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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federal Medical Centre, Owo
• Treatments: Azithromycin; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• booked pregnant women

• Consent for the study

• Availability for follow-up during the pregnancy by keeping the next ANC appointment

• Willingness to deliver at the study site

• Age ≥ 18years

• comply with use of IPT-SP or Azithromycin medication as required by the study

Exclusion Criteria:

• Women treated for malaria in the index pregnancy

• Women who are severely ill (have medical conditions requiring hospital admission)

• Women who report prior adverse drug reaction to sulpha-containing medications and Azithromycin

• Patients with multiple gestations, sickle cell disease, HIV, IUGR and APH

• Women who did not want to participate in the study

• Age <18years