Amniotic Fluid Embolism: What are the Outcomes and Maternal Mortality Rates?
BACKGROUND AND PURPOSE:
Mazza et al. (JAMA Network Open, 2022) examined the clinical, pregnancy, and delivery characteristics and maternal outcomes related to amniotic fluid embolism (AFE)
METHODS:
Retrospective cohort study
Population
Vaginal or cesarean deliveries from January 2016, to December 2019
Data obtained from the Healthcare Cost and Utilization Project’s National Inpatient Sample (NIS)
NIS represents hospital discharge data for more than 90% of the US population | Based on survey weights based on a random sampling of 20% of hospitalized patients annually
Exposure
AFE
Study design
The role of AFE on outcomes was assessed using a logistic regression model
Primary outcome
Clinical, pregnancy and delivery characteristics of AFE
Maternal mortality after AFE
Secondary outcomes
Severe maternal morbidity indicators
Maternal mortality per clinical and pregnancy characteristics
RESULTS:
14,684,135 deliveries
Median age: 29 (IQR, 25 to 33 years)
AFE diagnoses: 880
Incidence rate: 6.0 per 100,000 deliveries
In the multivariable analysis the following factors were associated with AFE
Patient factors
Older age | Asian and Black race | Western US region | Pregestational hypertension | Asthma | Illicit substance use | Grand multiparity
Early gestational age | Cervical ripening | Cesarean delivery | Operative delivery | Manual removal
Among these, placental accreta spectrum had the largest association with AFE
Adjusted odds ratio (aOR) 10.01 (95% CI, 7.03 to 14.24)
When stratified by the PAS subtypes, more severe forms of PAS had a greater association with AFE
Increta and percreta: aOR 17.35 (95% CI, 10.21 to 28.48)
Accreta: aOR 7.62 (95% CI, 4.8 to 12.01)
Patients who had AFE were more likely to experience
Coagulopathy
aOR 24.68 (95% CI, 19.38 to 31.44)
Cardiac arrest
aOR 24.56 (95% CI, 17.84 to 33.81)
Adult respiratory distress syndrome
aOR 10.72 (95% CI, 8.09 to 14.20)
The maternal mortality rate after AFE: 17.0%
This rate exceeded 30% when AFE co-occurred with other severe maternal morbidity indicators
AFE, cardiac arrest, and coagulopathy: 45.8%
AFE, shock, and cardiac rhythm conversion: 43.2%
AFE, cardiac arrest, coagulopathy, and shock: 38.6%
The maternal mortality rate also exceeded 30% when AFE occurred in the setting of placental pathology
AFE and PAS: 42.9%
AFE and placental abruption: 31.3%
CONCLUSION:
In this population, AFE occurred in 6.0 of every 100,000 deliveries
Risk factors associated with AFE were identified
Placenta accreta spectrum had the largest associated with AFE
Maternal mortality after AFE was high, at 17.0%
This rate increased if AFE co-occurred with other maternal morbidity indicators or placental pathology
The authors state
It is unknown whether adherence to the Society for Maternal-Fetal Medicine checklist for initial management of AFE is associated with improved maternal outcome
Other studies suggested the importance of high-quality cardiopulmonary resuscitation; correction of coagulopathy, including tranexamic acid use; and extracorporeal membrane oxygenation use for AFE management, but these procedures were not assessed in this study
RCT Results: Does Foot Massage Improve Symptoms for Postmenopausal Women?
BACKGROUND AND PURPOSE:
Gökbulut et al. (Menopause, 2022) assessed the impact of foot massage on anxiety, fatigue, and sleep in postmenopausal women
METHODS:
Randomized-controlled trial
Northern Turkey
Between November 1, 2021, and November 30, 2021
Participants
Gone through menopause naturally in the last year
Intervention
Foot massage once every day for 7 days
No treatment
Study design
The Fatigue Severity Scale (FSS) and the Beck Anxiety Inventory (BAI) were used to assess outcomes
Details of foot massage
One of the researchers was internationally certified
Quiet and comfortable environment with room temperature approximately 23°C to 26°C
Thumb pressure application, swiping, patting, rubbing, and squeezing movements were applied to each foot for 10 minutes same time everyday
Sample size: 70 total based on effect size of 0.40, an error level of 0.05, and a power of 0.95
Primary outcome
Fatigue score
Anxiety score
Sleep hours achieved
RESULTS:
Foot massage: 35 women | Control: 35 women
Women in the control group had lower pretest BAI scores than those in the experimental group (P<0.05)
Preintervention FSS scores and sleep hours were similar between the groups
After the foot massage treatment, women in the intervention group had lower (P
FSS scores
Foot massage: 2.3 (IQR, 1.6 to 3.4)
Control: 5.5 (IQR, 4.6 to 6.2)
BAI scores
Foot massage: 26.0 (IQR, 23.0 to 29.0)
Control: 36.0 (IQR, 31.0 to 43.0)
Women in the foot massage group also achieved a greater number of sleep hours after treatment (P
Foot massage: 8.0 (IQR, 8.0 to 10.0) hours
Control: 7.0 (IQR, 6.0 to 8.0) hours
CONCLUSION:
Postmenopausal women who received foot massage daily achieved a greater number of sleep hours and had lower anxiety and fatigue scores than women who did not receive treatment
Limitations include that data came from a specific geographic region
Previous studies have noted benefits of reflexology
The authors state
In this study, according to the posttest BAI scores of the participants, the anxiety levels of the women who underwent the foot massage intervention were significantly lower than those who did not undergo the intervention
Considering that the anxiety levels of the control group before the intervention were significantly lower than those in the experimental group it may be argued that foot massage applied during menopause is a very effective method of reducing anxiety
Providers keep medical charts for the purpose of providing good care, retaining accurate notes and, when necessary, sharing valuable information with colleagues. Even after a patient has left care, it is not unusual to receive a request for records. Patients may move or there may be important medical history that can help diagnose another family member at some point in the future (e.g., heritable cancer syndromes). Additionally, a well-documented medical record is always the best defense against a medical malpractice lawsuit. As courtroom adage goes, if it isn’t documented, it didn’t happen.
Notes made in the medical record at or near the time of treatment are regarded as highly reliable evidence. Without medical records, healthcare providers might not be able to show what care was provided and whether it met the standard of care. Simply stating the level of care and treatment rendered without providing documentation will often not succeed in a court of law, thus leaving the provider liable for the patient’s alleged injuries.
State and Federal Laws
State and federal laws regarding mandatory record retention requirements for hospitals or similar facilities differ from the laws for physician practices. The retention period for a minor’s records also varies. This variation exists to allow minors to bring suit for medical malpractice after they reach the age of majority for injuries that occurred when they were under age.
Generally, the Medicare Conditions of Participation (COP) require hospitals to retain records for five years (six years for critical access hospitals). HIPAA privacy regulations require records to be retained for six years from when the record was created to adhere to the federal statute of limitations for civil penalties for HIPAA violations. See record retention requirements from the healthit.gov site in ‘Learn More – Primary Sources’ below.
Medical Board and Medical Association Policies and Recommendations
When a direct state or federal law does not specify the retention period for physicians, medical boards may be able to provide policies or recommendations on how long a physician should keep records. For example, the Colorado State Board of Medical Examiners Policy 40-07 requires retaining all patient records for a minimum of 7 years after the last date of treatment, or 7 years after the patient reaches age 18 – whichever occurs later.
Storage and Safety Considerations
With the near mandatory use of electronic medical records, the storage of paper records will slowly be eliminated. However, attendant with the use of EMR comes the ever increasing need to prevent loss of data, or worse, hacking and cyber attacks on the electronic data across all industries. Antiquated infrastructure and uncorrected network vulnerabilities are frequent causes of successful attacks.
How Has Cervical Cancer Incidence Changed Over the Past 10 Years in the US?
BACKGROUND AND PURPOSE:
Incidence of cervical cancer may have plateaued between 2012 and 2017
A decline in cancer screening uptake has been reported, particularly among younger women
Shahmoradi et al. (JAMA, 2022) evaluated calendar trends in cervical cancer incidence by age at diagnosis
METHODS:
Time series data analysis
Data
National Program of Cancer Registries (NPCR) and Surveillance, Epidemiology, and End Results (SEER) from 2001 to 2019
Population
Cervical cancer cases
Study design
Hysterectomy-corrected incidence trends were assessed by removing the proportion of women with hysterectomy from the denominator
For age groups with increasing incidence, trends were examined by race and ethnicity, stage, and histology
Primary outcome
Incidence rates of cervical cancer
Trends in cases
Annual percentage changes (APCs) by 5-year age group
RESULTS:
227,062 reported cervical cancer cases
Overall, hysterectomy-corrected cervical cancer incidence declined
2001: 12.39 per 100,000
2019: 9.80 per 100,000
APC −1.2% (95% CI, −1.6 to −0.9)
Among women aged 30 to 34 years, after an initial decline from 2001 to 2012, incidence increased after 2012
2001: 12.77 per 100,000
2012: 10.14 per 100,000
2019: 11.60 per 100,000
2001 to 2012: APC −2.3% (95% CI, −2.8 to −1.7)
2012 to 2019: APC 2.5% (95% CI, 1.4 to 3.6)
Among this age group, hysterectomy-corrected cervical cancer incidence increased significantly for
Hispanic
APC 3.0% (95% CI, 0.3 to 5.7)
Non-Hispanic White
APC 2.8% (95% CI, 0.6 to 5.0)
Other racial and ethnic groups
APC 5.0% (95% CI, 2.7 to 7.4)
The APC for Black women was relatively stable from 2012 to 2019
APC −0.8% (95% CI, −2.8 to 1.2)
Increases occurred for
Localized stage cervical cancer
APC 2.8% (95% CI, 1.3 to 4.3)
Regional stage cervical cancer
APC 1.9% (95% CI, 0.7 to 3.1)
Squamous cell carcinoma
APC 2.6% (95% CI, 1.0 to 4.2)
Adenocarcinoma
APC 3.0% (95% CI, 0.9 to 5.1)
CONCLUSION:
Cervical cancer rates declined or were stable from 2012 to 2019, except among women aged 30 to 34
Among this age group the incidence increased by 2.5% per year after 2012
Possible Explanations for the Increased Incidence Include Guideline Changes in 2012
Co-testing (HPV and cytology): Could lead to increased detection of early-stage cancers
Increased screening interval: The authors state
In 2012, the US Preventive Services Task Force recommended an increase in screening interval in 21- to 65-year-old women with cytology every 3 years or in 30- to 65-year-old women with a combination of cytology and human papillomavirus testing every 5 years
Beginning in 2013, declines in screening participation among 21- to 29-year-old women were observed
Future studies are needed to assess factors that underlie the increase in cervical cancer incidence among 30- to 34-year-old women
Emergency contraception interventions are intended to prevent an unplanned pregnancy after unprotected or inadequately protected intercourse. Contraceptive failure or failure to use contraception are common indications for use.
CLINICAL ACTIONS:
Offer emergency contraception (EC) to all women who have had unprotected or inadequately protected intercourse and who do not desire pregnancy
There are no exclusionary health conditions –women who have contraindications to oral contraceptives can be given EC
Offer EC to all reproductive-aged women who have sustained sexual assault
No clinical examination or pregnancy testing is necessary
Treatment should be initiated as soon as possible, and should be made available up to 5 days after unprotected or inadequately protected intercourse
If menses are delayed by a week or more, a woman who has received EC should have a pregnancy test and clinical evaluation
EC may be used more than once even in the same menstrual cycle
Regular contraception should be started immediately after EC and women should abstain or use barrier contraception for 14 days or until onset of next menses
Those receiving uripristal acetate should delay starting hormonal contraception until 5 days after use
SYNOPSIS:
All of the methods below are effective only before a pregnancy is established. Hormonal EC does not pose a risk to an established pregnancy and is not associated with embryonal developmental abnormalities. Adverse effects for all of the oral methods include nausea and headache as well as irregular bleeding. Adverse effects for the copper IUD include perforation, changes in menses or dysmenorrhea. Pregnancy rates after EC range from 0% to 2.2% and may be impacted by body weight.
KEY POINTS:
Uripristal acetate, a selective progesterone receptor modulator, is given as a single 30 mg dose
Requires a prescription
Efficacy may be reduced in women with BMI ≥30
Effective up to 5 days after unprotected intercourse
FDA approved for EC
Progestin only EC, either 1 tablet Levonorgestrel in a single dose (1.5 mg) or as a split dose (1 dose of 0.75 mg of levonorgestrel followed by a second dose of 0.75 mg of levonorgestrel 12 hours later)
May be less effective in women with BMI ≥25
1 tablet formulation available over the counter without age restriction
2 tablet formulation available over the counter to women ≥17 years with photo ID
Effective for up to 3 days after unprotected intercourse
FDA approved for EC
Copper IUD insertion
Requires office visit and insertion by a clinician
Efficacy not impacted by body weight
Effective up to 5 days after unprotected intercourse
Safe and effective but not FDA labeled for use as EC
LNG-IUDs “are currently being investigated” (ACOG PB) | Recent RCT suggests LNG-IUD is not inferior to copper IUD (see ‘Related ObG Topics’)
Combined progestin-estrogen pills
Can use a variety of formulations (see ‘Learn More – Primary Sources’ WHO entry below for a list of appropriate formulations)
Two doses every 12 hours
All aim for 100 to 120 micrograms of ethinyl estradiol and 0.5 to 0.6 milligrams of levonorgestrel per dose
Requires a prescription
Effective up to 5 days after unprotected intercourse
Safe and effective but not FDA labeled for use as EC
The nuchal fold (NF) thickness is a measurement performed on prenatal ultrasound, and is the distance from the outer edge of the occipital bone to the outer edge of the skin in the midline. While both measurements are at the level of the fetal head or neck, a nuchal fold thickness, which is only performed in the second trimester, should not be confused with a first trimester nuchal translucency (NT) measurement.
If an enlarged second trimester nuchal fold measurement is obtained, next steps should include
Detailed anatomic study
If isolated finding
Offer NIPS screening (or Quad if NIPS unavailable or too expensive) or diagnostic testing (amniocentesis)
If NIPS is negative, no further aneuploidy evaluation is required
Note: ACOG guidance recommends offering prenatal screening for aneuploidy or invasive, diagnostic testing for all pregnant women regardless of age or aneuploidy risk
SYNOPSIS:
Second trimester thickened nuchal fold has a high specificity for aneuploidy. ACOG and SMFM define an abnormal nuchal fold as ≥ 6mm in the 2nd trimester (typically performed between 15w0d and 22w6d). It is the most powerful second trimester sonographic marker for Trisomy 21.
KEY POINTS:
Can be differentiated from a cystic hygroma by the lack of fluid filled loculations
Trisomy 21 risk is increased by a factor of 17 when the nuchal fold is thickened
Can also be associated with single gene abnormalities
If a CT (computed tomography) scan is being considered or has been ordered and the patient is pregnant, consider the following questions
Would a CT be ordered if the patient was not pregnant?
If the answer to the above is ‘yes’
Is there another option available that would provide the equivalent information on which to base management?
If yes
Consider an MRI, which is a safe alternative to CT imaging in cases where they are equivalent for the diagnosis in question
If no, and there is not an equal or better alternative
CT scan should be performed
Do not withhold associated contrast material if clinically indicated
In addition to a discussion of the risks and benefits with the patient, there are additional resources that can be accessed if necessary, including
Genetic counseling services
Clinical physicists: some centers have these individuals on staff and they can assist in calculating actual radiation dose and risks associated with exposure in pregnancy
SYNOPSIS:
The radiation exposure in pregnancy from CT procedures varies depending on the number and spacing of adjacent imaging sections. It is very unusual for a patient to be exposed to sufficient radiation to cause any significant adverse events. Clinically documented intellectual disability requires at least 610 mGy and growth restriction and anomalies have been reported at levels greater than 50mGy.
KEY POINTS:
Fetal Radiation Dose and CT Exam Type
Dosage levels
Very low-dose exam: 0.1 mGy
Low- to moderate-dose exam: 0.1 on 10 mGy
Higher-dose exam: 10 on 50 mGy
Type of CT Exam
Head or neck CT (very low-dose)
0.001 on 0.01 mGy
Chest CT or CT pulmonary angiography (low- to moderate-dose)
0.01 on 0.66 mGy
Limited CT pelvimetry (low- to moderate-dose)
<1 mGy
Abdominal CT (higher-dose)
1.3 on 35 mGy
Pulmonary Embolism
A CT evaluation of the chest results in a lower dose of fetal exposure to radiation compared with ventilation perfusion scanning
Radiation exposure from a spiral CT is comparable to conventional CT
The most commonly used contrast material is an iodinated media which carries a low risk of adverse effects
Contrast
Should be used only if absolutely required to obtain additional diagnostic information
Breastfeeding can be continued after the use of iodinated contrast material
RCT Results: 6 Weeks vs 3 Months of Rivaroxaban for Isolated Distal DVT
BACKGROUND AND PURPOSE:
Ageno et al. (BMJ, 2022) compared 6 weeks to 3 months of rivaroxaban in patients with symptomatic isolated distal deep vein thrombosis (DVT) for recurrence prevention
Rivaroxaban for the treatment of symptomatic Isolated Distal deep vein ThrombosiS (RIDTS) study
28 centers
Participants
Adults with symptomatic isolated distal DVT
Intervention
Standard dose rivaroxaban for six weeks followed by
Rivaroxaban 20 mg daily for an additional 6 weeks
Placebo daily for an additional 6 weeks
Study design
Follow-up: 24 months from study inclusion
Eligibility
Isolated distal DVT diagnosis ≤72 hours before baseline visit
Any type of parenteral or oral anticoagulant treatment was administered at an intermediate dose (eg, 1 mg/kg once daily for low molecular weight heparin) or therapeutic dose for no more than three days
Patients with cancer associated isolated distal DVT were excluded
Below the knee class II elastic compression stocking in the symptomatic leg and treatment with non-steroidal anti-inflammatory drugs were permitted
There was a reduced risk of the composite for recurrent venous thromboembolism in the additional rivaroxaban group
Additional rivaroxaban: 11%
Placebo: 19%
Relative risk (RR) 0.59 (95% CI, 0.36 to 0.95); P=0.03
Number needed to treat: 13 (95% CI, 7 to 126)
Recurrent isolated distal DVT occurred in fewer patients in the additional rivaroxaban group
Additional rivaroxaban: 8%
Placebo: 15%
P=0.02
There was no different in proximal DVT or pulmonary embolism
Additional rivaroxaban: 3%
Placebo: 4%
P=0.80
There were no major bleeding events
CONCLUSION:
3 months of rivaroxaban vs 6 weeks for treatment of isolated distal DVT reduced the risk of recurrent venous thromboembolism
The risk reduction was mainly through a reduced risk of recurrent isolated distal DVT
There was no increased risk of bleeding with this treatment
The authors state
Compared with placebo, rivaroxaban administered for six additional weeks in patients who completed a six week uneventful period of anticoagulation effectively reduces the risk of recurrent thrombosis over two years without increasing the risk of haemorrhage
The benefit of reduced risk of recurrence and no increased risk of major bleeds was consistent among patient subgroups, such as patients with axial vein thrombosis and patients with unprovoked event
Does Invasive Prenatal Testing in Twins Increase the Risk of Miscarriage?
BACKGROUND AND PURPOSE:
Navaratnam et al. (Prenatal Diagnosis, 2022) determine fetal losses for dichorionic diamniotic (DCDA) and monochorionic diamniotic (MCDA) twin pregnancies following transabdominal CVS or amniocentesis
METHODS:
Retrospective cohort study
6 tertiary fetal medicine centers in the UK and Belgium
Population
Individuals with DCDA or MCDA twin pregnancies
managed between 2000 and 2020
Exposures
Invasive prenatal testing: CVS (11w0d to 22w0d) or amniocentesis (15w0d to 22w0d)
No invasive procedure exposure
Primary outcomes
Overall fetal losses <24w0d
RESULTS:
DCDA fetuses
CVS: 258 fetuses | Controls: 3406
Amniocentesis: 406 | Controls: 3390
MCDA fetuses
CVS: 98 | Controls: 1124
Amniocentesis: 160 | Controls: 1122
There were more losses <24w0d with both procedures for both DCDA and MCDA twins
DCDA
CVS: Relative risk (RR) 5.54 (95% CI, 3.38 to 9.08)
Amniocentesis: RR 2.36 (95% CI, 1.22 to 4.56)
MCDA
CVS: RR 5.14 (95% CI, 2.51 to 10.54)
Amniocentesis: RR 7.01 (95% CI, 3.86 to 12.74)
Losses of normal (genetic and structural) fetuses were nonsignificant compared to controls
DCDA
CVS: RR 0.39 (95% CI, 0.05 to 2.83)
Amniocentesis: RR 1.16 (95% CI, 0.42 to 3.22)
MCDA
CVS: RR 2.3 (95% CI, 0.71 to 7.56)
Amniocentesis: RR 1.93 (95% CI, 0.59 to 6.38)
CONCLUSION:
Fetal loss is more common among both MCDA and DCDA twin pregnancies following invasive prenatal testing
Losses of genetically and structurally normal fetuses were nonsignificant compared to controls
The authors state
The uncertain procedure-related risk to structurally and genetically normal twins persists due to low numbers of adverse outcomes in our cohort and other published analyses
Any counselling should highlight different baseline risks between MCDA and DCDA twins and the contribution of maternal and pregnancy factors to outcomes for complex twin pregnancies
Beyond ARRIVE: Is Elective Induction Associated with Lower Risk of Cesarean in a Community Hospital Setting?
BACKGROUND AND PURPOSE:
Burrows et al. (Journal of Obstetrics and Gynaecology Canada, 2022) determined the impact of offering elective labor induction at 39 weeks in nulliparous, low-risk pregnancies
METHODS:
Retrospective cohort study
Single community hospital in Canada that began offering elective induction at 39 weeks in 2020
Study data includes deliveries between September 2018 and December 2021
Those in induction group had a significantly lower risk of
Cesarean delivery: OR 0.39 (95% CI, 0.15 to 0.99)
Composite adverse maternal outcomes: OR 0.34 (95% CI, 0.12 to 0.97)
Composite adverse perinatal outcomes: OR 0.26 (95% CI, 0.07 to 0.92)
CONCLUSION:
Performing induction of labor at 39 weeks in nulliparous individuals with low-risk pregnancies was associated with decreased risk for cesarean delivery and adverse maternal and perinatal outcomes vs expectant management
The authors state
The obstetricians at BGH found that most of their patients have appreciated having the option of elective induction at 39+ weeks
After an informed discussion of the ARRIVE trial results, and most recently the findings from this study, they approximated that 80% to 90% of their patients are currently opting for planned induction at 39+ weeks
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Disclosure of Unlabeled Use
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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