Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy (IPTp_IST)

April 10, 2014 updated by: London School of Hygiene and Tropical Medicine

A Trial of Intermittent Preventive Treatment With Sulfadoxine-pyrimethamine Versus Intermittent Screening and Treatment of Malaria in Pregnancy

The incidence of malaria, including the incidence in pregnant women, is declining in many African countries. Thus, there is a need to re-examine the efficacy and cost effectiveness of giving intermittent preventive treatment with sulphadoxine-pyrimethamine in pregnancy (SP-IPTp) on several occasions during pregnancy, an intervention that is threatened by increasing resistance to SP. Possible alternatives to SP-IPTp need to be explored. This applies especially to areas with highly seasonal malaria transmission where women are at risk for only a short period of the year.

The goal of this project is to determine whether in pregnant women who sleep under a long lasting insecticide treated bed net, screening and treatment at each scheduled antenatal clinic visit is as effective in protecting them from anaemia, low birth weight and placental infection as SP-IPTp.

Primigravidae and secundigravidae who present at antenatal clinics in study sites in four West African countries (Burkina Faso, Ghana, Mali and The Gambia) will be randomised to one of two groups. All women will be given a long lasting insecticide treated bed net on first presentation at the antenatal clinic. Women in group 1 (reference group) will receive SP-IPTp according to the current WHO guidelines. Those in group 2 will be screened with a rapid diagnostic test at each scheduled antenatal clinic visit and treated if parasitaemic. Approximately 5000 women will be recruited, 2500 in each group. Women will be encouraged to deliver in hospital where maternal haemoglobin and birth weight will be recorded and a placental sample obtained. Those who deliver at home will be visited within a week of delivery and maternal haemoglobin and infant weight recorded. Mothers and infants will be seen again six weeks after delivery. Also at delivery peripheral maternal blood sample will be obtained for the diagnosis of malaria using RDT, microscopy and PCR. The primary end points of the trial will be birth weight and anaemia at 38 weeks (+/-2 weeks) of gestation. The study is powered to show non-inferiority of group 2 compared to group 1. The costs and cost effectiveness of each intervention will be evaluated.

In the light of recent evidence suggesting that malaria infection during pregnancy, particularly in the last trimester may influence an infant's risk of malaria, we proposed to follow infants born to mothers recruited in the Navrongo site in Ghana who have received either IST or IPTp in pregnancy throughout the whole of their first year of life beyond the six weeks originally proposed. We have received approval for this from the ethic committees at Kwame Nkrumah University of Science and Technology, Ghana Health Service and Navrongo Health Research Centre. The aim is to obtain information on the incidence of both symptomatic and asymptomatic malaria infections in these infants during follow up of the infants.

The study will provide information to national malaria control programmes on whether there are alternative, safe and effective methods to the SP IPTp regimen for reducing the burden of malaria in pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5354

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso
        • Université de Ouagadougou
  • Gambia
      • Basse, Gambia
        • Medical Research Council Laboratories
  • Ghana
      • Navrongo, Ghana
        • Navrongo Health Research Centre
  • Mali
      • Bamako, Mali
        • Medical Research and Training Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Presence of a first or second pregnancy.
  2. Gestation between 16 to 30 weeks inclusive at first booking as determined by symphysio-fundal measurements.
  3. Provision of informed consent to join the trial.
  4. Residence in the study area and intention to stay in the area for the duration of the pregnancy.

Exclusion Criteria:

  1. Absence of informed consent.
  2. An intention to leave the study area before delivery.
  3. A history of sensitivity to sulphonamides.
  4. Clinical AIDS or known HIV positivity.
  5. Presence of any systemic illness likely to interfere with interpretation of the results of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: IPTp with SP
Study women will receive at least two doses of SP during their pregnancy, one at each of the recommended ante-natal visits during the 2nd and 3rd trimester.
Drug: SP-IPTp
Study women will receive at least two doses of Sulfadoxine Pyrimethamine during their pregnancy, one at each of the recommended ante-natal visits during the 2nd and 3rd trimester.
Other Names:
  • SP
EXPERIMENTAL: IST using RDTs
Scheduled intermittent screening using rapid diagnostic tests and treatment of those who are RDT positive during ante-natal clinic visits in the 2nd and 3rd trimester.
Drug: Intermittent screening and treatment of malaria in pregnancy (IST)
Scheduled intermittent screening of study women using rapid diagnostic test and treatment of those who are RDT positive during ante-natal clinic visits in the 2nd and 3rd trimester with arthemether lumefantrine.
Other Names:
  • Coartem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of low birth weight
Time Frame: 6 - 18 months
6 - 18 months
Prevalence of third trimester anaemia
Time Frame: 3 - 12 months
3 - 12 months
Prevalence of placenta malaria
Time Frame: 6 - 18 months
6 - 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of anaemia at the time of delivery or shortly afterwards.
Time Frame: 6 - 18 months
6 - 18 months
Prevalence of peripheral blood parasitaemia
Time Frame: 6 - 18 months
6 - 18 months
Episodes of clinical malaria during the course of the pregnancy.
Time Frame: 1 year
1 year
Serious adverse events in the mother.
Time Frame: 6 - 18 months
6 - 18 months
Adverse outcome of pregnancy - abortions, still births and neonatal deaths.
Time Frame: 6 - 18 months
6 - 18 months
Occurrence of congenital abnormalities.
Time Frame: 6 - 18 months
6 - 18 months
Feasibility and costs of each approach to the control of malaria in pregnancy.
Time Frame: 1 year
1 year
Cost per cases of maternal anaemia (severe and non-severe) and peripheral malaria averted.
Time Frame: 1 year
1 year
Acceptability of each approach by pregnant women and antenatal clinic staff.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Liverpool School of Tropical Medicine
Medical Research Council Unit, The Gambia
University of Ouagadougou, Burkina Faso
Navrongo Health Research Centre, Ghana
Medical Research and Training Centre, Mali

Investigators

  • Principal Investigator: Daniel Chandramohan, PhD, London School of Hygiene and Tropical Medicine
  • Principal Investigator: Feiko T Kuile, PhD, Liverpool School of Tropical Medicine, UK
  • Principal Investigator: Harry Tagbor, DrPH, Kwame Nkrumah University of Science & Technology, School of Medical Sciences, Ghana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (ESTIMATE)

March 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MiPcMA05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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