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

Study Overview
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Brief Summary
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Randomized controlled prospective comparative study

Detailed Description
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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

Official Title
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Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine in University College Hospital

Conditions
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Malaria

Intervention / Treatment
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* Drug: Sulphadoxine-pyrimethamine
* Drug: Sulphadoxine-pyrimethamine


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Two doses of sulphadoxine-pyrimethamine<br>500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken twice before delivery | Drug: Sulphadoxine-pyrimethamine<br>* Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly until delivery<br>* Other names: Vitadar;|
| Active Comparator: Monthly doses of sulphadoxine-pyrimethamine<br>500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken monthly delivery | Drug: Sulphadoxine-pyrimethamine<br>* Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets twice before delivery<br>* Other names: Vitadar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 Months |