HIV/AIDS Pregnancy and Childbirth
Conditions
Interventions
Selenium
Placebo
Sponsors
College of Medicine University of Lagos
Lagos University Teaching hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 15 to 49 years 2. Singleton gestation at 14 to 26 weeks’ gestation 3. On antiretroviral treatment (ART) for at least 3 months prior to enrolment.
Exclusion criteria
Exclusion criteria: 1. Multiple Gestations 2. Significant renal and hepatic impairment 3. An expected delivery date beyond March 2019 4. Mid-trimester pregnancy loss in the index pregnancy 5. Receipt of a long course of a mineral supplement containing selenium during the 6 months prior to enrolment 6. Refusal of consent at enrolment or withdrawal of consent during the study 7. Failure to receive the study intervention (selenium or placebo) for a cumulative period of at least 8 weeks before delivery. 8. To be excluded in the final analysis of the primary end-points (see below) are women who delivered by Caesarean section or those who had iatrogenic preterm delivery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preterm delivery ;Low birth weight in term neonates. | — |
Secondary
| Measure | Time frame |
|---|---|
| HIV disease progression (Change in CD4+ cells count, viral load and stage of the disease);Change in Haemoglobin levels;Adverse events (AE);Perinatal mortality. | — |
Countries
Nigeria
Contacts
Public ContactKehinde Okunade
Lecturer
Outcome results
None listed