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.
Study design and Patient recruitment
The design is a randomized comparative controlled study. Candidates for the study will be
recruited from the antenatal booking clinic of our institution after being duly informed that
participation is voluntary. Informed consent will be obtained after the purpose, procedure,
benefits, discomfort, risks and precautions associated with the study have been dully
explained to them. Due diligence will be taken in adequately responding to any question or
concern raised about the study. It will fully be explained to them that their participation
is entirely voluntary. Also, if they are unwilling at any point to participate, they will be
completely at liberty to discontinue their participation in the study which will not in any
away affect their further and adequate management in the hospital. It will be explained that
their participation in the study will not have any negative impact on them and their unborn
babies and it has no financial benefits but the outcomes of the study may contribute to
improved antenatal care. However, if there is additional financial cost (though not
immediately foreseen) to any patient outside the cost of routine ANC visit, the investigator
shall arrange for modest compensation. Consented eligible pregnant woman will be recruited
and those enrolled will be alloted into the two groups A and B of SP and Azithromycin
respectively using a computer program (SPSS software version 21, Armonk, NY:IBM) generated
sequence of numbers. Sequentially numbered sealed envelope containing either SP or AZ
labelled will be allotted one after the other to participants. The personnel involved in the
data collection and laboratory staff analyzing the samples will all not be aware of which
group of patient is taking SP or Azithromycin while the doctors involved in administering the
medication and the patients will be aware of which is being administered.
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