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

Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine in University College Hospital

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03599596

Enrollment

136

Registered

2018-07-26

Start date

2018-09-01

Completion date

2019-02-01

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

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

Interventions

DRUGSulphadoxine-pyrimethamine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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).	4 Months	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

Measure	Time frame	Description
Prevalence of drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine.	4 Months	Number of participants having drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine will be noted.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026