ABSTRACT
STUDY OBJECTIVE: To describe safety, tolerability, and effectiveness results through a minimum 2-year follow-up of patients who underwent permanent sterilization with the Essure insert. DESIGN: A retrospective multicenter study (Canadian Task Force classification II2). SETTING: Seven general hospitals and 4 clinical teaching centers in Italy. PATIENTS: A total of 1968 women, mean age 39.5 years (range, 23-48 years) who underwent office hysteroscopic sterilization using the Essure insert between April 1, 2003, and December 30, 2014. INTERVENTION: The women underwent office hysteroscopic bilateral Essure insert placement, with satisfactory device location and tube occlusion based on hysterosalpingography or hysterosalpingo-contrast sonography (HyCoSy). MEASUREMENTS AND MAIN RESULTS: Placement rate, successful bilateral tubal occlusion, perioperative adverse events, early postoperative (during the first 3 months of follow-up), and late complications were evaluated. Satisfactory insertion was accomplished in 97.2% of women and, in 4, perforation and 1 expulsion were detected during hysterosalpingography. Three unintended pregnancies occurred before the 3-month confirmation test. Two pregnancies were reported among women relying on the Essure inserts. Postprocedure pain was minimal and brief; in 9 women, pelvic pain became intractable, necessitating removal of the devices via laparoscopy. On telephone interviews, overall satisfaction was rated as "very satisfied" by the majority of women (97.6%), and no long-term adverse events were reported. CONCLUSION: The findings from this extended Italian survey further support the effectiveness, tolerability, and satisfaction of Essure hysteroscopic sterilization when motivated women are selected and well informed of the potential risks of the device. Moreover, the results do not demonstrate an increased incidence of complications and pregnancies associated with long-term Essure use. Patients with a known hypersensitivity to nickel may be less suitable candidates for the Essure insert.
Subject(s)
Sterilization, Reproductive , Sterilization, Tubal/methods , Adult , Fallopian Tubes/diagnostic imaging , Female , Follow-Up Studies , Humans , Hypersensitivity , Hysterosalpingography , Hysteroscopy , Italy , Laparoscopy , Middle Aged , Nickel/adverse effects , Pain/etiology , Pregnancy , Pregnancy, Unplanned , Retrospective Studies , Sterilization, Reproductive/adverse effects , Sterilization, Reproductive/instrumentation , Sterilization, Reproductive/methods , Sterilization, Tubal/adverse effects , Surveys and Questionnaires , Young AdultABSTRACT
Accurate diagnosis of the onset of labor remains a problem in obstetrics. Criteria commonly used to diagnose labor have never been scientifically evaluated. This prospective study involved 423 pregnant women who presented themselves with uterine contractions to 2 Italian hospitals (248 nulliparous patients total and 175 multiparous total) and who were either admitted or advised to return home. The obstetrician on duty collected data using a standardized form that listed common criteria for labor diagnosis. Multivariate analysis showed that a reduction of the interval between consecutive uterine contractions, odds ratio [OR] = 1.42; 95% confidence interval [95%CI] 1.06-1.90); abdominal pain of increasing intensity (OR = 1.42; 95% CI 1.01-2.02); cervical effacement (OR = 1.4; 95%CI 1.12-1.77); and cervical dilation (OR = 1.91; 95% CI 1.53-2.38) were significant markers of the onset of labor. On the other hand, backache had a negative diagnostic value (OR = 0.78; 95% CI 0.61-0.99). The value of criteria such as regular uterine contractions, loss of mucous plug, changes in intestinal habits, vomiting, pain that is relieved by walking, and changes in breathing pattern did not reach statistical significance.
