Obstetrics & Gynecology最新文献

{"title":"Postpartum Insurance Discontinuity and Use of Prescription Contraceptive Methods [ID: 1377734]","authors":"Kimberly Schaefer, Michele Hacker, Summer Hawkins, Rose Molina","doi":"10.1097/01.aog.0000930628.59860.5d","DOIUrl":"https://doi.org/10.1097/01.aog.0000930628.59860.5d","url":null,"abstract":"INTRODUCTION: Medicaid eligibility income thresholds increase during pregnancy and historically ended 60 days postpartum. Thus, this postpartum period is especially vulnerable to insurance discontinuity, which may decrease access to contraception. METHODS: We used Pregnancy Risk Assessment Monitoring System survey data (2012–2020) in 42 states. Exposure, assessed 2 or more months after childbirth, was categorized as continuous insurance, insurance loss, discontinuous Medicaid-to-private, and discontinuous private-to-Medicaid. We used modified Poisson regression to estimate risk ratios (RRs) with 95% CIs for using contraception methods requiring prescriptions compared to nonprescription methods/none, adjusted for race and ethnicity, language, education, age, marital status, federal poverty level, and year. We then stratified by Medicaid expansion status at time of delivery. RESULTS: Of 246,088 respondents, 76.4% held continuous insurance from childbirth to 2 or more months postpartum, 11.9% lost insurance, 7.6% experienced discontinuity from Medicaid-to-private insurance, and 4.1% from private-to-Medicaid. Compared to continuous insurance, the adjusted RR for prescription postpartum contraception was 0.88 (CI 0.86–0.89) for loss of insurance, 0.99 (0.97–1.01) for discontinuous Medicaid-to-private, and 0.96 (0.93–0.98) for discontinuous private-to-Medicaid. Stratification by Medicaid expansion status yielded similar results. Of respondents in states or time periods without Medicaid expansion, 16.2% experienced insurance loss compared to 7.9% of those with Medicaid expansion. CONCLUSION: Insurance loss 2 or more months after childbirth was associated with decreased likelihood of prescription postpartum contraception, with a higher proportion of respondents without Medicaid expansion vulnerable to such insurance loss. Increased state adoption of the federal 12-month postpartum Medicaid extension option could improve access to prescription postpartum contraception.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135096143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse Pregnancy Outcomes of Cervical Cerclage According to the Indications [ID: 1363547]","authors":"Tetsuya Kawakita, Lea Nehme","doi":"10.1097/01.aog.0000931020.06793.51","DOIUrl":"https://doi.org/10.1097/01.aog.0000931020.06793.51","url":null,"abstract":"INTRODUCTION: The objective of this study was to examine pregnancy outcomes of patients who underwent cervical cerclage according to cerclage indications. METHODS: This was a retrospective cohort study of patients with a singleton pregnancy who underwent cervical cerclage from 2014 to 2020 at a single academic institution. Patients were categorized according to cervical cerclage indications (history-indicated, ultrasound-indicated [cervical length 1–2.4 cm versus less than 1 cm], and physical exam indicated cerclage). Our primary outcome was spontaneous preterm delivery before 37 weeks of gestation. Outcomes were compared according to cervical cerclage indications. Multivariable logistic regression models were used to calculate adjusted odds ratios (aORs) and 95% CI, adjusting for a history of preterm delivery. Our IRB approved this analysis. RESULTS: Of 501 patients, 240 (47.9%), 115 (23.0%), 50 (10.0%), and 96 (19.2%) had a history-indicated, ultrasound-indicated (1–2.4 cm), ultrasound-indicated (<1 cm), and physical exam-indicated cerclage, respectively. Rates of preterm delivery were statistically different according to the indications. Compared to history-indicated cerclage, physical exam-indicated cerclage was associated with spontaneous preterm delivery (adjusted odds ratio [aOR] 3.97, 95% CI 2.27–6.97), preterm delivery (aOR 3.48, 95% CI 2.23–5.96), spontaneous preterm delivery less than 34 weeks (aOR 5.60, 95% CI 2.92–10.74), and neonatal demise or stillbirth (aOR 3.18, 95% CI 1.35–7.50). Compared to history-indicated cerclage, ultrasound-indicated cerclage (1–2.4 cm) was associated with preterm delivery (aOR 1.70, 95% CI 1.07–2.72) and neonatal intensive care unit (NICU) admission (aOR 1.81, 95% CI 1.11–2.96). Compared to history-indicated cerclage, ultrasound-indicated cerclage (<1 cm) was associated with spontaneous preterm delivery less than 34 weeks (aOR 2.46, 95% CI 1.02–5.94) and NICU admission (aOR 2.51, 95% CI 1.23–3.36). CONCLUSION: Compared to history-indicated cerclage, other cerclage indications were associated with increased odds of adverse pregnancy outcomes.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135096165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Examination of Acupuncture and Acupressure as an Integrative Treatment for Preeclampsia With Severe Features [ID: 1354672]","authors":"Zena Kocher, Sandra Castro-Pearson, Laura Colicchia, Anna Schulte, David Watson, Whitney Wunderlich","doi":"10.1097/01.aog.0000930912.64390.c4","DOIUrl":"https://doi.org/10.1097/01.aog.0000930912.64390.c4","url":null,"abstract":"INTRODUCTION: This study assessed whether acupuncture (AQ) and acupressure (AP) in conjunction with routine care are associated with improved blood pressure control or obstetric outcomes in hospitalized preeclampsia patients. METHODS: This is a retrospective matched cohort study (2010–2020) of patients with preterm preeclampsia with severe features admitted for expectant management. Integrative medicine services including AQ or AP were offered to antepartum patients starting in 2010. Patients receiving AQ/AP were matched with controls who received only routine care. Matching criteria included gestational age on admission, maternal age, parity, multiple gestation, chronic hypertension, and other clinical features. Controls were eligible for matching if their pregnancy continued at least 12 hours after the matched case received their first AQ/AP treatment. RESULTS: Among 416 patients admitted for preeclampsia, 146 had AQ/AP treatment, of which 104 were matched to controls for a final sample of 208 patients. Mean gestational age at admission was 30.6 weeks. Mean latency period from admission to delivery was 9.6 days (±7.6) in the treatment group and 7.3 days (±7.5) in the control group ( P =.006). Changes in mean arterial pressure (MAP) from 12, 8, and 6 hours before and after the first treatment were not significantly different between the matched pairs. CONCLUSION: Among patients hospitalized for preeclampsia with severe features, AQ/AP treatment was associated with significant prolongation of the latency period from admission to delivery, but was not associated with changes in MAP over the 12–24 hours surrounding the first treatment.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135096230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of Gonadotropin-Releasing Hormone Agonist (GnRH-a) in Ovarian Preservation in Females With Systemic Lupus Erythematosus (SLE) Receiving Cyclophosphamide (CYC) [ID: 1375370]","authors":"Dania Abid, Jun Chu, Sarfaraz Hasni, Zerai Manna, Syed Ali Abbas Naqvi","doi":"10.1097/01.aog.0000929868.28817.78","DOIUrl":"https://doi.org/10.1097/01.aog.0000929868.28817.78","url":null,"abstract":"INTRODUCTION: Systemic lupus erythematosus (SLE) female patients with severe disease manifestations are treated with cyclophosphamide (CYC), which causes ovarian cytotoxicity. Gonadotropin-releasing hormone agonist (GnRH-a) is often co-administered with CYC to preserve ovarian function and reproductive potential. However, there is a lack of evidence to support this use of GnRH-a. We conducted a retrospective study and questionnaire of SLE patients who received CYC with or without GnRH-a to evaluate its efficacy in preserving ovarian function. METHODS: This study was approved by the IRB of the National Institutes of Health (IRB#:001011). Review of medical records resulted in 50 female SLE patients treated with CYC who were less than 40 year old at the time of treatment: CYC only (n=20, group 1), CYC and GnRH-a (n=30, group 2). These patients were age/gender-matched with 50 SLE patients not treated with CYC (group 3). Data about demographics, SLE disease activity, damage accrual, cumulative CYC exposure, and pregnancy outcomes were collected by chart review. Self-reported questionnaires were used to collect data assessing menses cycles, pregnancies and their outcome, or infertility. RESULTS: There was no significant difference in SLE disease activity, baseline demographics, total damage accrual, or other clinical parameters between groups 1 and 2. The mean cumulative CYC dose was 1.2 g (group 1) and 1.5 g (group 2) ( P =.16). Number of pregnancies were similar: mean (SD) group 1=2 (1.6); group 2=1.2 (1.4); group 3=1.3 (1.4) ( P =.18). There were more miscarriages in group 1 compared to groups 2 and 3 ( P =.015). CONCLUSION: Our data suggest use of GnRH-a improves pregnancy outcomes in SLE patients on CYC, but prospective studies are needed to establish its safety and efficacy.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135096232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Uterine and Ovarian Histopathology in Transmasculine and Nonbinary Patients on Testosterone Compared to Cisgender Control Patients [ID: 1381367]","authors":"Maris Toland, Jessica Bentz, K. Bonasia, E. Damiano, Regina M DelBaugh, K. Gerjevic","doi":"10.1097/01.AOG.0000929752.88321.bf","DOIUrl":"https://doi.org/10.1097/01.AOG.0000929752.88321.bf","url":null,"abstract":"INTRODUCTION: Hormonal treatment is a critical aspect of health care for transgender and nonbinary patients, but scientific literature describing ovarian and uterine histopathology in the setting of testosterone therapy remains limited and conflicted. METHODS: After IRB approval and patient consent, uterine and ovarian histopathology was prospectively evaluated in 22 gender-diverse patients on testosterone compared with 21 premenopausal cisgender controls not on hormones undergoing hysterectomy. RESULTS: Average duration of testosterone administration was 54.9 months. Average age was 30 years in the testosterone group and 40.6 years in the control group. Average body mass index was 28 kg/m2 in the testosterone group and 31 kg/m2 in the control group. 18 (82%) patients in the testosterone group had inactive/atrophic endometria, compared with 2 (10%) in the control group. 4 (18%) patients in the testosterone group had proliferative endometria, compared to 10 (48%) in the control group. No patients on testosterone had secretory endometrium, compared to 6 (29%) in the control group. Leiomyoma were noted for 5 (23%) in the testosterone group and 4 (19%) in the control group. Adenomyosis was present in 1 (5%) in the testosterone group, compared to 5 (24%) in the control group. Low rates of preoperative cervical dysplasia were reported in both groups. All cervical and fallopian tube specimens in both groups were benign. CONCLUSION: Compared to a cisgender control group, patients on long-term testosterone therapy were more likely to have inactive/atrophic endometrium. Increasing our knowledge of the effects of testosterone has implications for preoperative surgical assessment and surveillance for patients not undergoing surgery.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78497813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Operational Effects of Implementing Hybrid Prenatal Care Models: A Retrospective Analysis [ID: 1374984]","authors":"Leena Ghrayeb, T.J. Bryan, Amy E. M. Cohn, A. Peahl, Yuanbo Zhang","doi":"10.1097/01.aog.0000930940.91989.49","DOIUrl":"https://doi.org/10.1097/01.aog.0000930940.91989.49","url":null,"abstract":"INTRODUCTION: Telemedicine is promising for improving prenatal care access but may generate unscheduled prenatal care utilization including phone calls and portal messages. We describe differences in care utilization between pregnant people receiving in-person only versus hybrid (in-person and telemedicine) models of prenatal care. METHODS: In this IRB-exempt electronic health record-based study, we identified patients who received prenatal care and gave birth at our academic institution between March 1, 2021 and March 31, 2022. We classified patients into four groups based on medical and social risk factors: A) completely low risk; B) high social risk only; C) high medical risk only; and D) completely high risk. We compared visit number, portal messages, and phone calls between patients who received hybrid versus in-person only care. We report medians for all measures. RESULTS: Of the 4,992 included patients, 48% received hybrid care. Patients in all groups had one additional visit if they received hybrid versus in-person care (A: 9 versus 8; B: 8 versus 7; C: 9 versus 8; D: 9 versus 8). Patients receiving hybrid care used more portal messages than patients in the same group who received in-person care: A: 8 versus 6; B: 9 versus 5; C: 10 versus 9; D: 12 versus 8. There was no significant difference in phone call utilization between the in-person and hybrid patient groups. CONCLUSION: Patients who received hybrid prenatal care tended to utilize prenatal care including both planned and unplanned services more frequently than exclusively in-person patients.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74935190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study Participants' and Clinicians' Experiences With Placement of a Novel Low-Dose Copper Intrauterine Device With a Nitinol Frame in Nulliparous Versus Parous Participants [ID: 1374840]","authors":"D. Turok, M. Hou, Colleen P McNicholas, Anita Nelson, K. Peters, Andrea Roe","doi":"10.1097/01.aog.0000931256.30898.ff","DOIUrl":"https://doi.org/10.1097/01.aog.0000931256.30898.ff","url":null,"abstract":"INTRODUCTION: Clinicians may perceive intrauterine device (IUD) placement to be more challenging for nulliparous versus parous users. This study assesses nulliparous versus parous study participants' and clinicians' experiences with placement of a novel, low-dose copper (175 mm2) IUD with a flexible nitinol frame. METHODS: This single-arm, IRB-approved, phase 3 clinical trial recruited pregnancy-capable people aged 17–45 at 42 U.S. centers. We compared nulliparous and parous participants' experiences for first IUD placement attempt including successful placement, participant-reported pain (on an 11-point numeric pain rating scale), investigator-reported ease of IUD placement (on a 5-point Likert scale), need for mechanical cervical dilation, and uterine perforation. RESULTS: Of 1,620 participants enrolled, 973 (60.1%) reported nulliparity and 647 (39.9%) parity. Successful IUD placement occurred at first attempt for 929 (96.0%) nulliparous versus 625 (96.6%) parous participants. Including second attempts, successful placement occurred for 1,601 (98.8%) participants. Nulliparous participants reported a mean pain score of 5.6 (±2.19) versus 4.0 (±2.55) for parous participants (P<.001), and investigators more frequently reported hard or very hard IUD placement in 81 (8.4%) nulliparous versus 22 (3.4%) parous participants (P<.001). Among nulliparous participants, 203 (21.2%) reported pain-related adverse events associated with placement versus 65 (10.1%) in parous participants (P<.001). Mechanical dilation was required for 202 (20.8%) nulliparous versus 79 (12.2%) parous participants (P<.001). Uterine perforation occurred in 1 nulliparous (0.10%) and 1 parous participant (0.15%). CONCLUSION: Despite experiencing more challenging IUD placements than parous participants, nulliparous trial participants experienced similar IUD placement success with this novel, low-dose copper IUD.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76085109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing Interest in Peer Doula-Facilitated Empathy and Self-Compassion Training Among Women With History of Early Pregnancy Loss (AIDES for EPL) [ID: 1344944]","authors":"Carmen Conroy, T. Jain, S. Mody","doi":"10.1097/01.AOG.0000931072.82355.2a","DOIUrl":"https://doi.org/10.1097/01.AOG.0000931072.82355.2a","url":null,"abstract":"INTRODUCTION: Limited data exist regarding the type of support patients need when experiencing early pregnancy loss (EPL). The objective of this study is to explore how patients emotionally cope with EPL and to assess whether there is interest in a peer EPL doula program with a self-compassion component. METHODS: We conducted semistructured interviews with 21 patients who had experienced EPL in the past 2 years. We evaluated the kinds of support that patients felt were most helpful, interest in a possible peer EPL doula intervention, and concerns or suggestions for the creation of such a program. Content analysis was utilized to process the data and identify themes. RESULTS: 52.38% (n=11) of interviewees reported expectant management of their EPL, 23.81% (n=5) reported medication management, and 23.81% (n=5) reported undergoing a dilation-and-curettage procedure. Participants represented various races and ethnicities, income brackets, and insurance statuses. We identified five themes: 1) therapy and in-person support groups are helpful when experiencing EPL, but are sometimes inaccessible; 2) social media support groups are initially advantageous for creating a sense of solidarity, but in the long term can be triggering; 3) support from a peer who has also experienced EPL is valuable; 4) developing self-compassion is important in emotionally coping with EPL; and 5) there is a demand for emotional and informational support after EPL. CONCLUSION: Given the unique types of support participants identified in this study, a peer EPL doula could feasibly provide the emotional and informational support patients desire when experiencing an EPL.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76117758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Prospective Study to Assess for Histologic Changes on Vulvar Biopsies in Postmenopausal Women With Lichen Sclerosus Treated With Fractionated CO2 Laser Therapy [ID: 1339895]","authors":"Jennifer Lee, Michael Cardis, Alexis Dieter, Maria J Etcheverry, Melissa Gonzales, Cheryl Iglesia","doi":"10.1097/01.aog.0000929996.57520.86","DOIUrl":"https://doi.org/10.1097/01.aog.0000929996.57520.86","url":null,"abstract":"INTRODUCTION: Lichen sclerosus (LS) is a chronic skin condition affecting men and women of all ages. Fractionated carbon dioxide (FxCO2) laser therapy has been proposed as a novel treatment modality. Our objective was to investigate histologic changes after FxCO2 laser therapy for vulvar LS and assess symptomatic improvement using the Skindex-16 questionnaire. METHODS: This prospective single-arm study was conducted from April 2021 to August 2022 at one academic medical center. Ten English-speaking postmenopausal women with biopsy-proven LS undergoing FxCO2 laser treatment were enrolled. Exclusion criteria included prior transvaginal mesh for prolapse, recent topical corticosteroid use, prior pelvic radiation, malignancy, active genital infection, or pregnancy. Institutional review board approval and written consent from participants were obtained. The vulvovaginal SmartXide2-V2-LR laser system FxCO2 laser (DEKA, Calenzano, Italy) was used to treat visually affected areas of vulvar and perianal LS with a single pass over three treatments spaced 4–6 weeks apart. Participants completed the Skindex-16 questionnaire and underwent vulvar biopsy at baseline and 4 weeks after the third FxCO2 laser therapy. Histologic slides were blinded and then scored by a dermatopathologist (MC) on a 5-point scale to assess sclerosus, inflammation, and epidermal atrophy. RESULTS: Participants had a mean age of 61 and were mostly White, privately insured with college/graduate-level education. Posttreatment vulvar biopsies showed significant improvement in sclerosus and epidermal atrophy (P<.05) with no statistically significant change in inflammation or Skindex-16 scores after FxCO2 laser treatment. A statistically significant correlation was found between sclerosus and Skindex-16 symptoms score (mean change of 21.4 units in Skindex-16 symptoms score for 1 unit change in histologic sclerosus score, P=.03). CONCLUSION: In postmenopausal women with vulvar LS undergoing FxCO2 laser therapy, symptomatic improvements are correlated with histologic changes in sclerosus on vulvar biopsy. FxCO2 laser therapy is a promising option for treatment of LS, and further studies are needed to assess safety and efficacy.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72694839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bleeding Patterns With Relugolix Combination Therapy in Women With Endometriosis-Associated Pain [ID: 1345374]","authors":"S. As-Sanie, L. Giudice, S. J. Imm, N. Johnson, C. Mehedințu, J. Perry","doi":"10.1097/01.aog.0000929844.43483.20","DOIUrl":"https://doi.org/10.1097/01.aog.0000929844.43483.20","url":null,"abstract":"INTRODUCTION: Relugolix combination therapy (Relugolix-CT: relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) significantly improved endometriosis-associated pain versus placebo in the SPIRIT 1&2 studies. Efficacy was maintained over 104 weeks in the long-term extension (LTE) study. Bleeding patterns in women treated up to 104 weeks with Relugolix-CT are reported. METHODS: SPIRIT 1&2 were IRB-approved phase 3, 24-week, randomized studies of Relugolix-CT, delayed Relugolix-CT (relugolix 40 mg monotherapy followed by Relugolix-CT; 12 weeks each), or placebo in premenopausal women (age 18–50 years) with moderate-to-severe endometriosis-associated pain. Eligible women completing SPIRIT 1&2 could enroll in the open-label LTE with once-daily Relugolix-CT. Bleeding days per cycle and bleeding patterns were recorded on eDiaries. Amenorrhea was defined as no bleeding over 28 consecutive days. RESULTS: Of 1,261 women originally randomized, 501 completed week 104. Baseline demographics and characteristics were balanced across treatment groups. The proportion of women achieving amenorrhea increased over time: 74.4% (95% CI 68.8–79.4) at week 24, and 82.3% (95% CI 74.6–88.4) at week 104. The average number of bleeding days per cycle (standard deviation) decreased over time from 5.8 (2.4) at baseline to 1.2 (3.3) at week 104. The number of heavy or extremely heavy bleeding days decreased from 1.9 at baseline to 0.0 at week 104. CONCLUSION: Treatment with Relugolix-CT in women with endometriosis-associated pain resulted in high rates of amenorrhea and complete elimination of heavy bleeding, thus demonstrating sustained benefit through 2 years. Findings may support patient counseling.","PeriodicalId":19405,"journal":{"name":"Obstetrics & Gynecology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74845033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}