Agrawal 2012.
Trial name or title | Impact of 2 oral iron supplementation regimens (intermittently and continuously/daily) for prevention of anaemia in pregnancy in women with normal haemoglobin levels. |
Methods | Randomised controlled trial. Stratified block randomisation with sequentially numbered, sealed, opaque envelopes. |
Participants | 150 apparently healthy pregnant women 19‐40 years of age with normal Hb levels between 13‐16 weeks' gestation attending antenatal care clinic, Department of Obstetrics and Gynecology, Kasturba Medical College, Maniopal, India. Exclusion criteria: suspected acute infection (upper respiratory tract and urinary tract infections, gastroenteritis), pre‐existing chronic illness, like chronic renal disease, hepatic cirrhosis, viral hepatitis, Inflammatory bowel disease, recent blood transfusion, beta‐thalassaemia and other haemoglobinopathies. |
Interventions | Participants will be randomised to 1 of 2 groups: group 1 will receive an oral intake with water of a capsule of Autrin® daily containing 98.6 mg elemental iron (as ferrous fumarate); group 2 will receive oral intake with water of the same capsule Autrin® only during 4 days a week (Monday‐Thursday). Oral iron in both the groups will be continued throughout pregnancy. |
Outcomes | Hb (more than 105 g/L), serum ferritin at 28 and 38 weeks' gestation, side effects of oral iron: nausea, vomiting, constipation, heartburn, diarrhoea, metallic taste, pre‐eclampsia, IUGR in 3rd trimester, preterm labor, birthweight, placenta weight, compliance. |
Starting date | Date of first enrolment: 01/01/2010. Recruitment ongoing. |
Contact information | Nimisha Agrawal Junior Resident Kasturba Medical College, Manipal, Department of Obstetrics and Gynecology, Kasturba Hospital, ManipalL‐576104, Udupi District, Karnataka, India 576104 Phone 0820‐2932600 Email: nimisha_4u@yahoo.co.in |
Notes | Sponsors: Manipal University, Manipal, India and Kasturba Medical College, Manipal, India. Trial registered retrospectively. |