Malaria Clinical Trial
Official title:
Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine in University College Hospital
| Verified date | July 2018 |
| Source | University College Hospital, Ibadan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Randomized controlled prospective comparative study
| Status | Not yet recruiting |
| Enrollment | 136 |
| Est. completion date | February 1, 2019 |
| Est. primary completion date | December 1, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University College Hospital, Ibadan |
Agomo CO, Oyibo WA, Odukoya-Maije F. Parasitologic Assessment of Two-Dose and Monthly Intermittent Preventive Treatment of Malaria during Pregnancy with Sulphadoxine-Pyrimethamine (IPTP-SP) in Lagos, Nigeria. Malar Res Treat. 2011;2011:932895. doi: 10.4061/2011/932895. Epub 2011 Oct 26. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |
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