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Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation.

ABSTRACT: Tubal ligation remains common in the USA, especially among low-income patients. To compare the effectiveness and safety of intrauterine contraceptives (IUC) to laparoscopic tubal ligation for Medicaid clients. We partnered with patient and clinician stakeholders to conduct a retrospective cohort study using California Medicaid claims for patients who had an IUC placed or laparoscopic tubal ligation performed in 2008-2014, excluding procedures performed within 42 days of a birth. We applied log-linear (Poisson) event-history regression models for clustered person-period data to adjust for sociodemographic variables and pre-procedure health status when examining associations between these contraceptive procedures and claims related to contraceptive failure, complications, and pain in the first year post-procedure. We identified 35,705 patients who had a levonorgestrel IUC placed, 23,628 patients who had a copper IUC placed, and 23,965 patients who underwent laparoscopic tubal ligation. In unadjusted analyses, rates of pregnancy within 1 year were similar following levonorgestrel IUC (2.40%) or copper IUC placement (2.99%) or tubal ligation (2.64%). In adjusted analyses, compared to tubal ligation, pregnancy was less common following placement of a levonorgestrel IUC (adj IRR 0.72, 95% CI 0.64-0.82) and similar with placement of a copper IUC (adj IRR 0.92, 95% CI 0.82-1.05). Procedural complications such as infection (0.35% vs. 2.91%) were significantly less common with IUC placement than tubal ligation. Claims for pelvic and abdominal pain decreased in frequency with time since all procedures; 6 to 12 months post-procedure, pelvic pain claims were less common after levonorgestrel IUC (adj IRR 0.69, 95% CI 0.65-0.73) or copper IUC placement (adj IRR 0.70, 95% CI 0.66-0.75) than tubal ligation. IUC appears at least as effective as laparoscopic tubal ligation at 1-year post-procedure with lower rates of infection and pelvic pain 6 to 12 months post-procedure. NCT03438682.

SUBMITTER: Schwarz EB

PROVIDER: S-EPMC8863411 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesTo determine if women with tubal patency experience more fluid loss compared to those with bilateral tubal occlusion following intrauterine instillation of fluid via a balloon catheter.Study designIn this prospective cohort pilot study, we enrolled women with prior Essure® procedures and healthy controls from September 2016 to July 2017. We excluded women using an implant or intrauterine device, or with a prior cesarean delivery or permanent contraception procedures other than Essure®. An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, we withdrew the fluid and recorded volumes in and out. Subjects then underwent hysterosalpingogram for evaluation of tubal patency. We conducted crude analyses with t-tests and sensitivity analyses.ResultsWe recruited 23 participants; ten provided analyzable data in each group. Hysterosalpingogram confirmed patency in all control and occlusion in all post-Essure® subjects in the analysis group. We found the median volume of saline lost among control subjects [7.8?mL (7.4, 8.4)] larger than post-Essure® participants [2.2?mL (2.0, 3.8), p?<?0.01]. While 50% of control subjects tolerated the full 10?mL of fluid instillation, none of the post-Essure® subjects tolerated this volume (p?=?0.03). A combination of saline loss ?4?mL and participant intolerance of the full 10?mL volume yielded sensitivity of 0.80 (95% CI: 0.57, 1.00) and specificity of 1.00 for bilateral tubal occlusion.ConclusionInstillation of a fixed volume into the uterus may discriminate between women with tubal patency and occlusion following permanent contraception procedures with high specificity and adequate sensitivity. These findings should be validated in larger, more diverse study populations.ImplicationsConfirmation of tubal occlusion following permanent contraception with an office-based approach could improve acceptability of transcervical approaches. The recent removal of Essure® from the U.S. market increases the need for novel transcervical procedures and occlusion verification methods.

Project description:ObjectivesThere have been conflicting reports of altered vaginal microbiota and infection susceptibility associated with contraception use. The objectives of this study were to determine if intrauterine contraception altered the vaginal microbiota and to compare the effects of a copper intrauterine device (Cu-IUD) and a levonorgestrel intrauterine system (LNG-IUS) on the vaginal microbiota.Study designDNA was isolated from the vaginal swab samples of 76 women using Cu-IUD (n=36) or LNG-IUS (n=40) collected prior to insertion of intrauterine contraception (baseline) and at 6 months. A third swab from approximately 12 months following insertion was available for 69 (Cu-IUD, n=33; LNG-IUS, n=36) of these women. The V4 region of the bacterial 16S rRNA-encoding gene was amplified from the vaginal swab DNA and sequenced. The 16S rRNA gene sequences were processed and analyzed using the software package mothur to compare the structure and dynamics of the vaginal bacterial communities.ResultsThe vaginal microbiota from individuals in this study clustered into 3 major vaginal bacterial community types: one dominated by Lactobacillus iners, one dominated by Lactobacillus crispatus and one community type that was not dominated by a single Lactobacillus species. Changes in the vaginal bacterial community composition were not associated with the use of Cu-IUD or LNG-IUS. Additionally, we did not observe a clear difference in vaginal microbiota stability with Cu-IUD versus LNG-IUS use.ConclusionsAlthough the vaginal microbiota can be highly dynamic, alterations in the community associated with the use of intrauterine contraception (Cu-IUD or LNG-IUS) were not detected over 12 months.ImplicationsWe found no evidence that intrauterine contraception (Cu-IUD or LNG-IUS) altered the vaginal microbiota composition. Therefore, the use of intrauterine contraception is unlikely to shift the composition of the vaginal microbiota such that infection susceptibility is altered.

Project description:BackgroundIn the United States, more intrauterine device (IUD) users select levonorgestrel IUDs than copper IUDs for long-term contraception. Currently, clinicians offer only copper IUDs for emergency contraception because data are lacking on the efficacy of the levonorgestrel IUD for this purpose.MethodsThis randomized noninferiority trial, in which participants were unaware of the group assignments, was conducted at six clinics in Utah and included women who sought emergency contraception after at least one episode of unprotected intercourse within 5 days before presentation and agreed to placement of an IUD. We randomly assigned participants in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD. The primary outcome was a positive urine pregnancy test 1 month after IUD insertion. When a 1-month urine pregnancy test was unavailable, we used survey and health record data to determine pregnancy status. The prespecified noninferiority margin was 2.5 percentage points.ResultsAmong the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group; the between-group absolute difference in both analyses was 0.3 percentage points (95% CI, -0.9 to 1.8), consistent with the noninferiority of the levonorgestrel IUD to the copper IUD. Adverse events resulting in participants seeking medical care in the first month after IUD placement occurred in 5.2% of participants in the levonorgestrel IUD group and 4.9% of those in the copper IUD group.ConclusionsThe levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. (Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT02175030.).

Project description:Background: Use of an in situ epidural catheter has been suggested to be efficient to provide anesthesia for postpartum tubal ligation (PPTL). Reported epidural reactivation success rates vary from 74% to 92%. Predictors for reactivation failure include poor patient satisfaction with labor analgesia, increased delivery-to-reactivation time and the need for top-ups during labor. Some have suggested that this high failure rate precludes leaving the catheter in situ after delivery for subsequent reactivation attempts. In this study, we sought to evaluate the success rate of neuraxial techniques for PPTL and to determine if predictors of failure can be identified. Methods: After obtaining IRB approval, a retrospective chart review of patients undergoing PPTL after vaginal delivery from July 2010 to July 2016 was conducted using CPT codes, yielding 93 records for analysis. Demographic, obstetric and anesthetic data (labor analgesia administration, length of epidural catheter in epidural space, top-up requirements, time of catheter reactivation, final anesthetic technique and corresponding doses for spinal and epidural anesthesia) were obtained. Results: A total of 70 patients received labor neuraxial analgesia. Reactivation was attempted in 33 with a success rate of 66.7%. Patient height, epidural volume of local anesthetic and administered fentanyl dose were lower in the group that failed reactivation. Overall, spinal anesthesia was performed in 60 patients, with a success rate of 80%. Conclusions: Our observed rate of successful postpartum epidural reactivation for tubal ligation was lower than the range reported in the literature. Our success rates for both spinal anesthesia and epidural reactivation for PPTL were lower than the generally accepted rates of successful epidural and spinal anesthesia for cesarean delivery. This gap may reflect a lower level of motivation on behalf of both the patients and anesthesia providers to tolerate "imperfect" neuraxial anesthesia once fetal considerations are removed.

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Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation.

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