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Abstract Background Prospective meta-analysis (PMA) is a collaborative research design in which individual sites perform randomized controlled trials (RCTs) and pool the data for meta-analysis. Members of the PMA collaboration agree upon specific research interventions and outcome measures, ideally before initiation but at least prior to any individual trial publishing results. This allows for uniform reporting of primary and secondary outcomes. With this approach, heterogeneity among trials contributing data for the final meta-analysis is minimized while each site maintains the freedom to design a specific trial. This paper describes the process of creating a PMA collaboration to evaluate the impact of misoprostol on ease of intrauterine device (IUD) insertion in nulliparous women. Methods After the principal investigator developed a preliminary PMA protocol, he identified potential collaborating investigators at other sites. One site already had a trial underway and another site was in the planning stages of a trial meeting PMA requirements. Investigators at six sites joined the PMA collaborative. Each site committed to enroll subjects to meet a pre-determined total sample size. A final common research plan and site responsibilities were developed and agreed upon through email and face-to-face meetings. Each site committed to contribute individual patient data to the PMA collaboration, and these data will be analyzed and prepared as a multi-site publication. Individual sites retain the ability to analyze and publish their site's independent findings. Results All six sites have obtained Institutional Review Board approval and each has obtained individual funding to meet the needs of that site's study. Sites have shared resources including study protocols and consents to decrease costs and improve study flow. This PMA protocol is registered with the Cochrane Collaboration and data will be analyzed according to Cochrane standards for meta-analysis. Conclusions PMA is a novel research method that improves meta-analysis by including several study sites, establishing uniform reporting of specific outcomes, and yet allowing some independence on the part of individual sites with respect to the conduct of research. The inclusion of several sites increases statistical power to address important clinical questions. Compared to multi-center trials, PMA methodology encourages collaboration, aids in the development of new investigators, decreases study costs, and decreases time to publication. Trial Registration ClinicalTrials.gov: NCT00613366, NCT00886834, NCT01001897, NCT01147497 and NCT01307111

Objective To investigate changes in female genital tract bacterial ecology associated with levonorgestrel intrauterine system (LNG IUS) use. Study Design Study participants were regularly cycling Caucasian women without recent history of pregnancy or exogenous hormone use. Vaginal, cervical and uterine samples were obtained at nine time intervals, from 1 week before to 12 weeks after LNG IUS placement. Replicate paired vaginal and cervical specimens were collected to determine the consistency of specimen collection and processing. Results A total of 406 samples from 11 women were available for analysis after DNA extraction, amplification and species identification. Of the 355 bacterial species or genera detected, Lactobacillus crispatus was most prevalent representing 48.9% of over 6 million total reads. L. crispatus reads of replicate vaginal samples were not significantly different [odds ratio (OR) 0.79, 0.36-1.73]. In addition, L. crispatus reads of vaginal and cervical samples from the same visit were not significantly different (OR 0.69, 0.31-1.51). Compared to sampling visits prior to LNG IUS placement, sampling visits after LNG IUS insertion were more likely to have L. crispatus reads greater than 50% of total reads (OR 2.13, 1.01-4.48). Of the 63 uterine samples demonstrating bacteria, Burkholderia genus proteobacteria, a common environmental contaminant, were most prevalent both before and after LNG IUS insertion accounting for 48.0% of all uterine sample reads. Conclusion The vaginal microbiome changes very little in response to LNG IUS placement. Further study is needed to place this finding in context with clinical outcomes. Implications There do not appear to be any clinically important differences in the vaginal microbiome in response to insertion of the LNG IUS. [ABSTRACT FROM AUTHOR]

Abstract: Objective: We investigated the 1-year pregnancy rates for emergency contraception (EC) users who selected the copper T380 intrauterine device (IUD) or oral levonorgestrel (LNG) for EC. Study Design: This prospective study followed women for 1 year after choosing either the copper T380 IUD or oral LNG for EC. The study was powered to detect a 6% difference in pregnancy rates within the year after presenting for EC. Results: Of the 542 women who presented for EC, agreed to participate in the trial and met the inclusion criteria, 215 (40%) chose the copper IUD and 327 (60%) chose oral LNG. In the IUD group, 127 (59%) were nulligravid. IUD insertion failed in 42 women (19%). The 1-year follow-up rate was 443/542 (82%); 64% of IUD users contacted at 1 year still had their IUDs in place. The 1-year cumulative pregnancy rate in women choosing the IUD was 6.5% vs. 12.2% in those choosing oral LNG [hazard ratio (HR) 0.53, 95% confidence interval (CI): 0.29–0.97, p=.041]. By type of EC method actually received, corresponding values were 5.2% for copper IUD users vs. 12.3% for oral LNG users (HR 0.42, 95% CI: 0.20–0.85, p=.017). A multivariable logistic regression model controlling for demographic variables demonstrates that women who chose the IUD for EC had fewer pregnancies in the following year than those who chose oral LNG (HR 0.50, 95% CI: 0.26–0.96, p=.037). Conclusion: One year after presenting for EC, women choosing the copper IUD for EC were half as likely to have a pregnancy compared to those choosing oral LNG. Implications: Compared to EC users who choose oral levonorgestrel, those who select the copper IUD have lower rates of pregnancy in the next year. Greater use of the copper IUD for EC may lower rates of unintended pregnancy in high-risk women. [Copyright &y& Elsevier]

Abstract: Background: There is a significant need for research on treatments that provide pain relief during intrauterine device (IUD) insertion. Misoprostol is frequently used before IUD insertion but is not always necessary and its use may increase pain and side effects. This survey evaluated how providers who perform IUD insertion in nulliparous women report using misoprostol to facilitate the procedure. Study Design: An anonymous Internet-based survey was distributed to members of three professional organizations with family planning providers. Results: Of 2211 survey respondents, 1905 (86%) reported providing IUDs to nulliparous women. Of those providing IUDs to nulliparous women, 947/1905 (49.7%) reported using misoprostol, and 380 (40%) of 947 of misoprostol users reported using the treatment empirically with all nulliparous IUD insertions. There was wide variation reported in dose, route and timing of misoprostol administration. Providers most commonly reported learning of misoprostol use for IUD insertion by word of mouth rather than through the literature. Conclusions: Despite conflicting published data, nearly half of survey respondents use misoprostol before IUD insertion. Considerable variation in the timing of misoprostol use may explain differences in perception of its effectiveness. Evidence-based information about misoprostol for IUD insertion in nulliparous women, including pharmacokinetics, efficacy and optimal dosing, is needed. [Copyright &y& Elsevier]

Background: Prospective meta-analysis (PMA) is a collaborative research design in which individual sites perform randomized controlled trials (RCTs) and pool the data for meta-analysis. Members of the PMA collaboration agree upon specific research interventions and outcome measures, ideally before initiation but at least prior to any individual trial publishing results. This allows for uniform reporting of primary and secondary outcomes. With this approach, heterogeneity among trials contributing data for the final meta-analysis is minimized while each site maintains the freedom to design a specific trial. This paper describes the process of creating a PMA collaboration to evaluate the impact of misoprostol on ease of intrauterine device (IUD) insertion in nulliparous women.Methods: After the principal investigator developed a preliminary PMA protocol, he identified potential collaborating investigators at other sites. One site already had a trial underway and another site was in the planning stages of a trial meeting PMA requirements. Investigators at six sites joined the PMA collaborative. Each site committed to enroll subjects to meet a pre-determined total sample size. A final common research plan and site responsibilities were developed and agreed upon through email and face-to-face meetings. Each site committed to contribute individual patient data to the PMA collaboration, and these data will be analyzed and prepared as a multi-site publication. Individual sites retain the ability to analyze and publish their site's independent findings.Results: All six sites have obtained Institutional Review Board approval and each has obtained individual funding to meet the needs of that site's study. Sites have shared resources including study protocols and consents to decrease costs and improve study flow. This PMA protocol is registered with the Cochrane Collaboration and data will be analyzed according to Cochrane standards for meta-analysis.Conclusions: PMA is a novel research method that improves meta-analysis by including several study sites, establishing uniform reporting of specific outcomes, and yet allowing some independence on the part of individual sites with respect to the conduct of research. The inclusion of several sites increases statistical power to address important clinical questions. Compared to multi-center trials, PMA methodology encourages collaboration, aids in the development of new investigators, decreases study costs, and decreases time to publication.Trial Registration: ClinicalTrials.gov: NCT00613366, NCT00886834, NCT01001897, NCT01147497 and NCT01307111. [ABSTRACT FROM AUTHOR]

Abstract: Background: The data analysis was conducted to describe the rate of unsuccessful copper T380A intrauterine device (IUD) insertions among women using the IUD for emergency contraception (EC) at community family planning clinics in Utah. Methods: These data were obtained from a prospective observational trial of women choosing the copper T380A IUD for EC. Insertions were performed by nurse practitioners at two family planning clinics in order to generalize findings to the type of service setting most likely to employ this intervention. Adjuvant measures to facilitate difficult IUD insertions (cervical anesthesia, dilation, pain medication, and use of ultrasound guidance) were not utilized. The effect of parity on IUD insertion success was determined using exact logistic regression models adjusted for individual practitioner failure rates. Results: Six providers performed 197 IUD insertion attempts. These providers had a mean of 14.1 years of experience (range 1–27, S.D. ±12.5). Among nulliparous women, 27 of 138 (19.6%) IUD insertions were unsuccessful. In parous women, 8 of 59 IUD insertions were unsuccessful (13.6%). The adjusted odds ratio (aOR) showed that IUD insertion failure was more likely in nulliparous women compared to parous women (aOR=2.31, 95% CI 0.90–6.52, p=.09). Conclusion: The high rate of unsuccessful IUD insertions reported here, particularly for nulliparous women, suggests that the true insertion failure rate of providers who are not employing additional tools for difficult insertions may be much higher than reported in clinical trials. Further investigation is necessary to determine if this is a common problem and, if so, to assess if the use of adjuvant measures will reduce the number of unsuccessful IUD insertions. [Copyright &y& Elsevier]

Objectives To report length of intrauterine device (IUD) and strings as well as technique for extraction when IUD removal occurs without visible strings. Study Design A prospective case series of 29 women who had IUDs removed in-office when strings were not visible at the external cervical os. Results One third ( n = 11) were found to have a total length of IUD and strings < 7.5 cm. All IUD removals were successfully performed as outpatient procedures. Conclusion Removal of IUDs without visible strings can be successfully done as an in-office procedure. Implications In-office removal of IUDs without visible strings is effective, safe and economically sound. [ABSTRACT FROM AUTHOR]