One-Year Follow-Up Results of a Multicenter, Single-Arm, Objective Performance Criteria-Controlled International Clinical Study of the Safety and Efficacy of the Minerva Endometrial Ablation System.

STUDY OBJECTIVE: To assess the safety and effectiveness of the Minerva endometrial ablation system for treating excessive uterine bleeding in premenopausal women. DESIGN: Multicenter, single-arm, objective performance criteria (OPC)-controlled international study (Canadian Task Force classification II-1). SETTING: Seven academic medical centers. PATIENTS: 105 premenopausal women symptomatic for menorrhagia secondary to dysfunctional uterine bleeding. INTERVENTION: Patients were treated using the Minerva endometrial ablation system. MEASUREMENTS AND MAIN RESULTS: Study success, based on a pictorial blood loss assessment chart (PBLAC) score ≤75, was observed in 96.2% of the patients at 1 year posttreatment. Some 69.5% of the patients experienced amenorrhea (PBLAC score 0). The mean duration of the procedure was 3.9 minutes. General anesthesia was used in 9% of cases, with the balance being performed under local and/or intravenous or spinal anesthesia regimens. No intraoperative adverse events and/or complications were reported. No patient required hysterectomy or any additional medical and/or surgical interventions to control bleeding during 1 year of follow-up. Efficacy (success) results were compared between the Minerva system and the OPC, which served as a statistical control. The OPC comprised the US Food and Drug Administration's (FDA) reported success rates of all FDA-approved endometrial ablation systems. The Minerva system had a statistically significantly superior success rate compared with the OPC control. CONCLUSION: The Minerva system was found to be safe and effective for treating patients suffering from menorrhagia. The procedure is quick and effective, does not require endometrial pretreatment, and precludes the need for additional surgical interventions to manage menorrhagia.

The role of uterine closure in the risk of uterine rupture.

OBJECTIVE: To evaluate the effects of prior single-layer compared with double-layer closure on the risk of uterine rupture. METHODS: A multicenter, case-control study was performed on women with a single, prior, low-transverse cesarean who experienced complete uterine rupture during a trial of labor. For each case, three women who underwent a trial of labor without uterine rupture after a prior low-transverse cesarean delivery were selected as control participants. Risk factors such as prior uterine closure, suture material, diabetes, prior vaginal delivery, labor induction, cervical ripening, birth weight, prostaglandin use, maternal age, gestational age, and interdelivery interval were compared between groups. Conditional logistic regression analyses were conducted. RESULTS: Ninety-six cases of uterine rupture, including 28 with adverse neonatal outcome, and 288 control participants were assessed. The rate of single-layer closure was 36% (35 of 96) in the case group and 20% (58 of 288) in the control group (P<.01). In multivariable analysis, single-layer closure (odds ratio [OR] 2.69; 95% confidence interval [CI] 1.37-5.28) and birth weight greater than 3,500 g (OR 2.03; 95% CI 1.21-3.38) were linked with increased rates of uterine rupture, whereas prior vaginal birth was a protective factor (OR 0.47; 95% CI 0.24-0.93). Single-layer closure was also related to uterine rupture associated with adverse neonatal outcome (OR 2.89; 95% CI 1.01-8.27). CONCLUSION: Prior single-layer closure carries more than twice the risk of uterine rupture compared with double-layer closure. Single-layer closure should be avoided in women who could contemplate future vaginal birth after cesarean delivery. LEVEL OF EVIDENCE: II.

Obstetrician or family physician: are vaginal deliveries managed differently?

BACKGROUND: In Canada, obstetricians and family physicians both provide obstetrical care. However, the effect of specialty training on obstetrical outcomes of low-risk pregnancies has not recently been evaluated. In this study we examine the role of specialty training on the management of vaginal deliveries. METHODS: We conducted a cohort study on all vaginal deliveries that took place at Sacré-Coeur Hospital between July 2000 and June 2006. We compared baseline characteristics of obstetricians and family physicians and used an unconditional logistic regression model to estimate the adjusted relative risk of undergoing different obstetrical interventions. RESULTS: Of a total 8807 vaginal deliveries, 1915 were conducted by eight obstetricians and 6892 were conducted by 21 family physicians. Apart from a higher rate of induction of labour in patients of obstetricians, baseline characteristics were comparable between the two groups. Overall rates of use of instruments were similar in the two groups; however, family physicians were less likely than obstetricians to perform an episiotomy (odds ratio [OR] 0.47; 95% confidence intervals [CI] 0.41-0.55) but more likely to have patients who sustained a perineal injury (OR 1.51; 95% CI 1.36-1.68). There were no differences in the incidence of third- and fourth-degree tears, and 5-minute Apgar scores were similar in both groups. CONCLUSION: Obstetricians and family physicians differ in the performance of episiotomies, and their patients differ in the resulting type of perineal injury. Instrument use and neonatal outcomes were similar in both groups. Major maternal and neonatal morbidity are unlikely to differ whether women with low-risk pregnancies are delivered by an obstetrician or a family physician.

Use of the NovaSure Impedance Controlled Endometrial Ablation System in patients with intracavitary disease: 12-month follow-up results of a prospective, single-arm clinical study.

STUDY OBJECTIVE: To assess the safety and effectiveness of the NovaSure Impedance Controlled Endometrial Ablation System for the treatment of excessive uterine bleeding in premenopausal and postmenopausal women with intracavitary disease (polyps or myomas) up to 3 cm. DESIGN: Prospective, single-arm study. (Canadian Task Force Classification II-2.) SETTING: Academic medical center. PATIENTS: This clinical study was conducted in 65 women with menometrorrhagia with confirmed (type I and II) submucous myomas up to 3 cm with and without polyps. INTERVENTION: Patients were treated with the NovaSure System and received no hormonal or mechanical pretreatment to thin the endometrial lining or as a uterine pathologic condition shrinking agent. MEASUREMENTS AND MAIN RESULTS: All patients were diagnosed with intracavitary disease during office hysteroscopy. Patients completed menstrual questionnaires at the initial screening and at 1 year after treatment. Twelve-month results demonstrated that the NovaSure System was effective in reducing excessive uterine blood loss. Success (defined as reduction to normal bleeding) was observed in 95% (95% CI: 86%-99%) of patients, with 69% (95% CI: 56%-80%) reporting amenorrhea at 1 year after treatment. The median treatment time (time of energy delivery) was 78 seconds (range 61-120 seconds). All patients underwent the procedure under local or intravenous sedation. No intraoperative or postoperative adverse events were reported. There was a significant decrease in premenstrual symptoms and dysmenorrhea at 12 months after the procedure. Ninety-five percent (95% CI: 86%-99%) of patients were satisfied with the procedure. CONCLUSION: Clinical results of this study demonstrate that the NovaSure System is safe and effective in treatment of patients with menometrorrhagia caused by intracavitary disease up to 3 cm.

The effect of computer-assisted evaluation of labor on cesarean rates.

Dystocia, or slow labor, is the leading cause of first-time cesarean sections. Current diagnostic guidelines for dystocia are vague, and there is no clear postoperative confirmatory evidence to assess the correctness of this diagnosis. For several decades, various professional organizations have indicated that cesarean rates could be lowered safely and have recommended levels that are far below national averages. The three major factors, of roughly equal importance, associated with cesarean for slow labor are the baby's weight, the mother's height, and the threshold at which the physician believes it is reasonable to intervene. The last is the only modifiable factor, and quality programs are a major part of changing medical behavior. By using two study designs, the effect of a mathematical method for evaluating labor progress on the rate of cesarean section was measured. In the prospective randomized clinical trial, the relative risk of cesarean in the experimental group was unchanged at 1.04. In the pretest-posttest analysis, the rates fell from 19.54% to 17.04% at 6 months and 16.62% at 12 months.