Browsing by Author "Battarbee, Ashley N."

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    Breastfeeding patterns among parturients with diabetes: a secondary analysis of the MOMPOD randomized clinical trial
    (Wiley, 2025) Sarker, Minhazur; Jacobs, Marni B.; Boggess, Kim; Battarbee, Ashley N.; Refuerzo, Jerrie; Zork, Noelia; Eichelberger, Kacey; Durnwald, Celeste; Landon, Mark; Aagaard, Kjersti; Wallace, Kedra; Scifres, Christina; Longo, Sherri; Stuebe, Alison; Ramos, Gladys A.; Obstetrics and Gynecology, School of Medicine
    Introduction: Insulin resistance is associated with decreased milk supply in lactating people. Metformin is hypothesized to increase breast milk production by decreasing insulin resistance, suggesting use may increase breastfeeding success. We aimed to determine the association between metformin use during pregnancy and breastfeeding initiation and continuation. Methods: This was a secondary analysis of the MOMPOD randomized controlled trial of metformin versus placebo in addition to insulin therapy among pregnant people with type 2 diabetes and early diabetes. We included parturients who delivered a living neonate, received at least one dose of study drug or placebo, endorsed an intention to breastfeed, and completed a breastfeeding survey. Breastfeeding intentions and breastfeeding outcomes were collected utilizing a breastfeeding questionnaire at 24-30 weeks and 30-days postpartum respectively. The primary outcome was breastfeeding at 30-days postpartum defined by exclusive or partial breastfeeding. Secondary outcomes included immediate breastfeeding defined as any breastfeeding during the postpartum hospital admission until at least postpartum day 3, onset of lactogenesis (days), breast and bra size, and breastfeeding challenges. Baseline characteristics and outcomes were compared using chi-square, t-test, or Wilcoxon tests, as appropriate. Results: Among the 794 women randomized and receiving either placebo or metformin in the primary trial, 378 (47.6%) met inclusion criteria with 194 (51.3%) in metformin and 184 (48.7%) in placebo groups. There were no significant differences in baseline characteristics. Immediate breastfeeding was comparable between groups (91.1% vs 88.9%, p=0.53) and there was no difference in onset of lactogenesis. Thirty days postpartum, breastfeeding rates were lower among all parturients and there was no difference between metformin and placebo groups (76.0% vs 66.7%, p=0.11). Also, there were no differences in partial or exclusive breastfeeding, breast cup or bra size, or breastfeeding challenges. Conclusion: Our data suggest no association between metformin use and breastfeeding patterns in those with type 2 or early diabetes in pregnancy. Antepartum metformin should not be recommended solely to improve breastfeeding success.
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    Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study
    (BMJ, 2024-02-29) Scifres, Christina M.; Battarbee, Ashley N.; Feghali, Maisa N.; Pierce, Stephanie; Edwards, Rodney K.; Smith, Emily M.; Guise, David; Bhamidipalli, Sruthi; Daggy, Joanne; Tuuli, Methodius G.; Obstetrics and Gynecology, School of Medicine
    Introduction: The prevalence of both obesity and gestational diabetes mellitus (GDM) has increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy and caesarean delivery. Women with GDM who are also overweight or obese have higher rates of pregnancy complications when compared with normal-weight women with GDM, which may occur in part due to suboptimal glycaemic control. The current recommendations for glycaemic targets in pregnant women with diabetes are based on limited evidence and exceed the mean fasting (70.9±7.8 mg/dL) and 1-hour postprandial (108.9±12.9 mg/dL) glucose values in pregnant individuals without diabetes. Our prior work demonstrated that the use of intensive (fasting <90 mg/dL and 1-hour postprandial <120 mg/dL) compared with standard (fasting <95 mg/dL and 1-hour postprandial <140 mg/dL) glycaemic targets resulted in improved glycaemic control without increasing the risk for hypoglycaemia in pregnant individuals with GDM, but the impact of intensive glycaemic targets on perinatal outcomes is unknown. Methods and analysis: The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomised clinical trial designed to investigate the impact of intensive versus standard glycaemic targets on perinatal outcomes in women with GDM who are overweight and obese. During the 5-year project period, a multidisciplinary team of investigators from five medical centres representing regions of the USA with high rates of obesity will randomise 828 overweight and obese women with GDM to either intensive or standard glycaemic targets. We will test the central hypothesis that intensive glycaemic targets will result in lower rates of neonatal composite morbidity including large for gestational age birth weight, neonatal hypoglycaemia, respiratory distress syndrome and need for phototherapy when compared with standard glycaemic targets using the intention-to-treat approach to analysis. Ethics and dissemination: The Institutional Review Board (IRB) at Indiana University School of Medicine approved this study (IRB# 11435; initial approval date 25 August 2021). We will submit the results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings.
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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.