Browsing by Author "Aagaard, Kjersti"

Now showing 1 - 3 of 3
  • Thumbnail Image
    Item
    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.
  • Thumbnail Image
    Item
    Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial
    (Elsevier, 2023) Martin, Samantha L.; Allman, Phillip H.; Dugoff, Lorraine; Sibai, Baha; Lynch, Stephanie; Ferrara, Jennifer; Aagaard, Kjersti; Zornes, Christina; Wilson, Jennifer L.; Gibson, Marie; Adams, Molly; Longo, Sherri A.; Staples, Amy; Saade, George; Beche, Imene; Carter, Ebony B.; Owens, Michelle Y.; Simhan, Hyagriv; Frey, Heather A.; Khan, Shama; Palatnik, Anna; August, Phyllis; Irby, Les'Shon; Lee, Tiffany; Lee, Christine; Schum, Paula; Chan-Akeley, Rosalyn; Duhon, Catera; Rincon, Monica; Gibson, Kelly; Wiegand, Samantha; Eastham, Donna; Oparil, Suzanne; Szychowski, Jeff M.; Tita, Alan; Chronic Hypertension and Pregnancy Consortium; Obstetrics and Gynecology, School of Medicine
    Background: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. Objective: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. Study design: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. Results: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. Conclusion: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.
  • Thumbnail Image
    Item
    Treatment for Mild Chronic Hypertension during Pregnancy
    (Massachusetts Medical Society, 2022) Tita, Alan T.; Szychowski, Jeff M.; Boggess, Kim; Dugoff, Lorraine; Sibai, Baha; Lawrence, Kirsten; Hughes, Brenna L.; Bell, Joseph; Aagaard, Kjersti; Edwards, Rodney K.; Gibson, Kelly; Haas, David M.; Plante, Lauren; Metz, Torri; Casey, Brian; Esplin, Sean; Longo, Sherri; Hoffman, Matthew; Saade, George R.; Hoppe, Kara K.; Foroutan, Janelle; Tuuli, Methodius; Owens, Michelle Y.; Simhan, Hyagriv N.; Frey, Heather; Rosen, Todd; Palatnik, Anna; Baker, Susan; August, Phyllis; Reddy, Uma M.; Kinzler, Wendy; Su, Emily; Krishna, Iris; Nguyen, Nicki; Norton, Mary E.; Skupski, Daniel; El-Sayed, Yasser Y.; Ogunyemi, Dotum; Galis, Zorina S.; Harper, Lorie; Ambalavanan, Namasivayam; Geller, Nancy L.; Oparil, Suzanne; Cutter, Gary R.; Andrews, William W.; Chronic Hypertension and Pregnancy (CHAP) Trial Consortium; Obstetrics and Gynecology, School of Medicine
    Background: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth. Methods: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth. Results: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99). Conclusions: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight.