Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
538 participants
OBSERVATIONAL
2022-10-11
2026-01-31
Brief Summary
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Detailed Description
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1. Infants born to RAPIDIRON Trial maternal participants from the intravenous (IV) iron arms will have higher hemoglobin and ferritin levels at birth (determined by cord blood) and at 4 months of age compared to infants born to mothers in the oral arm; and
2. Offspring born to RAPIDIRON Trial participants who received IV iron treatment will have higher developmental quotients (DQs) on the cognitive domain of the Bayley Scales of Infant Development (BSID) at 2 years of age compared to offspring born to RAPIDIRON Trial participants given oral iron treatment.
The specific aims of this study are as follows:
* To provide evidence that a single-dose of IV iron (either ferric carboxymaltose or iron isomaltoside, also known as ferric derisomaltose) given to pregnant women in the second trimester during the RAPIDIRON Trial will prove more effective for prevention of neonatal and postnatal iron deficiency in the offspring than the oral iron given to pregnant women per the parent trial protocol
* To assess if the offspring of women in the parent trial IV iron arms have better neurodevelopmental outcomes compared to the offspring of women treated with oral iron; and
* To determine longer-term hematologic effects in previously randomized mothers by obtaining ongoing hematologic indices, documented history of transfusion and hospitalization, and quality of life based on the use of a validated instrument.
This study will recruit pregnant mothers currently participating in the RAPIDIRON Trial, who will be approached to give consent for themselves and their offspring for participation in the RAPIDIRON-KIDS Study. Participation in RAPIDIRON-KIDS will involve assessments at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months of age. In addition to iron status, anthropometry, and questionnaires relating to child feeding and maternal quality of life, the following neurobehavioral tests will be utilized to assess the offspring at various timepoints: Preferential Looking Test, Ages \& Stages Questionnaire 3, Bayley Scales of Infant Development, Behavioral Rating Scale, India Scale for Assessment of Autism, and the Child Behavior Checklist for Ages 1.5-5.
Please see the protocol for additional details.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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RAPIDIRON IV iron intervention arm 1
Maternal participants in this arm were given a single dose of an IV iron formulation - ferric carboxymaltose - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age.
Ferric carboxymaltose
As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 1 were given a single dose of ferric carboxymaltose between 14 and 17 weeks of pregnancy.
RAPIDIRON IV iron intervention arm 2
Maternal participants in this arm were given a single dose of an IV iron formulation - iron isomaltoside - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age.
Iron isomaltoside
As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 2 were given a single dose of iron isomaltoside between 14 and 17 weeks of pregnancy.
RAPIDIRON active comparator arm
Maternal participants in this arm of the RAPIDIRON Trial were given ferrous sulfate tablets with 60mg elemental iron each and instructed to take two per day (one in the morning and one at night) throughout their pregnancy.
Ferric Sulfate
As part of the RAPIDIRON Trial, maternal participants randomized to the active comparator arm were given 200 ferrous sulfate tablets immediately after randomization (\~12 weeks of pregnancy). Participants were instructed to take two tablets a day, with each tablet containing 60mg elemental iron.
Interventions
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Ferric carboxymaltose
As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 1 were given a single dose of ferric carboxymaltose between 14 and 17 weeks of pregnancy.
Iron isomaltoside
As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 2 were given a single dose of iron isomaltoside between 14 and 17 weeks of pregnancy.
Ferric Sulfate
As part of the RAPIDIRON Trial, maternal participants randomized to the active comparator arm were given 200 ferrous sulfate tablets immediately after randomization (\~12 weeks of pregnancy). Participants were instructed to take two tablets a day, with each tablet containing 60mg elemental iron.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expressed intent of the RAPIDIRON Trial participant to remain in the designated Karnataka research are for delivery and during the follow-up period for the RAPIDIRON-KIDS Study to enable participation in study visits
* For the offspring - live-born singleton infants of Karnataka maternal participants randomized and treated in the RAPIDIRON Trial, if consent is provided by the mother
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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Jawaharlal Nehru Medical College
OTHER
S. Nijalingappa Medical College
UNKNOWN
Raichur Institute of Medical Sciences
UNKNOWN
Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Richard Derman, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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S. Nijalingappa Medical College
Bagalkot, Karnataka, India
Jawaharlal Nehru Medical College
Belagavi, Karnataka, India
Raichur Institute of Medical Sciences
Rāichūr, Karnataka, India
Countries
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References
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Derman RJ, Bellad RB, Bellad MB, Bradford-Rogers J, Georgieff MK, Aghai ZH, Thind S, Auerbach M, Boelig R, Leiby BE, Short V, Yogeshkumar S, Charantimath US, Somannavar MS, Mallapur AA, Pol R, Ramadurg U, Sangavi R, Peerapur BV, Banu N, Patil PS, Patil AP, Roy S, Vastrad P, Wallace D, Shah H, Goudar SS. RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study. Trials. 2023 Dec 20;24(1):818. doi: 10.1186/s13063-023-07740-z.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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R-2111-07169
Identifier Type: -
Identifier Source: org_study_id