Browsing by Author "Aagaard, Kjersti M."

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    Decreasing trend of gastroschisis prevalence in the United States from 2014 through 2022: Is attributed to declining birth rates in young, high-risk gravidae
    (Elsevier, 2025-02-12) Mustafa, Hiba J.; Zargarzadeh, Nikan; Moss, Kevin L.; Abiad, May; Gray, Brian; Aagaard, Kjersti M.; Buchmiller, Terry L.; Perrone, Erin E.; Shamshirsaz, Alireza A.; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public Health
    Objectives: To investigate the prevalence trend of gastroschisis in the United States between 2014 and 2022. Methods: A cross-sectional retrospective analysis of the Centers for the United States live births between 2014 and 2022. Pregnancies and neonatal singleton live births with documented isolated gastroschisis were included. Neonates with other major congenital anomalies and known chromosomal abnormalities were excluded. Prevalence per 10,000 live births along with 95 % confidence intervals was estimated. Results: Among 32,088,301 singleton live births, 6804 cases of isolated gastroschisis were identified (Point prevalence: 2 in 10,000 live births). A significant decline in gastroschisis prevalence was observed, decreasing from 2.86 per 10,000 live births in 2014-1.55 per 10,000 live births in 2022 (P < 0.001). The risk of gastroschisis was significantly higher in teen and nulliparous gravidae, with prepregnancy tobacco use, and among socially vulnerable populations (underweight, < 12th-grade education, Medicaid, non-Hispanic Indigenous Americans). The drop in gastroschisis births from 2014 to 2022, compared to non-gastroschisis births, is more significant in maternal age < 20 years, nulliparous, BMI < 18.5, and in smokers prior to pregnancy than in the overall population (P = 0.02, 0.0008, <0.0001, <0.0001, and 0.01 respectively). All of the associated maternal factors had a significant decline in prevalence (P < 0.001), which may influence the decreasing trend of gastroschisis. There was no perceived considerable impact of the COVID-19 pandemic on gastroschisis trends. Conclusions: The study highlights a notable decline in gastroschisis prevalence mostly attributable to a declining birth rate in the highest at-risk strata, suggesting recent increases in birth rates among these at-risk gravidae may reverse the trend of declining gastroschisis disease prevalence. These findings support the need for ongoing further research to understand effective means of sustaining this decreasing trend.
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    Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial
    (American Medical Association, 2023) Boggess, Kim A.; Valint, Arielle; Refuerzo, Jerrie S.; Zork, Noelia; Battarbee, Ashley N.; Eichelberger, Kacey; Ramos, Gladys A.; Olson, Gayle; Durnwald, Celeste; Landon, Mark B.; Aagaard, Kjersti M.; Wallace, Kedra; Scifres, Christina; Rosen, Todd; Mulla, Wadia; Valent, Amy; Longo, Sherri; Young, Laura; Marquis, M. Alison; Thomas, Sonia; Britt, Ashley; Berry, Diane; Obstetrics and Gynecology, School of Medicine
    Importance: Insulin is recommended for pregnant persons with preexisting type 2 diabetes or diabetes diagnosed early in pregnancy. The addition of metformin to insulin may improve neonatal outcomes. Objective: To estimate the effect of metformin added to insulin for preexisting type 2 or diabetes diagnosed early in pregnancy on a composite adverse neonatal outcome. Design, setting, and participants: This randomized clinical trial in 17 US centers enrolled pregnant adults aged 18 to 45 years with preexisting type 2 diabetes or diabetes diagnosed prior to 23 weeks' gestation between April 2019 and November 2021. Each participant was treated with insulin and was assigned to add either metformin or placebo. Follow-up was completed in May 2022. Intervention: Metformin 1000 mg or placebo orally twice per day from enrollment (11 weeks -<23 weeks) through delivery. Main outcome and measures: The primary outcome was a composite of neonatal complications including perinatal death, preterm birth, large or small for gestational age, and hyperbilirubinemia requiring phototherapy. Prespecified secondary outcomes included maternal hypoglycemia and neonatal fat mass at birth, and prespecified subgroup analyses by maternal body mass index less than 30 vs 30 or greater and those with preexisting vs diabetes early in pregnancy. Results: Of the 831 participants randomized, 794 took at least 1 dose of the study agent and were included in the primary analysis (397 in the placebo group and 397 in the metformin group). Participants' mean (SD) age was 32.9 (5.6) years; 234 (29%) were Black, and 412 (52%) were Hispanic. The composite adverse neonatal outcome occurred in 280 (71%) of the metformin group and in 292 (74%) of the placebo group (adjusted odds ratio, 0.86 [95% CI 0.63-1.19]). The most commonly occurring events in the primary outcome in both groups were preterm birth, neonatal hypoglycemia, and delivery of a large-for-gestational-age infant. The study was halted at 75% accrual for futility in detecting a significant difference in the primary outcome. Prespecified secondary outcomes and subgroup analyses were similar between groups. Of individual components of the composite adverse neonatal outcome, metformin-exposed neonates had lower odds to be large for gestational age (adjusted odds ratio, 0.63 [95% CI, 0.46-0.86]) when compared with the placebo group. Conclusions and relevance: Using metformin plus insulin to treat preexisting type 2 or gestational diabetes diagnosed early in pregnancy did not reduce a composite neonatal adverse outcome. The effect of reduction in odds of a large-for-gestational-age infant observed after adding metformin to insulin warrants further investigation.