Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location: The ACT or NOT Randomized Clinical Trial.

Importance: Women with an early nonviable pregnancy of unknown location are at high risk of ectopic pregnancy and its inherent morbidity and mortality. Successful and timely resolution of the gestation, while minimizing unscheduled interventions, are important priorities. Objective: To determine if active management is more effective in achieving pregnancy resolution than expectant management and whether the use of empirical methotrexate is noninferior to uterine evacuation followed by methotrexate if needed. Design, Setting, and Participants: This multicenter randomized clinical trial recruited 255 hemodynamically stable women with a diagnosed persisting pregnancy of unknown location between July 25, 2014, and June 4, 2019, in 12 medical centers in the United States (final follow up, August 19, 2019). Interventions: Eligible patients were randomized in a 1:1:1 ratio to expectant management (n = 86), active management with uterine evacuation followed by methotrexate if needed (n = 87), or active management with empirical methotrexate using a 2-dose protocol (n = 82). Main Outcomes and Measures: The primary outcome was successful resolution of the pregnancy without change from initial strategy. The primary hypothesis tested for superiority of the active groups combined vs expectant management, and a secondary hypothesis tested for noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed using a noninferiority margin of -12%. Results: Among 255 patients who were randomized (median age, 31 years; interquartile range, 27-36 years), 253 (99.2%) completed the trial. Ninety-nine patients (39%) declined their randomized allocation (26.7% declined expectant management, 48.3% declined uterine evacuation, and 41.5% declined empirical methotrexate) and crossed over to a different group. Compared with patients randomized to receive expectant management (n = 86), women randomized to receive active management (n = 169) were significantly more likely to experience successful pregnancy resolution without change in their initial management strategy (51.5% vs 36.0%; difference, 15.4% [95% CI, 2.8% to 28.1%]; rate ratio, 1.43 [95% CI, 1.04 to 1.96]). Among active management strategies, empirical methotrexate was noninferior to uterine evacuation followed by methotrexate if needed with regard to successful pregnancy resolution without change in management strategy (54.9% vs 48.3%; difference, 6.6% [1-sided 97.5% CI, -8.4% to ∞]). The most common adverse event was vaginal bleeding for all of the 3 management groups (44.2%-52.9%). Conclusions and Relevance: Among patients with a persisting pregnancy of unknown location, patients randomized to receive active management, compared with those randomized to receive expectant management, more frequently achieved successful pregnancy resolution without change from the initial management strategy. The substantial crossover between groups should be considered when interpreting the results. Trial Registration: ClinicalTrials.gov Identifier: NCT02152696.

Physician opinions regarding elective bilateral salpingectomy with hysterectomy and for sterilization.

STUDY OBJECTIVE: To gather opinions about the benefits and concerns of performing bilateral salpingectomy without oophorectomy during hysterectomy for benign indications and as a sterilization procedure. DESIGN: Survey study (Canadian Task Force classification III). SETTING: Practicing physicians in US institutions that have obstetrics and gynecology residency programs listed on the FREIDA website were surveyed electronically. INTERVENTION: A validated, standardized questionnaire designed to gather opinions about bilateral salpingectomy performed during hysterectomy or for sterilization was administered via SurveyMonkey to practitioners of obstetrics and gynecology. MEASUREMENTS AND MAIN RESULTS: Results were compiled and presented as percentages of total responders. A total of 234 surveys were returned. Fifty-four percent of physicians perform bilateral salpingectomy during hysterectomy, most commonly to reduce the risks of cancer (75%) and repeat operation (49.1%). Of the 45.5% of physicians who do not perform bilateral salpingectomy during hysterectomy, most (69.4%) believe there is no benefit. Fifty-eight percent of practitioners believe that bilateral salpingectomy is the most effective method of sterilization after age 35 years but choose this method only in patients in whom one sterilization procedure has failed or because of tubal disease. Only 7.2% of surgeons prefer it as an interval sterilization procedure. CONCLUSION: Most practitioners believe that bilateral salpingectomy is beneficial. Most also believe that bilateral salpingectomy is the most effective sterilization procedure; however, only 7.2% use this method as an interval procedure. More data are needed to evaluate the prophylactic effect of bilateral salpingectomy against postoperative sequelae.

A mixed-methods study of coping and depression in adolescent girls with polycystic ovary syndrome.

BACKGROUND AND PURPOSE: Polycystic ovary syndrome (PCOS) is a complex metabolic disorder associated with clinical manifestations that could be psychologically distressing to adolescent girls considering the concern of body image during the developmental stage of adolescence. Poor psychological functioning is related to increased mortality, higher health care costs, and negative health outcomes. Coping has been identified as impacting health and adaptation to illness; therefore, the purpose was to examine coping and depression in adolescent girls with PCOS. METHODS: Adolescent girls, aged 13-18 years and diagnosed with PCOS completed questionnaires regarding coping and depression and participated in interviews. A convergent, parallel, mixed-method design was used. CONCLUSIONS: Girls perceived very little control over the aspects of PCOS, with menstrual irregularities and the threat of infertility reported as the most stressful and least controllable aspects of PCOS. Lower control was a predictor of greater depression among the participants. IMPLICATIONS FOR PRACTICE: Providers should strive to establish rapport with adolescent girls and ask specifically about their concerns surrounding PCOS to provide meaningful health education. Providers should also be aware of the risk for depression among this population and should routinely screen patients and keep channels of communication open regarding the symptoms of depression.

Vaginitis: Beyond the Basics.

Vaginal complaints are one of the most common reasons women seek the advice of a health care provider. Uncomplicated infections such as vulvovaginal candidiasis, bacterial vaginosis, or trichomoniasis are easy to diagnose and treat. However, about 8% of patients will have a more complicated course with failure to respond to treatment or rapid recurrence of symptoms. Understanding the need for a methodical, diagnostic approach to help these women with recurrent or refractory cases of vaginal symptoms will aid the clinician achieve successful patient outcomes.

Six- and twelve-month documented removal rates among women electing postpartum inpatient compared to delayed or interval contraceptive implant insertions after Medicaid payment reform.

OBJECTIVE: This study aims to document 6- and 12-month removal rates for women receiving the contraceptive implant inpatient postpartum versus those receiving the same contraceptive method during an outpatient visit, in a setting where postpartum inpatient long-acting reversible contraceptive (LARC) services (devices plus provider insertion costs) are reimbursed by Medicaid. STUDY DESIGN: We conducted a retrospective cohort study among Medicaid-enrolled women using medical record review for all women receiving the etonogestrel implant between July 1, 2007 and June 30, 2014. We compared the percentage of women with the implant removed at 6 and 12 months as well as reasons for early removal, for inpatient postpartum implant insertions vs. delayed postpartum or interval outpatient implant insertions. RESULTS: A total of 4% of women (34/776 insertions) had documented implant removal within 6 months post-insertion, with no difference between postpartum inpatient and outpatient (delayed postpartum or interval). A total of 12% (62/518 insertions) of women had documented implant removal within 12 months. A lower percentage of women with postpartum inpatient insertions had the implant removed at 12 months post-insertion, compared to outpatient insertions (7% vs. 14%, p=.04). After controlling for age, parity, race and body mass index, women with postpartum inpatient insertions were less likely to have the implant removed within 12 months (OR=0.44, 95% CI 0.20-0.97). The most commonly stated reason for removal was abnormal uterine bleeding, regardless of insertion timing. CONCLUSION: In a setting with a Medicaid policy that covers postpartum inpatient LARC insertion, a low percentage of women who received an implant immediately postpartum had it removed within 1 year of insertion. IMPLICATIONS: A Medicaid payment policy that removes institutional barriers to offering postpartum inpatient contraceptive implants to women free-of-charge may facilitate meeting women's desires and intentions to delay subsequent pregnancy, as evidenced by low removal rates up to 12 months post-insertion. Further research with women is needed to assess how these services meet their postpartum contraceptive needs and desires to postpone or prevent subsequent pregnancy.

Posterior vaginal sling experience in elderly patients yields poor results.

OBJECTIVE: The objective of the study was to evaluate our experience with the posterior vaginal sling in an elderly population. STUDY DESIGN: Elderly patients with significant vaginal prolapse underwent a posterior vaginal sling using the IVS Tunneller device (Tyco Healthcare, United States Surgical, Norwalk, CT). Primary failure was defined as a postoperative pelvic organ prolapse quantitative point C (the apex of the vagina) within 2 cm of the preoperative value. Secondary failure was defined as any portion of the anterior or posterior vaginal walls protruding to or beyond the hymeneal ring (pelvic organ prolapse quantitative points Aa or Ap equal to or greater than 0). RESULTS: Twenty-one patients underwent the procedure; 19 were seen for follow up. The average age was 70 years (range 60-78). Twelve patients had primary or secondary failures (12 of 19, 63%). There were 5 primary failures (5 of 19, 26%) and 7 secondary failures (7 of 19, 37%). The mean time to failure was 7 weeks (range 1-18). CONCLUSION: In our elderly population, the posterior vaginal sling has a high failure rate, occurring early in the postoperative period.

Evaluation of a novel technique for wound closure using a barbed suture.

BACKGROUND: Suture knots present several disadvantages in wound closure, because they are tedious to tie and place ischemic demands on tissue. Bulky knots may be a nidus for infection, and they may extrude through skin weeks after surgery. Needle manipulations during knot-tying predispose the surgeon to glove perforation. A barbed suture was developed that is self-anchoring, requiring no knots or slack management for wound closure. The elimination of knot tying may have advantages over conventional wound closure methods. METHODS: This prospective, randomized, controlled trial was designed to show that the use of barbed suture in dermal closure of the Pfannenstiel incision during nonemergent cesarean delivery surgery produces scar cosmesis at 5 weeks that is no worse than that observed with conventional closure using 3-0 polydioxanone suture. Cosmesis was assessed by review of postoperative photographs by a blinded, independent plastic surgeon using the modified Hollander cosmesis score. Secondary endpoints included infection, dehiscence, pain, closure time, and other adverse events. RESULTS: The study enrolled 195 patients, of whom 188 were eligible for analysis. Cosmesis scores did not significantly differ between the barbed suture group and the control group. Rates of infection, dehiscence, and other adverse events did not significantly differ between the two groups. Closure time and pain scores were comparable between the groups. CONCLUSIONS: The barbed suture represents an innovative option for wound closure. With a cosmesis and safety profile that is similar to that of conventional suture technique, it avoids the drawbacks inherent to suture knots.

Perisurgical smoking cessation and reduction of postoperative complications.

OBJECTIVE: The purpose of this study was to determine if a perisurgical smoking cessation program reduces smoking-related postoperative complications in urogynecologic surgery. STUDY DESIGN: A review of patients that underwent pelvic reconstructive surgery from 1998 to 2003 was performed. All smokers underwent a perisurgical smoking cessation program of their choice for at least 1 month before surgery, and continued for 1 month after surgery. Complications unrelated to smoking (cystotomy, enterotomy, urethral obstruction, etc) were excluded in the smoking-potentiated complications. Problems considered to be potentiated by smoking were: wound, pulmonary, cardiac, and febrile morbidity. RESULTS: Eight hundred eighty-seven patients were included. There were 233 smoker cessation patients (SC) and 654 nonsmokers (NS). The total number of complications in the SC group was 61 (61/233, 26%) compared with 172 (172/654, 29%) in the NS group: (chi-square, P = .97). When looking at smoking-potentiated complications only, there were 34 (34/61, 56%) patients in the SC group and 90 (90/172, 52%) in the NS group (chi-square, P = .75). CONCLUSION: There are no differences in smoking-potentiated complications between nonsmoking patients and patients who undergo a perisurgical smoking cessation program.

Outcome of uterine embolization and hysterectomy for leiomyomas: results of a multicenter study.

OBJECTIVE: The purpose of this study was to estimate the outcomes of uterine embolization and hysterectomy for uterine leiomyomas. Study design This was a multicenter prospective study of patients who were treated with embolization (n=102 patients) and hysterectomy (n=50 patients) for leiomyomas. Changes in symptoms, complications, and quality of life were measured. The data analysis included linear and logistic regression, the Student t and paired t test, Fisher's exact test, and chi-squared test. RESULTS: For patients who underwent embolization, there were marked reductions in blood loss scores (P <.001) and menorrhagia questionnaire scores (P <.001) compared with baseline. At 12 months, a larger proportion of the patients who had undergone hysterectomy experienced improved pelvic pain (P=.021). Both groups had marked improvement in other symptoms and quality of life scores, with no difference between groups. Complications were more frequent in patients who underwent hysterectomy (50% vs 27.5%; P=.01). CONCLUSION: Both procedures substantially improved symptoms for most patients, with an advantage for hysterectomy at 12 months for pelvic pain. Serious complications were infrequent in both groups.