Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: Ferric carboxymaltose arm: Dose-up to 1 g
Frequency-Single dose
Route of
administration-Intravenous Duration of
therapy-A single dose administered during 14-17 weeks of pregnancy
Inte
Sponsors
Childrens Investment Fund Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Study Consent for Initial Participation 1. Pregnant women between 18–40 years of age at time of consent that received education about the study and capable of giving informed consent 2. Hemoglobin concentration of 7 – 10.4 g/dL 3. Expressed intent and expectation of remaining in the designated research area during the pregnancy and delivering at a facility in or near the research area and remaining in the area to enable study participation and data collection consistent with the research protocol 4. 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: 1. Presence of a live singleton, intrauterine fetus and dating ultrasound that indicates a pregnancy that, at randomization, would be between the beginning of week 14 and prior to 17 weeks 0 days; 2. Iron deficiency anemia defined for this study as moderate anemia with hemoglobin concentration level between 7 - 9.9 g/dL and serum transferrin saturation (TSAT) is
Exclusion criteria
Exclusion criteria: 1. 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) 2. History of cardiovascular disease, hemoglobinopathy, or other disease or condition con-sidered a contraindication for treatment, including conditions recommended for exclusion by the manufacturers of oral or IV iron to be used in this study 3. Any condition that in the opinion of the consenting physician warrants study exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants who achieve Hb of more than or equal to 11 g/dL at either a 30-34 week antenatal visit or at a birthing facility (comparing each IV iron arm to the oral iron arm) 2. Rate of Low birthweight (less than 2500 gram birthweight) births (comparing each IV iron arm to the oral iron arm)Timepoint: Up to delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal and neonatal mortalityTimepoint: Up to 42 days postpartum;Maternal or neonatal infection including documented COVID-19 infectionTimepoint: Up to 42 days postpartum;Maternal well-being (quality of life)Timepoint: At 42 days postpartum;Mode of delivery and C-sectionTimepoint: At the time of delivery;Need for neonatal resuscitationTimepoint: within 72 hours of birth;Neonatal admissions to an intensive care unitTimepoint: Birth to 28 days of Life;Participant need for “rescue therapy ? due to a drop in Hb level to less than 7 g/dL at any time after randomization and treatmentTimepoint: Up to 42 days postpartum;Possible change in treatment due to less than 1 g/dL improvement in Hb based upon analysis of blood collected at 26-30 weeks of pregnancyTimepoint: Up to 30 weeks of pregnancy;Pregnancy loss and stillbirthsTimepoint: Up to end of pregnancy;Preterm and small for gestational age birthsTimepoint: At the time of delivery;Referral of a study participant to a First Referral Unit or District Hospital with specialized services for thorough assessment of the causes of anemiaTimepoint: Up to 42 days postpartum;Self-reported breastfeeding practicesTimepoint: Up to 42 days postpartum;Time from delivery to cord clampingTimepoint: within 72 hours of birth;Unanticipated or extended hospitalizationsTimepoint: Up to 42 days postpartum;Weight gain of participants by trimester of pregnancyTimepoint: Up to delivery;Antepartum and severe postpartum hemorrhageTimepoint: Up to 42 days postpartum;Birth weight and length of live born babiesTimepoint: Measured within 72 hours post-delivery;Changes in hemoglobin concentration by moderate anemia subgroups (7 - 7.9, 8 - 8.9, and 9 - 9.9 g/dL)Timepoint: Up to delivery;Changes in other iron indices (Transferrin Saturation, Ferritin and Complete Blood Count parameters)Timepoint: Up to 42 days postpartum;Costs associated with clinical outcomes of IDA in pregnancy such as low birth weight, small for gestational age (SGA) and preterm infant | — |
Countries
India
Contacts
Public ContactDr Shivaprasad S Goudar
KLE Academy of Higher Education and Researchs J N Medical College
Outcome results
None listed