Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP)
Status:
Unknown status
Trial end date:
2020-01-31
Target enrollment:
Participant gender:
Summary
AZITHROMYCIN VERSUS SULPHADOXINE-PYRIMETHAMINE FOR PROPHYLAXIS AGAINST MALARIA IN PREGNANCY
IN OWO, SOUIHWESTERN NIGERIA: A RANDOMISED CONTROLLED TRIAL
OBJECTIVE: This study is to compare the efficacy of Azithromycin versus
sulphadoxine-pyrimethamine as options of chemoprophylaxis against malaria in pregnancy.
METHOD: This is a randomized controlled trial with parallel assignment that will be conducted
in the Obstetrics and Gynaecology department of the Federal Medical Centre. One hundred and
sixty four (164) pregnant women who are eligible will be randomly allocated to 2 groups (A
and B) of 84 each, using computer generated random numbers. Group A will receive
sulfadoxine-pyrimethamine for malaria prophylaxis while Group B will receive azithromycin.
All other aspects of antenatal care till delivery will be the same for all the women
recruited. Maternal venous blood samples for malaria parasitaemia will be collected on
recruitment and repeated at follow-up visits at any gestation there are symptoms of malaria;
maternal peripheral blood film, placental and cord blood samples will be collected at
delivery. All data will be documented in the data collection sheet. The results obtained will
be subjected to statistical analysis using statistical package for social sciences (SPSS)
version 21, Armonk, NY:IBM. The level of significance will be set at 5%. Outcomes will be
compared across groups using Chi-square.
Phase:
N/A
Details
Lead Sponsor:
Federal Medical Centre, Owo
Treatments:
Azithromycin Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine