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Anti-Malaria Prophylaxis for Pregnancy (AMPROP) Clinical Trial

Placenta Plasmodium Parasitaemia and Development of Resistance using Sulfadoxine/Pyrimethamine (SP) or Mefluoquine IPT/ITN Intervention among HIV Positive Pregnant Women in Lagos Nigeria: A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202104622127025
Enrollment
200
Registered
2021-04-21
Start date
2021-05-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Malaria

Interventions

Mefloquine
Sulphadozine Pyrimethamine Combination

Sponsors

Nigerian Institute of Medical Research
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Nigeria

Contacts

Public ContactEsther Ohihoin

Research Fellow Nigerian Institute of Medical Research

ohihoinesther@nimr.gov.ng+2348034057972

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026