Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine

University College Hospital, Ibadan136 enrolled

Overview

Randomized controlled prospective comparative study

This study is intended to be a randomized controlled comparative study conducted to compare the effect of monthly versus two doses of ante-natal intermittent preventive treatment with sulphadoxine-pyrimethamine

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

136

Conditions

Malaria

Interventions

Sulphadoxine-pyrimethamineDRUG

Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly until delivery

Sulphadoxine-pyrimethamineDRUG

Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets twice before delivery

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women * Gestational age between 16 and 28weeks. * No history of use of sulphadoxine-pyrimethamine prior to recruitment * Not on any medication for prophylaxis Exclusion Criteria: * Anaemia * HIV positive women * Pre-existing medical conditions e.g diabetes mellitus, haemoglobinopathy, hypertension, kidney disease, heart disease, any endocrine disorder like hypo/hyperthyroidism, Cushing' disease, connective tissue disorders like systemic lupus erythematosus, antiphospholipid syndrome or any otherautoimmune disease with poor feto-maternal outcomes in pregnancy. * History of Glucose -6-Phosphate Dehydrogenase (G6PD) deficiency in patient * Allergy to sulphonamides or pyrimethamine. * Non consenting patients * Multiple gestations

Outcomes

Primary Outcomes

Level of malaria parasitemia among pregnant women with monthly doses of sulphadoxine-pyrimethamine as compared to pregnant women with 2 doses of Intermittent Preventive Treatment of Malaria during Pregnancy with Sulphadoxine-Pyrimethamine (IPTp-SP).

Number of participants with high level of malaria parasitemia in monthly doses of sulphadoxine-pyrimethamine group will be compared with the number of participants in 2 doses of IPTp-SP group.

Time frame: 4 Months

Secondary Outcomes

Prevalence of drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine.

Number of participants having drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine will be noted.

Time frame: 4 Months

Data from ClinicalTrials.gov

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