Comparison Between 200 μg and 800 μg of Misoprostol for Cervical Ripening Prior to Operative Hysteroscopy: A Study Protocol for A Randomized Controlled Trial.

2020 ◽  
Author(s):  
Maria da Conceição Farias Souto Maior ◽  
Aurélio Antônio Ribeiro Costa ◽  
Alex Sandro Rolland Souza
Keyword(s):  
Study Protocol ◽  
Controlled Trial ◽  
Uterine Cavity ◽  
Invasive Procedure ◽  
University Teaching ◽  
Cervical Dilatation ◽  
Cervical Ripening ◽  
Teaching Hospitals ◽  
Cervical Canal ◽  
Operative Hysteroscopy

Abstract Background: Hysteroscopy, a minimally invasive procedure, has been increasingly used to treat disorders of the cervical canal and uterine cavity. However, difficulties related to the insertion of the hysteroscope through the cervical canal still remain. Although there are reported advantages in reducing cervical resistance with the use of misoprostol for cervical ripening, systematic reviews highlight the need to determine the optimal dose. This study was designed to compare two groups of patients submitted to cervical dilatation prior to operative hysteroscopy and pre-treated with either 200 µg or 800 µg of misoprostol for cervical ripening. Methods: A randomized, quadruple-blind clinical trial with patients submitted to cervical dilatation prior to operative hysteroscopy at university teaching hospitals in Recife, Pernambuco, Brazil. After the internal review boards of the participating institutes had approved the study protocol, data collection began on November 7, 2019, with expected completion on November 1, 2020. Patients included in the study following the informed consent process are randomly allocated to one of two groups, the first allocated to use 200 μg misoprostol and the second to use an 800-μg dose. In both groups, misoprostol will be administered vaginally 10-12 hours prior to operative hysteroscopy. The groups will be compared in relation to intraoperative and postoperative outcomes based on the following endpoints: baseline cervical dilatation, cervical length, degree of difficulty, duration of cervical dilatation, failure to dilate, adverse events and surgical complications. The chi-square test of association, Fisher's exact test and the Mann-Whitney test will be used to compare the groups, with an alpha error of <5% being considered significant. Discussion: The findings of this study will contribute towards establishing the optimal misoprostol dose for cervical ripening prior to operative hysteroscopy, ultimately facilitating hysteroscope insertion through the cervical canal. A gap will be filled in the currently available literature, providing future preoperative guidance. The 800-μg dose of misoprostol is expected to reduce resistance in the cervix and shorten the time until achieving cervical dilatation, delivering a less traumatic procedure for the patient. Therefore, the study is relevant for surgeons in this field, for the scientific community and, particularly, for patients. Trial registration: Clinical Trials Register: NCT04152317. Registered on November 5, 2019. URL https://clinicaltrials.gov/ct2/show/study/NCT04152317.

Comparison of outpatient with inpatient mifepristone usage for cervical ripening: study protocol for a randomized controlled trial

2021 ◽  
Vol 9_2021 ◽  
pp. 66-71
Author(s):  
Baev O.R. Baev ◽  
Karapetyan A.O. Karapetyan ◽  
Babich D.A. Babich ◽  
Sukhikh G.T. Sukhikh ◽  
◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Cervical Ripening ◽  
Randomized Controlled

scholarly journals Effectiveness of Acupuncture as Adjunctive Therapy in Type 2 Diabetic: Study Protocol for a Randomized Controlled Trial

2022 ◽  
Author(s):  
Yean Chin Cheok ◽  
Zalilah Mohd Shariff ◽  
Chan Yoke Mun ◽  
Lee Ping Yein ◽  
Ng Ooi Chuan
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Adjunctive Therapy ◽  
Controlled Trial ◽  
University Teaching ◽  
Teaching Hospitals ◽  
Secondary Outcome ◽  
Model Assessment

Abstract Background: The incidence of type 2 diabetes mellitus is increasing worldwide. The literature suggests that acupuncture is a possible complementary therapy for type 2 diabetes mellitus. This study aims to determine the effect of acupuncture as an adjunctive therapy on homeostasis model assessment-insulin resistance (HOMA-IR), adiposity and health-related quality of life (HRQOL) in patients with type 2 diabetes mellitus. Method and design: This randomised, double-blind, placebo controlled and parallel design trial will be carried out in three public university teaching hospitals in Malaysia. Eligible type 2 diabetes mellitus subjects will be randomly assigned to receive either acupuncture (n=30) or a placebo (n=30). The intervention is carried out using acupuncture ‘press’ needle on abdomen area (10 sessions of treatment), twice a week over 6 weeks. Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR and secondary outcomes of body mass index and waist circumference will be measured at the time of recruitment (baseline) and after completion of 10 sessions (week 7) of the treatment. Additionally, secondary outcome of HRQOL will be measured at the time of recruitment (baseline), after completion of 5 sessions (week 3/4) and 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit.Discussion: The findings of this study will provide important clinical evidence for the effect of acupuncture as adjunctive therapy on HOMA-IR, adiposity and HRQOL of type 2 diabetes mellitus. Name of the registry: US National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov). Trial registration Number: NCT04829045 Date of registration: 2 April 2021URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT04829045?cond=Type+2+diabetes%2C+acupuncture&draw=2&rank=1

scholarly journals O-EGS06 Trials and Tribulations: Educational Impact and Recommendations from the Implementation of Student-Led Recruitment in a Clinical Trial

2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
William Cambridge ◽  
Aya Riad ◽  
David Henshall ◽  
Heather McAdam ◽  
James Glasbey ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Students ◽  
Academic Career ◽  
Controlled Trial ◽  
Recruitment Rate ◽  
University Teaching ◽  
Teaching Hospitals ◽  
Free Text ◽  
Training Support

Abstract Background Medical students have an essential role in medical research, yet often feel unprepared and lack opportunities for involvement as recruiters within research studies. This study aimed to understand the educational effect of involvement in clinical trial recruitment on medical students, and to derive generalisable future recommendations. Methods Tracking wound infection with smartphone technology (TWIST) was a randomised controlled trial enrolling adult emergency abdominal surgery patients across two university teaching hospitals. All recruiters underwent pre-recruitment training based on “Generating Student Recruiters for Randomised Trials” (GRANULE) principles, and completed pre-and post-recruitment surveys. Respondent agreement with statements were assessed using 5-point Likert scales (from 1 [“strongly disagree”] to 5 [“strongly agree”]). Quantitative data were analysed using paired t-tests to compare differences pre- and post-involvement, and a thematic analysis approach adopted for anonymised free-text answers. Results Of 492 patients recruited to TWIST from 2016 to 2020, 86.0% (n = 423) were recruited by medical students. Following student involvement, the monthly recruitment rate tripled (4.8 to 15.7 patients). Thirty student recruiters (96.8%), completed both surveys, reporting significant improvements in clinical and academic competencies. This included increased confidence in gaining and documenting consent, as well as interest in pursuing a clinical-academic career. Over half (58.2%) felt the undergraduate curriculum had not prepared them for involvement in clinical trials (mean:2.47, SD: 0.94). There were three emergent themes regarding recommendations for involvement of students, based on their engagement, preparation, and support during recruitment. Conclusions Student recruitment in clinical trials is feasible and provides a route to developing a research-active medical workforce. It also accelerates recruitment to clinical trials, as well as benefiting students through development of clinical competencies and provision of additional exposure to research. Adequate training, support, and selection of suitable trials are essential for successful student engagement.

scholarly journals Comparative study of the effectiveness of two different dosage of sublingual misoprostal for cervical ripening before hysteroscopy

2020 ◽  
Vol 10 (1) ◽  
pp. 245
Author(s):  
Komal Jadon ◽  
Indu Chawla ◽  
Kanika Kumari
Keyword(s):  
Adverse Effects ◽  
Comparative Study ◽  
Vaginal Bleeding ◽  
Uterine Cavity ◽  
Cervical Ripening ◽  
Cervical Canal ◽  
Group I ◽  
Significant Difference ◽  
Sublingual Misoprostol ◽  
Group Ii

Background: Hysteroscopy a minimally invasive approach for evaluating uterine cavity, and has become an indispensable diagnostic and therapeutic procedure. The main limiting factor while performing office hysteroscopy is the level of pain or discomfort encountered during the procedure. The pain is attributed mainly to the difficulty in entering the internal cervical os with the hysteroscope and while distending uterine cavity. It could be reduced if cervix is ripened before the procedure. The purpose of this prospective observational study was to compare the effectiveness, adverse effects and surgery-related complications associated with two different doses of sublingual Misoprostol (100 and 200 µg) given 2-4 hours before hysteroscopy.Methods: A randomised comparative study was conducted in the department of Obstetrics and Gynaecology of ABVIMS and Dr. RML hospital New Delhi, from 1st November, 2018 to 31st March, 2020. One hundred and twenty women, fulfilling inclusion criteria were subjected to hysteroscopy. Women received either 100 µg (Group I) or 200 µg (Group II) of sublingual Misoprostol 2-4 hours prior to hysteroscopy. The primary outcome of the study was cervical dilatation as measured by the largest number of Hegar dilator that could be inserted without resistance at the beginning of procedure. The largest dilator that negotiated cervical canal without resistance at the beginning of procedure was recorded as the baseline cervical width. The secondary outcomes were subjective assessment of the surgeon of the ease of dilatation of cervix and adverse effects of drug (i.e. vaginal bleeding, shivering, fever and pain as measured on visual analog scale).Results: The mean baseline cervical width as measured by first Hegar dilator that could be passed through the cervical canal without resistance was 6.6±0.62 mm in group I and 6.94±1.21 mm in group II respectively                    (p value=0.016). Adverse effects like vaginal bleeding, shivering was more in group II compared to group I. No statistically significant difference was found between group I and II with regards to visual analog scale.Conclusions: 100 µg Misoprostol can be used for cervical ripening prior to hysteroscopy with minimal adverse effects.

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