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

Phase 1

• Conditions: Malaria
• Interventions: Drug: Sulphadoxine-pyrimethamine

• Registration Number: NCT03599596
• Lead Sponsor: University College Hospital, Ibadan

Brief Summary

Randomized controlled prospective comparative study

Detailed Description

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 Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-23
• Last Update Submitted: 2018-07-23
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26
• Study Start: 2018-09-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two doses of sulphadoxine-pyrimethamine	Sulphadoxine-pyrimethamine	500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken twice before delivery
Monthly doses of sulphadoxine-pyrimethamine	Sulphadoxine-pyrimethamine	500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken monthly delivery

Primary Outcome Measures

Name	Time	Method
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).	4 Months	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine.	4 Months	Number of participants having drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine will be noted.