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

U

University College Hospital, Ibadan

Status and phase

Unknown
Phase 1

Conditions

Malaria

Treatments

Drug: Sulphadoxine-pyrimethamine

Study type

Interventional

Funder types

Other

Identifiers

NCT03599596
UCHIbadan

Details and patient eligibility

About

Randomized controlled prospective comparative study

Full 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

Enrollment

136 estimated patients

Sex

Female

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

136 participants in 2 patient groups

Two doses of sulphadoxine-pyrimethamine
Active Comparator group
Description:
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken twice before delivery
Treatment:
Drug: Sulphadoxine-pyrimethamine
Drug: Sulphadoxine-pyrimethamine
Monthly doses of sulphadoxine-pyrimethamine
Active Comparator group
Description:
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken monthly delivery
Treatment:
Drug: Sulphadoxine-pyrimethamine
Drug: Sulphadoxine-pyrimethamine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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