ACT IN PREGNANT WOME

Not Applicable

• Conditions: Malaria; Pregnancy and Childbirth

• Registration Number: PACTR2010020001862624
• Lead Sponsor: Marcel Ukah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

a)Microscopically-confirmed P. falciparum malaria with parasitaemia of atleast one plus(1-10 parasites /100 thick film field).

b)Fever (T of 37.50C) or a history of fever,headaches,body pains within 24 hours of presentation

c)Ability to give informed consent
d)Willingness/ability to comply with follow up visits.

Exclusion Criteria

a)Severe malaria or danger signs of severe malaria (e.g. loss of consciousness, convulsions, anuria)
b)Women in the first 13 weeks of pregnancy i.e. 1st trimester
c)Use of any anti-malarial drug other than sulphadoxine pyrimethamine less than 7 days before presentation
d)Other chronic illness e.g. hypertension, sickle cell.
e)Other pregnancy related diseases e.g. eclampsia, antepartum hemorrhage
f)History of reaction to any of the study drugs
g)Patients not tolerating orally.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy, safety and tolerability of Artesunate-Amodiaquine fixed dose combination compared to the Artemether-Lumefantrine fixed dose combination in the treatment of acute uncomplicated P. falciparum malaria in pregnancy.

Secondary Outcome Measures

Name	Time	Method
Describe the pregnancy outcome in these women