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

Primary Purpose

Malaria

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Sulphadoxine-pyrimethamine
Sulphadoxine-pyrimethamine
Sponsored by
University College Hospital, Ibadan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Two doses of sulphadoxine-pyrimethamine

    Monthly doses of sulphadoxine-pyrimethamine

    Arm Description

    500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken twice before delivery

    500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken monthly delivery

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    July 12, 2018
    Last Updated
    July 23, 2018
    Sponsor
    University College Hospital, Ibadan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03599596
    Brief Title
    Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine
    Official Title
    Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine in University College Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    December 1, 2018 (Anticipated)
    Study Completion Date
    February 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University College Hospital, Ibadan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    136 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Two doses of sulphadoxine-pyrimethamine
    Arm Type
    Active Comparator
    Arm Description
    500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken twice before delivery
    Arm Title
    Monthly doses of sulphadoxine-pyrimethamine
    Arm Type
    Active Comparator
    Arm Description
    500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken monthly delivery
    Intervention Type
    Drug
    Intervention Name(s)
    Sulphadoxine-pyrimethamine
    Other Intervention Name(s)
    Vitadar
    Intervention Description
    Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly until delivery
    Intervention Type
    Drug
    Intervention Name(s)
    Sulphadoxine-pyrimethamine
    Other Intervention Name(s)
    Vitadar
    Intervention Description
    Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets twice before delivery
    Primary Outcome Measure Information:
    Title
    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).
    Description
    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 Outcome Measure Information:
    Title
    Prevalence of drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine.
    Description
    Number of participants having drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine will be noted.
    Time Frame
    4 Months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Sexes eligible for the study
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22312575
    Citation
    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.
    Results Reference
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