Premature Rupture of Membranes: Making the Diagnosis
Review the latest recommendations with Sina HaeriMD MHSA
Dr. Haeri is board-certified MFM provider who serves as the Chief Clinical Strategy Officer at SOC Telemed, and is also founder of Ouma Health maternity telehealth platform. He has set up more than 60 teleMFM clinical sites nationally to serve pregnant individuals in underserved communities
Upon completion of this activity, participants should be better able to
Discuss the important components of PROM evaluation with limitations of each element
Formulate an evidence-based and practical approach to PROM evaluation in practice
THE CASE:
24 year old G1P0, at 26w2d
Presents to triage for evaluation for prelabor rupture of membranes (PROM)
Entered prenatal care at 11w5d gestation
Otherwise uncomplicated course
Chief Complaint
Post-coital large gush of fluid from the vagina 3 hours prior to arrival to hospital
Reports some intermittent leaking
SYNOPSIS:
Overview of PROM
Prelabor rupture of membranes (PROM) refers to membrane rupture prior to onset of labor, and its management remains one of the most controversial issues in obstetrics. Preterm PROM (PPROM) prior to 37 week gestation is associated with over 1/3 of all preterm births, and poses a management dilemma when occurring prior to 22 to 23 weeks gestation. False positive PROM diagnosis may lead to unnecessary interventions, whereas a negative PROM diagnosis may lead to less than expected maternal-fetal surveillance, both of which can lead to adverse perinatal outcomes. Below are key points to consider to evaluate and help make the diagnosis of PROM.
History
Presentation
Patient will report leaking of fluid from the vagina or wetness of the perineum
Main differential is usually that of urine leakage, associated with full bladder
Other considerations include copious vaginal discharge
Questions are Guided to Sort Out the Differential Diagnosis
Intermittent vs continuous leakage
Urine leakage usually associated with coughing or overextended bladder and usually not intermittent or continuous flow
Odor
Urine or infection will have a smell | Amniotic fluid will not
Color
Urine vs amniotic fluid is usually not easy to distinguish based on color
Darker or yellow color more suggestive of vaginal discharge especially if more viscous
Patients will usually report if they see bleeding, but still important to ask and document
Timing of event
May be associated with trauma, although usually PROM is a spontaneous event
Pain
May be associated with UTI or chorioamnionitis (infected amniotic fluid)
Physical Examination
Step 1: Sterile Speculum Exam
If the following findings are observed, patient has PROM and manage accordingly
Amniotic fluid leaking through the cervix or
Pooling of amniotic fluid in the posterior vaginal vault
Step 2: Ultrasound Assessment of Amniotic Fluid Volume (AFV)
Normal amniotic fluid volume values
Deepest vertical pocket >2 cm and/or
Amniotic fluid index >5 cm
Next steps based on AVF
Normal AFV: Unlikely to have PROM (unless small leak present)
Oligohydramnios: Proceed to step 3
Step 3: Biochemical Tests
PAMG-1 (AmniSure®): placental alpha microglobulin-1 protein
Rapid, non-instrumental, point of care immunochromatographic assay
PAMG-1 is present in the blood, amniotic fluid and cervico-vaginal discharge of pregnant women
Sterile swab inserted into the vagina for 1 minute, and placed into solvent vial for 1 minute
Test-strip inserted into vial and results available within 5 to 10 minutes
Gestational age range: 11 to 42 weeks
Sensitivity 98.9% | Specificity 98.1%
Test is not impacted by semen or trace amount of blood
IGFBP-1 (Actim® Prom): Insulin like growth factor binding protein 1
Immunoassay rapid test
IGFBP-1 is present in the amniotic fluid of pregnant women
Gestational age range: ≥29 weeks
Sensitivity of 90.1% | Specificity of 91.0%
Test is not impacted by semen, trace amount of blood, or bacteria in vaginal secretions
PP12/AFP (ROM Plus®): IGFBP-1 (also known as PP12 [placental protein 12]) and AFP (alpha-fetoprotein)
Rapid immunochromatographic test
Test swab inserted into the vagina for 15 seconds and then placed in diluent, followed by test strip
Maternal and fetal AFP levels can be elevated for other reasons such as NTDs
Test has not been evaluated for potential interference in these clinical scenarios
Gestational age range: 23 to 37 weeks
Sensitivity 99% | Specificity 75%
Test is not impacted by trace amounts of blood
Comparative Studies
Ramsauer et al (2013): PAMG-1 had superior accuracy over IGFBP-1 when PROM diagnosis was equivocal
PAMG-1: Sensitivity 96.0% | Specificity 98.9%
IGFBP-1: Sensitivity 73.9% | Specificity 77.8%
Liang et al (2014): PAMG-1 demonstrated better performance characteristics compared to IGFBP-1 and Nitrazine
Cousins et al (2014): PAMG-1 demonstrated performance comparable with traditional ROM diagnostic evaluation including pooling, pH, and observation for ferning
Note: Biochemical tests are screening tests | Always place test results in the context of the clinical scenario, including patient history and findings | The pregnancy should never be managed based on biochemical testing alone
Additional Considerations
Other Clinical Tests
Nitrazine Paper
Standard pH values
Amniotic fluid pH: 7.1 to 7.3
Normal Vaginal pH: 4.5 to 6.0
Urine pH: <6
Sensitivity: 93% (at 1 hour of PROM) to 76% (at ≥24 hours of PROM)
Potential FN causes: Dilution from other vaginal fluids
Specificity: 92%
Potential FP causes: Other alkaline fluids such as blood, seminal fluid, soap, or infections (e.g., BV)
Arborization (ferning)
Different patterns observed on glass slide once fluid obtained from posterior vaginal fornix is allowed to dry (minimum 10 minutes)
False negative: Inadequate amniotic fluid | Contamination with vaginal discharge or blood
Note: ACOG includes nitrazine and ferning as diagnostic screening tests | UK NICE guideline and Royal College of Obstetricians and Gynaecologists (RCOG) recommend against the use of nitrazine and support the option of biochemical testing | The International Federation of Gynecology and Obstetrics (FIGO) likewise states that “biochemical markers are better than traditional methods … the rapid strip test based on PAMG-1 seems to be a more sensitive bedside test than other tests”
Invasive Dye Tests
Indication: Definitive approach when PROM diagnosis remains unclear
Indigo carmine has been traditional dye of choice but limited availability in the US
Other suggested options include sodium fluorescein and phenol red (see below)
Procedure
Instillation into the amniotic sac
1 mL indigo carmine in 9 mL of sterile saline injected transabdominally
Tampon in vagina for 20 minutes to check for leak
Alternative to indigo carmine
Sodium Fluorescein: 1 to 4 mL 5% (50-200 mg) | Followed by speculum exam of cervix at 15 and 45 minutes post injection using long wave UV light to look for yellow-green fluorescent fluid leaking from cervix
Phenol-sulfonphthalein (phenol red): Sufficient dose is 1 to 3 mL (currently not available in the US for clinical medical use)
Note: DO NOT USE Indocyanine Green, Phenazopyridine Hydrochloride, Evans Blue, or Methylene Blue
Early Term PROM
Leakage reported at 37w0d to 38w6d
Perform thorough PROM evaluation leakage
Avoid unnecessary early term deliveries
The Wrap Up
Important clues in this patient’s history include
Gush of fluid: Suggests true PROM, but not enough to make the diagnosis
Physical exam is key
Sterile speculum with direct visualization
If fluid leaking through cervix or pooling of amniotic fluid in the posterior vaginal vault – PROM diagnosis
If the above diagnostic requirements are not met
Consider biochemical protein marker testing of vaginal fluid to guide further management
ACOG does include pH and ferning, but they are associated with significant false positive and false negative rates, depending on the clinical scenario
Ultrasound may be of help in determining the correct diagnosis but must, like biochemical testing, be placed in clinical context
Thank you to QIAGEN for sponsoring this CurbsideConsult Summary
The views stated within are those of OBGConnect and not those of QIAGEN
PROM PODCAST Part I: Making the Diagnosis
Hosts Nancy Chescheir, MD, MFM, FACOG and Sina Haeri, MD, MHSA, FACOG have a case-based dialog about PROM.
Using multiple case studies, these two clinicians share their clinical pearls and discuss the key highlights involved in reaching a diagnosis, from history and physical exam to the accuracy of various clinical and biochemical tests available.
Thank you to QIAGEN for sponsoring this CurbsideConsult Summary
The views stated within are those of OBGConnect and not those of QIAGEN
The JADA System: An Important Tool in our Toolkit for Preventing and Managing Postpartum Hemorrhage
Faculty
Deena Goffman, MD, FACOG
Dr. Goffman is the Ellen Jacobson Levine and Eugene Jacobson Professor of Women’s Health in Obstetrics and Gynecology and Vice Chair for Quality and Patient Safety at Columbia University Irving Medical Center
Learning Objectives
Upon completion of this activity, participants should be better able to
Recognize novel opportunities in PPH management
Understand when and how to place vacuum induced hemorrhage control device
THE CASE
30 year old G2P1, at 38w2d undergoing induction of labor
Medical history significant for chronic hypertension, now with superimposed preeclampsia with severe features on magnesium sulfate for seizure prophylaxis
Gestational diabetes controlled with diet with estimated fetal weight of 4000 g
Prior uncomplicated vaginal birth and no other comorbidities
BACKGROUND
Postpartum Hemorrhage
Remains a leading cause of preventable severe maternal morbidity and mortality
Definition
Cumulative blood loss ≥1,000mL or
Blood loss accompanied by sign/symptoms of hypovolemia within 24 hours following the birth process (includes intrapartum loss) irrespective of mode of delivery
Critical Point – Cumulative Blood Loss of 500 to 999 mL
Blood loss between 500 to 999mL in the setting of vaginal birth is not typical
This finding alone should trigger increased supervision and potential interventions as clinically indicated
Timely recognition of abnormal bleeding allows for increased surveillance and early, proactive intervention
While there is always a differential diagnosis for abnormal bleeding, uterine atony is the most common etiology accounting for approximately 80% of PPH cases
TREATMENT
Uterotonic Medications
Much focus over last 10 years on the need for institution specific stage-based emergency hemorrhage management plans
Follow a similar framework and outline the steps teams should take in the setting of abnormal bleeding and/or PPH
Once PPH etiology identified as uterine atony there are only a handful of uterotonic medications available to treat the condition
Oxytocin | Methergine | Hemabate | Misoprostol (although misoprostol has been deemed a treatment of uncertain usefulness)
Note: Health history may lead to contraindications for use of uterotonics with the most common being
Methergine contraindicated in hypertensive disorders
Hemabate contraindicated in asthma
Non-Uterotonic Medication – TXA
More recently, an additional non-uterotonic medication, tranexamic acid (TXA) has demonstrated promise as an anti-fibrinolytic
May assist in achieving hemostasis in the setting of PPH irrespective of etiology
Unresponsive to Medications
In uterine atony, when medications do not achieve adequate control, additional options include
Devices
Surgical techniques
Interventional radiologic procedures
We will now turn our attention to a novel device, the JADA System, an FDA cleared intrauterine vacuum-induced hemorrhage control device
JADA SYSTEM
Real-world Use Data (RUBY)
800 patients enrolled across 16 US sites
66% vaginal births
34% cesarean births
Treatment success
92.5% in vaginal births
83.7% in cesarean births
Works better when used earlier with success dropping to <50% when >3L blood loss prior to placement
No safety events determined to be definitively device-related
Works quickly with bleeding controlled within 5 minutes
73.8% of vaginal births
62.2% of cesarean births
Short indwelling median treatment time
3.1 hours for vaginal birth
4.6 hours for cesarean birth
Pearls
Many consider the device the equivalent of a mechanical uterotonic
The order of the steps matter
Use a visual aid to help ensure team success
Ensure uterine atony is the primary etiology for bleeding
Be prepared to place device expeditiously
Many use a single dose of antibiotics to cover the manual sweep of the cavity and device use
If there is ongoing blood loss after vacuum applied, consider alternative etiology for bleeding
Practical Tips for Placement
Manually remove clot from the uterine cavity
Remove air from the cervical seal prior to placement
Compress the uterine loop in your dominant hand
Guide the loop into the lower uterine segment with the cervical seal positioned at the external os
Fill the seal with 60 to 120mL sterile fluid
Turn on and set vacuum source to 80 mmHg +/- 10 mmHg
Occlude end of tubing to test vacuum
Connect sterile vacuum tubing to JADA
Typical to see uterine contraction with prompt cessation of bleeding | Often blood is only visible within the tubing not even making it to the wall canister
If blood continues to flow begin to consider alternative source for bleeding and make arrangements for additional treatment
If there is cessation of bleeding, treat for at least 1 hour with tube taped to patient inner thigh
If the patient requires movement to another location, use portable vacuum
Removal Process
Verify that bleeding remains controlled
Ensure that tube remains secured to patient’s inner thigh
Disconnect vacuum tubing from JADA with vacuum on
Remove sterile fluid from cervical seal
Observe for 30 minutes to verify bleeding remains controlled
Remove device slowly while supporting the uterine fundus
Avoiding Pitfalls
Ensure that the cavity is empty prior to placement the device will not clear clot
The patient must be 3cm dilated to allow placement
Often blood is only visualized in the tubing…this does not mean the device isn’t working
Ensure that fluid is removed from cervical seal during 30 minute observation prior to device removal
CASE FOLLOW UP
Patient was at high risk for PPH due to multiple risk factors including
Macrosomia | Induction of labor | Magnesium sulfate
Vaginal birth with active management of the third stage of labor including
Controlled cord traction | Massage and oxytocin initiated with delivery of the anterior shoulder
Bleeding was noted after delivery of placenta
Quantitative blood loss (QBL) of 625mL was calculated with ongoing bleeding observed
PPH cart and kit were at bedside
Bladder emptied, fundal massage performed and a dose of Hemabate was given with ongoing bleeding | Diagnosis of uterine atony was made
No lacerations were identified
The JADA system was called for at a QBL of 764mL
Bimanual exam was performed
Clot cleared from uterine cavity
No retained products of conception were palpated
JADA was placed with prompt improvement in uterine tone and blood noted in the vacuum tubing without active flow into the wall suction canister
After 1 hour of treatment
Bleeding remained controlled and the tube remained secured to patient’s inner thigh
The vacuum tubing was disconnected from JADA with the vacuum on
All sterile fluid was removed from the cervical seal
Bleeding and uterine tone were observed for 30 minutes
Bleeding remained controlled and the device was removed approximately 90 minutes after initial placement
The patient was transferred to the postpartum unit with a total cumulative QBL of 879mL, hemodynamically stable and doing well.
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Meta-Analysis: Does Vitamin D Reduce the Risk of Progression from Prediabetes to Diabetes?
BACKGROUND AND PURPOSE:
Pittas et al. (Annals of Internal Medicine, 2023) evaluated whether administration of vitamin D decreases risk for diabetes among people with prediabetes
METHODS:
Systematic review and individual patient data (IPD) meta-analysis
Study inclusion criteria
RCTs
Studies specifically designed to test the effects of oral vitamin D vs placebo on new-onset diabetes in adults with prediabetes
Study design
Analyses were conducted by intention to treat
Studies testing cholecalciferol and eldecalcitol vs matching placebos were included
Primary outcome
Time to event for new-onset diabetes
Secondary outcomes
Regression to normal glucose regulation
Adverse events
RESULTS:
3 trials | 4190 participants
Risk of bias was low
Vitamin D reduced risk for diabetes in adults with prediabetes
Adjusted hazard ratio (aHR) 0.85 (95% CI, 0.75 to 0.96)
3-year absolute risk reduction: 3.3% (95% CI, 0.6 to 6.0)
The effect of vitamin D did not differ in prespecified subgroups
Among participants assigned to the vitamin D group who maintained a mean serum 25-hydroxyvitamin D level of ≥125 nmol/L (50 ng/mL) during follow-up vs 50 to 74 nmol/L (20 to 29 ng/mL), cholecalciferol reduced the risk for diabetes
HR 0.24 (95% CI, 0.16 to 0.36)
3-year absolute risk reduction: 18.1% (95% CI, 11.7 to 24.6)
Vitamin D increased the likelihood of regression to normal glucose regulation
Rate ratio 1.30 (95% CI, 1.16 to 1.46)
There was no evidence of difference in the rate ratios for adverse events
Kidney stones: rate ratio 1.17 (95% CI, 0.69 to 1.99)
Hypercalcemia: rate ratio 2.34 (95% CI, 0.83 to 6.66)
Hypercalciuria: rate ratio 1.65 (95% CI, 0.83 to 3.28)
Death: rate ratio 0.85 (95% CI, 0.31 to 2.36)
CONCLUSION:
For adults with prediabetes, vitamin D supplements reduce the risk of progression to diabetes
The authors state
This IPD meta-analysis of vitamin D trials, specifically designed and conducted for diabetes prevention, overcame limitations of meta-analyses that used aggregate data from heterogeneous studies and provides evidence supporting the use of vitamin D in people with prediabetes to reduce their risk for progression to type 2 diabetes
Can Women with Mild Cognitive Impairment Revert Back to Normal Cognition?
BACKGROUND AND PURPOSE:
Reversion to normal cognition (NC) from mild cognitive impairment (MCI) is possible, although most individuals with MCI do progress to dementia
Iraniparast et al. (Neurology, 2022) estimated transition rates from mild cognitive impairment (MCI) to normal cognition (NC) and dementia as well as associated impact of risk factors
METHODS:
Secondary analysis of longitudinal data
Nun Study
Cognitive ability of cohort of religious sisters assessed at baseline and yearly until death or study end (12 annual assessments)
≥75 years
Population
Women from the Nun Study Cohort
Exposures
Age
APOE
e4 allele of the APOE gene increases risk for late-onset Alzheimer disease
Cognitive reserve indicators
Education
Academic performance: High school grades
Written language skills: Idea density | Grammatical complexity
Study design
Modelling was used to estimate transition between cognitive states
Transitions were considered
Reversible between NC and MCI
Nonreversible from dementia and MCI
Primary outcome
Instantaneous transition rates between NC, MCI and dementia
Rate of reversion to NC vs progression to dementia
RESULTS:
619 participants
MCI during study period: 472
MCI patient outcomes during study period
≥1 reverse transition to NC: 30.3%
Never developed dementia: 83.9%
Mean follow-up: 8.6 years
In models that adjusted for age group and APOE
Higher level of education significantly increased the relative rate ratio (RR) of reversion vs. progression
Bachelor’s degree: aRR ratio 2.60 (95% CI, 1.05 to 6.45)
Master’s degree or higher: aRR ratio 2.94 (95% CI, 1.27 to 7.22)
Cognitive reserve indicators were significantly associated with a higher adjusted RRs of reversion vs. progression
Higher vs. lower levels for English grades
RR ratio: 1.83 (95% CI, 1.07 to 3.14)
Idea density
RR ratio: 3.93 (95% CI, 1.30 to 11.92)
Grammatical complexity
RR ratio: 5.78 (95% CI, 1.56 to 21.42)
CONCLUSION:
Many participants with MCI did not progress to dementia, and in ~30% of cases actually experienced reversion to normal cognition
Indicators of cognitive reserve, such as education level and written language skills, were associated with higher rates of reversion vs progression
Limitations of the study include: The Nun Study cohort may not be generalizable | Transitions may reflect cognitive reserve but may also reflect normal variation over time
The authors state
Knowledge of predictors of reversion from MCI to NC is important to inform the design and interpretation of clinical trials, given that a substantial proportion of participants may experience improvement from MCI to NC even without intervention
Evidence of predictors of these reverse transitions may also inform population-level intervention strategies targeting these characteristics to prevent or postpone MCI and dementia
Does Maternal COVID-19 Vaccination Protect Against Infant Hospitalization Due to COVID?
BACKGROUND AND PURPOSE:
Halasa et al. (CDCMMWR, 2022) assessed the effectiveness of maternal completion of a 2-dose mRNA COVID-19 vaccination series during pregnancy against COVID-19 hospitalization in infants
METHODS:
Test-negative, case-control study
Real-world evaluation at 20 US pediatric hospitals during a period of Delta and Omicron variant circulation
Participants
Infants aged <6 months admitted outside of their birth hospitalization to a pediatric hospital during July, 2021 to January, 2022
Case infants had a positive COVID-19 test
Control infants had a negative COVID-19 test
Exposure
Maternal vaccination ≥14 days before delivery
Defined as completion of a 2-dose series of either Pfizer-BioNTech or Moderna mRNA COVID-19 vaccine
Study design
Control-infants were matched to case-infants by site and were hospitalized within 3 to 4 weeks of a case-infant’s admission date
In a secondary analysis, effectiveness of maternal receipt of the second dose of COVID-19 vaccination early in pregnancy (within the first 20 weeks) and late in pregnancy (21 weeks through 14 days before delivery) was assessed
Primary outcome
Vaccine effectiveness (VE) of maternal vaccination against infant COVID-19 hospitalization
RESULTS:
Case infants: 176 | Control infants: 203
Median age 2 months
Had at least one underlying medical condition: 21%
Born premature (<37 weeks): 22%
Effectiveness of maternal vaccination during pregnancy against COVID-19 hospitalization in infants aged <6 months
VE: 61% (95% CI, 31 to 78%)
Effectiveness of a completed 2-dose COVID-19 vaccination series early in pregnancy (first 20 weeks)
VE: 32% (95% CI, –43% to 68%)
Effectiveness of vaccine completion late in pregnancy (21 weeks through 14 days before delivery)
VE: 80% (95% CI, 55 to 91%)
CONCLUSION:
Maternal COVID-19 immunization appears to provide protection to infants through passive transplacental antibody transfer
Maternal vaccination had a VE of 61% for preventing COVID-19 hospitalization in infants
The authors state
Overall, these findings indicate that maternal vaccination during pregnancy might help protect against COVID-19 hospitalization among infants aged <6 months
Does Epidural Use During Vaginal Delivery Reduce the Risk of Severe Maternal Morbidity?
BACKGROUND AND PURPOSE:
Guglielminotti et al. (JAMA Network Open, 2022) assessed the association between the use of labor neuraxial analgesia for vaginal delivery and Severe Maternal Morbidity (SMM)
METHODS:
Population-based cross-sectional study
Data derived from hospital discharge records from New York between January 2010 and December 2017
Population
5 to 49 years
Undergoing first vaginal delivery
Exposures
Neuraxial analgesia: Epidural or combined spinal-epidural
No neuraxial analgesia
Study design
Odds ratios (OR) of SMM associated with neuraxial analgesia were estimated using inverse propensity score–weighting and stratified according to
Race and ethnicity (non-Hispanic White vs racial and ethnic minority women, including non-Hispanic Asian or Pacific Islander, non-Hispanic Black, Hispanic, and other race and ethnicity)
The comorbidity index for obstetric patients (low-risk vs high-risk women)
Primary outcome
Severe maternal morbidity (SMM)
Secondary outcome
Postpartum hemorrhage (PPH)
RESULTS:
575,524 included women
Mean age: 26 (SD, 6) years
Race/ethnicity
Non-Hispanic Asian or Pacific Islander: 8.0%
Non-Hispanic Black: 15.4%
Hispanic: 18.2%
Non-Hispanic White: 44.9%
Other race and ethnicity: 13.0%
Comorbidity index
Low-risk: 69.6%
High-risk: 30.4%
Received neuraxial analgesia: 47.4%
Incidence of SMM and PPH
SMM: 1.3%
Of these, PPH: 35.6%
Incidence of SMM by neuraxial analgesia exposure, before weighting
With neuraxial analgesia: 1.3%
No neuraxial analgesia: 1.4%
There was a decreased risk of SMM associated with neuraxial analgesia
Risk difference for SMM: −0.21% (95% CI, −0.30 to −0.12)
Adjusted OR 0.86 (95% CI, 0.82 to 0.90)
This association was similar between
Non-Hispanic White women and racial and ethnic minority women
Low-risk and high-risk women
More than one-fifth of the observed association of neuraxial analgesia with the risk of SMM was mediated through the decreased risk of PPH
21% (95% CI, 14 to 28%)
CONCLUSION:
Neuraxial analgesia exposure during vaginal delivery is associated with a 14% decreased risk of severe maternal morbidity
This associated risk reduction was similar across race, ethnicity, and comorbidity index
More than 20% of the observed SMM risk reduction was due to a decreased risk of PPH
Limitations of the study include
Oservational design which demonstrates association but not causation | Only intrapartum SMM documented, not the 15% of severe adverse outcomes that occur following discharge
The authors suggest the following reasons why neuraxial analgesia may reduce PPH and SMM
Earlier evaluation and management of early PPH due to enhanced maternal monitoring and early detection of blood loss following delivery
How Effective are IUDs Compared to Tubal Ligation?
BACKGROUND AND PURPOSE:
Schwarz et al. (Journal of General Internal Medicine, 2022) compare the effectiveness and safety of IUDs to laparoscopic tubal ligation for Medicaid clients
METHODS:
Retrospective cohort study
California database
Medicaid claims data
Population
IUD placed or laparoscopic tubal ligation
Procedure performed between 2008 and 2014
Exposures
IUD placement
Tubal ligation
Study design
Study included stakeholder advisory board including patients and clinicians
Linear regression models used to test associations between contraceptive procedure and outcomes
Adjustments for sociodemographic variables and pre-procedure health status
In unadjusted analyses, rates of pregnancy within 1 year were similar among the groups
Levonorgestrel IUD: 2.40%
Copper IUD: 2.99%
Tubal ligation: 2.64%
In adjusted analyses, compared to tubal ligation, pregnancy was less common following placement of
Levonorgestrel IUD
Adjusted incident rate ratio (aIRR) 0.72 (95% CI, 0.64 to 0.82)
Copper IUD
aIRR 0.92 (95% CI, 0.82 to 1.05)
Procedural complications such as infection were significantly less common with IUD placement than tubal ligation
IUD placement: 0.35%
Tubal ligation: 2.91%
Claims for pelvic and abdominal pain decreased in frequency over time regardless of contraceptive approach
At 6 to 12 months post-procedure, pelvic pain claims were less common after
Levonorgestrel IUD placement
aIRR 0.69 (95% CI, 0.65 to 0.73)
Copper IUD placement
aIRR 0.70 (95% CI, 0.66 to 0.75)
Results unchanged even after excluding patients at highest risk for post-procedure complications
CONCLUSION:
Among patients with medicaid insurance, placement of a levonorgestrel or copper IUD is at least as effective at preventing pregnancy as tubal ligation 1-year post-procedure
Compared to tubal ligation, pregnancy within 1 year was
Lower than laparoscopic tubal ligation
Similar for copper IUD
Pain and infection were less common in patients who received an IUD vs tubal ligation
The authors state
As desire for reversal of tubal ligation is known to occur, it is important that all patients considering tubal ligation receive thorough counseling regarding the comparative safety and effectiveness of IUC prior to undergoing tubal ligation
Can Vaccination Lead to Improved Long-COVID Symptoms?
BACKGROUND AND PURPOSE:
Risk factors and disease progression of Long-COVID or post-acute sequelae of SARS-CoV-2 infection are not well understood
It isn’t clear whether vaccination can help prevent or improve symptoms of long-COVID
Nehme et al. (Journal of General Internal Medicine, 2022) described the association of vaccination and the evolution of six cardinal symptoms embodying post-acute sequelae of SARS-CoV-2
METHODS:
Survey based study
Participants
Individuals who previously tested positive for SARS-CoV-2 infection (RT-PCR test) at a testing center in Switzerland
Survey was sent between April 23 to July 27, 2021
Exposures
Post-acute sequelae of SARS-CoV-2
Vaccination status
Study design
At the time of the study, the public health recommendations in Switzerland were for previously infected individuals to preferably receive one dose of vaccination only
Primary outcome
Persistence of symptoms
Fatigue | Difficulty concentrating or memory loss | Loss of or change in smell | Loss of or change in taste | Shortness of breath | Headache
RESULTS:
2094 participants
Vaccinated, one dose: 26.6%
Vaccinated, two doses: 20.5%
Symptom status following vaccination
Symptoms disappeared: 30.8%
Symptoms improved: 35.5%
Symptoms remained stable: 28.7%
Symptoms worsened: 3.3%
Vaccination (one or two doses) was associated with a decreased prevalence of the six cardinal post-SARS-CoV-2 symptoms
Adjusted odds ratio (aOR) 0.72 (95% CI, 0.56 to 0.92)
Vaccination with 2 doses was associated with a decreased prevalence of
Dyspnea: aOR 0.34 (95% CI, 0.14 to 0.82)
Change in taste: aOR 0.38 (95% CI, 0.18 to 0.83)
Any one symptom: aOR 0.60 (95% CI, 0.43 to 0.83)
CONCLUSION:
Compared to no vaccination, participants who were vaccinated reported improvement in post-acute SARS-CoV-2 sequelae
The authors state
If confirmed, this would mean that vaccination not only prevents infection but also can potentially improve post-acute sequelae of SARS-CoV-2
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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.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
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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