Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial

Inclusion criteria

• Female
• At least 15 and less than 25 years old at enrolment
• Never given birth
• Resident within the Demographic Surveillance System (DSS) area
• Willing to adhere to the study requirements (including weekly observed drug intake)
• Provision of written informed consent (if non emancipated minor by guardian/parent with minor's assent

Exclusion criteria

• No menses for >3 months and/or palpable uterus or positive pregnancy test if history unclear
• Concurrent enrolment in another study
• Intention to move out of the study area for more than 2 months within the next 18 months
• Any significant illness at the time of screening that requires hospitalization, including clinical signs of severe anaemia (conjunctival or mucosal pallor, tachycardia, respiratory distress)
• History or presence of major clinical disease likely to influence pregnancy outcome (sickle cell disease, diabetes mellitus, severe renal or heart disease, open tuberculosis, epilepsy)