Iron Deficiency Anemia Clinical Trial
— RAPIDIRONOfficial title:
Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial
Verified date | May 2024 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. Anemia rates are among the highest in South Asia, with a recent national survey indicating that over half of pregnant women in India are classified as anemic. For nearly 40 years, India's first-level treatment for anemia in pregnancy has been oral iron; however, side effects, poor adherence to tablet ingestion, and low therapeutic impact are among reasons to consider a new paradigm for treatment of pregnant women with iron deficiency anemia (IDA). Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial is a 3-arm, randomized-controlled trial designed to assess if a single dose of an intravenous (IV) iron formulation, administered early in the second trimester of pregnancy for treatment of moderate IDA, will result in a greater proportion of participants in the IV iron arms achieving a normal hemoglobin concentration in the third trimester when compared to participants randomized to receive oral iron. This trial is also designed to test the hypothesis that the low birth weight (LBW) rate for participants randomized to the IV iron arms will be lower when compared to the LBW rate of those randomly assigned to the oral iron arm. The three arms include two IV iron arms (arm 1 - ferric carboxymaltose, arm 2 - iron isomaltoside, also known as ferric derisomaltose) and an active, comparator arm receiving oral iron, which is the standard of care. This study will be conducted in two states in India - Karnataka and Rajasthan. This study supports the overall goals of the Indian Ministry of Health and Family Welfare for pregnancy care; thus, all study participants will be followed according to the Ministry's antenatal care guidelines, and data will be collected through 42 days post-delivery. (see attached protocol for more detail)
Status | Completed |
Enrollment | 4368 |
Est. completion date | January 21, 2024 |
Est. primary completion date | December 14, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria for Study Consent for Initial Participation: - Pregnant women between 18-40 years of age at time of consent that received education about the study and were capable of giving informed consent; - Hemoglobin concentration of 7 - 10.4 g/dL; - Expressed intent and expectation of remaining in the designated research area during pregnancy and delivering in a facility in or near the research area and remaining in the area to enable study participant and data collection consistent with the research protocol; - Expressed willingness that specifically includes agreement to randomization to the standard care study arm (of oral iron) or to one of the two arms involving treatment with single-dose IV iron. Additional Inclusion Criteria for Randomization and Continued Study Participation: - Iron deficiency anemia, defined for this study as moderate anemia with hemoglobin concentration level between 7 - 9.9 g/dL, serum transferrin saturation (TSAT) <20%, and/or ferritin <30 ng/mL; - Presence of a live, singleton, intrauterine fetus and dating ultrasound (at visit #2) that indicates a pregnancy that, at randomization, would be between the beginning of week 14 and prior to 17 weeks 0 days. Exclusion Criteria: - Fetal anomaly, if detectable when an initial ultrasound is done to date the pregnancy (subsequent discovery of a fetal anomaly is not viewed as an exclusion criterion); - History of cardiovascular disease, hemoglobinopathy, or other disease or condition considered a contraindication for treatment, including conditions recommended for exclusion by the manufacturers of oral or IV iron to be used in this study; - Any condition that, in the opinion of the consenting physician, warrants study exclusion. |
Country | Name | City | State |
---|---|---|---|
India | S. Nijalingappa Medical College | Bagalkot | Karnataka |
India | Jawaharlal Nehru Medical College | Belgaum | Karnataka |
India | Sawai Man Singh Medical College | Jaipur | Rajasthan |
India | Raichur Institute of Medical Sciences | Raichur | Karnataka |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University | Children's Investment Fund Foundation, Jawaharlal Nehru Medical College, Raichur Institute of Medical Sciences, S. Nijalingappa Medical College, Sawai Mansingh Medical College |
India,
electronic medicines compendium (emc). Ferinject (ferric carboxymaltose). Retrieved 30 July 2020 from: https://www.medicines.org.uk/emc/product/5910/.
electronic medicines compendium (emc). Monofer 100mg/ml solution for injection/infusion. Retrieved 30 July 2020 from: https://www.medicines.org.uk/emc/product/5676/smpc.
International Institute for Population Sciences (IIPS). National Family Health Survey-5, 2019-21, India Fact Sheet. Retrieved 8 February 2022 from: http://rchiips.org/nfhs/NFHS-5_FCTS/India.pdf.
Ministry of Health and Family Welfare, Government of India. (April 2018). Anemia Mukt Bharat - Intensified National Iron Plus Initiative (I-NIPI) - Operational Guidelines for Programme Managers. Retrieved 13 April 2022 from: https://anemiamuktbharat.info/wp-content/uploads/2019/09/Anemia-Mukt-Bharat-Operational-Guidelines-FINAL.pdf.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | An independent cost-effectiveness analysis will be conducted by an expert in the field with a background in health economics and the cost-effectiveness of health care interventions. | This analysis will compare costs of administration of each IV iron formulation used in this study versus oral iron therapy, taking into consideration costs associated with clinical outcomes of IDA in pregnancy. | After randomization to 42 days post-delivery | |
Primary | Return to non-anemic status in the last trimester of pregnancy | Return to non-anemic status, defined as hemoglobin concentration =11 g/dL, measured at either a 30-34 week antenatal visit or prior to delivery | 30-34 week antenatal visit or prior to delivery | |
Primary | Low birth weight (<2500 grams) deliveries | Low birth weight (<2500 grams) deliveries | Delivery/birth | |
Secondary | Changes in hemoglobin concentration by moderate anemia subgroups | Changes in hemoglobin concentration will be analyzed by moderate anemia subgroups according to baseline hemoglobin (i.e., 7-7.9, 8-8.9, and 9-9.9 g/dL) | 30-34 week antenatal visit or prior to delivery | |
Secondary | Changes in transferrin saturation | Changes in transferrin saturation measured as a ratio of serum iron to total iron-binding capacity (%). | After randomization to 42 days post-delivery | |
Secondary | Changes in ferritin | Changes in ferritin measured in ng/mL. | After randomization to 42 days post-delivery | |
Secondary | Changes in offspring hemoglobin measured from cord blood | Changes in offspring hemoglobin concentration from cord blood measured in g/dL | Delivery/birth | |
Secondary | Offspring transferrin saturation from cord blood | Transferrin saturation measured as a ratio of serum iron to total iron-binding capacity (%). | Delivery/birth | |
Secondary | Offspring ferritin from cord blood | Measured in ng/mL. | Delivery/birth | |
Secondary | Weight gain | Weight gain of participants by trimester of pregnancy | After randomization to delivery | |
Secondary | Mode of delivery/incidence of c-section | Mode of delivery, incidence of c-section deliveries | Delivery/birth | |
Secondary | Incidence of hemorrhage | Incidence of antepartum and severe postpartum hemorrhage | Delivery/birth | |
Secondary | Incidence of hypertensive disorders | Hypertensive disorders | After randomization to 42 days post-delivery | |
Secondary | Incidence of maternal infections | Maternal infections, including documented COVID-19 | After randomization to 42 days post-delivery | |
Secondary | Incidence of neonatal infections | Neonatal infections, including documented COVID-19 | After randomization to 42 days post-delivery | |
Secondary | Incidence of maternal mortality | Maternal death | After randomization to 42 days post-delivery | |
Secondary | Incidence of neonatal mortality | Neonatal death | After randomization to 42 days post-delivery | |
Secondary | Incidence of pregnancy loss and stillbirth | Pregnancy losses and stillbirths | After randomization to delivery | |
Secondary | Newborn length | Birth length of newborns measured in cm | Measured within 72 hours of delivery | |
Secondary | Newborn weight | Birth weight of newborns measured in grams | Measured within 72 hours of delivery | |
Secondary | Incidence of neonatal resuscitation | Neonatal resuscitations | Within 72 hours of birth | |
Secondary | Incidence of neonatal admissions to an intensive care unit | Neonatal admissions to intensive care units within 28 days of delivery | Birth to 28 days of life | |
Secondary | Time from delivery to cord clamping | Time from delivery to umbilical cord clamping | Within 72 hours of birth | |
Secondary | Incidence of unscheduled healthcare visits | Maternal unscheduled healthcare/hospital visits or extended hospitalizations | After randomization to 42 days post-delivery | |
Secondary | Incidence of breastfeeding | Breastfeeding and exclusive breastfeeding practices, as self-reported by mothers at the 42 day postpartum visit | 42 days after delivery | |
Secondary | Well-being/quality of life | Maternal well-being/quality of life, as measured by the World Health Organization Disability Assessment Schedule II (WHODAS-II) | 42 days after delivery | |
Secondary | Incidence of need for 'rescue therapy' | Incidence of need for 'rescue therapy' or measures implemented for management of severe anemia if a participant's hemoglobin drops below 7 g/dL | After randomization to delivery | |
Secondary | Referral for evaluation due to little improvement | Incidence of referral of a participant, regardless of study arm, to a higher level of care for further investigation of causes of anemia and consideration of possible change in treatment approach due to a <1 g/dL improvement in hemoglobin concentration after at least 2 months from initiation of the randomly assigned treatment, based on analysis of blood drawn at a study monitoring visit at 26-30 weeks of pregnancy | 26-30 weeks of pregnancy | |
Secondary | Incidence of preterm and small for gestational age births | Preterm and small for gestational age births | Delivery/birth |
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