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Intermittent Preventative Treatment With Sulfadoxine-Pyrimethamine in Gambian Multigravidae

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ClinicalTrials.gov Identifier: NCT00120809
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : January 12, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Sulfadoxine-pyrimethamine Phase 3

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Detailed Description:

Objective

The objective of this study was to determine whether intermittent preventative treatment (IPTp) with sulfadoxine-pyrimethamine (SP) reduced the prevalence of anemia and low birth weight in Gambian multigravidae.

Study area

The study was carried out in 14 mother and child health (MCH) clinics situated on the north and south banks of the River Gambia near to the town of Farafenni in the centre of the country. In this area, malaria is highly seasonal with an entomological inoculation rate of 10 -50 infectious bites per year.

Study population

All women who attended one of the study clinics during the trial period and who were multigravidae were asked if they wished to join the study. If this was the case, an initial screening questionnaire was administered to assess their suitability to do so. Eligibility criteria were - a pregnancy of more than 15 weeks gestation, a hemoglobin (Hb) concentration of more than 7 g/dL, absence of a history of sensitivity to sulfonamides and absence of any chronic underlying illness.

Randomisation

If a woman met the eligibility criteria, informed written consent was sought and, if this was given, the woman was formally recruited to the study and allocated a trial number and randomised to receive either SP or placebo. Randomisation was done in blocks of 12; each field worker was assigned a number of blocks to ensure balanced recruitment between centers.

Drug administration

Women were allocated to receive SP (pyrimethamine 25 mg + sulfadoxine 500 mg)(Cosmos Pharmaceuticals, Nairobi) or matching placebo. An initial dose of SP or placebo (three tablets) was given at the time of enrolment into the trial and at all subsequent visits to the antenatal clinic up to a maximum of four treatments. All women were given iron and folic acid supplements as recommended by the Ministry of Health guidelines.

Surveillance

Women were visited at home twice per week by a project field worker to assess their health and to encourage them to attend the ante-natal clinic at monthly intervals. Women with a high risk of obstetric complications were encouraged to deliver in hospital but most women delivered at home.

If a delivery occurred in hospital or a health center a finger prick blood sample was obtained and the birth weight was measured. In the case of women who delivered at home, the weight of the new born baby was measured within 5 days of delivery and a finger prick blood sample obtained for measurement of Hb concentration and preparation of blood films.

Women were visited at home six weeks after delivery when an additional blood sample was obtained and one year later to investigate the health of their child.

Laboratory methods

Hemoglobin concentration was measured using a Hemocue (Hemocue AB, Angelholm, Sweden). Thick blood films were stained with Giemsa and examined for malaria parasites. Each slide was read by two microscopists. If discrepant results were obtained, the slide was read by a third microscopist and the majority view accepted.

Trial end-points

The co-primary trial end-points were hemoglobin concentration at, or shortly after, birth and birthweight or weight of the baby shortly after birth.

Sample size

To detect a 20% reduction in the estimated risk of severe anemia (Hb <7 g/dl) among multigravidae, estimated to be 30% in the control group, with 80 % power at the 5% level of significance and allowing for a 30% loss to follow-up it was calculated that a study with 1115 women in each arm was required. To show a reduction in the proportion of low birthweight babies from the expected 18% in the control group to 12% in the SP group with 80% power it was estimated that 2 x 1538 women would be needed. Thus, the target sample size was 3,000.

Data management and analysis

All data were double entered and verified. Prior to the breaking of the code the data base was locked and a copy given to the chair of the Data Safety Monitoring Board (DSMB). Statistical analysis was done using S-plus and STATA. An analytical plan was prepared and approved by the DSMB before the code was broken.

Trial oversight

The trial was monitored by a DSMB. It was conducted in line with the requirements of Good Clinical Practice.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomised, Placebo Controlled Trial of Intermittent Preventative Treatment With Sulfadoxine-pyrimethamine in Gambian Multigravidae.
Study Start Date : July 2002
Estimated Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Hemoglobin concentration at delivery.
  2. Birthweight.

Secondary Outcome Measures :
  1. Hemoglobin concentration six weeks after delivery.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to sulfonamides.
  • Chronic illness.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120809


Locations
Gambia
Medical Research Council Laboratories
Banjul, Gambia, PO Box 273
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Medical Research Council Unit, The Gambia
Department of State for Health and Social Welfare, The Gambia
Investigators
Study Chair: Brian Greenwood, MD London School of Hygiene and Tropical Medicine
More Information

Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00120809     History of Changes
Other Study ID Numbers: ITCRVG27b
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
Malaria
Pregnancy
Multigravidae
Intermittent preventative treatment
Sulfadoxine-pyrimethamine

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents