249 research outputs found

    Exploring women's sensory experiences of undergoing colposcopy and related procedures: implications for preparatory sensory information provision

    Get PDF
    INTRODUCTION: Some women experience distress during colposcopy examinations which is partly related to women's fear, or experience, of pain during the procedure. However, little is known about women's sensory experiences of colposcopy (other than pain) or what might impact on these experiences. The aim of this study was to explore women's sensory experiences of colposcopy and related procedures and identify factors which influenced negative sensory experiences. METHODS: In-depth interviews were conducted with 23 women who had undergone, for the first time, a colposcopy (some with related procedures, including punch biopsies and loop excision) as part of follow-up for abnormal cervical cytology. Interviews were analysed thematically using the Framework Approach to organise the data and identify emerging higher-order themes. RESULTS: Women described a range of sensory experiences including pain or discomfort, cramping, stinging and cold sensations (due to the application of acetic acid to the cervix). Four key themes emerged as important aspects of the overall sensory experience: levels of pain, treatment-specific sensations, anaesthetic-specific sensations and solution-specific sensations. Factors that may influence women having a negative sensory experience were sensory expectations of the procedure(s) and lack of preparatory sensory information. DISCUSSION: Our study provides unique in-depth insight into women's sensory experiences of colposcopy and related procedures and suggests women require more preparatory sensory information. The issues identified as contributing to women having a negative sensory experience may help inform the development of pre-colposcopy information which may better prepare women with abnormal cervical cytology for follow-up examinations

    Perinatal mortality and other severe adverse pregnancy outcomes associated with treatment of cervical intraepithelial neoplasia: meta-analysis

    Get PDF
    Objective To assess the relative risk of perinatal mortality, severe preterm delivery, and low birth weight associated with previous treatment for precursors of cervical cancer

    Understanding Women's Differing Experiences of Distress after Colposcopy: A Qualitative Interview Study.

    Get PDF
    BACKGROUND: Women who have an abnormal cervical cytology test may be referred for a colposcopy. Accumulating evidence suggests some women may experience distress after colposcopy. This exploratory study examined women's differing experiences of post-colposcopy distress with the aim of identifying factors that are predictive of, or protective against, distress. METHODS: We carried out semistructured, qualitative interviews with 23 women who had undergone colposcopies. Interviews were transcribed verbatim, coded, and analyzed thematically. The Framework Approach was used to summarize and organize the data and identify emerging higher order themes. RESULTS: Two forms of post-colposcopy distress emerged: 1) short term and 2) long term. Short-term distress was experienced immediately after the colposcopy and in the days afterward, and was usually related to the physical experience of the colposcopy. Long-term distress typically persisted over time and was related to concerns about fertility, cervical cancer, and sexual intercourse. The drivers of short-term and long-term distress differed. Factors related to short-term distress were feeling unprepared for the procedure, having a negative experience of the procedure, and attending the clinic alone. Factors related to long-term distress were future intentions to have (more) children, having physical after-effects of the procedure that impacted on the woman's life, and being under on-going clinic surveillance. Absence of these factors (e.g., being accompanied to the clinic) was protective against short- and long-term distress. CONCLUSIONS: Colposcopy can lead to short- and long-term post-procedural distress for some women. We identified a range of factors, some potentially modifiable, that seem to influence the chances of experiencing distress. These results may inform the development of strategies or interventions aimed at preventing or minimizing distress after colposcopy and related procedures

    A Single-Arm, Proof-Of-Concept Trial of Lopimune (Lopinavir/Ritonavir) as a Treatment for HPV-Related Pre-Invasive Cervical Disease

    Get PDF
    BACKGROUND: Cervical cancer is the most common female malignancy in the developing nations and the third most common cancer in women globally. An effective, inexpensive and self-applied topical treatment would be an ideal solution for treatment of screen-detected, pre-invasive cervical disease in low resource settings. METHODS: Between 01/03/2013 and 01/08/2013, women attending Kenyatta National Hospital's Family Planning and Gynaecology Outpatients clinics were tested for HIV, HPV (Cervista®) and liquid based cervical cytology (LBC -ThinPrep®). HIV negative women diagnosed as high-risk HPV positive with high grade squamous intraepithelial lesions (HSIL) were examined by colposcopy and given a 2 week course of 1 capsule of Lopimune (CIPLA) twice daily, to be self-applied as a vaginal pessary. Colposcopy, HPV testing and LBC were repeated at 4 and 12 weeks post-start of treatment with a final punch biopsy at 3 months for histology. Primary outcome measures were acceptability of treatment with efficacy as a secondary consideration. RESULTS: A total of 23 women with HSIL were treated with Lopimune during which time no adverse reactions were reported. A maximum concentration of 10 ng/ml of lopinavir was detected in patient plasma 1 week after starting treatment. HPV was no longer detected in 12/23 (52.2%, 95%CI: 30.6-73.2%). Post-treatment cytology at 12 weeks on women with HSIL, showed 14/22 (63.6%, 95%CI: 40.6-82.8%) had no dysplasia and 4/22 (18.2%, 95%CI: 9.9-65.1%) were now low grade demonstrating a combined positive response in 81.8% of women of which 77.8% was confirmed by histology. These data are supported by colposcopic images, which show regression of cervical lesions. CONCLUSIONS: These results demonstrate the potential of Lopimune as a self-applied therapy for HPV infection and related cervical lesions. Since there were no serious adverse events or detectable post-treatment morbidity, this study indicates that further trials are clearly justified to define optimal regimes and the overall benefit of this therapy. TRIAL REGISTRATION: ISRCTN Registry 48776874

    Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial

    Get PDF
    Background: Cryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy. Methods: We report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1–5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239. Findings: Between Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital. Interpretation: Results from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results. Funding: US National Institutes of Health

    Misoprostol in addition to routine treatment of postpartum hemorrhage: A hospital-based randomized-controlled trial in Karachi, Pakistan

    Get PDF
    <p>Abstract</p> <p>Background</p> <p>Postpartum hemorrhage (PPH) remains a major killer of women worldwide. Standard uterotonic treatments used to control postpartum bleeding do not always work and are not always available. Misoprostol's potential as a treatment option for PPH is increasingly known, but its use remains ad hoc and available evidence does not support the safety or efficacy of one particular regimen. This study aimed to determine the adjunct benefit of misoprostol when combined with standard oxytocics for PPH treatment.</p> <p>Methods</p> <p>A randomized controlled trial was conducted in four Karachi hospitals from December 2005 – April 2007 to assess the benefit of a 600 mcg dose of misoprostol given sublingually in addition to standard oxytocics for postpartum hemorrhage treatment. Consenting women had their blood loss measured after normal vaginal delivery and were enrolled in the study after losing more than 500 ml of blood. Women were randomly assigned to receive either 600 mcg sublingual misoprostol or matching placebo in addition to standard PPH treatment with injectable oxytocics. Both women and providers were blinded to the treatment assignment. Blood loss was collected until active bleeding stopped and for a minimum of one hour after PPH diagnosis. Total blood loss, hemoglobin measures, and treatment outcomes were recorded for all participants.</p> <p>Results</p> <p>Due to a much lower rate of PPH than expected (1.2%), only sixty-one patients were diagnosed and treated for their PPH in this study, and we were therefore unable to measure statistical significance in any of the primary endpoints. The addition of 600 mcg sublingual misoprostol to standard PPH treatments does, however, suggest a trend in reduced postpartum blood loss, a smaller drop in postpartum hemoglobin, and need for fewer additional interventions. Women who bled less overall had a significantly smaller drop in hemoglobin and received fewer additional interventions. There were no hysterectomies or maternal deaths among study participants. The rate of transient shivering and fever was significantly higher among women receiving misoprostol</p> <p>Conclusion</p> <p>A 600 mcg dose of misoprostol given sublingually shows promise as an adjunct treatment for PPH and its use should continue to be explored for its life-saving potential in the care of women experiencing PPH.</p> <p>Trial Registration</p> <p>Clinical trials.gov, Registry No. NCT00116480</p
    corecore