Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device.

OBJECTIVE: To assess the real-world effectiveness and safety of a U.S. Food and Drug Administration (FDA)-cleared intrauterine vacuum-induced-hemorrhage control device for postpartum hemorrhage (PPH) management. METHODS: Sixteen centers in the United States participated in this observational, postmarket registry medical record review (October 2020 through March 2022). The primary effectiveness outcome was treatment success , defined as bleeding control after insertion with no treatment escalation or bleeding recurrence. Additional outcomes included blood loss, time to device insertion, indwelling time, bleeding recurrence, and time to bleeding control. Treatment success and severe maternal morbidity measures (transfusion of 4 or more units of red blood cell, intensive care unit admission, and hysterectomy) were evaluated by blood loss before insertion. To assess safety, serious adverse events (SAEs) and adverse device effects were collected. All outcomes were summarized by mode of delivery; treatment success was summarized by bleeding cause (all causes, any atony, isolated atony, nonatony). RESULTS: In total, 800 individuals (530 vaginal births, 270 cesarean births) were treated with the device; 94.3% had uterine atony (alone or in combination with other causes). Median total blood loss at device insertion was 1,050 mL in vaginal births and 1,600 mL in cesarean births. Across all bleeding causes, the treatment success rate was 92.5% for vaginal births and was 83.7% for cesarean births (95.8% [n=307] and 88.2% [n=220], respectively, in isolated atony). Median indwelling time was 3.1 hours and 4.6 hours, respectively. In vaginal births, 14 SAEs were reported among 13 individuals (2.5%). In cesarean births, 22 SAEs were reported among 21 individuals (7.8%). Three (0.4%) SAEs were deemed possibly related to the device or procedure. No uterine perforations or deaths were reported. CONCLUSION: For both vaginal and cesarean births in real-world settings, rapid and effective bleeding control was achieved with an FDA-cleared intrauterine vacuum-induced hemorrhage-control device. The safety profile was consistent with that observed in the registrational trial (NCT02883673), and SAEs or adverse device effects were of the nature and severity expected in the setting of PPH. This device is an important new tool for managing a life-threatening condition, and timely utilization may help to improve obstetric hemorrhage outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04995887.

Occurrence of Chronic Pelvic Pain, Abnormal Uterine Bleeding, and Hysterectomy Post-procedure among Women Who Have Undergone Female Sterilization Procedures: A Retrospective Claims Analysis of Commercially Insured Women in the US.

STUDY OBJECTIVE: To evaluate the frequency of chronic pelvic pain (CPP), abnormal uterine bleeding (AUB), and hysterectomy after hysteroscopic sterilization (HS) or laparoscopic sterilization (LS) in the United States. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Commercially insured women. PATIENTS: Women (aged 18-49 years) with claims for HS or LS from January 1, 2010 to December 31, 2012 were identified from the MarketScan Commercial database. Women were required to have 6 months of continuous coverage before (baseline) and 24 months after (follow-up) the procedure date. Women with ≥1 diagnosis for a pain condition (pain in pelvis/lower abdomen, low back pain, chronic headache, fibromyalgia) and/or AUB (excessive/frequent menstruation, irregular menstrual cycle, metorrhagia) during baseline were identified with International Classification of Diseases, Ninth Revision, Clinical Modification codes. INTERVENTIONS: HS/LS. MEASUREMENTS AND MAIN RESULTS: Outcome measurements were proportions of women with CPP, AUB, and hysterectomy during follow-up. Among the study population 10 224 women underwent HS, whereas 8051 underwent LS. During baseline 23.3% and 26.9% of women with HS and LS, respectively, had a pre-existing pain diagnosis. Among both HS and LS study cohorts, greater proportions of women with a pre-existing pain condition versus those without had CPP in the 24 months afterward (HS cohort: 19.8% vs 9.3%, p < .001; LS cohort: 23.8% vs 11.4%, p < .001). During baseline 11.7% and 6.4% of women with HS and LS, respectively, had pre-existing AUB. Among cohorts, greater proportions of women with pre-existing AUB versus those without had AUB in the 24 months afterward (HS cohort: 21.2% vs 7.3%, p < .001; LS cohort: 15.9% vs 6.4%, p < .001). Among women who underwent HS and LS, pre-existing pain and AUB were associated with higher rates of hysterectomy postprocedure. Multivariable regression results showed similar direction of findings. CONCLUSION: Among women who underwent HS and LS, pre-existing pain conditions and AUB were associated with higher rates of CPP and AUB postprocedure, respectively, and both pre-existing conditions were associated with a greater frequency of subsequent hysterectomy.

Comparison of Healthcare Costs Among Commercially Insured Women in the United States Who Underwent Hysteroscopic Sterilization Versus Laparoscopic Bilateral Tubal Ligation Sterilization.

BACKGROUND: This study evaluated healthcare costs of index procedures and during a 6-month follow-up of women who had hysteroscopic sterilization (HS) versus laparoscopic bilateral tubal ligation (LBTL). MATERIALS AND METHODS: Women (18-49 years) with claims for HS and LBTL procedures were identified from the MarketScan commercial claims database (January 1, 2010, to December 31, 2012) and placed into separate cohorts. Demographics, characteristics, index procedure costs, and 6-month total healthcare costs and sterilization procedure-related costs were compared. Multivariable regression analyses were used to examine the impact of HS versus LBTL on costs. RESULTS: Among the study population, 12,031 had HS (mean age: 37.0 years) and 7286 had LBTL (mean age: 35.8 years). The majority (80.9%) who had HS underwent the procedure in a physician's office setting. Fewer women who had HS versus LBTL received the procedure in an inpatient setting (0.5% vs. 2.1%), an ambulatory surgical center setting (5.0% vs. 23.8%), or a hospital outpatient setting (13.4% vs. 71.9%). Mean total cost for the index sterilization procedure was lower for HS than for LBTL ($3964 vs. $5163, p < 0.0001). During the 6-month follow-up, total medical and prescription costs for all causes ($7093 vs. $7568, p < 0.0001) and sterilization procedure-related costs ($4971 vs. $5407, p < 0.0001) were lower for women who had HS versus LBTL. Multivariable regression results confirmed that costs were lower for women who had HS versus LBTL. CONCLUSIONS: Among commercially insured women in the United States, HS versus LBTL is associated with lower average costs for the index procedure and lower total healthcare and procedure-related costs during 6 months after the sterilization procedure.

Temporal trend in the use of hysteroscopic vs laparoscopic sterilization and the characteristics of commercially insured and Medicaid-insured females in the US who have had the procedures.

PURPOSE: Limited research has examined the factors associated with female permanent contraception procedures. This study evaluated the temporal trend in the use of hysteroscopic sterilization (HS) vs laparoscopic sterilization (LS) and characteristics of commercially insured and Medicaid-insured women in the US who have had the procedures. METHODS: Women aged 15-49 years with claims for HS and LS procedures were identified from two MarketScan databases, one consisting of commercial claims and the other Medicaid claims, during the time period of January 1, 2003 to December 31, 2012 and January 1, 2006 to December 31, 2011, respectively. Proportions and characteristics of women who underwent HS or LS procedures were determined. Multivariable logistic regressions were used to identify characteristics associated with the use of HS vs LS. RESULTS: Commercially insured women who had HS (n=32,012) vs LS (n=64,725) were slightly older (37.2 years vs 36.4 years, respectively, P<0.001) but had similar Charlson Comorbidity Index scores. Among commercially insured women, those who had a sterilization procedure during 2008-2012 were more likely to undergo HS (odds ratio: 7.1, P<0.001) than those who had a sterilization procedure during 2003-2007. Medicaid-insured women who had HS (n=2,001) were also slightly older than women who had LS (n=12,523; 30.1 years vs 28.8 years, respectively, P<0.001) but had a higher mean Charlson Comorbidity Index score (0.32 vs 0.25, respectively, P<0.001). Among Medicaid-insured women, the likelihood of having HS vs LS increased 3.3-fold (P<0.001) in years 2009-2011 compared to years 2006-2008. Among both populations, older age, obesity, and the use of oral contraceptives within the previous 12 months were associated with having HS vs LS. CONCLUSION: Among both commercially insured and Medicaid-insured women, the likelihood of having HS vs LS increased over time.

Brief report: attitudes toward hormone therapy after the Women's Health Initiative: a comparison of internists and gynecologists.

In the Women's Health Initiative (WHI), postmenopausal women receiving combination hormone therapy (HT) experienced more adverse outcomes than placebo recipients. To determine whether gynecologists and internists interpreted the WHI differently, we conducted a survey in which physicians responded to a hypothetical asymptomatic woman who asks whether to continue HT. In response to this scenario, gynecologists were more likely than internists to hold permissive views about prescribing HT (66% vs 35%; P<.001). These results suggest that gynecologists may be less concerned than internists about the adverse events associated with HT, or that gynecologists have stronger beliefs about benefits of HT.