NCT00120809

Brief Summary

Malaria is particularly harmful during pregnancy causing anemia in the mother and low birth weight which, in turn, increases infant mortality. Thus, the World Health Organization (WHO) now recommends that all pregnant women who live in malaria endemic areas of Africa should receive sulfadoxine-pyrimethamine (SP) at monthly intervals during the second and third trimesters of pregnancy. Malaria is especially severe during first pregnancies and the value of intermittent preventative treatment with SP during first pregnancies has been clearly shown. However, it is less certain whether multigravidae, who are at less risk, also benefit from intermittent preventative treatment with SP. To investigate this, a trial has been conducted in Gambian multigravidae who were given intermittent preventative treatment with SP or placebo during the second and third trimesters. The prevalence of anemia six weeks after delivery, low birth weight and poor outcome of pregnancy in women in each group were studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

1 active site

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

July 1, 2002

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

July 12, 2005

Last Update Submit

January 11, 2017

Conditions

Malaria

Keywords

MalariaPregnancyMultigravidaeIntermittent preventative treatmentSulfadoxine-pyrimethamine

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin concentration at delivery.

  • Birthweight.

Secondary Outcomes (1)

  • Hemoglobin concentration six weeks after delivery.

Interventions

Sulfadoxine-pyrimethamineDRUG

Eligibility Criteria

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

You may qualify if:

  • Multigravid pregnancy.
  • Residence in study area.
  • Informed consent.

You may not qualify if:

  • Allergy to sulfonamides.
  • Chronic illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Council Laboratories

Banjul, PO Box 273, The Gambia

Location

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Brian Greenwood, MD

    London School of Hygiene and Tropical Medicine

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 19, 2005

Study Start

July 1, 2002

Study Completion

September 1, 2004

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

TH(1)