Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.

Objectives: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies.

Design: We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future CRN.

Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials.

Clinical trials to address the COVID-19 public health emergency have broadly excluded pregnant people from participation, illustrating a long-standing trend of clinical trial exclusion that has led to a clear knowledge gap and unmet need in the treatment and prevention of medical conditions experienced during pregnancy and of pregnancy-related conditions. Drugs (includes products such as drugs, biologics, biosimilars and vaccines) approved for a certain medical condition in adults are also approved for use in pregnant adults with the same medical condition, unless contraindicated for use in pregnancy. However, there are limited pregnancy-specific data on risks and benefits of drugs in pregnant people, despite their approval for all adults.

Accidental Flibanserin Ingestion in Children Causing Acute Respiratory and Central Nervous System Depression: What Health Care Professionals Need to Know.

This commentary serves to raise awareness for health care professionals about the potential risks of accidental ingestion of flibanserin tablets by children. Flibanserin was approved by the U.S.

EXOGENOUS Sex Hormones and Sex Hormone Receptor Modulators in COVID-19: Rationale and Clinical Pharmacology Considerations.

Male patients with coronavirus disease 2019 (COVID-19) fare much worse than female patients in COVID-19 severity and mortality according to data from several studies. Because of this sex disparity, researchers hypothesize that the use of exogenous sex hormone therapy and sex hormone receptor modulators might provide therapeutic potential for patients with COVID-19. Repurposing approved drugs or drug candidates at late-stage clinical development could expedite COVID-19 therapy development because their clinical formulation, routes of administration, dosing regimen, clinical pharmacology, and potential adverse events have already been established or characterized in humans.

Pentosan associated retinal pigmentary changes: FDA's perspective on an emerging postmarketing safety finding.

Introduction And Hypothesis: Recent publications describe pigmentary changes in the retina associated with the use of pentosan polysulfate sodium, the only FDA-approved oral agent for relief of bladder pain or discomfort associated with interstitial cystitis.

Methods: To evaluate this association, we reviewed data from the FDA Adverse Event Reporting System and published case reports and observational studies.

Results: The totality of clinical and epidemiology evidence does not resolve the question of causation between pentosan use and retinal pigmentary changes; however, several elements support a potential association.

Prescription medications for use in pregnancy-perspective from the US Food and Drug Administration.

Obstetrical healthcare providers frequently field questions about the safety of medications recommended or prescribed to their pregnant patients. Most women use as least 1 medication during pregnancy; however, there is little information about the safety or appropriate dosing of many medications during this phase of life. In addition, the development of drugs for use in pregnant women trails behind the development of drugs intended for other sectors of the population.

Launching the Reduction of Peripartum Racial/Ethnic Disparities Bundle: A Quality Improvement Project.

Introduction: Health care organizations have a responsibility to reduce racial and ethnic perinatal health disparities. In the United States, Black women experience the worst perinatal outcomes. The process for successfully addressing this problem in clinical practice remains unclear.

Evidence-based pregnancy testing in clinical trials: Recommendations from a multi-stakeholder development process.

Most clinical trials exclude pregnant women in order to avoid the possibility of adverse embryonic and/or fetal effects. Currently, there are no evidence-based guidelines regarding appropriate methods for identifying early pregnancy among research subjects. This lack of guidance results in wide variation in pregnancy testing plans, leading to the potential for inadequate protection against embryonic or fetal exposure in some cases and unnecessary burdens on research participants in others, as well as inefficiencies caused by disagreements among sponsors, investigators, and regulators.

Domperidone for Lactation: What Health Care Providers Need to Know.

This commentary serves to raise health care provider awareness about the regulatory status and available evidence regarding domperidone for insufficient lactation. Breastfeeding provides significant health benefits for mothers and infants, and insufficient milk production remains the most common reason for early weaning. Domperidone, a dopamine receptor antagonist that may increase milk production, is not approved for any human use in the United States.

Preconception counseling and care in the setting of HIV: clinical characteristics and comorbidities.

Objective: To describe the demographic and clinical characteristics of HIV-infected individuals and HIV-affected couples who were referred for preconception counseling (PCC) at a large urban US-based HIV clinic.

Methods: Electronic medical records were reviewed for HIV-infected individuals and HIV-affected couples. Medical, reproductive, surgical, psychosocial, and family history data were abstracted.

A randomized trial of chewing gum to prevent postoperative ileus after laparotomy for benign gynecologic surgery.

Objective: To assess whether chewing gum prevents postoperative ileus after laparotomy for benign gynecologic surgery.

Methods: A randomized study was conducted from December 1, 2010, to February 29, 2012. Patients scheduled to undergo laparotomy were randomly assigned to receive chewing gum or routine care after surgery.

Surgical site infections after hysterectomy among HIV-infected women in the HAART era: a single institution's experience from 1999-2012.

Objective: We sought to determine risk factors associated with surgical site infection (SSI) among a cohort of human immunodeficiency virus (HIV)-infected women undergoing hysterectomy during the era of highly active antiretroviral therapy.

Study Design: This is a retrospective study of HIV-infected women who underwent a hysterectomy for benign indications at a tertiary care center. Electronic medical records were reviewed from January 1999 through December 2012.

Retroperitoneal leiomyoma: a case report.

Background: Retroperitoneal leiomyomata are rare neoplasms. These masses can be asymptomatic or can cause pelvic discomfort, urinary frequency, abdominal fullness or back pain.

Case: A 28-year-old, nulliparous female presented with worsening dysmenorrhea and bulk symptoms from fibroids.

Update on trends for inpatient surgical management of tubal ectopic pregnancy in Maryland.

Objectives: In Maryland, an analysis from 1994-1999 found that most hospitalized patients with tubal pregnancy underwent extirpative operations. The objective of this study was to determine whether practice patterns had changed over time.

Methods: Using the Maryland Health Service Cost Review Commission (HSCRC) database from January 1, 2000-December 31, 2004, subjects were identified by ICD-9 code 633.

A national analysis of the relationship between hospital volume, academic center status, and surgical outcomes for abdominal hysterectomy done for leiomyoma.

Background: Volume-to-outcomes relationships have been established for high-risk surgical procedures. To determine whether hospital volume and academic center status affect surgical outcomes in a lower-risk procedure, morbidity and mortality in patients undergoing abdominal hysterectomy for leiomyoma were evaluated.

Study Design: Administrative data from the National Inpatient Sample were used to conduct a retrospective analysis of 172,344 individuals who had primary diagnoses of leiomyomata (ICD-9 diagnosis codes of 218.

Prevalence of genital prolapse in 3 ethnic groups.

Objective: To compare the prevalence of genital prolapse stratified by Asian American, black and white ethnic groups in women presenting for routine gynecologic examinations and to screen them for symptoms of pelvic floor problems.

Study Design: This was a descriptive study of women presenting for annual examinations. Demographic information on age, weight, gravidity, parity, weight of largest vaginally delivered infant, gynecologic surgery, medical problems (including hypertension, diabetes, pulmonary disease, smoking) and menopausal status were obtained from the patient and chart.

Extramammary Paget's disease of the axilla: an unusual case.

Extramammary Paget's disease is a rare lesion, often involving the skin of the genital or perianal regions. Less commonly, it has been reported to affect the skin of the axilla. There are very few other cases of extramammary Paget's disease reported in the literature, and the appropriate use of newer techniques such as magnetic resonance imaging and sentinel lymph node biopsy in this setting is not well-studied.

Randomized Pilot Study Comparing Rates of Endocervical Cell Recovery between Conventional Pap Smears and Liquid-Based Cytology in a Pregnant Population.

OBJECTIVE.: To determine whether liquid-based cytology improves Pap smear adequacy, as defined by the presence of endocervical cells, compared with conventional cytology during pregnancy. MATERIALS AND METHODS.

The accuracy of clinical evaluation of posterior vaginal wall defects.

We retrospectively reviewed 106 cases of defect-directed rectocele repair. Preoperative standardized evaluation of rectovaginal septum support was performed. Support defects were identified at surgery by visually identifying breaks in the rectovaginal fascia.