59.1% vs 89.1%, OR 2.06, 95% CI, 1.87-2.27, P <.001), to submit a sample (32.9% vs 45.0%, OR 1.49, 95% CI, 1.27-1.74, P <.001), and to complete testing (16.0% vs 34.2%, OR 2.38, 95% CI, 2.00-2.83, P <.001). Most clinicians agreed or strongly agreed that the screening tool improved the identification of patients meeting hereditary cancer risk assessment guidelines (92.1%), saved time (64.9%), and was easy to incorporate (68.4%) and that patient education improved their ability to deliver hereditary cancer risk assessment standard of care (84.2%). Most patients agreed or strongly agreed that virtual education helped them understand the purpose (91.7%) and implications (92.6%) of genetic testing.

Conclusion: A guideline-based online patient screening tool and virtual patient education were well received. The online tool enabled identification of significantly more guideline-eligible candidates for hereditary cancer risk assessment, and education improved patients' genetic literacy. Together, these tools ultimately improved the genetic testing completion rate.

Objective: It remains unclear whether modifying laparoscopic radical hysterectomy to adopt tumor-free principles can improve oncologic outcomes in patients with early-stage cervical cancer.

Methods: We performed a single-center retrospective cohort study of 276 patients with early-stage cervical cancer who were treated between January 2017 and January 2023, including 151 patients who underwent laparoscopic radical hysterectomy that incorporated modified tumor-free techniques (MTF group) and 125 patients who underwent conventional laparoscopic radical hysterectomy with a uterine manipulator and unprotected intracorporeal colpotomy (non-MTF group). Oncologic outcomes and perioperative results were analyzed using inverse probability treatment weighting (IPTW).

Results: Patients in the MTF group had shorter length of hospital stay than those in the non-MTF group. However, there were no significant differences in operative time, decrease in hemoglobin, or complications. After a median follow-up of 36.0 months (range 15.3-62.0 months) for the MTF group and 66.8 months (range 3.0-82.5 months) for the non-MTF group, recurrence was observed in two (1.3%) and 16 (12.8%) of the patients, respectively. The 2-year disease-free survival (DFS) rates in the MTF group and non-MTF group were 99.3% and 91.9%, respectively. In the primary analysis limited to 2-year survival, the adjusted multivariate analysis showed that use of modified tumor-free techniques was an independent predictor of longer DFS (hazard ratio 0.10 95% CI, 0.01-0.77, P =.027). After IPTW, patients in the MTF group had a more favorable DFS than those in the non-MTF group (log-rank P =.031).

Conclusion: Laparoscopic radical hysterectomy that incorporates modified tumor-free techniques is a feasible treatment for patients with early-stage cervical cancer. Oncologic outcomes of individuals who underwent this procedure were more favorable than those of conventional laparoscopic radical hysterectomy.

Objective: To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF).

Methods: MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24-36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose. Primary efficacy endpoints included newborn and infant severe RSV-associated medically attended lower respiratory tract illness within 180 days after birth. The RSV-A and RSV-B serum neutralizing antibody titers were determined in a subset of pregnant participants and their newborns.

Results: In this final analysis, 7,420 pregnant participants were randomized, and 7,307 children were born (RSVpreF n=3,660, placebo n=3,647). Vaccine efficacy , defined as protection against newborn and infant severe RSV-associated medically attended lower respiratory tract illness, was 82.4% (95% CI, 57.5-93.9) and 70.0% (95% CI, 50.6-82.5) within 90 and 180 days of birth, respectively. The RSVpreF induced robust immune responses in pregnant participants and resulted in highly efficient transfer of maternal antibodies to their newborns across subgroups (by gestational age at delivery and at vaccination, number of days from vaccination to delivery, country, maternal age). Final RSVpreF safety results in pregnant and newborn and infant participants were consistent with the primary analysis with no new safety concerns identified.

Conclusion: This final analysis of MATISSE trial data confirms the primary analysis conclusions: Maternal vaccination with RSVpreF has a favorable safety profile in both pregnant and newborn and infant participants and demonstrates efficacy against RSV-associated lower respiratory tract illness in infants through age 6 months. The RSVpreF induces robust immune responses in pregnant individuals, with corresponding high RSV-neutralizing titers in their newborns.

Clinical trial registration: ClinicalTrials.gov , NCT04424316.

Objective: To compare the rates of treatment failure in cases of early pregnancy loss between mifepristone-misoprostol and misoprostol only.

Methods: This retrospective cohort study included patients who received medical treatment for early pregnancy loss between 2016 and 2023 at a single medical center. Patients returned for a follow-up ultrasonogram after 1 week and were treated again with misoprostol if needed. Finally, they were instructed to obtain an ultrasonogram after menstruation and to return for evaluation in case retained product of conception was suspected. We defined treatment failure as needing any surgical intervention because of retained product of conception, including cases when retained product of conception was diagnosed and treated after menstruation. In May 2022, we changed our protocol for treating early pregnancy loss from misoprostol to mifepristone and misoprostol. We compared the failure rate between patients who received mifepristone-misoprostol and those treated with misoprostol only.

Results: A total of 999 patients were included: 224 in the mifepristone-misoprostol group and 775 in the misoprostol-only group. The rate of treatment failure was significantly lower in the mifepristone-misoprostol group compared with the misoprostol-only group (17.8% vs 25.1%, P =.002). After multivariant analysis was performed, the use of mifepristone and misoprostol was associated with a reduction of 34% in the odds ratio for treatment failure compared with misoprostol alone (adjusted odds ratio 0.661, 95% CI, 0.44-0.97, P =.038). In addition, prior vaginal delivery was associated with a lower risk for treatment failure, and increasing gestational age (according to ultrasonogram) was correlated with a higher risk for treatment failure.

Conclusion: The addition of mifepristone to misoprostol was associated with a significantly lower rate of treatment failure, including late surgical intervention for early pregnancy loss, compared with misoprostol alone.

Objective: To investigate differences in health care utilization between immediate (within 10 minutes of placental delivery) and delayed (after 24 hours) intrauterine device (IUD) placement.

Methods: This retrospective cohort study was conducted with data from Kaiser Permanente Northern California from 2017 to 2019 and included patients with an IUD placed between 0 and 63 days postpartum. The primary outcome for health care utilization was the number of obstetrician-gynecologist (ob-gyn) or women's health office visits within 1 year. Secondary outcomes included formal imaging studies, surgical intervention, and hospitalizations related to IUD complications within 1 year. An additional secondary outcome was live births at 120 days and 1 year.

Results: Among 1,543 immediate and 10,332 delayed postpartum IUD placements, the number of visits to an ob-gyn or women's health office within 1 year was slightly increased with delayed placement (mean 2.30 vs 2.47, P <.001). Imaging was increased in the immediate compared with the delayed group (10.5% vs 4.1%, P <.001). Laparoscopy was decreased in the immediate compared with the delayed group (0.0% vs 0.4%, P =.005), with no significant difference in hysteroscopy (0.2% vs 0.1%, P =.413). Hospitalizations were rare and increased in the immediate group (0.4% vs 0.02%, P <.001). Lastly, there was no difference in repeat pregnancies between groups at 120 days (both 0.2%) or at 1 year (2.9% vs 2.5%, P =.342).

Conclusion: Compared with delayed placement, immediate postpartum IUD placement is not associated with increased office visits. Immediate placement is associated with an increase in imaging but a decrease in laparoscopic surgery to manage IUD-related complications. There was no difference in live birth rates at 6 months or 1 year between groups.

Objective: To investigate whether yoga and meditation added to usual care improves treatment response in women with interstitial cystitis-bladder pain syndrome.

Methods: This randomized trial compared women with interstitial cystitis-bladder pain syndrome receiving standard care alone (control group) with those receiving standard care plus meditation and yoga (mind-body group). Standard care was defined as behavioral changes or medications recommended by the American Urological Association. Individuals in the control group received standard care, and those in the mind-body group received standard care augmented with a commercially available meditation application and standardized yoga tutorial video. Both groups continued their current interstitial cystitis-bladder pain syndrome standard care treatments. The primary outcome was the modified GRA (Global Response Assessment), comparing responders (moderately, markedly improved) with nonresponders at 12 weeks. On power analysis assuming α=5% and β=80%, a sample size of 82 participants was required to find 30% difference on the GRA between groups. Weekly GRA scores over 12 weeks were also compared. Secondary outcomes included ICPI (Interstitial Cystitis Problem Index)/ICSI (Interstitial Cystitis Symptom Index), pain, pain interference, anxiety/depression, and self-efficacy scores and treatment escalation over 12 weeks.

Results: Among 97 randomized participants (49 mind-body group, 48 control group), groups did not differ in characteristics or symptoms at baseline. The mind-body group had more GRA responders compared with the control group at 12 weeks (31/43 [72.1%] vs 10/39 [25.6%], relative risk [RR] 2.8, 95% CI, 1.6-4.6), corroborated by superior weekly GRA results over 12 weeks. The mind-body group had superior beneficial change on the ICPI (RR 1.8, 95% CI, 0.5-3.1), ICSI (RR 1.9, 95% CI, 0.2-3.6), and pain (RR 1.4, 95% CI, 0.4-2.5) scores than the control group at 12 weeks. The mind-body group required less treatment escalation than the control group (2/45 [4.4%] vs 14/42 [33.3%], RR 0.13, 95% CI, 0.03-0.55).

Conclusion: The addition of meditation and yoga to standard interstitial cystitis-bladder pain syndrome care was associated with improved treatment response and required fewer additional interventions compared with standard care alone.

Clinical trial registration: ClinicalTrials.gov, NCT04820855.

Objective: To assess the content validity of the classification of maternal level of care of the American Hospital Association Database for research use.

Methods: This was a secondary data analysis where we classified the maternal level of care in the 2018 American Hospital Association Database and linked this to birth hospitalizations from five states in the 2016 and 2017 State Inpatient Databases: Delaware, Florida, Kentucky, Maryland, and Washington. We compared maternal level of care classification with birth volume quartiles, hospital size quartiles, and teaching status to predict the birth hospital for women with high OCI (Obstetric Comorbidity Index) scores and hospital-to-hospital transfers. We calculated the odds of birth at the highest-level hospital, controlling for maternal race, rural residence, primary payer, and state.

Results: People with high OCI scores and hospital-to-hospital transfer had increased odds of birth at hospitals classified as maternal level III or IV, large hospitals, and teaching hospitals. The probability of birth at the highest-level hospital for people with high OCI scores was increased 4.9% for a level III or IV hospital, 2.6% for a large hospital, and 1.2% for a teaching hospital. The probability of birth at the highest-level hospital for people with hospital transfer was increased 5.2% for a level III or IV hospital, 1.4% for a large hospital, and 14.4% for a teaching hospital.

Conclusion: Researchers can classify the maternal level of care using the American Hospital Association Database to study maternal risk-appropriate care.

The purpose of this review is to serve as an update on congenital cytomegalovirus (CMV) evaluation and management for obstetrician-gynecologists and to provide a framework for counseling birthing people at risk for or diagnosed with a primary CMV infection or reactivation or reinfection during pregnancy. A DNA virus, CMV is the most common congenital viral infection and the most common cause of nongenetic childhood hearing loss in the United States. The risk of congenital CMV infection from transplacental viral transfer depends on the gestational age at the time of maternal infection and whether the infection is primary or nonprimary. Although the risk of congenital CMV infection is lower with infection at earlier gestational ages, clinical sequelae are more severe with maternal infections earlier in gestation. At present, routine screening for maternal CMV infection is not recommended by U.S. guidelines. When maternal primary infection is confirmed in early pregnancy, emerging data support consideration of maternal antiviral therapy to prevent congenital CMV infection. When congenital CMV infection is confirmed, typically after an abnormal prenatal ultrasound result, there are more limited data on the utility of maternal antiviral therapy. Universal newborn screening for congenital CMV infection is not mandatory in most U.S. states at present. Newborns diagnosed with congenital CMV infection undergo an extensive evaluation to determine whether neurologic symptoms are present, which guides postnatal evaluation and management. In this review, we discuss the diagnosis and management of maternal CMV infection, the risk and diagnosis of congenital CMV infection, prevention and potential treatment of congenital CMV infection in utero, and neonatal congenital CMV infection diagnosis and management.