HPV Vaccine Recommendations Including Guidance for Ages 27 to 45
SUMMARY:
The most recent evidence-based HPV vaccine recommendations address when to administer the vaccine and dosing. One area that has elicited more recent guidance focuses on whether to offer the HPV vaccine to individuals over the age of 26.
The FDA (October 2018) extended approval of HPV vaccine to individuals age 27-45 years
ACIP (June 2019) voted to
Expand routine and catch-up HPV vaccination in males through 26 years of age who are inadequately vaccinated
Offer HPV vaccine to individuals age 27-45 years who have not been adequately vaccinated based on shared clinical decision making
ACIP published their final recommendations (August 2019) in the CDC’s Morbidity and Mortality Weekly Report
Children and adults aged 9 through 26 years: HPV vaccination is routinely recommended at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated.
Adults aged >26 years: Catch-up HPV vaccination is not recommended for all adults aged >26 years. Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated. HPV vaccines are not licensed for use in adults aged >45 years.
These recommendations for children and adults aged 9 through 26 years and for adults aged >26 years apply to all persons, regardless of behavioral or medical risk factors for HPV infection or disease.
For persons who are pregnant, HPV vaccination should be delayed until after pregnancy; however, pregnancy testing is not needed before vaccination.
Persons who are breastfeeding or lactating can receive HPV vaccine. Recommendations regarding HPV vaccination during pregnancy or lactation have not changed.
ACIP suggests considering the following points for shared-decision making with adults who are 27 to 45 years of age
HPV is very common, usually transient and asymptomatic
Although typically acquired in young adulthood, some adults are at risk for acquiring new HPV infection
A new sex partner is a risk factor, while those in long-term, mutually monogamous partnerships are not likely to acquire a new HPV infection
HPV types: Sexually active adults will likely have been exposed to some HPV types, but not all HPV types are vaccine targets
There is no antibody test to determine immunity
HPV vaccine has high efficacy in young persons not yet exposed to vaccine-type HPV
Lower vaccine effectiveness may be expected in those with HPV risk factors
Multiple lifetime sex partners | Previous infection with vaccine-type HPV | immunocompromising conditions
HPV vaccines are prophylactic only and can’t prevent infection progression, improve time to clearance or treat HPV-related disease
In summary, the CDC states
For adults aged 27 years and older, clinicians can consider discussing HPV vaccination with people who are most likely to benefit. HPV vaccination does not need to be discussed with most adults over age 26 years
Updated ACOG HPV vaccine recommendations
Routine HPV vaccination is recommended for females and males
Target age is 11-12 years but can be given through age 26
Can be given from age of 9
Do not test for HPV DNA prior to vaccination
Vaccinate even if patient was tested and is HPV DNA positive
If not vaccinated between 11-12 years
Vaccinate between 13–26 years (catch up period)
Women 27–45 years and not previously unvaccinated
Use shared clinical decision making
ACOG “does not recommend that an individual who received the quadrivalent HPV vaccine be revaccinated with 9-valent HPV vaccine, including those aged 27–45 years who previously completed some, but not all, of the vaccine series when they were younger”
Pregnancy
HPV vaccine is not recommended during pregnancy
Pregnancy testing prior to HPV vaccination not recommended
If vaccination schedule is interrupted by pregnancy, resume postpartum with the next dose
HPV vaccine can and should be given to breastfeeding women ≤ 26 who have not been vaccinated
Counsel to expect mild local discomfort and that this is not a cause for concern
Watch adolescents for at least 15 minutes following vaccination due to risk of fainting in this population
AAP HPV Vaccine Implementation Guidance 2017
The AAP has also endorsed the CDC HPV recommendations and provides the following guidance
The AAP and the ACIP of the CDC recommend HPV vaccination with any available vaccine for routine immunization of females at 11 or 12 years of age, and recommend either 9vHPV or 4vHPV** for routine immunization of males 11 or 12 years of age. The vaccination series can be started as young as 9 years of age, and in the case of a child who has been the victim of sexual abuse, HPV vaccination is recommended beginning at 9 years of age.
AAP recommends that physicians frame their HPV discussions with families as an opportunity to prevent HPV-related cancer deaths rather than as an STI vaccine
ACS
The ACS endorses ACIP CDC guidance regarding HPV guidance except for the approach to take with individuals who are 27 to 45 years and not adequately vaccinated
The ACS does not endorse the 2019 Advisory Committee on Immunization Practices recommendation for shared clinical decision making for some adults aged 27 through 45 years who are not adequately vaccinated because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit
Transvaginal Ultrasound in the Evaluation of Postmenopausal Bleeding
SUMMARY:
Postmenopausal uterine bleeding needs to be evaluated quickly and transvaginal ultrasound can play an important role in the initial work-up.
Endometrial Thickness
Measure the maximum anterior-posterior thickness on a long-axis transvaginal view
Transvaginal ultrasound is appropriate for the initial evaluation
Thin endometrial echo
Defined as ≤4mm
Endometrial fluid should not be included in measuring endometrial thickness
>99% NPV for endometrial cancer
Cannot exclude all pathology, including endometrial cancers such as uterine papillary serous, mucinous, clear cell
Thickened endometrium is not diagnostic of a particular pathology
Recommended Management
Transvaginal ultrasound
Should only be used as an initial evaluation if there is low prior probability for cancer or hyperplasia
Additional evaluation is required if persistent/recurrent bleeding
Either transvaginal ultrasound or endometrial sampling are ‘reasonable’ alternatives as first line – both not required if low risk
Proceed to endometrial sampling if abnormal endometrium is seen on transvaginal ultrasound
Endometrial sampling
First-line test if clinical risk factors are present (see ‘Endometrial Cancer: The Basics’ in ‘Related ObG Topics’ below) or clinical presentation is suspicious
Outpatient endometrial sampling using disposable device is method of choice
NOTE: Proceed to hysteroscopy with D&C if persistent or recurring bleeding and blind sampling is negative for endometrial hyperplasia or malignancy
KEY POINTS:
If transvaginal ultrasound image inadequate proceed to following options
Transvaginal ultrasound can be used to further evaluate and if a thin echo is seen and bleeding has stopped, no further work-up is necessary
Persistent/recurrent bleeding needs a histologic evaluation even in the presence of a thin echo
Postmenopausal women who are not bleeding
Transvaginal ultrasound should not be used as a screening tool for endometrial cancer in this population
If an endometrial echo >4mm is found incidentally, this is not an automatic ‘trigger’ for further evaluation but rather should be placed in context and “individualized … based on patient characteristics and risk factors”
ACOG & SMFM Guidance on the Use of IUDs and Contraceptive Implants
SUMMARY:
IUDs and etonogestrel single-rod contraceptive implants are categorized as Long-Acting Reversible Contraception (LARC). ACOG and other professional and public health entities are calling for reduced barriers and improved access to LARC. The latest ACOG practice bulletin reviews various LARC options, including clinical considerations such as use in the postpartum period and management in the setting of pelvic infections. ACOG has also released an updated ‘Quick Coding Guide’ for LARC that can be found in ‘Learn More – Primary Sources’ section.
Subdermal implant with a core containing 68 mg of etonogestrel
FDA approved for 3 years
Clinical Considerations
Nulliparous and Adolescents
LARCs should be offered routinely as safe and effective contraceptive options for nulliparous women and adolescents
Use of LARCs in adolescents supported by the AAP
IUD
MEC category 2 (advantages outweigh risks)
Risk of infection is low
No evidence of association with infertility or tubal occlusion
High satisfaction rate based on continuation rates
Expulsion rates may be higher in adolescents vs older women and multiparous vs nulliparous
Like the general population, nulliparous women and adolescents prefer LNG-IUD
Implant
MEC category 1 (no restrictions)
Continuation rates higher in adolescents compared to OCPs
SMFM Guidance on Women at High Risk for Medical Complications (2019)
Use of LARC is encouraged for women at highest risk for adverse health events as a result of a future pregnancy (GRADE 1B)
SMFM recommends discussion take place in the prenatal period regarding availability of immediate postpartum LARC and MEC guidelines should be used to determine best method for particular medical conditions (GRADE 1C)
Counseling should include discussion around expulsion rates but appear to be outweighed by benefit of higher continuation rates (GRADE 1C)
Providers who intend to utilize immediate postpartum LARC should obtain appropriate training (Best Practice)
SMFM recommends that for women who are eligible and desire LARC, following a high-risk pregnancy, immediate postpartum LARC should be used vs delayed placement due to overall superior efficacy and cost-effectiveness (GRADE 1B)
Encourage breastfeeding following immediate postpartum LARC based on current evidence (GRADE 1B)
SMFM suggests that if a women wishes and is eligible for LARC, but immediate postpartum is not feasible, consider early postpartum placement (GRADE 2C)
Contraceptive counseling should be (Best Practice)
Patient-centered
Within a shared decision-making framework
Timing of Insertion
Interval insertion
Insertion may be performed at any time during menstrual cycle if patient is not pregnant
No benefit to inserting during menses
Postabortion LARC Insertion
Routinely offer immediate insertion following first trimester and second trimester abortion (induced or spontaneous)
Postpartum LARC Insertion
Offer immediate LARC insertion (IUD and implant) prior to hospital discharge
Higher IUD expulsion rates (10-27%), but cost-benefit supports immediate insertion
Considered ACOG ‘best practice’
Waiting 4-6 weeks may result in barrier to access
Contraindications to IUD placement include chorioamnionitis, endometritis, or puerperal sepsis or ongoing postpartum hemorrhage
Effect on Breastfeeding
Copper IUD: No hormonal concerns
LNG-IUD and implant: Studies do not demonstrate a deleterious effect on breast feeding including milk volume/composition, newborn weight or exclusive breastfeeding rates
ACOG recommends shared decision making regarding concerns
Patients should be counseled regarding
Theoretical risk of reduced duration of breastfeeding
Lack of data supporting a negative association
Infection Risk and IUD
Asymptomatic women who are at low risk of STDs and have undergone routine screening
No additional screening required at the time of IUD insertion
Women who have not been screened for STDs or at increased risk for STDs
Requires CDC-recommended STD screening at the time of a single visit for IUD insertion
Do not delay IUD placement while waiting on results
Treat a positive test without removing the IUD
Purulent cervicitis is a contraindication to IUD placement
If known chlamydia or gonorrhea infection, delay IUD insertion following infection treatment until
Antibiotic course is complete
Symptoms resolved
Pelvic/cervical exam normal
Repeat testing at 3 months for gonorrhea or chlamydia to rule out reinfection
Routine antibiotic prophylaxis is not recommended prior to IUD insertion
Actinomyces on cytology is an incidental finding
No treatment or IUD removal required if patient is asymptomatic
Pregnancy with IUD in situ
Determine location of pregnancy to rule out ectopic pregnancy
Remove IUD if strings visible as benefits outweigh risks
If patient opts to retain IUD, counsel regarding risks (which are not totally eliminated by IUD removal)
ACOG and AUGS have updated the Pelvic Organ Prolapse (POP) recommendations. Guidelines now address the FDA order for manufacturers to discontinue sale and distribution of mesh for treatment of POP in the US. The FDA order applies only to mesh placed vaginally for POP and does not apply to (1) transvaginal mesh for SUI or (2) sacrocolpopexy (abdominal placement). POP is considered ‘benign’, but symptoms can seriously impact quality of life, affecting defecatory, voiding and sexual function.
CLINICAL ACTIONS:
POP Definition and Staging
Definition
Descent of uterus or vagina which may result in organ prolapse
Pelvic organ prolapse only should be considered a problem if it is causing prolapse symptoms (ie, pressure with or without a bulge) or sexual dysfunction or if it is disrupting normal lower urinary tract or bowel function
POP-Q Staging
See below in ‘Learn More – Primary Sources’ for link to AUGS POP-Q tool
Stage 0
No prolapse
Stage 1
Criteria for stage 0 are not met
Most distal prolapse is more than 1 cm above the level of the hymen
Stage 2
Most distal prolapse is between 1 cm above and 1 cm below the hymen
Stage 3
Most distal prolapse is >1 cm below the hymen but no further than 2 cm less than the total vaginal length
Stage 4
Complete procidentia or vault eversion
History
Women presenting with POP should undergo a careful history and physical examination with attention to the degree of bother caused by the prolapse
Assess urinary incontinence and bladder emptying
Gravitational effect (increased organ displacement): Is voiding more difficult after standing?
Does manually reducing the bulge (‘splinting’) improve urinary flow?
Assess bowel function
Straining | Laxative use | Splinting to reduce rectocele and improve rectal emptying
Impact on sexual function
Dyspareunia | Coital continence
Physical
Comprehensive abdominal and physical exam
For some patients, extent of descent can be evaluated in the supine position but if unclear, having patient stand may uncover extent of prolapse
Pelvic floor tone
Ask patient to contract and relax musculature and grade on following scale
Absent | Weak | Normal | Strong
Use single blade to hold away opposite vaginal wall during visual exam of the vault and apex
Urinary symptoms
Voiding symptoms or prolapse is evident beyond hymenal ring
Perform postvoid residual volume (catheter or ultrasound)
Note: Consider urodynamics in the presence of incontinence and ≥stage II prolapse or voiding dysfunction
Urgency or other UTI symptoms
Perform urinalysis: Culture and microscopy
Assess the pelvic organs and perform a pelvic organ prolapse quantification (POP-Q)
The POP-Q system is recommended before treatment of POP to quantify the degree of prolapse
Note: If findings do not match symptoms, referral to urogynecologist “may be needed”
KEY POINTS:
Risk Factors
Increasing parity | Vaginal delivery | Age | Menopausal status | Obesity | Connective tissue disorders | Chronic constipation
Treatment
Nonsurgical
Consider nonsurgical treatment options when appropriate
Modifiable risk factors include obesity and constipation
Pelvic muscle exercises
Pessary – generally considered low-risk option and a good alternative for women who wish to maintain fertility
Follow up 3 to 4 months if patient can not replace own pessary; Otherwise annual visit sufficient
In case of erosion, remove pessary for 2 to 4 weeks and apply local estrogen therapy (may resolve without estrogen therapy) | Consider more frequent pessary removal and cleaning
Surgical Therapy for Failed/Declined Nonsurgical Treatment
Upper vaginal prolapse
Abdominal sacrocolpopexy
Uterosacral ligament suspension
Sacrospinous fixation
Anterior wall prolapse
Anterior colporrhaphy
Posterior wall prolapse
Posterior colporrhaphy
Additional Notes on Surgical Treatment
Vaginal apex suspension (uterosacral or sacrospinous ligament suspension) should be performed at the time of hysterectomy for uterine prolapse
Anterior wall prolapse is commonly associated with apical prolapse
Both should be surgically corrected if present to reduce risk of recurrent POP
Posterior wall prolapse repair is more effectively done vaginally rather than transanally
Candidates for abdominal sacrocolpopexy (mesh or biologic graft from vaginal apex to anterior longitudinal ligament of sacrum) include those at high risk for recurrence
Age <60 years
POP-Q stage 3 or 4
BMI >26
Authors of the Cochrane Review (2016) of sacrocolpopexy for apical repair concluded that mesh was not superior to native tissue repair
Sacral colpopexy is associated with lower risk of awareness of prolapse, recurrent prolapse on examination, repeat surgery for prolapse, postoperative SUI and dyspareunia than a variety of vaginal interventions
Synthetic Mesh and Biologic Graft Materials in Vaginal POP Surgery
FDA (April 2019) ordered manufacturers of synthetic mesh for POP to discontinue sale and distribution in the US
This order applies to transvaginal mesh only and not transabdominal POP or SUI
Vaginal Prolapse Repair
Both mesh or biologic grafts are associated with greater likelihood of repeat surgery for combined outcomes of prolapse, stress incontinence or mesh exposure
Data on biologic grafts (e.g. cadaver) are limited and of low quality (most no longer available for use)
Posterior Wall Prolapse
Use of synthetic mesh or biologic grafts is associated with increased complications (mesh exposure) and no improvement in outcome
Mesh or grafts should not be used routinely in the primary repair of posterior wall prolapse
Anterior Wall Prolapse
Biologic grafts show minimal/ no difference in recurrence risk vs native tissue repair
Synthetic mesh improves anatomic outcome, but is associated with
Increased risk of repeat surgery for prolapse, urinary incontinence and mesh exposure
Longer operating times and greater blood loss
11% risk of mesh erosion following anterior vaginal repair
7% of cases that will require surgical correction
Dyspareunia rate of approximately 9%
Notes:
Use of mesh or biologic grafts should only be undertaken by surgeons who have training specific for these procedures
Training should include patient selection, anatomy, intraoperative and postoperative techniques, treatment of any adverse outcomes
Routine intraoperative cystoscopy should be performed during POP surgery when there is risk to the bladder or ureter
AUGS 2013 position statement on credentialing includes the following
It is imperative that local hospitals and health systems establish and strictly enforce robust processes to both/credential and audit surgeons with specific expertise, experience, training and skill to perform these procedures. AUGS has developed, and published credentialing guidelines for transvaginal mesh surgery for pelvic organ prolapse and sacrocolpopexy for the treatment of pelvic organ prolapse.
Local Estrogen Treatment Options for Vaginal Atrophy
CLINICAL ACTIONS:
A growing number of estrogen treatment options are available for postmenopausal vaginal atrophy. Vulvovaginal atrophy is a common symptom of atrophic vaginitis (also referred to as the genitourinary syndrome of menopause or GSM) and can occur in both perimenopausal and postmenopausal women. If a patient reports vaginal dryness, consider the following
Establish a diagnosis of postmenopausal atrophy based on thorough history and physical exam
Confirm with an appropriate pelvic/ vaginal exam
Discuss use of estrogen, understanding that for some women based on medical history, systemic estrogen might not be an appropriate option
Even with a personal history of cancer, local estrogen may be an appropriate treatment (see ‘Key Points’ and ‘Related ObG Topics’ below) depending on the clinical scenario
Vaginal estrogens can be prescribed as
A cream inserted twice weekly using an applicator
A tablet inserted with an applicator
A soft gel pellet inserted twice weekly with no applicator (FDA approved May, 2018)
Ring made of silicone elastomere containing a drug core of estradiol hemihydrate (replaced every 3 months)
Local Estrogen Routes and Dosing for GSM
Estradiol-17β ring (releases 7.5 micrograms/d)
Replace every 3 months
Estradiol vaginal tablet (10 micrograms/d)
Place nightly for 2 weeks
Maintenance is one tablet 2 times/week
Note: this is the corrected dose in ACOG PB 141
Estradiol-17β cream (0.1 mg active ingredient/g)
2-4 g/d for 1 to 2 weeks
Gradually reduce to ½ initial dosage for 1 – 2 weeks
Maintenance is 1 g, 1 to 3 times/week
Conjugated estrogen cream (0.625 mg/g)
0.5–2 g/d for 21 days then off for 7 days
In practice during maintenance therapy, most women apply 1 – 3 times /week
Vaginal inserts (4-μg and 10-μg)
1 vaginal insert daily for 2 weeks
Maintenance is 1 insert twice weekly
SYNOPSIS:
Patients may experience vaginal atrophy as itching, dryness or pain during sexual activity. Vaginal estrogen has been shown to improve moderate to severe menopausal vaginal atrophy. Options for topical estrogen treatment are increasing. Women’s healthcare professionals need to confirm appropriate use of estrogen and help patients identify which treatment option will work best for their situation and lifestyle.
KEY POINTS:
During perimenopause and menopause, estrogen levels decline in vaginal tissues
Referred to as vulvovaginal atrophy (VVA), this may result in discomfort or pain during intercourse or general dryness and discomfort
If patient complains of dyspareunia, and clinical examination is consistent with postmenopausal vaginal atrophy / atrophic vaginitis, local estrogen is the first line and most effective treatment
Estrogen treatment may not be appropriate or desired by all patients
Ascertain if estrogen is an appropriate option for the patient
Screen for a history of breast or uterine cancer
History of blood clots
Liver conditions
If patient is appropriate for treatment with local estrogen, offering the spectrum of choices can help a patient identify the product that will work best for them
While there is a theoretical concern regarding systemic estrogen absorption and risk for uterine cancer, based on evidence, professional organizations consider “the addition of progestin for endometrial protection is not needed” (ACOG)
Differentiating factors include
Creams
Can be used on the vulva as well as internally in the vagina
Tablets or caplets
Some can be used during the day
Some tablets may need to be used at night because of the way they dissolve
Applicators
May be an issue of patient preference and warrants discussion
Ring
Benefits include ease of use
For some women, there may be structural issues related to comfort and/or retention (e.g., short or narrow vagina / prolapse)
Make patients aware that there are non-estrogen options available for use by women who are not appropriate candidates for local estrogen including
Prasterone | Ospemifene
Laser Treatments have been advocated as a possible treatment, however VVA not a currently FDA-approved indication
ACOG Guidance on Preventing Gynecologic Post-Procedure Infection
SUMMARY:
The ACOG Practice Bulletin on the prevention of infection following gynecologic procedures incorporates many of the CDC 2017 recommendations for the prevention of surgical site infection, (see ‘Learn More – Primary Sources’ section below).
The key highlights of the ACOG document include the following:
Preop Prophylaxis
Treat remote infections prior to elective surgeries (e.g., UTIs)
Do not shave the incision site unless there is concern about interference with the procedure
Clippers preferable
Do not use a razor
Glycemic control
Target <200 mg/dL with or without diabetes (CDC guidance)
Screen women pre-operatively for diabetes if at high risk
Shower or full body bath
CDC recommendation does not specify a particular soap or antiseptic, but ACOG states that chlorhexidine “is a reasonable choice based on limited evidence that suggests increased efficacy compared with soap or placebo”
Preop surgical skin prep with alcohol-based agent unless contraindicated (CDC)
ACOG states “Chlorhexidine–alcohol is an appropriate choice” and that while iodophors also have broad spectrum coverage, they tend to be aqueous and not alcohol based
Povidone-iodine: For abdominal surgery, scrub time may be as long as 5 minutes, followed with towel removal and then painting with topical povidone-iodine solution; dry for 2 minutes prior to draping
Chlorhexidine–alcohol: Scrub for 2 minutes for moist sites (inguinal fold and vulva) and 30 seconds for dry sites (abdomen); dry for 3 minutes prior to draping
Vaginal cleansing prior to hysterectomy or vaginal surgery
Use 4% chlorhexidine gluconate or povidone–iodine
Only povidone–iodine FDA approved for vaginal prep
High alcohol concentration (70% isopropyl alcohol) chlorhexidine gluconate is contraindicated for vaginal prep due to risk of irritation
4% chlorhexidine gluconate soap (4% alcohol) is well tolerated and an alternative to iodine-based preparations in cases of allergy or when surgeon preference
Maintain aseptic technique by all members of scrubbed staff
Minimize traffic in the OR
Intraop Prophylaxis
Minimize wound disruption and use excellent surgical technique (e.g., hemostatis, gentle tissue handling, avoidance of hypothermia etc.)
Data lacking as to whether there is benefit in closure of subcutaneous dead space in gyn surgery
Appropriate use of antimicrobial prophylaxis (see detail in ‘Key Points’ below)
Administer within 1 hour prior to procedure
Obesity: Increase dosing based on weight
Long procedure: Redose cefazolin 4 hours from the preoperative dose (not from start of procedure)
Excessive blood loss: Additional dose of cefazolin if blood loss >1,500 mL
Preop screening for bacterial vaginosis
Screening and initiation of therapy with metronidazole or one of the other CDC-recommended treatment regimens “can be considered”
If the therapy duration of 5–7 days encroaches on the scheduled time for surgery, it would be reasonable to continue therapy perioperatively for at least 4 days
Laparoscopic procedures (no entry into bowel or vagina)
Not recommended
HSG (chromotubation/saline infusion sonography)
Not recommended
Hysteroscopy (operative/diagnostic)
Not recommended
Endometrial ablation
Not recommended
IUD insertion
Not recommended
Oocyte retrieval and embryo transfer
Not recommended
D&C for nonpregnancy indications
Not recommended
Urodynamics
If UTI identified, treat appropriately
History of MRSA Colonization or Infection
The following is recommended
Hospital-recommended MRSA antibiotic prophylaxis protocol OR
Adjustment of the preoperative prophylactic antibiotic regimen to include a single preoperative intravenous dose of vancomycin is recommended
Joint guidelines of the American Society of Health-System Pharmacists, Infectious Diseases Society of America, Surgical Infection Society, and the Society for Healthcare Epidemiology of America recommend Vancomycin 15 mg/kg for prophylaxis
Penicillin Allergy
No immediate hypersensitivity reaction (anaphylaxis, urticaria, bronchospasm)
Can use cephalosporin
Cephalosporin allergy: Clindamycin 900 mg or metronidazole 500 mg PLUS Gentamicin 5mg/kg or aztreonam 2 g
Immediate hypersensitivity reaction or Stevens-Johnson syndrome
Cephalosporin allergy: Clindamycin 900 mg or metronidazole 500 mg PLUS Gentamicin 5mg/kg or aztreonam 2 g
Additional Notes
Interval to repeat
Clindamycin: 6 hours
Aztreonam: 4 hours
First generation cephalosporins may provide better prophylaxis than second line agents
Therefore, important to obtain an accurate allergy history to not inadvertently limit access to first generation cephalosporins
How to Tell the Difference Between the Flu and a Cold?
SUMMARY:
The CDC provides information on how to discriminate between the flu and the ‘common cold’. Both conditions are viral in origin. Co-infection with bacteria is possible and in the case of infection with influenza virus, can lead to significant and serious complications.
‘Signs and Symptoms’ Comparisons
Influenza
Cold
Symptom onset
Abrupt
Gradual
Fever
Usual
Rare
Aches
Usual
Slight
Chills
Fairly common
Uncommon
Fatigue, weakness
Usual
Sometimes
Sneezing
Sometimes
Common
Stuffy nose
Sometimes
Common
Sore throat
Sometimes
Common
Chest discomfort, cough
Common
Mild to moderate
Headache
Common
Rare
Credit: Centers for Disease Control and Prevention
KEY POINTS:
Flu Symptoms
Patient may experience just a few or many
Fever or feeling feverish/chills
Cough
Sore throat
Runny or stuffy nose
Muscle or body aches
Headaches
Fatigue (tiredness)
Some people may have vomiting and diarrhea, though this is more common in children than adults
Note: Not everyone with flu will have a fever
Flu Complications
Moderate complications
Sinus and ear infections
Serious flu complications (can result from either influenza virus infection alone or from co-infection of flu virus and bacteria)
Pneumonia
Heart inflammation (myocarditis)
Brain inflammation (encephalitis)
Muscle inflammation (myositis, rhabdomyolysis)
Multi-organ failure (e.g., respiratory and kidney failure)
Sepsis
Exacerbation of chronic medical problems
Asthma attacks
Worsening of heart disease
High Risk Categories
The following are at high risk of complications related to influenza virus infection
Young children
Adults aged 65 years and older
Pregnant women are at especially high risk
Note: To see the comprehensive list of high risk flu categories (and more), see the CDC Emergency Advisory below in the ‘Related ObG Topics’ section
FDA Approves Secnidazole: Single-Dose Oral Treatment for BV
SUMMARY:
The FDA has approved a single-dose oral therapy, secnidazole, for the treatment of bacterial vaginosis (BV)
Available first quarter 2018
Secnidazole is a 5-nitroimidazole with a longer half-life than metronidazole that has been available in Europe and Asia
Dosage regimen
Administer a single 2-gram packet of granules once orally, without regard to the timing of meals
Sprinkle entire contents of packet onto applesauce, yogurt or pudding and consume all of the mixture within 30 minutes without chewing or crunching the granules
A glass of water may be taken after the administration of secnidazole to aid in swallowing
Not intended to be dissolved in any liquid
Primary side effect is vulvo-vaginal candidiasis
Pregnancy (as per FDA)
Limited available data with SOLOSEC use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. In animal reproduction studies, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose.
Lactation (as per FDA)
Breastfeeding is not recommended. Discontinue breastfeeding for 96 hours after administration
EVIDENCE:
A European study by Bohbot et al (Infectious Diseases in Obstetrics and Gynecology, 2010) demonstrated that secnidazole was comparable to metronidazole in effectiveness and safety
Hillier et al. (Obstetrics & Gynecology, 2017) assessed the efficacy of secnidazole as a one-dose treatment for BV in a US population
METHODS
3-arm, phase 2, double-blind, randomized placebo-controlled study
Subjects were categorized into 3 arms:
1 g Secnidazole group
2 g Secnidazole group
Placebo group (bittering agent added so no difference in taste)
Randomization took in to account number of BV episodes within past year (≤ 3 vs ≥ 4)
Inclusion criteria
Non-pregnant
≥ 18 years of age
Met all 4 Amsel criteria (discharge; pH ≥ 4.7; ≥ 20% clue cells; positive whiff test)
Agree to abstain from sexual activity for 1 week after treatment
Exclusion criteria
Allergy to metronidazole
Pregnancy
Vaginal bleeding
Refusal to abstain from alcohol for 3 days post treatment
Concomitant or recent antimicrobial medications
Primary outcome was clinical cure for BV 21-30 days following treatment (1998 FDA guidance)
Normal vaginal discharge
Negative 10% potassium hydroxide whiff test
Clue cells less than 20% of total epithelial cells on microscopic examination of the vaginal wet mount using saline at the test of cure visit
Secondary outcomes were
Microbiologic cure (Nugent score 0-3)
Therapeutic cure meeting both microbiological and clinical cure
RESULTS
In modified intent-to-treat group (all randomized patients who met all study selection criteria), clinical, microbiological, and therapeutic cure rates were (n= 188):
2g secnidazole group: 67.7%, 40.3%, and 40.3%
1g secnidazole group: 51.6%, 23.4%, and 21.9%
Placebo group: 17.7%, 6.5%, and 6.5% in placebo group
All treatment-emergent adverse events were mild or moderate
Majority were related to infections and equal across all groups
Yeast infections were unusual (only 7 women, 5 having received the medication)
Only 1/144 women randomized to secnidazole had nausea
Consistent with well established safety profile outside the US
CONCLUSION
1 or 2 grams of secnidazole was significantly (P<0.001) better than placebo in treating BV
Lyme disease is a serious condition caused by six species of spirochetal bacteria, most commonly Borrelia burgdorferi in North America, following a deer tick bite that requires treatment. Clinical disease can occur within days to several months following a tick bite. Lyme disease is endemic to the northeastern states from Virginia to easternCanada, the upper Midwest, particularly Wisconsin and Minnesota, and northern California. The following provides key points regarding diagnosis, treatment, prophylaxis and tick removal.
DIAGNOSING LYME DISEASE:
Early localized disease features:
Erythema migrans (EM)
70 to 80% of infected individuals
At site of tick bite approximately day 7 to 14 days after bite (range 3 to 30 days)
Expands slowly and develops central clearing
May have multiple lesionsindicating disseminated disease (not multiple tick bites)
Fever, headache, and fatigue
Joint and muscle aches
Swollen lymph nodes
Ixodes tick and Erythema Migrans images courtesy DermNetNZ.org
Carditis :palpitations, chest pain, light headedness, fainting, shortness of breath, and difficulty breathing with exertion
Multiple EM lesions
Conjunctivitis
Late disease features (months to years after tick bite):
Large joing polyarthralgia
Confluent mononeuropathy multiplex
Encephalomyelitis
Testing
Note: The CDC has updated the Lyme laboratory screening algorithm
CDC still recommends the two step approach
Step 1: Serologic testing using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay
Step 2: Follow step one with a western immunoblot assay for specimens yielding positive or equivocal results
Modified two-step approach
Two enzyme immunoassays (EIA) are run concurrently or sequentially
The CDC states that
When cleared by FDA for this purpose, serologic assays that utilize a second EIA in place of western immunoblot assay are acceptable alternatives for the serologic diagnosis of Lyme disease
Note: When EM is present and patient has been to a Lyme endemic area serologic testing is not recommended and treatment can be initiated following clinical diagnosis
KEY POINTS:
Two-tiered serologic testing is more sensitive the longer infection has been present
Myth that Lyme disease can become chronic and no longer detectable on lab testing
Testing can remain positive for years so can not be used to test for cure
Treatment
First line therapy for adults with early localized Lyme disease
Doxycycline: 100 mg twice per day for 10 days, or
Amoxicillin: 500 mg 3 times per day for 14 days, or
Cefuroxime axetil (500 mg twice per day) for 14 days
Therapy for early disseminated Lyme disease with neurologic manifestations:
Doxycycline100 mg twice per day for 14 to 21 days, or
Ceftriaxone IV 2 g daily for 14 to 21 days
Therapy for early disseminated Lyme disease with mild carditis (1st degree AV block with PR interval ≤ 300 milliseconds:
Doxycyline100 mg twice per day for 14 to 21 days, or
Amoxicillin 500 mg three times per day for 14 to 21 days, or
Cefuroxime 500 mg twice per day orally for 14 to 21 days
Therapy for early disseminated Lyme disease with severe carditis (symptomatic, 1st degree AV block with PR interval ≥ 300 milliseconds
If severe carditis(symptomatic, 1st degree AV block with PR interval ≥300 milliseconds, 2nd or 3rd degree AV block) then patient should be admitted for telemetry monitoring and treated with Ceftriaxone IV 2 g daily for 14 to 21 days
For treatment of late Lyme disease, including arthritis, the antibiotic course is extended to 28 daysusing the above antibiotics for early localized disease
The CDC concurs with the following IDSA recommendation that advises strongly against the treatment of chronic Lyme disease (highest level of evidence ‘I’, based on randomized controlled trials) as overtreatment with unnecessary antibiotics may prove fatal (e.g. septic shock, C. difficile, paraspinal abscess and osteomyelitis):
There is no convincing biologic evidence for the existence of symptomatic chronic B. burgdorferi infection among patients after receipt of recommended treatment regimens for Lyme disease. Antibiotic therapy has not proven to be useful and is not recommended for patients with chronic (⩾6 months) subjective symptoms after recommended treatment regimens for Lyme disease.
Prophylaxis: Management of asymptomatic individuals following a tick bite
Routine use of antimicrobial prophylaxis or serologic testing is not recommended
A single dose of doxycycline may be offered to adult patients (200 mg dose) when all the following are met:
The attached tick can be reliably identified as an adult or nymphal I. scapularis deer tick that is estimated to have been attached for ⩾36 h based on the degree of engorgement of the tick with blood or on certainty about the time of exposure to the tick
Prophylaxis can be started within 72 h of the time that the tick was removed
Ecologic information indicates that the local rate of infection of these ticks with B. burgdorferi is ⩾20% (occurs in parts of New England, in parts of the mid-Atlantic States, and in parts of Minnesota and Wisconsin)
Doxycycline is not contraindicated
Tick Removal
The risk of getting a tick-borne disease is small if the tick is removed soon after it becomes attached
Deer ticks must remain attached one to two days to transmit Lyme disease, and about one day for other tick-borne diseases
Use tweezers to grasp the tick close to its mouth
Gently and slowly pull the tick straight outward
To avoid contact with the bacteria, if present, do not squeeze the ticks’ body
Wash the area and apply an antiseptic to the bite
Watch for early signs and symptoms of Lyme disease
Prolactinoma: Early Detection, Evaluation and Management
CLINICAL ACTIONS:
Prolactinomas are generally benign prolactin-secreting tumors and account for 40-66% of all pituitary adenomas. The vast majority are microadenomas (diameter < 1cm) and suppress the hypothalamic-pituitary gonadal hormonal axis, while 10% are macroadenomas (≥ 1cm) and may cause additional mass effects due to size. Ageprevalence varies widely, but they are commonly found in women during childbearing years, in part due to development of menstrual irregularities. Despite their benign nature, if diagnosis is delayed bone loss and vertebral fractures can occur, and the loss of bone density can be permanent.
Clinical signs and symptoms:
Oligo or amenorrhea
Galactorrheaand gynecomastia
Loss of libido and erectile dysfunction
Infertility
Decreased bone density
Mass effect:
Headache
Visual field abnormalities
Evaluation:
Endocrine Society practice guideline
“To establish the diagnosis of hyperprolactinemia, we recommend a single measurement of serum prolactin; a level above the upper limit of normal confirms the diagnosis as long as the serum sample was obtained without excessive venipuncture stress”
History should be obtained to rule out obvious causes of elevated prolactin such as medications
MRI pituitary with and without contrast to assess size and type of tumor
Prolactin levels
Prolactin levels above 200 µg/L is usually a prolactinoma
Prolactin levels above 500 µg/L likely indicates a macroprolactinoma
Prolactin macroadenomas can present with a falsely normal prolactin level due to the “hook effect” (false negative levels if excessive amount of analyte is present)
When prolactin values are lower than expected in a patient, consider discussion with endocrinologist or clinical pathologist for further guidance
Non-prolactin secreting pituitary adenomas can cause pituitary stalk or hypothalamus compression and consequent prolactinemia
TSH, free thyroxine (FT4), and creatinine levels to exclude secondary causes
Treatment:
Minimal symptoms (mild galactorrhea and normal menses): observation and monitor q6-12 months may be acceptable
Oligo or amenorrhea (pregnancy not desired): oral contraceptives or other estrogen/progesterone combinations
Most patients placed on dopamine agonists
Cabergoline > bromocriptine in reducing prolactin levels
Nearly 80% of patients treated with dopamine agonists will normalize prolactin level and reduce the size of their adenoma
Transsphenoidal surgery
Can result in normal prolactin levels in majority of microadenomas and up to 40% in macroadenomas
Recommended: When dopamine agonists not tolerated/desired | Acute tumor complications |Visual deficits not corrected with medical therapy
Recurrence is possible (20% over 10 years)
Radiotherapy
Rarely used for those cases that do not respond to the above
Chemotherapy
Temozolamide rarely used with limited success
Follow Up
Once prolactin levels have improved monitoring is recommended with repeat prolactin levels every 3 to 6 months for the first year and then every 6 to 12 months thereafter
MRI should be repeated in 1 year for microadenomas or 3 months for macroadenomas after medical therapy is initiated
Therapy may be tapered after 2 years of treatment for patients with normal prolactin levels and no visible tumor on MRI
Recurrence rates after stopping dopamine agonists is between 26 to 69% and most likely to occur in the first year, and should be monitored with serial prolactin measurements every 3 months for the first year and annually thereafter
SYNOPSIS:
The prevalence of prolactinomas is reported to be between 35 to 50 per 100,000. They are most commonly seen in women (10:1 ratio female/male) and the usual age range is between 20 to 50 years of age. Dopamine originating in hypothalamic neurons is a principal inhibitory regulator of prolactin release by pituitary lactotrophs and this pathway is the basis of medical treatments. Fortunately, only a minority of microadenomas will continue to grow (< 10%) but early detection, monitoring and a management plan, which may be multidisciplinary, is required for good outcomes. Consider accessing expertise in endocrinology and radiology to ensure correct differential between prolactinoma and non-secreting pituitary adenoma as treatment for the latter is usually surgical, not medical.
KEY POINTS:
Severe adverse effects of dopamine inhibitors are unusual but cabergoline may include compulsive behavior (e.g. excessive gambling) as well as cardiac valvular abnormalities at high doses
Screening & Treatment of Gynecologic infections in the HIV-Positive Woman
Gynecologic infections are more common, and may be more difficult to eradicate, in the HIV population. Overall, treatment protocols remain the same, irrespective of HIV status, although there are some differences depending on the disorder.
CLINICAL ACTIONS:
Screen at entry to care and at least annually for the following: N.gonorrhoeae, C. trachomatis, syphilis and vaginal trichomoniasis
Screen for hepatitis C on entry to care
At-risk seronegative individuals should be screened at least annually
Consider type specific HSV serologic testing for those presenting for an STD evaluation
Approximately 70% of persons with HIV are HSV-2 seropositive | 95% are seropositive for either HSV-1 or HSV-2
HSV-2 infection increases the risk of HIV acquisition two- to three-fold and in coinfected patients
HSV-2 reactivation results in increases in HIV RNA levels in blood and genital secretions
Screen on entry to care for hepatitis B with HBsAg, anti-HBc and/or anti-HBs
Offer vaccination to seronegative individuals with hepatitis B or combined hepatitis A and B vaccine
Recheck immunity after vaccination complete
SYNOPSIS:
While it is critical to remain vigilant with regard to STDs and pelvic infections, women with ulcerative conditions of the genitalia, including syphilis and herpes, are at increased risk of HIV acquisition and transmission to partners, lending an urgency to prompt treatment or suppression (see separate entry on ulcerative conditions).
KEY POINTS:
Bacterial vaginosis is more prevalent/persistent in HIV-positive women
Diagnosis and treatment options are the same
Vulvovaginal candidiasis is more common among HIV-positive women and associated with decreased CD4+ counts
Treatment is the same as for HIV-negative women
For azole-refractory Candida glabrata vaginitis
Boric acid 600 mg vaginal suppository once daily for 14 days
Note: Severe or recurrent vaginitis should be treated with oral fluconazole (100 to 200 mg) or topical antifungals for ≥7 days
Treatment for gonorrhea/chlamydia is the same as for HIV-negative women
Retest 3 months after treatment as reinfection is common
Pelvic inflammatory disease is treated with the same antimicrobials for the same duration as for HIV-negative
There is a greater incidence of tubo-ovarian abscess among HIV-positive, but overall response to therapy is the same as for HIV-negative
Trichomoniasis is more prevalent among HIV-positive and should be treated with a one week course of metronidazole
Parasitic conditions such as scabies or pediculosis pubis are treated the same regardless of HIV status
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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