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

This study has been completed.
Sponsor:
Collaborators:
Medical Research and Training Centre, Mali
Université de Ouagadougou, Burkina Faso
Medical Research Council Unit, The Gambia
Navrongo Health Research Centre, Ghana
Liverpool School of Tropical Medicine
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01084213
First received: March 3, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Malaria
Pregnancy
Anaemia
Drug: Intermittent screening and treatment of malaria in pregnancy (IST)
Drug: SP-IPTp
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Trial of Intermittent Preventive Treatment With Sulfadoxine-pyrimethamine Versus Intermittent Screening and Treatment of Malaria in Pregnancy

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Prevalence of low birth weight [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
  • Prevalence of third trimester anaemia [ Time Frame: 3 - 12 months ] [ Designated as safety issue: No ]
  • Prevalence of placenta malaria [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of anaemia at the time of delivery or shortly afterwards. [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
  • Prevalence of peripheral blood parasitaemia [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
  • Episodes of clinical malaria during the course of the pregnancy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serious adverse events in the mother. [ Time Frame: 6 - 18 months ] [ Designated as safety issue: Yes ]
  • Adverse outcome of pregnancy - abortions, still births and neonatal deaths. [ Time Frame: 6 - 18 months ] [ Designated as safety issue: Yes ]
  • Occurrence of congenital abnormalities. [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
  • Feasibility and costs of each approach to the control of malaria in pregnancy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cost per cases of maternal anaemia (severe and non-severe) and peripheral malaria averted. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Acceptability of each approach by pregnant women and antenatal clinic staff. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 5354
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Coartem

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084213

Locations
Burkina Faso
Université de Ouagadougou
Ouagadougou, Burkina Faso
Gambia
Medical Research Council Laboratories
Basse, Gambia
Ghana
Navrongo Health Research Centre
Navrongo, Ghana
Mali
Medical Research and Training Centre
Bamako, Mali
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Medical Research and Training Centre, Mali
Université de Ouagadougou, Burkina Faso
Medical Research Council Unit, The Gambia
Navrongo Health Research Centre, Ghana
Liverpool School of Tropical Medicine
Investigators
Principal Investigator: Brian Greenwood, MD London School of Hygiene & Tropical Medicine, UK
Principal Investigator: Daniel Chandramohan, PhD London School of Hygiene & Tropical Medicine, UK
Principal Investigator: Paul Milligan, PhD London School of Hygiene & Tropical Medicine, UK
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
  More Information

No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01084213     History of Changes
Other Study ID Numbers: MiPcMA05
Study First Received: March 3, 2010
Last Updated: April 10, 2014
Health Authority: Mali: Ministere de l'Enseignement Superieur et de la Recherche Scientifique-Universite de Bamako
Burkina Faso: Comité national d'éthique pour la recherche en santé (CNERS),Ministère de la Santé
The Gambia: Government /MRC laboratories Joint Ethics Committee
Ghana: Health Service Ethics Committee,

Keywords provided by London School of Hygiene and Tropical Medicine:
Low birth weight
Placenta malaria
Anaemia
Intermittent preventive treatment
Intermittent screening and treatment
Rapid diagnostic test

Additional relevant MeSH terms:
Anemia
Malaria
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 16, 2014