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To describe rates of postpartum sterilization and indications for unfulfilled requests when Medicaid policy is not a limiting factor.We conducted a single-institution, retrospective review. Women who requested postpartum tubal ligation after vaginal delivery from August 2015 to March 2019 were studied. Select demographic characteristics were compared between those who did and did not undergo the procedure. Reasons for why the procedure was cancelled, alternate contraceptive plans, and subsequent pregnancies were collected. Statistical analysis included the t test and chi-squared test, with p0.05 considered significant.A total of 4103 patients requested postpartum tubal ligation following vaginal delivery. About 3670 (89.4%) procedures were performed and 433 (10.6%) were canceled. Of the 433, 423 (98%) were not performed at patient request; 10 (2 %) were cancelled based on physician recommendation. Of these, 3 were due to significant maternal anemia in the setting of refusal of blood products, 1 due to anesthesia concerns, 1 for increased body mass index, and 1 due to delivery events. Alternative contraception methods were offered; 72 (28% of patients not receiving a tubal ligation) received Depo Provera prior to discharge. One-fourth (n = 110, 25.4%) did not keep the postpartum follow-up appointment. 83 (19.2%) of the 433 patients had at least one subsequent pregnancy. Although over half expressed interest at the time of discharge in long-acting reversible contraceptives, only 20% obtained this method at the postpartum visit.Postpartum sterilization was predominantly achieved, among women whose requests were unfulfilled, the majority (98%) were at patient request with a minority by physician recommendation.When the availability of postpartum tubal ligation is independent of Medicaid reimbursement and the hospital system and providers are organized to support timely access to permanent postpartum contraception, the majority of tubal ligations requests can be fulfilled following vaginal delivery.

Pregnancy and childbirth are known risk factors associated with the development of pelvic organ prolapse; specific intrapartum risk factors are not well characterized.This study aimed to determine intrapartum factors associated with increased risk of pelvic organ prolapse identified after delivery.A planned secondary analysis of a multicenter randomized clinical trial of delayed vs immediate pushing among nulliparous women at ≥37 weeks of gestation in labor with neuraxial analgesia was conducted at 6 academic and community hospitals in the United States. Intrapartum characteristics were identified, and Pelvic Organ Prolapse Quantification assessments at 6 weeks and 6 months after delivery were performed. The primary outcome was pelvic organ prolapse, defined as stage 2 or greater prolapse using the Pelvic Organ Prolapse Quantification assessment at 6 months. Multivariable logistic regression was used to refine risk estimates while adjusting for randomization group, macrosomia, and maternal age.Among the 941 women participating in the pelvic floor follow-up, 793 women had Pelvic Organ Prolapse Quantification assessments at 6 weeks with 91 of 793 women (11.5%) demonstrating stage 2 or greater prolapse. Of the 728 women followed up at 6 months, stage 2 or greater prolapse was identified in 58 of 728 women (8.0%). Prostaglandin use for induction of labor was associated with an increased risk at 6 months (adjusted odds ratio, 2.15; 95% confidence interval, 1.18-3.91; P.01). The length and type (spontaneous vs induced) of the first stage of labor were not significantly associated with stage 2 or greater prolapse. Moreover, increased length of the second stage of labor and duration of pushing were not associated with stage 2 or greater prolapse. After adjusting for confounding factors, cesarean delivery was protective of pelvic organ prolapse at 6 months (adjusted odds ratio, 0.12; 95% confidence interval, 0.02-0.90).The management of the first and second stages of labor, including time length, was not associated with stage 2 or greater prolapse at 6 months. The findings that prostaglandin exposure was associated with increased risk likely were not directly affecting the risk of prolapse but may be surrogates for other labor features that deserve exploration. Cesarean delivery was associated with protection from stage 2 or greater pelvic organ prolapse at 6 months, consistent with previous literature.

OBJECTIVE To evaluate the association of increasing body mass index (BMI) on postpartum tubal ligation safety and estimate the rates of procedure complication. METHODS We conducted a single-institution, retrospective review. Women undergoing postpartum permanent contraception after vaginal delivery from August 2015 to March 2019 were studied. Our primary outcome included a composite morbidity of intraoperative complications (bleeding requiring additional surgery, and extension of incision), blood transfusion, aborted procedure, anesthetic complication, readmission, wound infection, venous thromboembolism, ileus or small bowel obstruction, incomplete transection, and subsequent pregnancy. Statistical analysis included t test, χ test, and Wilcoxon rank-sum test, with P

Beyond heterogeneous cancer cells, the tumor microenvironment includes stromal and immune cells, blood vessels, extracellular matrix and biologically active molecules. Abnormal signaling, uncontrolled proliferation and high interstitial pressure all contribute to a chaotic, non-hierarchical vascular organization. Using an immune competent 4T1 breast adenocarcinoma murine model, this study fully characterizes the architecture and immunocyte milieu of the tumor microenvironment. Heterogeneous vessel distribution, chaotic connectivity, limited perfusion, cancer cell density, immune phenotype, and biological responses to immune therapy are presented. Cancer cell density mirrored the distribution of large, perfusable vessels, both predominately in the tumor periphery. Intratumoral administration of the proinflammatory cytokine IL-12 led to an increase in CD45(+) leukocytes, with a specific increase in CD4(+) and CD8(+) T cells, and a decrease in the percentage of Gr-l(lo) myeloid-derived suppressor cells. Concomitantly, serum G-CSF and VEGF decreased, while CXCR9 and interferon gamma increased. The distribution pattern of infiltrating monocytes/macrophages, visualized using a fluorescent perfluorocarbon emulsion, indicated that macrophages predominately localize in the vicinity of large blood vessels. Electron microscopy supports the presence of dense tumor cell masses throughout the tumor, with the largest vessels present in the surrounding mammary fat pad. Overall, the large vessels in the 4T1 tumor periphery support high vascular perfusion and myeloid accumulation. The pro-inflammatory cytokine IL-12 stimulated a transition towards T helper 1 cytokines within the tumor and in serum, supporting suppression of tumor growth and angiostatic conditions.

Key Points Question What is the current state of US Food and Drug Administration labeling of medications in relation to pregnancy and lactation? Findings In this cross-sectional study of 290 newly approved medications from January 2010 to December 2019, all products submitted after June 20, 2015, were in compliance with the Pregnancy and Lactation Labeling Rule (PLLR); however, of those submitted between 2010 and 2015, 32.6% were not in PLLR format by the designated date of June 30, 2019. Human data on pregnancy and lactation were available in less than 20% of new product labeling. Meaning This study found that with the implementation of PLLR in the last decade, new therapeutic products are in compliance with the new rule; however, more than one-third of labels remain out of PLLR compliance., This cross-sectional study identifies the drugs that have adhered to the new US Food and Drug Administration Pregnancy and Lactation Labeling Rule, sheds light on the continued need for implementation of pregnancy, lactation, and reproduction into clinical studies, and evaluates how many new therapeutic products have human and animal data specific to pregnancy and lactation., Importance The US Food and Drug Administration (FDA) Pregnancy and Lactation Labeling Rule (PLLR), implemented in 2015, includes information on pregnancy, lactation, and women and men with reproductive potential. Objectives To identify the drugs that have adhered to the new PLLR format; to shed light on the continued need for implementation of pregnancy, lactation, and reproduction into clinical studies; and to evaluate how many new therapeutic products have human and animal data specific to pregnancy and lactation. Design, Setting, and Participants This cross-sectional study of 290 new therapeutic drugs reviewed labeling data for newly FDA-approved therapeutic products from January 2010 to December 2019. Therapeutic products submitted on or after June 30, 2015, were required to be in PLLR format; those approved from June 30, 2007, to June 29, 2015, had until June 30, 2019, to be in PLLR format. Approval data and subsequent labeling revision were evaluated for pregnancy and lactation data (human and animal), pregnancy registry, black-box warnings, and inclusion of PLLR labeling format. Exposures Date of new drug approval by FDA. Main Outcomes and Measures Compliance with PLLR; presence of animal or human data; presence of pregnancy registries; and presence of information regarding female and male reproductive potential. Results A total of 290 new molecular entities or therapeutic products were approved by the FDA between 2010 and 2019 in 19 categories. Black-box warnings occurred in 89 drugs (30.7%; 95% CI, 25.4%-36.3%), with 3 (3.4%; 95% CI, 0.7%-9.5%) involving pregnancy. All products submitted after June 30, 2015, were in PLLR format; however, of the 138 submitted between 2010 and that date, 45 (32.6%; 95% CI, 24.9%-41.1%) were not in PLLR format by June 30, 2019. During the 10 years of data analyzed, significantly more were in PLLR format (P for trend

The Task Force on Research Specific to Pregnant Women and Lactating Women was established by the 21st Century Cures Act and charged with providing advice and guidance to the Secretary of Health and Human Services on activities related to identifying and addressing gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women, including the development of, collaboration on, and coordination of such activities. The Task Force developed 15 recommendations based on information gleaned during four meetings and a public comment period. These recommendation include concrete actionable items to facilitate information and data for providers and the public.