Pregnancy Clinical Trial
Official title:
Randomized Controlled Trial of Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Prophylaxis Against Malaria in Pregnancy (IPT)
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.
Status | Not yet recruiting |
Enrollment | 168 |
Est. completion date | January 31, 2020 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Nigeria | FMCOWO | Owo | Ondo |
Lead Sponsor | Collaborator |
---|---|
Federal Medical Centre, Owo |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | low birth weight | number of low birthweight babies among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy | at the time of delivery | |
Primary | malaria parasitaemia during pregnancy | number of pregnant women with maternal peripheral blood parasitaemia during pregnancy among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy | through study completion, an average of 6 months | |
Secondary | malaria parasitaemia at the point of delivery | number of pregnant women with maternal peripheral blood and placental parasitaemia, number of new born with cord blood parasitaemia at birth among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy | at the time of delivery |
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