scholarly journals Safety and Efficacy of an Atraumatic Uterine Cervical Traction Device: A Pilot Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Hélène Legardeur ◽  
Gessica Masiello-Fonjallaz ◽  
Martine Jacot-Guillarmod ◽  
Patrice Mathevet
Keyword(s):  
Pilot Study ◽  
Contraceptive Device ◽  
Clinical Trial Registration ◽  
Safety And Efficacy ◽  
Patient Reported ◽  
Intrauterine Contraceptive ◽  
Cervical Traction ◽  
Traction Device ◽  
Study Support ◽  
Vaginal Canal

Introduction: Alignment of the uterine cervix with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently available instruments are traumatic tenacula, which can cause pain and bleeding and represent an obstacle for certain patients to pursue their medical follow-up. A novel investigational cervical vacuum tenaculum, enables atraumatic traction of the cervix using a semi-circular suction pad, designed to conform to the anatomical shape of the external cervical os. Suction is generated by manually pulling out a sliding tube in a vacuum chamber.Methods: We performed a single arm non-comparative pilot study to assess the safety and efficacy of the cervical vacuum tenaculum in 13 women receiving an IUD. Data on procedural efficacy, safety, patient-reported pain scores at specific time points during IUD insertion procedure and patient satisfaction were collected prospectively.Results: Insertion of IUD was successful with use of the study device in 7 of the 13 enrolled patients (54%). No bleeding or only limited ecchymosis were caused by the device. No adverse events were reported. Participants reported very little pain (mean Visual Analog Scale <10) when applying the device. Participants who achieved IUD insertion with the device reported strong overall satisfaction with the procedure.Conclusions: The suction-based atraumatic tenaculum can be used to manipulate the cervix during IUD insertion with satisfactory efficacy and safety. The results of this pilot study support further studies of this device in larger populations comparing with standard single-tooth tenaculum.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT 04441333.

scholarly journals Safety and efficacy of faecal microbiota transplantation by Anaerobic Cultivated Human Intestinal Microbiome (ACHIM) in patients with systemic sclerosis: study protocol for the randomised controlled phase II ReSScue trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048541
Author(s):  
Anna-Maria Hoffmann-Vold ◽  
Håvard H Fretheim ◽  
Vikas K Sarna ◽  
Imon Barua ◽  
Maylen N Carstens ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Pilot Study ◽  
Phase Ii ◽  
Intestinal Microbiome ◽  
Induction Phase ◽  
Inflammatory Disorder ◽  
Faecal Microbiota ◽  
Safety And Efficacy ◽  
Faecal Microbiota Transplantation ◽  
Patient Reported

IntroductionIn the multisystem inflammatory disorder systemic sclerosis (SSc), gastrointestinal tract (GIT) affliction is highly prevalent. There are no known disease modifying therapies and the negative impact is substantial. Aiming for a new therapeutic principle, and inspired by recent work showing associations between gut microbiota changes and GIT symptoms in SSc, we performed a pilot study on faecal microbiota transplantation (FMT) with the single-donor bacterial culture ‘Anaerobic Cultivated Human Intestinal Microbiome (ACHIM)’. Motivated by positive pilot study signals, we designed the ReSScue trial as a phase II multicentre, placebo-controlled, randomised 20-week trial to evaluate safety and efficacy on lower GIT symptoms of FMT by ACHIM in SSc.Methods and analysesWe aim to include 70 SSc participants with moderate to severe lower GIT symptoms, defined by the validated patient-reported University of California Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 2.0 questionnaire. The trial includes three parts. In part A1 (induction phase) lasting from week 0 to week 12, participants will be randomised 1:1 to repeat infusions of 30 mL ACHIM or placebo at week 0 and 2 by gastroduodenoscopy. In part A2, which is an 8-week subsequent maintenance phase, all study participants will receive 30 mL ACHIM at week 12 and followed until week 20 on continued blind. In part B, which will last until the last participant completes part A2, the participants will be followed through a maximum 16-week extended monitoring period, for longer-term data on safety and intervention effects. Primary endpoint is change from baseline to week 12 in UCLA GIT subscale scores of diarrhoea or bloating, depending on the worst symptom at baseline evaluated separately for each patient. Secondary endpoints are safety measures and changes in UCLA GIT scores (total, diarrhoea and bloating).Ethics and disseminationThis protocol was approved by the Northern Norwegian Committee for Medical Ethics. Study findings will be published.Trial registration numberNCT04300426; Pre-results.Protocol versionV.3.1.

scholarly journals Outcome of immediate postpartum intrauterine contraceptive device in caesarean versus vaginal insertion: a comparative study

2017 ◽  
Vol 6 (2) ◽  
pp. 694
Author(s):  
Aswathy Shanavas ◽  
Sujamol Jacob ◽  
Nirmala Chellamma
Keyword(s):  
Tertiary Care ◽  
Significant Risk ◽  
Intrauterine Contraceptive Device ◽  
P Value ◽  
Contraceptive Device ◽  
Maternal Child Health ◽  
Chi Square ◽  
Safety And Efficacy ◽  
Vaginal Deliveries ◽  
Intrauterine Contraceptive

Background: Immediate Postpartum Intrauterine Contraceptive device is a novel approach to contraception which integrates Maternal - Child health and family planning services. It is a postpartum method which provides long term reversible contraception to women before discharge from the delivery setting. More research is needed in the field of PPIUCD to enhance awareness and acceptance in the community. This study is designed to compare the safety and efficacy of PPIUCD inserted at cesarean versus vaginal delivery.Methods: This is a prospective study conducted at Sree Avittom Thirunal Hospital, Govt. Medical College, and Kerala – A tertiary care teaching institution. A total of 126 patients with cesarean or vaginal deliveries had PPIUCD insertions and they were followed up for a period of one year. The outcome measures analyzed were safety measures – menstrual irregularities, vaginal discharge, pelvic infection and perforation and efficacy measures - failure, expulsion and removal. Data are expressed in frequency and percentage. Chi square test was used for comparison and P value <0.05 was considered significant.Results: The study shows that PPIUCD is an effective intervention in both cesarean and vaginal delivery with no significant differences in safety and efficacy depending on the route of insertion. There was no case of perforation or failure and no significant risk of infection in either group. Spontaneous expulsion occurred in two cases inserted by vaginal route. Missing string incidence is high in the cesarean group compared to vaginal insertion.Conclusions: PPIUCD is a safe effective and convenient method of contraception and should be encouraged in both vaginal and cesarean deliveries.

scholarly journals Cervico-vaginal inflammatory cytokine alterations after intrauterine contraceptive device insertion: A pilot study

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0207266 ◽  
Author(s):  
Priya Sharma ◽  
Kamnoosh Shahabi ◽  
Rachel Spitzer ◽  
Michele Farrugia ◽  
Rupert Kaul ◽  
...  
Keyword(s):  
Pilot Study ◽  
Inflammatory Cytokine ◽  
Intrauterine Contraceptive Device ◽  
Contraceptive Device ◽  
Intrauterine Contraceptive

Rectovaginal Fistula Due to Missing Intra Uterine Contraceptive Device

2018 ◽  
Vol 13 (2) ◽  
pp. 64-66
Author(s):  
Alexander Bambala Kawimbe
Keyword(s):  
Rectovaginal Fistula ◽  
Psychological Symptoms ◽  
Control Measure ◽  
Obstetric Care ◽  
Contraceptive Device ◽  
Poor Access ◽  
Healthy Female ◽  
Intrauterine Contraceptive ◽  
Affected Woman ◽  
Rare Situation

Rectovaginal fistula is an abnormal communication between the rectum and the vaginal. This leads to uncontrollable passage of feces and flatus through the vagina. It therefore causes distressing physical, social and psychological symptoms on the affected woman. The commonest cause of Rectovaginal Fistula is obstetric trauma commonly in developing countries with poor access to Obstetric care or substandard care provision. The case reported here highlights a rare situation in which a birth control measure of Intrauterine Contraceptive Device (IUD) in a 36 years old healthy female leads to a high Rectovaginal fistula.Keywords: fecal incontinence, missing IUD, rectovaginal fistula

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