Validation of an ICD-10-based algorithm to identify stillbirth in the Sentinel System.

PURPOSE: To develop and validate an International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM)-based algorithm to identify cases of stillbirth using electronic healthcare data. METHODS: We conducted a retrospective study using claims data from three Data Partners (healthcare systems and insurers) in the Sentinel Distributed Database. Algorithms were developed using ICD-10-CM diagnosis codes to identify potential stillbirths among females aged 12-55 years between July 2016 and June 2018. A random sample of medical charts (N = 169) was identified for chart abstraction and adjudication. Two physician adjudicators reviewed potential cases to determine whether a stillbirth event was definite/probable, the date of the event, and the gestational age at delivery. Positive predictive values (PPVs) were calculated for the algorithms. Among confirmed cases, agreement between the claims data and medical charts was determined for the outcome date and gestational age at stillbirth. RESULTS: Of the 110 potential cases identified, adjudicators determined that 54 were stillbirth events. Criteria for the algorithm with the highest PPV (82.5%; 95% CI, 70.9%-91.0%) included the presence of a diagnosis code indicating gestational age ≥20 weeks and occurrence of either >1 stillbirth-related code or no other pregnancy outcome code (i.e., livebirth, spontaneous abortion, induced abortion) recorded on the index date. We found ≥90% agreement within 7 days between the claims data and medical charts for both the outcome date and gestational age at stillbirth. CONCLUSIONS: Our results suggest that electronic healthcare data may be useful for signal detection of medical product exposures potentially associated with stillbirth.

Comparison of healthcare utilization and outcomes by gestational diabetes diagnostic criteria.

OBJECTIVE: To compare healthcare utilization and outcomes using the Carpenter-Coustan (CC) criteria vs. the National Diabetes Data Group (NDDG) criteria for gestational diabetes mellitus (GDM). METHODS: This is a retrospective cohort study. Prior to 8/21/2013, patients were classified as "GDM by CC" if they met criteria. After 8/21/2013, patients were classified as "GDM by NDDG" if they met criteria and "Meeting CC non-GDM" if they met CC, but failed to reach NDDG criteria. "Non-GDM" women did not meet any criteria for GDM. Records were reviewed after delivery. RESULTS: There was a 41% reduction in GDM diagnosed using NDDG compared to CC (P=0.01). There was no significant difference in triage visits, ultrasounds for growth or hospital admissions. Women classified as "Meeting CC non-GDM" were more likely to have preeclampsia than "GDM by CC" women [OR 11.11 (2.7, 50.0), P=0.0006]. Newborns of mothers "Meeting CC non-GDM" were more likely to be admitted to neonatal intensive care units than "GDM by CC" [OR 6.25 (1.7, 33.3), P=0.006], "GDM by NDDG" [OR 5.56 (1.3, 33.3), P=0.018] and "Non-GDM" newborns [OR 6.47 (2.6, 14.8), P=0.0003]. CONCLUSION: Using the NDDG criteria may increase healthcare costs because while it decreases the number of patients being diagnosed with GDM, it may also increase maternal and neonatal complications without changing maternal healthcare utilization.

Combined hormonal contraception use in reproductive-age women with contraindications to estrogen use.

BACKGROUND: The Centers for Disease Control and Prevention's US Medical Eligibility Criteria for Contraceptive Use recommends that combined hormonal contraceptives (ie, birth control pills, contraceptive patch, vaginal ring) should be avoided in women with specific medical conditions because of the increased risk of cardiovascular events associated with estrogen use. Whether women with category 3 (theoretical or proven risk usually outweigh the advantages) or category 4 (unacceptable health risk) contraindications are appropriately avoiding estrogen-containing combined hormonal contraceptives is unknown. OBJECTIVE: We describe the prevalence of combined hormonal contraceptive use among a sample of reproductive-age women with medical contraindications to estrogen use. Our hypothesis was that women with categories 3 and 4 contraindications would use estrogen-containing contraception less often than women without medical contraindications. We also explored whether inappropriate estrogen-containing contraceptive use is related to contraceptive provider characteristics. STUDY DESIGN: Data are from the baseline survey of the MyNewOptions study, which included privately insured women residing in Pennsylvania aged 18-40 years, who were sexually active and not intending pregnancy in the next year. Women were surveyed about their medical conditions, contraceptive use, and characteristics of their contraceptive provider. Women were considered to have a contraindication to combined hormonal contraceptives if they reported a category 3 or category 4 contraindication: hypertension, smokers older than age 35 years, a history of venous thromboembolism, diabetes with complications, coronary artery disease, systemic lupus erythematosus with antiphospholipid antibodies, breast cancer, or migraine headaches with aura. χ(2) tests for general association were used to compare combined hormonal contraceptives use, contraceptive health provider characteristics, and sociodemographic data in women with and without contraindications to estrogen use. RESULTS: The MyNewOptions baseline study sample included 987 adult women who were mostly young (46% were 18-25 years), white (94%), employed (70%), and married or cohabiting (54%). Thirteen percent (n = 130) of the sample had a medical contraindication to estrogen-containing contraceptive use: migraine with aura (81%) was the most common contraindication, followed by smokers older than age 35 years (7%), hypertension (11%), history of venous thromboembolism (4%), and diabetes with complications (2%). High use of combined hormonal contraceptives was reported among the women with medical contraindications to estrogen at 39% (n = 51). This was not statistically different from women without a medical contraindication (47%, P = .1). Among the 130 women with a contraindication, whether they did or did not use an estrogen-containing contraceptive did not vary by education level, income, or weight category. With respect to their contraceptive prescribers, there were no differences in prescriber specialty, provider type, or clinic type comparing women using and not using an estrogen-containing contraceptive. CONCLUSION: Among this study sample of reproductive-age women, there was a high rate of combined hormonal contraceptive use in women with a medical contraindication to estrogen use. These women may be at an increased risk for cardiovascular events. Processes need to be improved to ensure that women with medical contraindications to estrogen-containing contraception are being offered the safest and most effective methods, including long-acting reversible contraceptives, such as intrauterine devices and the contraceptive implant.

US term stillbirth rates and the 39-week rule: a cause for concern?

BACKGROUND: More than a decade ago an obstetric directive called "the 39-week rule" sought to limit "elective" delivery, via labor induction or cesarean delivery, before 39 weeks 0 days of gestation. In 2010 the 39-week rule became a formal quality measure in the United States. The progressive adherence to the 39-week rule throughout the United States has caused a well-documented, progressive reduction in the proportion of term deliveries occurring during the early-term period. Because of the known association between increasing gestational age during the term period and increasing cumulative risk of stillbirth, however, there have been published concerns that the 39-week rule-by increasing the gestational age of delivery for a substantial number of pregnancies-might increase the rate of term stillbirth within the United States. Although adherence to the 39-week rule is assumed to be beneficial, its actual impact on the US rate of term stillbirth in the years since 2010 is unknown. OBJECTIVE: To determine whether the adoption of the 39-week rule was associated with an increased rate of term stillbirth in the United States. STUDY DESIGN: Sequential ecological study, based on state data, of US term deliveries that occurred during a 7-year period bounded by 2007 and 2013. The patterns of the timing of both term childbirth and term stillbirth were determined for each state and for the United States as a whole. RESULTS: A total of 46 usable datasets were obtained (45 states and the District of Columbia). During the 7-year period, there was a continuous reduction in all geographic entities in the proportion of term deliveries that occurred before 39 weeks of gestation. The overall rate of term stillbirth, when we compared 2007-2009 with 2011-2013, increased significantly (1.103/1000 vs 1.177/1000, RR 1.067, 95% confidence interval 1.038-1.096). Furthermore, during the 7-year period, the increase in the rate of US term stillbirth appeared to be continuous (estimated slope: 0.0186/1000/year, 95% confidence interval 0.002-0.035). Assuming 3.5 million term US births per year, and given 6 yearly "intervals" with this rate increase, it is possible that more than 335 additional term stillbirths occurred in the United States in 2013 as compared with 2007. In addition, during the 7-year period, there was a progressive shift in the timing of delivery from the 40th week to the 39th week. Absent this confounding factor, the magnitude of association between the adoption of the 39-week rule and the increase in rate of term stillbirth might have been greater. CONCLUSIONS: Between 2007 and 2013 in the United States, the adoption of the 39-week rule caused a progressive reduction in the proportion of term births occurring before the 39th week of gestation. During the same interval the United States experienced a significant increase in its rate of term stillbirth. This study raises the possibility that the 39-week rule may be causing unintended harm. Additional studies of the actual impact of the adoption of the 39-week rule on major childbirth outcomes are urgently needed. Pressures to enforce the 39-week rule should be reconsidered pending the findings of such studies.

Management of gestational hypertension - the impact of HYPITATa.

AIMS: The objective of this study was to examine the impact of one trial (the HYPITAT trial) on management of gestational hypertension. STUDY DESIGN: This is a retrospective cohort study of 5077 patients delivered at our institution from 7/1/2008 to 6/15/2011. "Pre-HYPITAT" was defined as 7/1/2008-9/30/2009 and "Post-HYPITAT" as 10/1/2009-6/15/2011. The primary outcome is the rate of delivery intervention for gestational hypertension. Secondary maternal and neonatal outcomes were analyzed in patients with gestational hypertension only. Statistical analyses included the χ2-test, Fisher's exact test, and the two-sample t-test. RESULTS: The rate of delivery intervention Pre-HYPITAT was 1.9%, compared to 4% Post-HYPITAT (P<0.001). There was no significant change in secondary outcomes. CONCLUSION: There was a statistically significant increase in delivery intervention for gestational hypertension at our institution after the publication of the HYPITAT trial. There was no significant change in immediate maternal or neonatal outcomes for patients with gestational hypertension.

Cardiac and Obstetric Outcomes Associated With Mitral Valve Prolapse.

Mitral valve prolapse (MVP) is the most common valvular heart disease in women of reproductive age. Whether MVP increases the likelihood of adverse outcomes in pregnancy is unknown. The study objective was to examine the cardiac and obstetric outcomes associated with MVP in pregnant women. This retrospective cohort study, using the Healthcare Cost and Utilization Project National Readmission Sample database between 2010 and 2017, identified all pregnant women with MVP using the International Classification of Disease, Ninth and Tenth Revisions codes. The maternal cardiac and obstetric outcomes in pregnant women diagnosed with MVP were compared with women without MVP using multivariable logistic and Cox proportional hazard regression models adjusted for baseline demographic characteristics. There were 23,000 pregnancy admissions with MVP with an overall incidence of 16.9 cases per 10,000 pregnancy admissions. Pregnant women with MVP were more likely to die during pregnancy (adjusted hazard ratio 5.13, 95% confidence interval [CI] 1.09 to 24.16), develop cardiac arrest (adjusted odds ratio [aOR] 4.44, 95% CI 1.04 to 18.89), arrhythmia (aOR 10.96, 95% CI 9.17 to 13.12), stroke (aOR 6.90, 95% CI 1.26 to 37.58), heart failure (aOR 5.81, 95% CI 3.84 to 8.79), or suffer a coronary artery dissection (aOR 25.22, 95% CI 3.42 to 186.07) compared with women without MVP. Pregnancies with MVP were also associated with increased risks of preterm delivery (aOR 1.21, 95% CI 1.02 to 1.44) and preeclampsia/hemolysis, elevated liver enzymes, and low platelets syndrome (aOR 1.22, 95% CI 1.05 to 1.41). In conclusion, MVP in pregnancy is associated with adverse maternal cardiac outcomes and higher obstetric risks.

Identification of small for gestational age by population-based and customized growth charts in newborns of obese and normal-weight primiparous women.

OBJECTIVE: Our hypothesis was that newborns of obese mothers would be more likely to be classified as small for gestational age (SGA) by their customized growth curves than by the standard growth curves when compared to newborns of normal-weight mothers. METHODS: This is a retrospective cohort of primiparous patients delivering between 1 July 2008 and 30 June 2012. Normal-weight was defined as BMI ≤25 kg/m(2) and obese as BMI ≥ 30 kg/m(2). Infant birth-weight was characterized as SGA or non-SGA from the Lubchenco curve, the Fenton Preterm Growth Chart, and the customized growth curve. RESULTS: Infants were more likely to be classified as SGA on the customized curve compared with Lubchenco curve. Odds ratio was 2.8 (CI: 1.7-4.4; p = 0.001) for obese women and was 2.9 (CI: 1.7-5.1; p < 0.001) for normal-weight women. Infants were also more likely to be classified as SGA based on the customized curve compared with the Fenton Preterm Growth Curve. The odds ratio was 2.3 (CI: 1.4-3.8; p = 0.001) for obese women and was 1.5 (CI: 1.01-2.33; p = 0.04) for normal-weight women. CONCLUSIONS: Population-based curves may mask SGA in obese women. Our study demonstrates that customized growth curves identify more SGA than population-based growth curves in obese and normal-weight women.