Obstetrics and gynecology最新文献

Despite efforts to address inequities, research on women's health conditions (defined as those that uniquely or differently affect women and female individuals) remain significantly understudied. As directed by Congress, the National Institutes of Health (NIH) Office of Research on Women's Health requested the National Academies of Sciences, Engineering, and Medicine (National Academies) to conduct an assessment of the state of women's health research at the NIH. The findings of the National Academies committee include: 1) a significant funding inequity, with less than 8% of the total NIH grant budget for fiscal year 2023 allocated to women's health research; 2) a need for improved strategic NIH-wide priority setting, oversight, and adherence to existing policies to support women's health research; 3) a need for a specific institute for research on conditions specific to women's health; and 4) a need for sufficient training and additional funding to grow and retain the women's health research workforce. The National Academies committee recommends restructuring women's health research at the NIH by creating a new Women's Health Research Institute and cross-disciplinary Women's Health Research Fund, including greater accountability and an infusion of new funds to support both research and career development in women's health. The combination of the new institute, greater prioritization and accountability, and new funding would lead to more rapid innovations and advancements, with the ultimate goal of improving women's health and well-being, which, in turn, improves the well-being of families and communities and bolsters a vibrant, healthier society.

Objective: To describe the presentation, outcomes, and management strategies for cases of subcapsular liver hematoma associated with preeclampsia, eclampsia, or HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome.

Methods: This was a case series of individuals with subcapsular liver hematoma managed at a single level IV center over a 10-year period, from 2013 to 2024. Presenting signs and symptoms, laboratory findings, time of onset, management strategies, acute perinatal and maternal outcomes, and long-term outcomes such as subsequent pregnancies were reviewed in the medical record and recorded. Data were summarized using descriptive statistics, with results reported as means, standard deviations, and ranges. Categorical variables were summarized as counts and percentages.

Results: There were 13 cases of subcapsular liver hematoma associated with preeclampsia, eclampsia, and HELLP syndrome between 2013 and 2024. In 10 of the 13 pregnancies (76.9%), delivery was preterm. The most common presenting symptoms were epigastric or right upper quadrant pain (53.8%), followed by abdominal distention (38.5%). Diagnosis of subcapsular liver hematoma was made in the antepartum period for six patients and was made in the postpartum for seven patients. The diagnosis was confirmed in all cases by computed tomography. Conservative management with close hemodynamic monitoring and transfusion of blood and blood products was sufficient in 11 (84.6%) patients; two patients underwent surgical exploration. The mean duration of hospital stay was 10 days (range 2-21 days). Maternal complications included pleural effusions, acute kidney injury, and pulmonary edema. There were no maternal deaths. There were four stillbirths and no neonatal deaths. Four people had five subsequent pregnancies; delivery was preterm in all five pregnancies, two pregnancies were complicated by subsequent HELLP syndrome, and one patient developed recurrent subcapsular liver hematoma.

Conclusion: Subcapsular liver hematoma is a rare complication of preeclampsia, eclampsia, and HELLP syndrome that is associated with substantial maternal and perinatal morbidities. Conservative management with hemodynamic monitoring and transfusion of blood and blood products was sufficient for management in the majority of cases. All subsequent pregnancies resulted in preterm births.

Objective: To examine the prevalence and severity of postcesarean residual niche, evaluated using saline infusion sonohysterography, in an expanded cohort of women with one prior cesarean delivery and to assess the effect of uterine closure technique on the risk of placenta accreta spectrum (PAS) disorders.

Methods: This secondary analysis includes 70 patients who underwent saline infusion sonohysterography after one prior cesarean delivery. Patients were grouped according to hysterotomy closure technique: two-layer endometrium-free closure (technique A), and two- or one-layer routine closures (technique B). Niche dimensions and residual myometrial thickness were measured. The primary outcome was clinically significant niche (depth larger than 2 mm), a risk factor for PAS. Groups were compared using χ2, unpaired t test, Kruskal-Wallis, and logistic regression with significance at P<.05.

Results: There were 33 patients in the technique A group and 37 patients in the technique B group. Technique A was associated with smaller niche dimensions (P=.018 for width, .005 for depth, and .002 for length), and exhibited thicker residual myometrial thickness (8.5 mm vs 5.5 mm, P=.041) and a lower incidence of clinically significant niches. The odds of having a clinically significant niche were 27 times higher in the technique B group (adjusted odds ratio 27.1, 95% CI, 4.35-168.81, P<.001).

Conclusion: Uterine closure techniques are associated with the development and size of postcesarean residual niches, which are critical risk factors for PAS disorders. Use of an endometrium-free closure technique during primary cesarean delivery is associated with a reduced risk of future niche formation and PAS complications.

Objective: To assess trends in risk for obstetric venous thromboembolism (VTE).

Methods: This retrospective cohort study analyzed data from the 2008-2019 Merative MarketScan Commercial Claims and Encounters and Medicaid Multi-State databases. Women aged 15-54 years with a delivery hospitalization and health care enrollment from 1 year before pregnancy to 60 days after delivery were identified. Risk for VTE during pregnancy from 2009 to 2019 was analyzed with joinpoint regression, with trends reported as the average annual percent change (APC). Venous thromboembolism events were identified with diagnosis codes along with pharmacy receipt of anticoagulants. Additionally, the association between risk factors for VTE and VTE events was evaluated with log-Poisson regression models with unadjusted and adjusted risk ratios (aRR) with 95% CIs as measures of association.

Results: Among 1,970,971 pregnancies, there were 5,270 VTE events, of which 35.5% (n=1,871) included a pulmonary embolism diagnosis and 64.5% (3,399) included a deep vein thrombosis diagnosis, alone. Risk for VTE increased significantly during pregnancy over the study period, with an APC of 9.2% (95% CI, 5.7-12.9%). Rates of VTE also increased individually during the antenatal period (APC 8.2%, 95% CI, 3.7-12.9%), during delivery hospitalizations (APC 12.2%, 95% CI, 7.4-17.3%), during the postpartum period (APC 8.4%, 95% CI, 5.9-11.0%), and individually for vaginal and cesarean delivery hospitalizations. Trends analyses individually for pulmonary embolism (APC 12.4%, 95% CI, 8.6-16.4%) and deep vein thrombosis (APC 7.6%, 95% CI, 4.0-11.3%) also demonstrated significant increases. In adjusted analyses for VTE, obesity (aRR 1.91, 95% CI, 1.78-2.05), chronic heart disease (aRR 3.14, 95% CI, 2.93-3.37), tobacco use (aRR 1.61, 95% CI, 1.34-1.95), asthma (aRR 1.46, 95% CI, 1.33-1.60), and preeclampsia (aRR 1.44, 95% CI, 1.31-1.58) were the factors associated the greatest increased adjusted relative risk.

Conclusion: Risk for obstetric VTE increased significantly over the study period. Risk increased during the antenatal, delivery, and postpartum periods and for both cesarean and vaginal delivery.

Objective: To describe preterm birth frequency and newborn and infant outcomes overall and among preterm children in the MATISSE (Maternal Immunization Study for Safety and Efficacy) trial of maternal vaccination with bivalent respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVpreF) to protect infants against severe RSV-associated illness.

Methods: MATISSE was a global, phase 3, randomized, double-blind trial. Pregnant individuals received single injections of RSVpreF or placebo. Adverse events of special interest, including preterm birth (gestational age less than 37 weeks) and low birth weight (2,500 g or less), were collected through 6 months after delivery (pregnant participants) and from birth through age 12 or 24 months (pediatric participants).

Results: Overall, 7,386 pregnant participants received RSVpreF (n=3,698) or placebo (n=3,688); 7,305 newborns and infants were included in the analysis. Most children in both groups were born full term (more than 93%) with normal birth weight (95% or higher). Newborn and infant outcomes, including rates of low birth weight and neonatal hospitalization, were favorable and comparable between groups. Preterm birth rates were 5.7% in the RSVpreF arm and 4.7% in the placebo arm (relative risk [RR] 1.20, 95% CI, 0.98-1.46); most were late preterm. Newborn and infant outcomes, including rates of low birth weight and neonatal hospitalization, were comparable between groups. Twenty-two newborn or infant deaths occurred during the study (RSVpreF n=8, placebo n=14). When stratified by income region, preterm birth rates in RSVpreF and placebo recipients were both 5.0% in high-income countries. Rates in non-high-income countries were 7.0% and 4.0% in the RSVpreF and placebo groups, respectively, and 8.3% and 4.0% in South Africa (RR 2.06, 95% CI, 1.21-3.51).

Conclusion: In this study of maternal RSVpreF vaccination, no clinically significant increase in adverse events of special interest, including preterm birth, low birth weight, or neonatal hospitalization, was observed among pregnant people in the overall analysis. In subgroup analysis of non-high-income countries, an elevated risk of preterm birth was observed. More research is needed to better ascertain preterm delivery risk factors, particularly aimed at minimizing disparities among geographic regions.

Funding source: This study was sponsored by Pfizer.

Clinical trial registration: ClinicalTrials.gov, NCT04424316.

Objective: To systematically assess the existing empiric evidence regarding a potential relationship between higher body weight and procedural abortion complications.

Data sources: EMBASE, MEDLINE, CINAHL, Web of Science, Google Scholar, and Clinicaltrials.gov were searched.

Methods of study selection: Our search identified 409 studies, which were uploaded to Covidence for review management; 133 duplicates were automatically removed. A team of two reviewers screened 276 studies, and a third reviewer resolved conflicts. Studies were included if they 1) consisted of peer-reviewed research published between 2010 and 2022, 2) were conducted in the United States, 3) included people with a higher body weight (body mass index [BMI] 30 or higher) in the study sample, and 4) assessed at least one outcome of procedural abortion safety stratified by a measure of body weight.

Tabulation, integration, and results: We extracted study data using Covidence and calculated an odds ratio for each study to facilitate the synthesis of results. Six studies assessing a total of 38,960 participants were included. No studies found a significant relationship between procedural abortion complications and higher body weight overall. Subgroup analysis from one study identified a significant increase in complications specifically among participants with BMIs higher than 40 who had second-trimester abortions. All studies used a retrospective cohort design and fulfilled Newcastle-Ottawa Scale criteria to be considered good quality. Studies varied in terms of clinical settings, patient populations, gestations assessed, clinician training levels, and care protocols.

Conclusion: Overall, higher body weight was not associated with an increased risk of procedural abortion complications in the included studies. The practice of referring patients undergoing procedural abortion with a higher body weight for hospital-based care is not based on recent safety evidence. On the contrary, this practice threatens the health of people with a higher body weight by potentially delaying their access to abortion care, extending their pregnancies into later gestations, and blocking their ability to access an abortion altogether.

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 evaluate the correlation in temporal trends in obesity and endometrioid endometrial cancer incidence in the United States using two comprehensive national databases.

Methods: This is a cohort study in which data on endometrioid endometrial cancer were obtained from the U.S. Cancer Statistics from 2001 to 2018 and corrected for hysterectomy and pregnancy. Data on obesity were collected from the NHANES (National Health and Nutrition Examination Survey) database from 1988 to 2018. Average annual percentage changes (AAPCs) were used to describe trends. Pearson correlation coefficients (r) were calculated to examine the relationship between trends. SEER*Stat 8.3.9.2 and joinpoint regression program 5.2.0 were used for statistical analysis.

Results: From U.S. Cancer Statistics data, 586,742 cases of endometrioid cancer were identified from 2001 to 2018. The average annual increase in endometrioid cancer was as follows: Hispanic 1.37% (95% CI, 1.14-1.60, P<.001), Black 1.30% (95% CI, 1.04-1.57, P<.001), and White -0.17 (95% CI, -0.91 to 0.58, P=.656). Women aged 20-29 years had a 4.48% annual increase (95% CI, 3.72-5.25, P<.001) and women aged 30-39 years had a 3.00% annual increase in rates (95% CI, 2.65-3.36, P<.001). According to the NHANES data, the prevalence of obesity in 2018 in adult women was as follows: Black 56.80%, Hispanic 44.10%, and White 40.90%. An examination of trends by age showed that women aged 20-29 years had the highest annual rise in obesity compared with other age groups (AAPC 7.36%, 95% CI, 4.0-10.8, P<.05). Strong and statistically significant correlations between endometrioid cancer and obesity trends were noted for Black (r=0.78, P=.01) and Hispanic (r=0.91, P<.001) women, as well as women aged 20-29 years (r=0.72, P=.03) and 30-39 years (r=0.88, P=.001).

Conclusion: The current data demonstrate a temporal association between the increasing incidence of obesity and endometrioid endometrial cancer, and this effect disproportionately affects younger women and Black and Hispanic women.

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.