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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-02-01

Brief Summary

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Randomized controlled prospective comparative study

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Detailed Description

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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

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Two doses of sulphadoxine-pyrimethamine

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

Group Type ACTIVE_COMPARATOR

Sulphadoxine-pyrimethamine

Intervention Type DRUG

Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly until delivery

Monthly doses of sulphadoxine-pyrimethamine

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

Group Type ACTIVE_COMPARATOR

Sulphadoxine-pyrimethamine

Intervention Type DRUG

Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets twice before delivery

Interventions

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Sulphadoxine-pyrimethamine

Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly until delivery

Intervention Type DRUG

Sulphadoxine-pyrimethamine

Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets twice before delivery

Intervention Type DRUG

Other Intervention Names

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Vitadar Vitadar

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes