Effective and safe treatment for malaria in pregnancy in India: a randomised controlled trial.

Phase 2

Completed

• Conditions: Health Condition 1: null- This study will be conducted with symptomatic or asymptomatic uncomplicated falciparum malaria in 2nd and 3rd trimester during pregnancy

• Registration Number: CTRI/2009/091/001055
• Lead Sponsor: Malaria in Pregnancy Consortium Liverpool School of Tropical Medicine Liverpool UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

(i) Pregnant women of all parities having P falciparum parasitaemia (mono infection)in 2nd and 3rd trimester

Exclusion Criteria

(i) Hb <7; (ii) gestation <12 or >36 wks; (iii) age <18 years (iv) abnormal liver or renal function; (v) history of taking an antimalarial within the last 7 days; (vi) history of allergy to any of the study drugs; (vii) taking part in any other clinical trials of drugs or vaccines; (viii) severe malaria (based either on clinical presentation or parasitological grounds); (ix) Other conditions requiring hospitalization or evidence of severe concomitant infection; (x) Known chronic disease (cardiac, haemoglobinopathy); (xi) History of convulsions during the present illness or history of psychiatric disorder or seizures (xii) vivax malaria or mixed infection
Inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified