Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine
1 other identifier
interventional
136
0 countries
N/A
Brief Summary
Randomized controlled prospective comparative study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2018
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedJuly 26, 2018
July 1, 2018
3 months
July 12, 2018
July 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Prevalence of drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine.
4 Months
Study Arms (2)
Two doses of sulphadoxine-pyrimethamine
ACTIVE COMPARATOR500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken twice before delivery
Monthly doses of sulphadoxine-pyrimethamine
ACTIVE COMPARATOR500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken monthly delivery
Interventions
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly until delivery
Eligibility Criteria
You may qualify if:
- Pregnant women
- Gestational age between 16 and 28weeks.
- No history of use of sulphadoxine-pyrimethamine prior to recruitment
- Not on any medication for prophylaxis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 22312575BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 12, 2018
First Posted
July 26, 2018
Study Start
September 1, 2018
Primary Completion
December 1, 2018
Study Completion
February 1, 2019
Last Updated
July 26, 2018
Record last verified: 2018-07