Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: India Multiple Micronutrient Supplement (India-MMS): One India-MMS tablet contains Iron 40 mg, Folate 500 mcg, Vitamin A 400 mcg, Vitamin C 65 mg, Vitamin D 400 IU, Thiamine 1.6 mg, Rib
Sponsors
Dr Reddys Laboratories Limited
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: Participants will be enrolled in the study if they meet all the following criteria: 1.Pregnant participants aged 18 years or above 2.Pregnant women attending their antenatal care (ANC) visit at the designated study clinic/site 3.Pregnant women with Normal Hemoglobin (Hb 11.0gm/dl), or diagnosed with mild Anaemia (10 10.9 g/dL) or moderate Anaemia (7 9.9 g/dL). 4.Pregnant women with a gestational age of 9-12 weeks will be screened, as determined by the last menstrual period (LMP) and ultrasonography performed at the day of screening 5.Women intending to reside in the region until at least the time of delivery. Also, women who may be travelling to their native place prior to, or at the time of delivery, and agree to provide their details 6.Women who have provided written informed consent to participate in the study 7.Willingness to comply with study procedures, including follow-up visits and nutritional assessment
Exclusion criteria
Exclusion criteria: Participants will be excluded from participation if they meet any of the following criteria: 1.Diagnosed with severe Anaemia, defined as hemoglobin levels less 7 g/dL 2.Presence of any hemoglobinopathies (e.g., sickle cell disease, thalassemia) 3.Pre-existing medical conditions like uncontrolled diabetes mellitus, uncontrolled hypertension, kidney and liver diseases, cardiac diseases, autoimmune disorders, previous malignancy, immunodeficiency, psychiatric disorders, HIV, Hepatitis B & C etc 4. History of substance abuse (alcohol, tobacco, or illicit drugs) during pregnancy 5. Any contraindication to study interventions as determined by the investigator 6. Known allergy or intolerance to study-related nutritional supplements 7. Participation in any investigational drug or medical intervention trial within the past three months 8. Severe nutritional disorders/ deficiencies or eating disorders that may impact the ability to follow nutritional recommendations 9. Has any gastrointestinal disorders that may affect nutrient absorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of pregnant women with 3rd trimester Anaemia, defined as Hb less than 11g/dlTimepoint: Visit 1 to Visit 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of live births who are SGA defined as having a birthweight below the 10th percentile for the gestational age and sex (based on Intergrowth Chart) Proportion of livebirths with low birth weight, defined as a birthweight less than 2.5 kg Mean change in maternal serum ferritin from baseline till 3rd trimester and baseline to the day of childbirth Mean maternal hemoglobin concentration in 3rd trimester and on the day of childbirth (before delivery) Mean change in maternal hemoglobin concentration from baseline till 3rd trimester and baseline to the day of childbirth Proportion of pregnant women with iron deficiency with inflammation adjusted serum ferritin less than 15 mcg l assessed in the 3rd trimester and on the day of childbirth Proportion of fetal deaths birth at any gestational age that does not breathe or show any sign of life Mean weight length and head circumference of livebirth infantsTimepoint: Visit 7 Visit 7 Visit 1 to visit 6 & Visit 7 Visit 6 & visit 7 Visit 1 to visit 6 & Visit 7 Visit 6 & visit 7 Visit 1 to Visit 7 Visit 7 | — |
Countries
India
Contacts
Public ContactDr Neeraj Prasad
JSS Medical Research Asia Pacific Private Limited,
Outcome results
None listed