Objective:The objective was to compare the performance of three postpartum hemorrhage risk screening tools with a known patient data set. Design:This is a retrospective secondary data analysis of a parent study whose aim was to develop a novel biomarker for detecting elevated blood loss with childbirth. Setting:A single tertiary care hospital in the United States. Participants:Inclusion criteria for the parent study were ≥ 37 weeks, ≥ 18 years, and pregnancy with one live fetus (no multiples). Eligible participants were identified upon admission to the labor unit and enrolled after informed consent was obtained. Methods/Main Outcome Measures:Statistical analyses were computed using Stata SE, v18. Bivariate associations between binary outcomes and continuous measures were calculated using independent t-tests. Bivariate associations between binary outcomes and categorical measures were calculated using chi-square tests. Results:Recruitment occurred June through September 2021 and included n = 525 participants. When using the American College of Obstetricians and Gynecologists' threshold of ≥ 1000 mL, 13.3% (n = 70) of parturients experienced a hemorrhage. When using the World Health Organization's definition of postpartum hemorrhage of ≥ 500 mL, the prevalence of hemorrhage was 36.8% (n = 193). Sensitivity was highest in identifying hemorrhage with the Association of Women's Health, Obstetric and Neonatal Nurses' tool. When high- and medium-risk scores were considered, the tool had 86% (95% CI: 83.0%-89.0%) accuracy in identifying cases of hemorrhage. This tool also had the highest negative predictive value (78.7%, CI 75.2%-82.2%). Conclusions:The tool with the highest sensitivity and negative predictive values identified 21% of cases as "low risk" that went on to experience blood loss ≥ 500 mL, thus underscoring the need for better predictive models.
OBJECTIVE:To develop and internally validate a practical and data-driven risk-scoring system to predict blood transfusion during hospitalization for delivery in a contemporary U.S. cohort. METHODS:This was a secondary analysis of a multicenter cohort of patients who delivered on randomly selected days at 17 U.S. hospitals (2019-2020). Patients with placenta accreta spectrum were excluded. The primary outcome was any blood transfusion during hospitalization for delivery. Candidate risk factors for transfusion were selected based on relevant literature. A multivariable logistic regression model was developed and internally validated using stratified k-fold (k=5) cross validation with stepwise backward elimination that used significance level of 0.05. Each risk factor included in the final model was assigned a point value by dividing the log of the odds ratio (OR) by the log of the OR of the factor with the lowest value. The summed points for an individual generate a numeric risk score predictive of transfusion. Performance of the risk score to predict transfusion was assessed using the area under the receiver operating curve (AUC). RESULTS:Of 21,780 included individuals, 2.5% (n=545) received a blood transfusion. Factors associated with the highest risk for transfusion in the final model included thrombocytopenia, and placental abruption or significant antepartum bleeding. Risk score outputs among patients in the cohort ranged from 0 to 17 (maximum possible 26) with a corresponding predicted risk for transfusion from 1.0% to 84.4%. The AUC for prediction of transfusion in the validation subsample was 0.81 (95% CI, 0.76-0.85). CONCLUSION:We developed a clinically applicable numeric risk score to predict blood transfusion during hospitalization for delivery. Future work should externally validate this risk-scoring system.
The expanded maternal comorbidity index developed by Leonard et al uses pre-existing maternal health conditions (eg, hypertension, asthma) to produce a risk score that predicts severe maternal morbidity (SMM). This tool has been adopted into clinical and research use without external validation in a data source not reliant on administrative codes. We assessed the validity of the maternal comorbidity index to predict SMM in a modern obstetric cohort using data derived from detailed medical record abstraction. In this secondary analysis of a multicenter cohort of patients delivering at 17 U.S. hospitals (2019-2020), the maternal comorbidity index risk score was applied to all individuals and the performance of the score to predict SMM was assessed using the area under the receiver operating curve (AUC). Of 20,898 individuals in this cohort, 668 (3.2%) experienced SMM. The AUC for the maternal comorbidity index was 0.72 (95% CI, 0.70-0.74) to predict SMM and 0.83 (95% CI, 0.79-0.86) to predict SMM without transfusion. The expanded maternal comorbidity index for prediction of SMM was externally valid, and findings support the ongoing use of this tool.
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality. Uterine atony accounts for most PPH, where myometrial fatigue is a significant and unobservable indictor. OBJECTIVE: The primary aim was to develop an algorithm using non-invasive photoplethysmography (PPG) data to provide intrapartum decision support indicating subjects at high-risk of requiring postpartum nonprophylactic intervention for hemorrhage. The algorithm was designed using machine learning, with the goal to constrain the learning process such that the resulting model targets myometrial fatigue for predicting need for PPH intervention. This study was a primary, prospective, observational study at a single academic hospital. Patients with a live, term singleton pregnancy were eligible upon admission for a non-planned cesarean. A wearable PPG device was placed on the participant’s wrist from active labor through 24 hours postpartum and collected data at 5Hz.The algorithm was designed to recognize PPG waveform signatures that corresponded to specific variations in heart rate timing modeled to correlate with myometrium fatigue. Since myometrial fatigue was not observable, administration ofnonprophylactic uterotonic was recorded as a reference standard. Admission PPH risk score was recorded for each subject as a baseline. PPG data was obtained from 403 participants. Subjects receiving nonprophylactic postpartum uterotonics were labeled as case subjects (190). Subjects were randomly divided into 202 training subjects (87 cases) for designing the algorithm and 201 test subjects (103 cases). Test subject evaluations demonstrated the system could predict PPH intervention 1-6 hours before delivery with a >2.5x improvement in sensitivity (40% vs. 15%) compared to PPH risk score, with no decrease in positive predictive value. Elevated risk for PPH intervention was identified 1 to 6 hours ahead of delivery with significantly higher sensitivity than admission PPH risk scores. Advanced warning for PPH would allow time to mobilize resources for appropriate and timely treatment.
Objective This study aimed to develop a prediction model that estimates the probability that a pregnant person who has had asymptomatic or mild coronavirus disease 2019 (COVID-19) prior to delivery admission will progress in severity to moderate, severe, or critical COVID-19. Study Design This was a secondary analysis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients who delivered from March through December 2020 at hospitals across the United States. Those eligible for this analysis presented for delivery with a current or previous asymptomatic or mild SARS-CoV-2 infection. The primary outcome was moderate, severe, or critical COVID-19 during the delivery admission through 42 days postpartum. The prediction model was developed and internally validated using stratified cross-validation with stepwise backward elimination, incorporating only variables that were known on the day of hospital admission. Results Of the 2,818 patients included, 26 (0.9%; 95% confidence interval [CI], 0.6–1.3%) developed moderate–severe–critical COVID-19 during the study period. Variables in the prediction model were gestational age at delivery admission (adjusted odds ratio [aOR], 1.15; 95% CI, 1.08–1.22 per 1-week decrease), a hypertensive disorder in a prior pregnancy (aOR 3.05; 95% CI, 1.25–7.46), and systolic blood pressure at admission (aOR, 1.04; 95% CI, 1.02–1.05 per mm Hg increase). This model yielded an area under the receiver operating characteristic curve of 0.82 (95% CI, 0.72–0.91). Conclusion Among individuals presenting for delivery who had asymptomatic–mild COVID-19, gestational age at delivery admission, a hypertensive disorder in a prior pregnancy, and systolic blood pressure at admission were predictive of delivering with moderate, severe, or critical COVID-19. This prediction model may be a useful tool to optimize resources for SARS-CoV-2-infected pregnant individuals admitted for delivery. Key Points
BACKGROUND:Recent data in nonpregnant individuals suggest a protective effect of influenza vaccination against SARS-CoV-2 infection and its severity. OBJECTIVES:Our primary objective was to evaluate whether influenza vaccination was associated with COVID-19 severity and pregnancy and neonatal outcomes among those infected with SARS-CoV-2. The secondary objective was to examine the association between influenza vaccination and SARS-CoV-2 infection. STUDY DESIGN:Secondary analysis of a multicenter retrospective cohort of pregnant people who tested positive for SARS-CoV-2 between March and August 2020, and a cohort of random deliveries during the same time period. The associations between 2019 influenza vaccination and the primary outcome of moderate-to-critical COVID-19 as well as maternal and perinatal outcomes were examined among all people who tested positive for SARS-CoV-2 between March and August 2020. The association between 2019 influenza vaccination and having a positive SARS-CoV-2 test was examined among a cohort of individuals who delivered on randomly selected dates between March and August 2020. Univariable and multivariable analyses were performed. RESULTS:Of 2325 people who tested positive for SARS-CoV-2, 1068 (45.9%) were vaccinated against influenza in 2019. Those who received the influenza vaccine were older, leaner, more likely to have private insurance, and identify as White or Hispanic. They were less likely to smoke tobacco and identify as Black. Overall, 419 (18.0%) had moderate, 193 (8.3%) severe, and 52 (2.2%) critical COVID-19. There was no association between influenza vaccination and moderate-to-critical COVID-19 (29.2% vs. 28.0%, adjusted OR 1.10, 95% CI 0.90-1.34) or adverse maternal and perinatal outcomes among those who tested positive. Of 8152 people who delivered in 2020, 4658 (57.1%) received the influenza vaccine. Prior vaccination was not associated with a difference in the odds of SARS-CoV-2 infection (3.8% vs. 4.2%, adjusted OR 0.94, 95% CI 0.74-1.19). CONCLUSION:Prior influenza vaccination was not associated with decreased severity of COVID-19 or lower odds of SARS-CoV-2 infection in pregnancy.
BACKGROUND: Venous thromboembolism accounts for approximately 9% of pregnancy-related deaths in the United States. National guidelines recommend postpartum risk stratification and pharmacologic prophylaxis in at-risk individuals. Knowledge on modern rates of postpartum pharmacologic thromboprophylaxis and its associated risks is limited. OBJECTIVE: This study aimed to describe the rate of, and factors associated with, initiation of postpartum pharmacologic prophylaxis for venous thromboembolism, and to assess associated adverse outcomes. STUDY DESIGN: This was a secondary analysis of a multicenter cohort of individuals delivering on randomly selected days at 17 US hospitals (2019-2020). Medical records were reviewed by trained and certified personnel. Those with an antepartum diagnosis of venous thromboembolism, receiving antepartum anticoagulation, or known SARS-CoV-2 infection were excluded. The primary outcome was use of postpartum pharmacologic thromboprophylaxis. Secondary outcomes included bleeding complications, surgical site infection, hospital readmission, and venous thromboembolism through 6 weeks postpartum. The rate of thromboprophylaxis administration was assessed by mode of delivery, institution, and continuance to the outpatient setting. Multivariable regression models were developed using k-fold cross-validation with stepwise backward elimination to evaluate factors associated with thromboprophylaxis administration. Univariable and multivariable logistic models with propensity score covariate adjustment were performed to assess the association between thromboprophylaxis administration and adverse outcomes. RESULTS: Of 21,114 individuals in the analytical cohort, 11.9% (95% confidence interval, 11.4%-12.3%) received postpartum pharmacologic thromboprophylaxis; the frequency of receipt was 29.8% (95% confidence interval, 28.7%-30.9%) following cesarean and 3.5% (95% confidence interval, 3.2%-3.8%) following vaginal delivery. Institutional rates of prophylaxis varied from 0.21% to 34.8%. Most individuals (83.3%) received thromboprophylaxis only as inpatients. In adjusted analysis, cesarean delivery (adjusted odds ratio, 19.17; 95% confidence interval, 16.70-22.00), hysterectomy (adjusted odds ratio, 15.70; 95% confidence interval, 4.35-56.65), and obesity (adjusted odds ratio, 3.45; 95% confidence interval, 3.02-3.95) were the strongest factors associated with thromboprophylaxis administration. Thromboprophylaxis administration was not associated with surgical site infection (0.9% vs 0.6%; odds ratio, 1.48; 95% confidence interval, 0.80-2.74), bleeding complications (0.2% vs 0.1%; odds ratio, 2.60; 95% confidence interval, 0.99-6.80), or postpartum readmission (0.9% vs 0.3%; adjusted odds ratio, 1.38; 95% confidence interval, 0.68-2.81). The overall rate of venous thromboembolism was 0.06% (95% confidence interval, 0.03%-0.10%) and was higher in those receiving prophylaxis (0.2%) compared with those not receiving prophylaxis (0.04%). CONCLUSION: Approximately 1 in 10 patients received postpartum pharmacologic thromboprophylaxis in this US cohort. Rates of prophylaxis varied widely by institution. Cesarean delivery, hysterectomy, and obesity were predominant factors associated with postpartum thromboprophylaxis administration.
Objective This study aimed to test the hypothesis that being pregnant and delivering during the coronavirus disease 2019 (COVID-19) pandemic was associated with changes in gestational weight gain (GWG) or frequency of small- (SGA) or large-for-gestational-age (LGA) neonates. Study Design Secondary analysis of a multicenter observational cohort comparing pregnant people who delivered during the COVID-19 pandemic (June–December 2020) to people who delivered prior to the pandemic (March–December 2019). Those with multiple gestations, fetuses with major congenital anomalies, implausible GWG values, unavailable body mass index (BMI), or who were severe acute respiratory syndrome coronavirus-2-positive were excluded. The primary outcome was frequency of optimal recommended GWG based on prepregnancy BMI. Neonatal outcomes included birth weight, ponderal index, and frequency of SGA, LGA, and small head circumference for live births. Multivariable regression analysis was used to assess associations between exposure to the pandemic and outcomes. Results A total of 10,717 pregnant people were included in our analysis. A total of 4,225 pregnant people were exposed to the pandemic and 6,492 pregnant people delivered prior to the COVID-19 pandemic. Pregnant people exposed to the pandemic were older and more likely to have gestational diabetes. The frequency of appropriate GWG was 28.0% during the pandemic and 27.6% before the pandemic (adjusted odds ratio [aOR]: 1.02, 95% confidence interval [CI]: 0.93–1.11). Excessive GWG was more likely (54.9 vs. 53.1%; aOR: 1.08, 95% CI: 1.001–1.17), and inadequate GWG was less likely during the pandemic (17.0 vs. 19.3%; aOR: 0.86, 95% CI: 0.77–0.95). The frequency of SGA was 5.4% during the pandemic and 6.1% before the pandemic (aOR: 0.90, 95% CI: 0.76–1.06), and the frequency of LGA was 16.0% during the pandemic versus 15.0% before the pandemic (aOR: 1.06, 95% CI: 0.95–1.18). Other neonatal outcomes including birth weight percentile (62.1 [35.8–83.2] vs. 60.2 [34.4–82.2]; adjusted mean difference (aMD) = 1.50, 95% CI: −0.28 to 3.29), ponderal index (2.6 g/cm3 [2.4–2.8] in both groups; aMD = 0.01, 95% CI: 0.00–0.02), and small head circumference for livebirths (<10th percentile [8.2 vs. 8.1%; aOR: 1.03, 95% CI: 0.89–1.19], <3rd percentile [3.5 vs. 3.1%; aOR: 1.16, 95% CI: 0.93–1.44]) were similar between groups as well. Conclusion Being pregnant and delivering during the COVID-19 pandemic was associated with a higher likelihood of excessive GWG and a lower likelihood of inadequate GWG. Key Points
BACKGROUND: SARS-CoV-2 infection during pregnancy is associated with adverse pregnancy outcomes, including fetal death and preterm birth. It is not known whether that risk occurs only during the time of acute infection or whether the risk persists later in pregnancy.OBJECTIVE: This study aimed to evaluate whether the risk of SARS-CoV-2 infection during pregnancy persists after an acute maternal illness.STUDY DESIGN: A retrospective cohort study of pregnant patients with and without SARS-CoV-2 infection delivering at 17 hospitals in the United States between March 2020 and December 2020. Patients experiencing a SARS-CoV-2-positive test at or before 28 weeks of gestation with a subsequent delivery hospitalization were compared with those without a positive SAR-CoV-2 test at the same hospitals with randomly selected delivery days during the same period. Deliveries occurring at < 20 weeks of gestation in both groups were excluded. The study outcomes included fetal or neonatal death, preterm birth at < 37 weeks of gestation and < 34 weeks of gestation, hypertensive disorders of pregnancy (HDP), any major congenital malformation, and size for gestational age of < 5th or < 10th percentiles at birth based on published standards. HDP that were collected included HDP and preeclampsia with severe features, both overall and with delivery at < 37 weeks of gestation.RESULTS: Of 2326 patients who tested positive for SARS-CoV-2 during pregnancy and were at least 20 weeks of gestation at delivery from March 2020 to December 2020, 402 patients (delivering 414 fetuses or neo-nates) were SARS-CoV-2 positive before 28 weeks of gestation and before their admission for delivery; they were compared with 11,705 patients without a positive SARS-CoV-2 test. In adjusted analyses, those with SARS-CoV-2 before 28 weeks of gestation had a subsequent increased risk of fetal or neonatal death (2.9% vs 1.5%; adjusted relative risk, 1.97; 95% confidence interval, 1.01-3.85), preterm birth at < 37 weeks of gestation (19.6% vs 13.8%; adjusted relative risk, 1.29; 95% confidence interval, 1.02-1.63), and HDP with delivery at < 37 weeks of gestation (7.2% vs 4.1%; adjusted relative risk, 1.74; 95% confidence interval, 1.19-2.55). There was no difference in the rates of preterm birth at < 34 weeks of gestation, any major congenital malformation, and size for gestational age of < 5th or < 10th percentiles. In addition, there was no significant difference in the rate of gestational hypertension overall or preeclampsia with severe features.CONCLUSION: There was a modest increase in the risk of adverse pregnancy outcomes after SARS-CoV-2 infection.
OBJECTIVE:To evaluate whether preterm birth rates changed in relation to the onset of the coronavirus disease 2019 (COVID-19) pandemic and whether any change depended on socioeconomic status. METHODS:This is an observational cohort study of pregnant individuals with a singleton gestation who delivered in the years 2019 and 2020 at 1 of 16 U.S. hospitals of the Maternal-Fetal Medicine Units Network. The frequency of preterm birth for those who delivered before the onset of the COVID-19 pandemic (ie, in 2019) was compared with that of those who delivered after its onset (ie, in 2020). Interaction analyses were performed for people of different individual- and community-level socioeconomic characteristics (ie, race and ethnicity, insurance status, Social Vulnerability Index (SVI) of a person's residence). RESULTS:During 2019 and 2020, 18,526 individuals met inclusion criteria. The chance of preterm birth before the COVID-19 pandemic was similar to that after the onset of the pandemic (11.7% vs 12.5%, adjusted relative risk 0.94, 95% CI 0.86-1.03). In interaction analyses, race and ethnicity, insurance status, and the SVI did not modify the association between the epoch and the chance of preterm birth before 37 weeks of gestation (all interaction P>.05). CONCLUSION:There was no statistically significant difference in preterm birth rates in relation to the COVID-19 pandemic onset. This lack of association was largely independent of socioeconomic indicators such as race and ethnicity, insurance status, or SVI of the residential community in which an individual lived.
OBJECTIVE: Scalable interventions are needed to improve preventive care for those with increased cardiovascular disease (CVD) risk identified during pregnancy. We hypothesized that an automated reminder message for clinicians (nudge) would increase counseling at the postpartum visit on patient transitions of care. METHODS: We conducted a single-center, randomized controlled trial including birthing people with a hypertensive disorder of pregnancy evaluating a nudge compared with usual care. The nudge, including counseling phrases and patient-specific information on hypertensive diagnosis, was sent to the obstetric clinician through the electronic medical record up to 7 days before the postpartum visit. The primary outcome was documentation of counseling on transitions of care to primary care or cardiology. Secondary outcomes were documentation of CVD risk, use of counseling phrases, and preventive care visit within 6 months. A sample size of 94 per group (n=188) was planned to compare the nudge intervention with usual care; given the anticipated loss to follow-up, the sample size was increased to 222. Intention-to-treat analyses were performed, with P<.05 considered significant. RESULTS: From February to June 2021, 392 patients were screened, and 222 were randomized and analyzed. Of these, 205 (92.3%) attended a postpartum visit. Groups were similar, but more women in the usual care group had diabetes (16.1% vs 6.7%, P=.03). After adjustment for diabetes, patients in the nudge group were more likely to have documented counseling on transitions of care (38.8% vs 26.2%, adjusted relative risk [aRR] 1.53, 95% CI 1.02–2.31), CVD risk (21.4% vs 8.4%, aRR 2.57, 95% CI 1.20–5.49), and use of aspirin in a future pregnancy (14.3% vs 1.9%, aRR 7.49, 95% CI 1.66–33.93). Counseling phrases were used more often in the nudge group (11.2% vs 0.9%, aRR 12.27, 95% CI 1.50–100.28). Preventive care visit attendance did not differ by group (22.1% vs 24.6%, aRR 0.91, 95% CI 0.57–1.47). CONCLUSION: A timely electronic reminder to obstetric clinicians improved counseling about transitions of care after hypertensive disorders of pregnancy but did not result in increased preventive care visit attendance. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04660032.
OBJECTIVE: To evaluate whether delivering during the early the coronavirus disease 2019 (COVID-19) pandemic was associated with increased risk of maternal death or serious morbidity from common obstetric complications compared with a historical control period. METHODS: This was a multicenter retrospective cohort study with manual medical-record abstraction performed by centrally trained and certified research personnel at 17 U.S. hospitals. Individuals who gave birth on randomly selected dates in 2019 (before the pandemic) and 2020 (during the pandemic) were compared. Hospital, health care system, and community risk-mitigation strategies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in response to the early COVID-19 pandemic are described. The primary outcome was a composite of maternal death or serious morbidity from common obstetric complications, including hypertensive disorders of pregnancy (eclampsia, end organ dysfunction, or need for acute antihypertensive therapy), postpartum hemorrhage (operative intervention or receipt of 4 or more units blood products), and infections other than SARS-CoV-2 (sepsis, pelvic abscess, prolonged intravenous antibiotics, bacteremia, deep surgical site infection). The major secondary outcome was cesarean birth. RESULTS: Overall, 12,133 patients giving birth during and 9,709 before the pandemic were included. Hospital, health care system, and community SARS-CoV-2 mitigation strategies were employed at all sites for a portion of 2020, with a peak in modifications from March to June 2020. Of patients delivering during the pandemic, 3% had a positive SARS-CoV-2 test result during pregnancy through 42 days postpartum. Giving birth during the pandemic was not associated with a change in the frequency of the primary composite outcome (9.3% vs 8.9%, adjusted relative risk [aRR] 1.02, 95% CI 0.93–1.11) or cesarean birth (32.4% vs 31.3%, aRR 1.02, 95% CI 0.97–1.07). No maternal deaths were observed. CONCLUSION: Despite substantial hospital, health care, and community modifications, giving birth during the early COVID-19 pandemic was not associated with higher rates of serious maternal morbidity from common obstetric complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04519502.
Objective Opioid prescription after cesarean delivery is excessive and can lead to chronic opioid use disorder. We assessed the impact of an enhanced recovery after surgery (ERAS) pathway on inpatient opioid consumption after cesarean delivery. Study Design An ERAS pathway was implemented as a quality improvement initiative in December 2019. Preintervention (PRE) data were collected from March to May 2019 to assess baseline opioid consumption. Postintervention (POST) data were collected from January to March 2020. The primary outcome was inpatient postoperative opioid consumption in morphine milligram equivalents (MME). Secondary outcomes included the consumption of any opioids, postpartum length of stay, and opioid prescription at discharge. Results A total of 92 women were in the PRE group and 91 were in the POST group. Inpatient opioid consumption decreased by 87.3% from PRE to POST, from 124.7 (interquartile range [IQR]: 10-181.6) MME to 15.8 (IQR: 0-75) MME ( p < 0.001). There was no difference in median postpartum length of stay (3.4 days PRE vs. 3.3 days POST; p = 0.12). The proportion of women who did not consume any opioids increased by 75.4% from PRE to POST ( p = 0.02). The proportion of women discharged with an opioid prescription decreased by 25.6% from PRE to POST ( p = 0.007), despite no formal change to prescribing practices. After adjustment for differences in race/ethnicity and gravidity, there was still a reduction in total inpatient opioid consumption ( p < 0.001) and an increase in the proportion of women not consuming any opioids (adjusted relative risk (RR): 2.14, 95% confidence interval [CI]: 1.18-3.87), but the difference in rate of prescription of opioids at discharge was no longer statistically significant (adjusted RR: 0.70, 95% CI: 0.48-1.02). Conclusion Adoption of an ERAS pathway for cesarean delivery resulted in a marked reduction in inpatient opioid consumption. Such a pathway can be implemented across institutions and may be a powerful tool in combating the opioid epidemic.
Importance:It remains unknown whether SARS-CoV-2 infection specifically increases the risk of serious obstetric morbidity. Objective:To evaluate the association of SARS-CoV-2 infection with serious maternal morbidity or mortality from common obstetric complications. Design, Setting, and Participants:Retrospective cohort study of 14 104 pregnant and postpartum patients delivered between March 1, 2020, and December 31, 2020 (with final follow-up to February 11, 2021), at 17 US hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Gestational Research Assessments of COVID-19 (GRAVID) Study. All patients with SARS-CoV-2 were included and compared with those without a positive SARS-CoV-2 test result who delivered on randomly selected dates over the same period. Exposures:SARS-CoV-2 infection was based on a positive nucleic acid or antigen test result. Secondary analyses further stratified those with SARS-CoV-2 infection by disease severity. Main Outcomes and Measures:The primary outcome was a composite of maternal death or serious morbidity related to hypertensive disorders of pregnancy, postpartum hemorrhage, or infection other than SARS-CoV-2. The main secondary outcome was cesarean birth. Results:Of the 14 104 included patients (mean age, 29.7 years), 2352 patients had SARS-CoV-2 infection and 11 752 did not have a positive SARS-CoV-2 test result. Compared with those without a positive SARS-CoV-2 test result, SARS-CoV-2 infection was significantly associated with the primary outcome (13.4% vs 9.2%; difference, 4.2% [95% CI, 2.8%-5.6%]; adjusted relative risk [aRR], 1.41 [95% CI, 1.23-1.61]). All 5 maternal deaths were in the SARS-CoV-2 group. SARS-CoV-2 infection was not significantly associated with cesarean birth (34.7% vs 32.4%; aRR, 1.05 [95% CI, 0.99-1.11]). Compared with those without a positive SARS-CoV-2 test result, moderate or higher COVID-19 severity (n = 586) was significantly associated with the primary outcome (26.1% vs 9.2%; difference, 16.9% [95% CI, 13.3%-20.4%]; aRR, 2.06 [95% CI, 1.73-2.46]) and the major secondary outcome of cesarean birth (45.4% vs 32.4%; difference, 12.8% [95% CI, 8.7%-16.8%]; aRR, 1.17 [95% CI, 1.07-1.28]), but mild or asymptomatic infection (n = 1766) was not significantly associated with the primary outcome (9.2% vs 9.2%; difference, 0% [95% CI, -1.4% to 1.4%]; aRR, 1.11 [95% CI, 0.94-1.32]) or cesarean birth (31.2% vs 32.4%; difference, -1.4% [95% CI, -3.6% to 0.8%]; aRR, 1.00 [95% CI, 0.93-1.07]). Conclusions and Relevance:Among pregnant and postpartum individuals at 17 US hospitals, SARS-CoV-2 infection was associated with an increased risk for a composite outcome of maternal mortality or serious morbidity from obstetric complications.
The American College of Obstetricians and Gynecologists recommends additional antibiotic prophylaxis for cesarean delivery if estimated blood loss (EBL) is >1500 mL and to consider 3 g of cefazolin if maternal weight is >120 kg. Our institutional guidelines recommend 3 g. We previously evaluated adherence to these guidelines at our institution and found poor adherence to recommendations. We implemented a quality improvement (QI) initiative to address these deficiencies and assessed our initial outcomes. Retrospective cohort at a single institution (approximately 5000 deliveries/year) of pre-intervention (10/2016-07/2018) and post-intervention (08/2018-06/2019) cesarean deliveries. Cesarean deliveries were included if: 1) cefazolin was given for prophylaxis and 2) weight > 120 kg or EBL > 1500 mL. A plan-do-study-act cycle was initiated with fishbone analysis identifying points of change. The changes were 1) education on antibiotic dosing to providers, 2) provision of 3g Ancef in operating rooms, and 3) routine discussion of EBL at fascial closure. In 8/2018 we implemented the multi-disciplinary QI initiative. Proportions of deliveries with recommended antibiotics were compared with chi square test and were plotted in p charts monthly (weight) or quarterly (EBL) due to sample size. Special cause rules were applied to assess the effect of the intervention on antibiotic dosing process. In our cohort, 253 deliveries met criteria by weight and 58 by EBL, which represented 4% of deliveries. The proportion receiving recommended antibiotics was higher in the post vs. pre-intervention group for weight (66% vs 20%, p< 0.001) and EBL (82% vs 24%, p< 0.001). Special cause variation was identified for weight (8 consecutive points above the mean, Figure 1) and EBL (1 point above upper confidence limit, Figure 2) indicating successful process change. A multidisciplinary QI initiative resulted in increased adherence to antibiotic prophylaxis guidelines. Future study to assess impact on surgical site infection is needed.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
The Society for Maternal-Fetal Medicine proposed obstetric quality measures in 2017. One measure is documentation prior to hospital discharge of 1) transition to primary care and 2) education on cardiometabolic risks in women with hypertensive disorders of pregnancy (HDP). We evaluated current practice at our institution. Retrospective longitudinal study of women enrolled in a text-based blood pressure program from 9/2018-02/2019. We excluded chronic hypertension without superimposed preeclampsia. We abstracted counseling in the discharge summary and postpartum note from the electronic medical record. We defined counseling as documentation of 1) follow-up with primary care or 2) risk of cardiovascular disease (CVD). A multivariable regression was performed to analyze factors associated with counseling. We then compared the proportion of women counseled on HDP versus contraception at the postpartum visit. The majority of women had gestational hypertension or preeclampsia without severe features (Table 1). Among 317 women, only 5 (1.6%) had counseling on primary care follow-up and 0 (0.0%) on CVD risk in the discharge summary. Postpartum visits were scheduled in our hospital system for 284 women and 251 attended (88.4%). Follow-up with primary care, CVD risk, or both were documented in 64 (25.5%), 21 (8.4%), and 12 (4.8%) notes, respectively. Black race (aOR 2.18, 95% CI 1.03-4.61) and history of HDP (aOR 2.58, 95%CI 1.13-5.86) were positively associated with counseling, while nulliparity (aOR 0.18, 95% CI 0.05-0.67) was associated with decreased odds of counseling (Table 2). Women were significantly more likely to have contraceptive counseling than any HDP counseling (95.2% vs. 29.5%, p< 0.001). Despite consistent evidence on risks of HDP after pregnancy, counseling about those risks is rare in the postpartum period. Improved communication of risks is the first step in improving maternal health in the “fourth trimester”. Guidance for improving counseling on HDP may be drawn from contraceptive counseling practices.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
Objective To analyze the impact of ≥1 major congenital anomaly (CA) on risk and hospitalization for common neonatal morbidities. Study Design Retrospective infant cohort: 241,033 preterm and 3,446,156 term singletons in the US Premier Healthcare database (2006–2013) with up to 1-year follow-up. Discharge records were searched for ≥1 CA and neonatal morbidities. Results Five morbidities demonstrated strong increasing rates as GA decreased. RRs in preterm infants with CAs relative to those without CAs were: RDS (2.17, 95% CI 2.14–2.21), sepsis (2.42, 95% CI 2.37–2.46), apnea (2.04, 95% CI 2.01–2.07), infectious diseases (2.37, 95% CI 2.34–2.41), and hyperbilirubinemia (1.25, 95% CI 1.24–1.26). Median length of NICU stay (days) was consistently longer in infants with ≥1 CA relative to infants without CA during each GA period. Conclusions Preterm infants with ≥1 major CA have increased risk of hospitalization for common morbidities, implying compromised neonatal health regardless of CA type.
Background: Cerebral autosomal dominant arteriopathy with subcortical infarcts leukoencephalopathy (CADASIL) is a hereditary disease characterized by early adult-onset of neurologic manifestations such as migraine, dementia, and stroke. The prevalence of CADASIL is 4.15 per 100 000 adults. Pregnancy and puerperium are associated with worsening of symptoms. Case: We present a 31-year-old G3P0020 patient with a pre-pregnancy diagnosis of CADASIL followed during pregnancy and postpartum period. The patient had a strong family history of CADASIL as well as neurologic symptoms of headaches and vision changes. The patient was started on aspirin and her pregnancy was managed by a multidisciplinary team. She was admitted at 34 weeks for an evaluation of severe headaches and lower limb weakness. She had an uncomplicated cesarean delivery at 39 weeks and an uncomplicated postpartum period.
BACKGROUND:Cell-free deoxyribonucleic acid (DNA) is increasingly being used to screen for fetal aneuploidy. The majority of fetal cell-free DNA in the maternal blood results from release from the syncytiotrophoblast as a result of cellular apoptosis and necrosis. Elevated levels of fetal cell-free DNA may be indicative of underlying placental dysfunction, which has been associated with preterm birth. Preliminary studies have demonstrated that fetal cell-free DNA is increased in pregnancies complicated by spontaneous preterm birth. There are limited data on the association between fetal cell-free DNA levels and fetal fraction and preterm birth in asymptomatic women in the first and second trimesters. Preliminary studies have failed to find an association between first-trimester cell-free DNA levels and preterm birth, whereas there is conflicting evidence as to whether elevated second-trimester cell-free DNA is associated with a subsequent spontaneous preterm birth clinical event.OBJECTIVE:The objective of the study was to evaluate the association between first- and second-trimester cell-free DNA fetal fraction and preterm birth.STUDY DESIGN:This was a retrospective cohort study of women with singleton pregnancies at increased risk for aneuploidy who had cell-free DNA testing at 10-20 weeks' gestation between October 2011 and May 2014. The cohort was subdivided by gestational age at the time of cell-free DNA testing (10-14 weeks or 14.1-20 weeks). The primary outcome was preterm birth less than 37 weeks' gestation, and the secondary outcomes were preterm birth at less than 34 weeks' gestation and spontaneous preterm birth at less than 37 and 34 weeks' gestation.RESULTS:Among 1349 pregnancies meeting inclusion criteria 119 (8.8 %) had a preterm birth prior to 37 weeks with 49 cases (3.6 %) delivering prior to 34 weeks. Whereas there was no significant association between fetal fraction and the preterm birth outcomes for those who underwent cell-free DNA testing at 10-14 weeks' gestation, there were significant associations among those screened at 14.1-20.0 weeks' gestation. Fetal fraction greater than or equal to the 95th percentile at 14.1-20.0 weeks' gestation was associated with an increased risk for preterm birth less than 37 and 34 weeks' gestation (adjusted odds ratio, 4.59; 95% confidence interval, 1.39-15.2; adjusted odds ratio, 22.0; 95% confidence interval, 5.02-96.9).CONCLUSION:Elevated fetal fraction levels at 14.1-20.0 weeks' gestation were significantly associated with an increased incidence of preterm birth. Our findings warrant future exploration including validation in a larger, general population and investigation of the potential mechanisms that may be responsible for the initiation of preterm labor associated with increased fetal cell-free DNA.