NCT00131703

Brief Summary

Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in the primigravidae. Implementation of appropriate control and preventive measures is challenged by the fact that malaria infection in pregnancy is often asymptomatic and parasitized red blood cells sequestrated in the placental microcirculation may not be detectable in the peripheral blood. In addition, the widespread prevalence of parasites resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about newer antimalarials, poverty and inadequate supply have made antimalarial treatment options available to pregnant women very limited. These have necessitated an urgent search for alternative safe and efficacious treatment options for pregnant women. The objective of this study is to assess the efficacy, safety and tolerability of four antimalarial treatment options in rural Ghana within a programme setting.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

First QC Date

August 18, 2005

Last Update Submit

March 3, 2025

Conditions

MalariaPregnancy

Keywords

ScreeningTreatmentAmodiaquineSulphadoxine-pyrimethamineMalaria in pregnancy

Outcome Measures

Primary Outcomes (2)

  • Prevalence of parasitaemia on day 28 post treatment.

  • Prevalence of parasitaemia on day 14 post treatment.

Secondary Outcomes (10)

  • Incidence of adverse drug events within seven days following treatment.

  • Proportions of pregnant women withdrawn from the study due to the occurrence of adverse drug events (clinical and laboratory) by day 7 following initiation of treatment.

  • Change in maternal haemoglobin concentrations at days 14 and 28 following treatment.

  • Prevalence of peripheral parasitaemia at delivery.

  • Prevalence of placental parasitaemia at delivery.

  • +5 more secondary outcomes

Interventions

AmodiaquineDRUG
Sulphadoxine-pyrimethamineDRUG
ChloroquineDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age of at least 16 weeks.
  • P. falciparum parasitaemia of any density with or without symptoms.
  • Informed consent.
  • No known adverse reaction to any of the study drugs.
  • Residence in the study area.

You may not qualify if:

  • Past obstetric and medical history that might adversely affect the interpretation of outcomes such as repeated stillbirths and eclampsia.
  • History of severe adverse drug reactions to co-trimoxazole in the past.
  • Haemoglobin concentration below 5.0 g/dl.
  • Severe malaria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tagbor H, Bruce J, Browne E, Randal A, Greenwood B, Chandramohan D. Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial. Lancet. 2006 Oct 14;368(9544):1349-56. doi: 10.1016/S0140-6736(06)69559-7.

    PMID: 17046467RESULT

MeSH Terms

Conditions

Malaria

Interventions

Amodiaquinefanasil, pyrimethamine drug combinationChloroquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Harry K Tagbor, MD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 19, 2005

Study Start

March 1, 2003

Study Completion

March 1, 2005

Last Updated

March 4, 2025

Record last verified: 2025-03