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Quebec's Medical Protocol No 628001 Initiating diagnostic measures and pharmacological treatment in a female with unusual vaginal discharge Developed in collaboration with an advisory committee consisting of Québec clinicians and experts. Validated by the Comité d’excellence clinique en ordonnances nationales of the Institut national d’excellence en santé et en services sociaux (INESSS). CLINICAL SITUATION OR TARGET POPULATION Symptomatic female: ► A sexually active female with unusual vaginal discharge with or without pre- or postmenstrual spotting or postcoital bleeding. Asymptomatic sexual partner (male or female)1: ► An asymptomatic individual identified as a sexual partner of a female with laboratory-documented Trichomonas vaginalis vaginitis. CONTRAINDICATIONS TO THE APPLICATION OF THIS PROTOCOL ► < 14 years of age; ► Pregnancy, breastfeeding; 2 ► Immunocompromised state ; ► Abnormal uterine bleeding, if: • Menopause; • Bleeding that has persisted for 6 months or longer; • History of gynecological cancer; ► The presence of a contraindication to the use of a recommended drug, with no appropriate alternative; ► Four or more episodes of bacterial vaginosis in the past 12 months (each as evaluated by a physician or a nurse); ► Four or more episodes of vulvovaginal candidiasis in the past 12 months (each as evaluated by a physician or a nurse). INSTRUCTIONS 1. PRECAUTIONS For a victim of sexual assault, also follow the recommendations in the Guide d’intervention médicosociale. 1 For asymptomatic individuals identified as sexual partners of a female who has been treated pharmacologically for a syndrome consistent with cervicitis, refer to the Protocole national pour le traitement d’une infection à Chlamydia trachomatis ou à Neisseria gonorrhoeae chez une personne asymptomatique. 2 Examples of possible causes of an immunocompromised state (see Appendix V of the Guide québécois de dépistage des ITSS): congenital immune deficiency, leukemia, lymphoma, multiple myeloma, nonhematologic cancer, acquired immune deficiency (such as during HIV infection), hemodialysis, and the use of immunosuppressants. INESSS | Quebec’s medical protocol – Unusual vaginal discharge 1 2. HEALTH STATUS ASSESSMENT 2.1. Presence of signs and symptoms Look for and characterize the following: ► Unusual vaginal discharge; ► Pre- or postmenstrual spotting; ► Postcoital bleeding. Look for the following: ► Signs and symptoms of a sexually transmitted and blood-borne infection (STBBI) at other sites of exposure. ► Signs and symptoms of a complicated infection (e.g., lower abdominal pain, deep dyspareunia, joint involvement or a deterioration in overall health with fever). 2.2. Medical history ► Pregnancy; ► Voluntary termination of pregnancy (VTP) or an invasive gynecological procedure; ► Date of last menstruation; ► Barrier method of contraception; ► Date and results of last STBBI screening test; ► STBBI history; ► History of bacterial vaginosis or vulvovaginal candidiasis (previous number of episodes, confirmed or not by a physician, nurse or laboratory tests). 2.3. Medication history ► Medication use; ► Drug allergies; ► Use of antibiotics in the past month; ► Hormonal contraception, a levonorgestrel intrauterine system (IUS), a copper intrauterine device, emergency oral contraception. 2.4. STBBI risk factors Inquire about STBBI risk factors and assess the indications for STBBI screening. Consult the tool ITSS à rechercher selon les facteurs de risque décelés. 2.5. Pelvic inflammatory disease risk factors Look for risk factors for pelvic inflammatory disease (PID): ► Having undergone a VTP or an invasive gynecological procedure (e.g., an endometrial biopsy, a hysteroscopy, hysterosonography or hysterosalpingography) in the past month. ► A levonorgestrel IUS or a copper intrauterine device installed in the past month. ► A history of at least one episode of C. trachomatis or N. gonorrhoeae infection in the past year. ► Previous history of PID. INESSS | Quebec’s medical protocol – Unusual vaginal discharge 2 3. PHYSICAL EXAMINATION 3.1. Overall health and vital signs Take temperature, if warranted. 3.2. Inspection of external genitalia Inspection of the vulva, urethra and perianal region. Look for the following: erythema, edema, fissures, excoriations, or ulcerous, vesicular, erosive, pustular or verrucous lesions. 3.3. Speculum examination Inspection of the cervix and vaginal walls. Describe the unusual vaginal discharge (consult the Comparative table of features consistent with cervicitis, bacterial vaginosis, vulvovaginal candidiasis or trichomoniasis, in Section 5). Look for the following: unusual vaginal discharge, inflammatory appearance of the vaginal walls and cervix, a purulent or mucopurulent endocervical exudate, endocervical bleeding (brittle cervix) or petechiae on the genital mucosa (strawberry cervix). 3.4. Bimanual examination Examination of the uterus and adnexal structures. A bimanual examination is indicated if: ► Pre- or postmenstrual spotting or postcoital bleeding; ► PID risk factors; ► A purulent or mucopurulent endocervical exudate; ► Endocervical bleeding upon swabbing (brittle cervix). Look for the following: lower abdominal tenderness, adnexal tenderness (unilateral or bilateral) or cervical motion tenderness, masses or other structural abnormalities. 4. INVESTIGATION 4.1. Specimens and microbiological tests If unusual vaginal discharge consistent with bacterial vaginosis, vulvovaginal candidiasis or trichomoniasis: ► If a process is in place to provide supervision of the examens de biologie médicale délocalisés (EBMD), obtain a vaginal secretion specimen for a pH measurement and a potassium hydroxide (KOH) amine odour test at the point service3. ► Obtain a vaginal secretion specimen for the appropriate microbiological tests3. If a purulent or mucopurulent endocervical exudate: ► Obtain a vaginal or endocervical specimen to screen for C. trachomatis and N. gonorrhoeae by nucleic acid amplification testing (NAAT) and an endocervical specimen for an N. gonorrhoeae culture. If signs or symptoms of pharyngeal or rectal infection: ► Obtain a pharyngeal or rectal specimen (depending on the location of the symptoms) to screen for C. trachomatis and N. gonorrhoeae by NAAT and an N. gonorrhoeae culture specimen. 3 As per the recommendations in the laboratory procedures at the facility concerned. INESSS | Quebec’s medical protocol – Unusual vaginal discharge 3 In the case of sexual practices implying pharyngeal or rectal exposure with no signs or symptoms at these sites: ► Consult the tool Prélèvements et analyses recommandés en fonction de l’infection recherchée chez les personnes asymptomatiques (dépistage). If risk factors for C. trachomatis or N. gonorrhoeae infection: ► Obtain a vaginal or endocervical specimen to screen for C. trachomatis and N. gonorrhoeae by NAAT and an endocervical specimen for an N. gonorrhoeae culture. If risk factors for other STBBIs: ► Determine the STBBIs to screen for in accordance with the tool ITSS à rechercher selon les facteurs de risque décelés. ► Obtain the specimen or specimens to screen for the other STBBIs to be checked for according to the tool Prélèvements et analyses recommandés en fonction de l’infection recherchée chez les personnes asymptomatiques (dépistage). If there is a possibility that the patient is pregnant or if she experiences pre- or postmenstrual spotting or postcoital bleeding: ► Do a urine pregnancy test. 4.2. Details concerning specimens Regardless of type of specimen, it is important to consult the laboratory at the facility concerned for details on the tests used locally (e.g., suitable specimen collection sites, the types of specimens accepted, the applicable specimen collection conditions, storage and transport). INESSS | Quebec’s medical protocol – Unusual vaginal discharge 4 5. COMPARATIVE TABLE OF FEATURES CONSISTENT WITH CERVICITIS, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS OR TRICHOMONIASIS C. TRACHOMATIS VULVOVAGINAL AND BACTERIAL VAGINOSIS TRICHOMONIASIS CANDIDIAISIS* N. GONORRHOEAE Clinical manifestations (none of these infections necessarily presents by all the clinical manifestations listed) Adherent, Vaginal Thick, curd-like Frothy appearance Purulent homogeneous, fluid discharge Whitish to yellowish Yellowish to greenish Whitish to greyish Malodorous: fishy Odour Nonspecific Nonspecific Malodorous smell Itching None None or slight Moderate to severe Moderate to severe Purulent or mucopurulent endocervical exudate Erythema, edema, fissures, excoriations Petichiae on the Pre- or genital epithelium postmenstrual Associated Other Not applicable (strawberry cervix) spotting, postcoital symptoms (pain, bleeding superficial Superficial dyspareunia, dyspareunia, dysuria Endocervical external dysuria) bleeding upon swabbing (brittle cervix epithelium) Clinical criteria Vaginal pH Not applicable Vaginal pH > 4.5 Vaginal pH ≤ 4.5 Vaginal pH > 4.5 Amine odour Not applicable Yes No No (with KOH) Laboratory criteria Nugent’s score ≥ 7‡: Yeast present on wet C. trachomatis vaginal flora consistent Presence of Result mount or Gram with bacterial T. vaginalis N. gonorrhoeae staining vaginosis * Predisposing factor: recent use of antibiotics. ‡ Nugent’s score ≥ 7 or another microbiological test result consistent with bacterial vaginosis. INESSS | Quebec’s medical protocol – Unusual vaginal discharge 5 6. THERAPEUTIC APPROACH IN THE PRESENCE OF A PURULENT OR MUCOPURULENT ENDOCERVICAL EXUDATE SUGGESTIVE OF CERVICITIS 6.1. Treatment indication If there is a purulent or mucopurulent endocervical exudate,
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