Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: PRENATAL TABLET: 1 tab once daily
Control Intervention1: folic acid tablet: folic acid 5 mg OD
duration whole duration of pregancy
Control Intervention2: Folic acid at a dose of 5 mg OD
Sponsors
Fourrts (India) Laboratories Pvt.Limited
Eligibility
Inclusion criteria
Inclusion criteria: Time elapsed from the first day of the last menstrual period (LMP) not more than 8 weeks Singleton live pregnancy Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: Women with severe anemia ( Hb 7g/L) Recent consumption of antifolates (like methotrexate) folic acid antagonists (like valproic acid) or any medications known to interfere with folate absorption as per Investigator s discretion Prior pregnancy with neural tube defect (NTD) or any other congenital defect Diagnosis of neural tube defect (NTD) in the biological father of the fetus or any blood relative of the patient Diagnosis of epilepsy and seizure disorders History of tumor Family history of reproductive organ cancer History of clinically significant complications including renal disease with altered renal function History of any condition that could interfere with folate absorption or metabolism such as clinically significant gastrointestinal disease like chronic diarrhea inflammatory bowel disease partial gastrectomy unresolved gastrointestinal symptoms like diarrhea vomiting steatorrhea Pre existing maternal diabetes or insulin dependent diabetes Alcohol abuse during current pregnancy Illicit drug use during the current pregnancy as per the Investigator s judgment Known allergy hypersensitivity proven inefficiency or contraindications to the study medication any of its excipients or products containing any of the excipients Participation in another clinical trial concurrently or within 30 days before screening Planned participation in any other trial during the entire duration of the study Refusal or inability to comply with the requirements of the protocol for any reason Any other condition in the patient which in the opinion of the Investigator could confound the results of the trial put the patient at undue risk, or make the patient unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in maternal hemoglobin Hb gL from baseline to 20 weeks of gestation in both treatment arms Change in maternal serum niacin nmolL levels from baseline to 20 weeks of gestation in both treatment arms Change in maternal serum folate nmolL levels from baseline to 20 weeks of gestation in both treatment arms Timepoint: To evaluate the effectiveness of L methylfolate niacin and iron based periconceptional supplementation compared to folic acid alone in improving maternal biomarkers related to nutritional status and anemia prevention | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants experiencing maternal side effects (eg fatigue nausea vomiting) till 40 weeks or delivery in both treatment arms Proportion of participants experiencing maternal morbidity outcomes pre eclampsia or eclampsia gestational hypertension premature rupture of membranes placental abruption infection during pregnancy need for blood transfusion) at week 40 or delivery in both treatment arms.Timepoint: Baseline week 0, week 12, week 20,week 32, week 40 or delivery | — |
Countries
India
Contacts
Public ContactPalaniappan N
Sri Ramachandra Institute of Higher education and Research
Outcome results
None listed