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

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ClinicalTrials.gov Identifier: NCT01084213
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : April 11, 2014
Sponsor:
Collaborators:
Medical Research and Training Centre, Mali
University of 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

Tracking Information
First Submitted Date  ICMJE March 3, 2010
First Posted Date  ICMJE March 10, 2010
Last Update Posted Date April 11, 2014
Study Start Date  ICMJE June 2010
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
  • Prevalence of low birth weight [ Time Frame: 6 - 18 months ]
  • Prevalence of third trimester anaemia [ Time Frame: 3 - 12 months ]
  • Prevalence of placenta malaria [ Time Frame: 6 - 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
  • Prevalence of anaemia at the time of delivery or shortly afterwards. [ Time Frame: 6 - 18 months ]
  • Prevalence of peripheral blood parasitaemia [ Time Frame: 6 - 18 months ]
  • Episodes of clinical malaria during the course of the pregnancy. [ Time Frame: 1 year ]
  • Serious adverse events in the mother. [ Time Frame: 6 - 18 months ]
  • Adverse outcome of pregnancy - abortions, still births and neonatal deaths. [ Time Frame: 6 - 18 months ]
  • Occurrence of congenital abnormalities. [ Time Frame: 6 - 18 months ]
  • Feasibility and costs of each approach to the control of malaria in pregnancy. [ Time Frame: 1 year ]
  • Cost per cases of maternal anaemia (severe and non-severe) and peripheral malaria averted. [ Time Frame: 1 year ]
  • Acceptability of each approach by pregnant women and antenatal clinic staff. [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy
Official Title  ICMJE A Trial of Intermittent Preventive Treatment With Sulfadoxine-pyrimethamine Versus Intermittent Screening and Treatment of Malaria in Pregnancy
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Malaria
  • Pregnancy
  • Anaemia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: SP-IPTp
  • 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.
    Intervention: Drug: Intermittent screening and treatment of malaria in pregnancy (IST)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2014)
5354
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2010)
5000
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Burkina Faso,   Gambia,   Ghana,   Mali
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01084213
Other Study ID Numbers  ICMJE MiPcMA05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Medical Research and Training Centre, Mali
  • University of Ouagadougou, Burkina Faso
  • Medical Research Council Unit, The Gambia
  • Navrongo Health Research Centre, Ghana
  • Liverpool School of Tropical Medicine
Investigators  ICMJE
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
PRS Account London School of Hygiene and Tropical Medicine
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP