Anti-Malaria Prophylaxis for Pregnancy (AMPROP) Clinical Trial

Not Applicable

• Conditions: Malaria

• Registration Number: PACTR202104622127025
• Lead Sponsor: igerian Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

A. HIV POSITIVE POPULATION
1.HIV positive pregnant women
2. Above 13wks gestational age
3. Afebrile at the time of recruitment
4.Not sensitive to sulphadozine
5. Not sensitive to standard ITN
6.Not sensitive to mefloquine

B. HIV NEGATIVE POPULATION
1.HIV negative pregnant women
2. Above 13wks gestational age
3. Afebrile at the time of recruitment
4.Not sensitive to sulphadozine
5. Not sensitive to mefloquine
6. Not sensitive to standard ITN

Exclusion Criteria

A. HIV POSITIVE POPULATION

1. SCD IN PREGNANCY
2. Known febrile illness in the Index pregnancy
3. Known sensitivity to sulphadozine/pyrimethamine combination
4. Known sensitive to mefloquine

B. HIV NEGATIVE POPULATION

1. SCD IN PREGNANCY
2. Known febrile illness in the Index pregnancy
3. Known sensitivity to sulphadozine/pyrimethamine
4. Known sensitivity to mefloquine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRIMARY OUTCOME MEASURES:<br>1.Placenta parasitaemia <br>2.Number of episodes of febrile illness associated with a positive malaria parasitaemia<br>3.Peripheral blood parasitaemia, demonstrable in the third trimester.<br>4.Number of cases of SP resistance<br>5.Number of cases of Mefloquine resistance<br><br><br><br>

Secondary Outcome Measures

Name	Time	Method
SECONDARY OUTCOME MEASURES:<br><br>1. Miscarriages<br>2. Intra-uterine deaths<br>3. Hospital admissions<br>4. Low birth weight <br>5. Maternal anaemia <br>6. Side effects and Adverse effect profile of the interventional agents<br>