TY - JOUR
T1 - Protocol for a multicenter, double-blinded placebo-controlled randomized controlled trial comparing intravenous ferric derisomaltose to oral ferrous sulfate for the treatment of iron deficiency anemia in pregnancy
T2 - The IVIDA2 trial
AU - Lewkowitz, Adam K.
AU - Stout, Molly J.
AU - Carter, Ebony B.
AU - Ware, Crystal F.
AU - Jackson, Tracy L.
AU - D'Sa, Viren
AU - Deoni, Sean
AU - Odibo, Anthony O.
AU - Gopalakrishnan, Riley
AU - Liu, Jingxia
AU - Rouse, Dwight J.
AU - Auerbach, Michael
AU - Tuuli, Methodius G.
N1 - Funding Information:
This study is funded by the NICHD ( R01 HD105855 ; PI: Methodius Tuuli) and supported by an unrestricted grant from Pharmacosmos Therapeutics Inc . (MPI: Methodius Tuuli & Adam Lewkowitz).
Funding Information:
Data Processing: The Data Coordinating Center (DCC) will be responsible for data management and analysis. Data will be collected and managed with REDCap, an established, secure, web-based data capture and management tool developed at Vanderbilt University and supported by the bioinformatics team at WIHRI [28,29]. Refer to Supplement A: Data Processing for more information.This study is funded by the NICHD (R01 HD105855; PI: Methodius Tuuli) and supported by an unrestricted grant from Pharmacosmos Therapeutics Inc. (MPI: Methodius Tuuli & Adam Lewkowitz).The study is funded by the NICHD (R01 HD105855; PI: Methodius Tuuli) and supported by an unrestricted grant from Pharmacosmos Therapeutics Inc. (MPI: Methodius Tuuli & Adam Lewkowitz). Neither NICHD nor Pharmacosmos Therapeutics, Inc has no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of this manuscript and the decision to submit for publication. The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official view of NICHD or Pharmacosmos Therapeutics Inc.
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/12
Y1 - 2022/12
N2 - Background: Iron deficiency anemia (IDA) is common during pregnancy and associated with adverse maternal and neonatal outcomes. Treatment with iron supplementation is recommended during pregnancy, but the optimal delivery route is unclear. Oral iron risks has high risk of gastrointestinal side effects and low absorption. Intravenous iron is infused directly but is expensive. The American College of Obstetricians and Gynecologists currently recommends oral iron to treat IDA in pregnancy with intravenous iron reserved as second-line therapy, if needed. This approach is associated with persistent anemia, increasing the risk of peripartum blood transfusion. We aim to provide data on optimal route of iron repletion for IDA in pregnancy. Methods: In IVIDA2, a double-blind, placebo controlled, multicenter randomized trial in the United States, 746 pregnant people with moderate-to-severe IDA (hemoglobin <10 g/dL and ferritin <30 ng/mL) at 24–28 weeks' gestation will be randomized 1:1 to either a single 1000 mg dose of intravenous ferric derisomaltose and oral placebo (1–3 times daily) or a single placebo infusion with 1–3 times daily 325 mg ferrous sulfate (65 mg elemental iron) tablet. The primary outcome is peripartum blood transfusion (blood transfusion from delivery to 7 days postpartum). Secondary outcomes include adverse medication reactions, maternal and neonatal hematologic indices, and offspring neurodevelopment. Ethics and dissemination: A central ethical review board—Advarra—granted ethical approval (Pro00060930). Participating centers—Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of Ethics and dissemination: A central ethical review board—Advarra—granted ethical approval (Pro00060930). Participating centers—Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of.
AB - Background: Iron deficiency anemia (IDA) is common during pregnancy and associated with adverse maternal and neonatal outcomes. Treatment with iron supplementation is recommended during pregnancy, but the optimal delivery route is unclear. Oral iron risks has high risk of gastrointestinal side effects and low absorption. Intravenous iron is infused directly but is expensive. The American College of Obstetricians and Gynecologists currently recommends oral iron to treat IDA in pregnancy with intravenous iron reserved as second-line therapy, if needed. This approach is associated with persistent anemia, increasing the risk of peripartum blood transfusion. We aim to provide data on optimal route of iron repletion for IDA in pregnancy. Methods: In IVIDA2, a double-blind, placebo controlled, multicenter randomized trial in the United States, 746 pregnant people with moderate-to-severe IDA (hemoglobin <10 g/dL and ferritin <30 ng/mL) at 24–28 weeks' gestation will be randomized 1:1 to either a single 1000 mg dose of intravenous ferric derisomaltose and oral placebo (1–3 times daily) or a single placebo infusion with 1–3 times daily 325 mg ferrous sulfate (65 mg elemental iron) tablet. The primary outcome is peripartum blood transfusion (blood transfusion from delivery to 7 days postpartum). Secondary outcomes include adverse medication reactions, maternal and neonatal hematologic indices, and offspring neurodevelopment. Ethics and dissemination: A central ethical review board—Advarra—granted ethical approval (Pro00060930). Participating centers—Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of Ethics and dissemination: A central ethical review board—Advarra—granted ethical approval (Pro00060930). Participating centers—Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of.
KW - Ferric derisomaltose
KW - Ferrous sulfate
KW - Iron deficiency anemia
KW - Pregnancy
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85141521475&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2022.106992
DO - 10.1016/j.cct.2022.106992
M3 - Article
C2 - 36368479
AN - SCOPUS:85141521475
SN - 1551-7144
VL - 123
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106992
ER -