Induction of Labour This Is an Update of NICE Inherited Clinical Guideline D
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OVESTIN PESSARY (0.5Mg)
NEW ZEALAND DATA SHEET 1. OVESTIN PESSARY (0.5mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains 0.5 mg Estriol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pessary 0.5 mg - white, torpedo formed pessary. One pessary (2.5 g weight) contains 0.5 mg oestriol. Length 26.5 mm; largest diameter 14 mm. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Atrophy of the lower urogenital tract related to oestrogen deficiency, notably • for the treatment of vaginal complaints such as dyspareunia, dryness and itching. • for the prevention of recurrent infections of the vagina and lower urinary tract. • in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence. Pre- and postoperative therapy in postmenopausal women undergoing vaginal surgery. A diagnostic aid in case of a doubtful atrophic cervical smear. 4.2 Dose and method of administration Dosage OVESTIN is an oestrogen-only product that may be given to women with or without a uterus. Atrophy of the lower urogenital tract 1 pessary per day for the first weeks, followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1 pessary twice a week) is reached. Pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery 1 pessary per day in the 2 weeks before surgery; 1 pessary twice a week in the 2 weeks after surgery. A diagnostic aid in case of a doubtful atrophic cervical smear 1 pessary on alternate days in the week before taking the next smear. Administration OVESTIN pessaries should be inserted intravaginally before retiring at night. -
UK Clinical Guideline for Best Practice in the Use of Vaginal Pessaries for Pelvic Organ Prolapse
UK Clinical Guideline for best practice in the use of vaginal pessaries for pelvic organ prolapse March 2021 Developed by members of the UK Clinical Guideline Group for the use of pessaries in vaginal prolapse representing: the United Kingdom Continence Society (UKCS); the Pelvic Obstetric and Gynaecological Physiotherapy (POGP); the British Society of Urogynaecology (BSUG); the Association for Continence Advice (ACA); the Scottish Pelvic Floor Network (SPFN); The Pelvic Floor Society (TPFS); the Royal College of Obstetricians and Gynaecologists (RCOG); the Royal College of Nursing (RCN); and pessary users. Funded by grants awarded by UKCS and the Chartered Society of Physiotherapy (CSP). This guideline was completed in December 2020, and following stakeholder review, has been given official endorsement and approval by: • British Association of Urological Nurses (BAUN) • International Urogynecological Association (IUGA) • Pelvic Obstetric and Gynaecological Physiotherapy (POGP) • Scottish Pelvic Floor Network (SPFN) • The Association of Continence Advice (ACA) • The British Society of Urogynaecology (BSUG) • The Pelvic Floor Society (TPFS) • The Royal College of Nursing (RCN) • The Royal College of Obstetricians and Gynaecologists (RCOG) • The United Kingdom Continence Society (UKCS) Review This guideline will be due for full review in 2024. All comments received on the POGP and UKCS websites or submitted here: [email protected] will be included in the review process. 2 Table of Contents Table of Contents ................................................................................................................................ -
Pessary for Management of Pelvic Organ Prolapse
Pessary for management of Pelvic Organ Prolapse Cathy Davis Clinical Nurse Specialist Department of Urogynaecology King’s College Hospital, London Definition of Prolapse The descent of one or more of the anterior vaginal wall, posterior vaginal wall, uterus (cervix) or vaginal vault (cuff scar after hysterectomy). The presence of any such sign should be correlated with relevant POP symptoms. (Haylen et al 2016) Risk Factors • Increased intra-abdominal pressure • Chronic cough • Chronic constipation • Weight lifting • Presence of abdominal tumours - fibroids & ovarian cysts • High impact exercise • Age/ Menopause • Obesity Risk Factors contd.... • Smoking • Multiparity • Congenital weakness – rare; due to deficiency in collagen metabolism • Injury to pelvic floor muscles • Iatrogenic/ pelvic surgery - hysterectomy Symptoms of POP • May be asymptomatic – a small amount of prolapse can often be normal • Sensation of a lump or bulge " coming down" - most common • Backache • Heaviness • Dragging or discomfort inside the vagina – often worse on standing /sitting for prolonged periods • Seeing a lump or bulge Symptoms of POP contd.... • Bladder / Urinary symptoms -Frequency -Difficulty initiating voids, low-flow, incomplete bladder emptying -Leakage on certain movements or when lifting heavy objects -Recurrent urinary tract infections • Bowel symptoms -Constipation - Incomplete bowel emptying - May have to digitate to defecate/use aides • Symptoms related to Sex – uncomfortable, lack of sensation Diagnosis of Prolapse • Vaginal examination • -
And Double-Balloon Catheters for Cervical Ripening and Labor Induction
Comparison Between The Ecacy and Safety of The Single- (Love Baby) and Double-Balloon Catheters for Cervical Ripening and Labor Induction Meng Hou Xi'an Jiaotong University https://orcid.org/0000-0002-6510-886X Weihong Wang Xi'an Jiaotong University Medical College First Aliated Hospital Dan Liu Xi'an Jiaotong University Medical College First Aliated Hospital Xuelan Li ( [email protected] ) Xi'an Jiaotong University Medical College First Aliated Hospital Research article Keywords: cervix, balloon catheters, single- and double-balloon catheters, labor induction, cervical ripening Posted Date: July 16th, 2020 DOI: https://doi.org/10.21203/rs.3.rs-37246/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/23 Abstract Background: Induced labor is а progressively common obstetric procedure, Whether the specically designed double-balloon catheter is better than the single-balloon device in terms of ecacy, eciency and safety yet remains controversial. Methods: In our study We have performed a Retrospective study in which 220 patients with immature cervix were admitted for induction of labor either through single cervix balloon catheter (love-baby) (SBC) or double cervix balloon catheter (DBC). The comparison showed that the cervical bishop score was slightly higher for the SBC after removal or expulsion of the balloon. Results:This was a proof that SBC demonstrates slightly better ecacy for cervical ripening with a shorter time from balloon placement to spontaneous vaginal delivery than DBC. No signicant differences in the comparison between SBC and DBC following other parameters like spontaneous vaginal delivery, the initiate uterine contractions rate, the number of patients that needed oxytocin, the balloon spontaneous expulsion rate and others have been detected. -
Combi Soft Gel Pessary & External Cream
Combi Soft Gel Pessary Canesten & External Cream 500mg vaginal capsule & 2% w/w cream Clotrimazole Read all of this leaflet carefully because it contains important To treat internal thrush, your doctor may recommend that you use the information for you. pessary without the help of an applicator. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. HOW TO USE CANESTEN® COMBI • This medicine has been prescribed for you. Do not give it to anyone else 3. under any circumstances. The Soft Gel Pessary: • If you have any unusual effects after using this product, tell your doctor. Unless directed otherwise by your doctor, the Soft Gel Pessary should be inserted as high as possible into the vagina, preferably before going to sleep IN THIS LEAFLET at night for convenient and comfortable treatment. Wash your hands before removing the foil from the blister pack and again 1. What is Canesten Combi and what is it used for? afterwards when you have used the applicator. 2. Before you use Canesten Combi 3. How to use Canesten Combi 1. Remove the applicator from the packaging. Pull out the plunger A until it 4. Possible side effects stops. Remove the pessary from the foil blister pack and place firmly into the 5. How to store Canesten Combi applicator B. 6. Further information 1. WHAT IS CANESTEN® COMBI AND WHAT IS IT USED FOR? Canesten Combi Soft Gel Pessary & External Cream is a full course of treatment for vaginal thrush (candidiasis) because it treats both the internal cause and external symptoms. -
U.S. Medical Eligibility Criteria for Contraceptive Use, 2010
Morbidity and Mortality Weekly Report www.cdc.gov/mmwr Early Release May 28, 2010 / Vol. 59 U.S. Medical Eligibility Criteria for Contraceptive Use, 2010 Adapted from the World Health Organization Medical Eligibility Criteria for Contraceptive Use, 4th edition department of health and human services Centers for Disease Control and Prevention Early Release CONTENTS The MMWR series of publications is published by the Office of Surveillance, Epidemiology, and Laboratory Services, Centers for Introduction .............................................................................. 1 Disease Control and Prevention (CDC), U.S. Department of Health Methods ................................................................................... 2 and Human Services, Atlanta, GA 30333. How to Use This Document ......................................................... 3 Suggested Citation: Centers for Disease Control and Prevention. [Title]. MMWR Early Release 2010;59[Date]:[inclusive page numbers]. Using the Categories in Practice ............................................... 3 Recommendations for Use of Contraceptive Methods ................. 4 Centers for Disease Control and Prevention Contraceptive Method Choice .................................................. 4 Thomas R. Frieden, MD, MPH Director Contraceptive Method Effectiveness .......................................... 4 Peter A. Briss, MD, MPH Unintended Pregnancy and Increased Health Risk ..................... 4 Acting Associate Director for Science Keeping Guidance Up to Date ................................................... -
A Guide to Obstetrical Coding Production of This Document Is Made Possible by Financial Contributions from Health Canada and Provincial and Territorial Governments
ICD-10-CA | CCI A Guide to Obstetrical Coding Production of this document is made possible by financial contributions from Health Canada and provincial and territorial governments. The views expressed herein do not necessarily represent the views of Health Canada or any provincial or territorial government. Unless otherwise indicated, this product uses data provided by Canada’s provinces and territories. All rights reserved. The contents of this publication may be reproduced unaltered, in whole or in part and by any means, solely for non-commercial purposes, provided that the Canadian Institute for Health Information is properly and fully acknowledged as the copyright owner. Any reproduction or use of this publication or its contents for any commercial purpose requires the prior written authorization of the Canadian Institute for Health Information. Reproduction or use that suggests endorsement by, or affiliation with, the Canadian Institute for Health Information is prohibited. For permission or information, please contact CIHI: Canadian Institute for Health Information 495 Richmond Road, Suite 600 Ottawa, Ontario K2A 4H6 Phone: 613-241-7860 Fax: 613-241-8120 www.cihi.ca [email protected] © 2018 Canadian Institute for Health Information Cette publication est aussi disponible en français sous le titre Guide de codification des données en obstétrique. Table of contents About CIHI ................................................................................................................................. 6 Chapter 1: Introduction .............................................................................................................. -
Comparing Labor Progression and Outcomes in Term Gestations: Are Elective Inductions Worth the Risk?
Title: Comparing Labor Progression and Outcomes in Term Gestations: Are Elective Inductions Worth the Risk? Abstract: Despite good evidence to support the risks associated with having a cesarean delivery, the rate continues to climb. The rate of cesarean delivery rate in the United States was approximately 33% in 2009 and is indeed nearly 30% of all deliveries at Unity Point Health Methodist. This study sought to examine the effectiveness of implementing a new Bishop Score policy in attempt to decrease the rate of cesarean deliveries in our hospital. We examined all elective inductions in term gestations over a specific period of time with interest in the delivery outcomes of those inductions and implemented a new policy for elective inductions. All providers who performed deliveries at our hospital were notified of plans to change the then current policy. We examined all cases of elective inductions from June – November 2012 and January – June 2013. After applying all inclusion and exclusion criteria, the rate of elective inductions increased (68.2%), the overall rate of cesarean deliveries among elective inductions decreased (9.1%) as well as the overall cesarean section rate (10.8%), (p-value 0.7361). The length-of-stay, length- of-labor and admission-to-pitocin administration were all decreased among the elective inductees with favorable bishop scores, but perhaps the most significant of all findings in this study was cost savings, with a total savings of nearly $114,000. These findings support the new Bishop Score policy and possibly represent a pivotal point in the downward trend of cesarean deliveries. Introduction: The rate of elective inductions and cesarean deliveries has reached an all-time high in the United States. -
Intra-Vaginal Prostaglandin E2 Versus Double-Balloon Catheter for Labor Induction in Term Oligohydramnios
Journal of Perinatology (2015) 35, 95–98 © 2015 Nature America, Inc. All rights reserved 0743-8346/15 www.nature.com/jp ORIGINAL ARTICLE Intra-vaginal prostaglandin E2 versus double-balloon catheter for labor induction in term oligohydramnios G Shechter-Maor1, G Haran1, D Sadeh-Mestechkin1, Y Ganor-Paz1, MD Fejgin1,2 and T Biron-Shental1,2 OBJECTIVE: Compare mechanical and pharmacological ripening for patients with oligohydramnios at term. STUDY DESIGN: Fifty-two patients with oligohydramnios ⩽ 5 cm and Bishop score ⩽ 6 were randomized for labor induction with a vaginal insert containing 10 mg timed-release dinoprostone (PGE2) or double-balloon catheter. The primary outcome was time from induction to active labor. Time to labor, neonatal outcomes and maternal satisfaction were also compared. RESULT: Baseline characteristics were similar. Time from induction to active labor (13 with PGE2 vs 19.5 h with double-balloon catheter; P = 0.243) was comparable, with no differences in cesarean rates (15.4 vs 7.7%; P = 0.668) or neonatal outcomes. The PGE2 group had higher incidence of early device removal (76.9 vs 26.9%; P = 0.0001), mostly because of active labor or non-reassuring fetal heart rate. Fewer PGE2 patients required oxytocin augmentation for labor induction (53.8 vs 84.6% P = 0.034). Time to delivery was significantly shorter with PGE2 (16 vs 20.5 h; P = 0. 045) CONCLUSION: Intravaginal PGE2 and double-balloon catheter are comparable methods for cervical ripening in term pregnancies with oligohydramnios. Journal of Perinatology (2015) 35, 95–98; doi:10.1038/jp.2014.173; published online 2 October 2014 INTRODUCTION better mimic the natural course of labor and might have an Ultrasound estimation of amniotic fluid volume is an important advantage in cervical ripening. -
Regulations Governing the Classification of Medical Devices (Draft)
Regulations Governing the Classification of Medical Devices (Draft) Article 1 These Regulations are enacted pursuant to Paragraph 2, Article 3 of the Medical Devices Act (hereinafter “this Act”). Article 2 Medical devices are classified into the following categories according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty: 1. Clinical chemistry and clinical toxicology devices 2. Hematology and pathology devices 3. Immunology and microbiology devices 4. Anesthesiology devices 5. Cardiovascular devices 6. Dental devices 7. Ear, nose, and throat devices 8. Gastroenterology and urology devices 9. General and plastic surgery devices 10. General hospital and personal use devices 11. Neurological devices 12. Obstetrical and gynecological devices 13. Ophthalmic devices 14. Orthopedic devices 15. Physical medicine devices 16. Radiology devices Article 3 Medical devices are classified into the following classes according to their risk level: 1. Class I: Low risk 2. Class II: Medium risk 3. Class III: High risk 1 Article 4 Product items of the medical device classification are specified in the Annex. In addition to rules stated in the Annex, medical devices whose function, intended use, or working principle are special may have their classification determined according to the following rules: 1. If two or more categories, classes, or product items are applicable to the same medical device, the highest class of risk level is assigned. 2. The accessory to a medical device, intended specifically by the manufacturer for use with a particular medical device, is classified the same as the particular medical device, unless otherwise specified in the Annex. 3. -
Draft Guidance on Dinoprostone
Contains Nonbinding Recommendations Draft Guidance on Dinoprostone This draft guidance, once finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Generic Drugs. Active ingredient: Dinoprostone Form/Route: Gel; Endocervical Recommended study: 1 study Type of study: Bioequivalence (BE) Study with Clinical Endpoint Design: Randomized, double blind, parallel, placebo-controlled in vivo Strength: 0.5 mg/3 gm (single dose) Subjects: Pregnant female patients at or near term with a medical or obstetrical indication for the induction of labor. Additional comments: Specific recommendations are provided below. Analytes to measure (in appropriate biological fluid): Not Applicable Bioequivalence based on (90% CI): Clinical endpoint Waiver request of in vivo testing: Not Applicable Dissolution test method and sampling times: Not Applicable Additional comments regarding the BE study with a clinical endpoint: 1) The OGD recommends a BE study with a clinical endpoint comparing the dinoprostone endocervical gel, 0.5 mg/3 gm test product versus the reference listed drug (RLD) and placebo control, with each subject receiving a single dose administered into the cervical canal just below the level of the internal os with the primary endpoint evaluation occurring 12 hours after dosing of the assigned product. 2) The recommended primary endpoint of the study is the proportion of subjects in the per protocol (PP) population identified as “treatment success” occurring during the 12-hour observation period after dosing of the assigned product. -
Vaginal Support Pessaries: Indications for Use and Fitting Strategies
SERIES Vaginal Support Pessaries: Indications for Use and Fitting Strategies Shanna Atnip and Katharine O’Dell ESSARIES P elvic floor disorders are © 2012 Society of Urologic Nurses and Associates common in women, and as the population ages, Atnip, S., & O’Dell, K. (2012). Vaginal support pessaries: Indications for use and these disorders may be fitting strategies. Urologic Nursing, 32(3), 114-125. Pseen more frequently by health ERIES ON care providers (Nygaard et al., Flexible silicone vaginal support pessaries offer a low-risk, effective option for S 2008). When pelvic symptoms treatment of symptoms of pelvic organ prolapse. This first article in a three-part series summarizes clinical recommendations and current evidence related to are associated with loss of struc- pessary indications, choice, and fitting. tural support of the pelvic organs and vagina, vaginal support pes- PECIAL Key Words: Pelvic organ prolapse, pessary, indications, fitting. saries offer an important option S for relief (American College of Objectives: Obstetricians & Gynecologists 1. List the symptoms of pelvic organ prolapse that may be successfully treated [ACOG], 2007). with a vaginal support pessary. Historically, vaginal pessaries have been used to manage pelvic 2. Discuss the various types of pessaries and their uses to treat pelvic organ floor relaxation and were made prolapse. from a variety of materials, 3. Outline the pessary selection process and steps to pessary fitting. including fruit, metal, porcelain, rubber, and acrylic (Shah, Sultan, genic, and washable, and can gen- & Thakar, 2006). Modern pessaries erally be sterilized using an auto- are made from silicone, acrylic, clave, boiling water, or a cold ster- Shanna Atnip, MSN, WHNP-BC, is a Nurse latex, or rubber.