Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy

Pregnancy Clinical Trial

— IPTp_IST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084213
• Other study ID #: MiPcMA05
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2010
• Last updated: April 10, 2014
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: April 2014
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: Ministere de l'Enseignement Superieur et de la Recherche Scientifique-Universite de BamakoBurkina Faso: Comité national d'éthique pour la recherche en santé (CNERS),Ministère de la SantéThe Gambia: Government /MRC laboratories Joint Ethics CommitteeGhana: Health Service Ethics Committee,
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5354
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anaemia
• Malaria
• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Burkina Faso	Université de Ouagadougou	Ouagadougou
Gambia	Medical Research Council Laboratories	Basse
Ghana	Navrongo Health Research Centre	Navrongo
Mali	Medical Research and Training Centre	Bamako

Sponsors (6)

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

Countries where clinical trial is conducted

Burkina Faso,  Gambia,  Ghana,  Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of low birth weight		6 - 18 months	No
Primary	Prevalence of third trimester anaemia		3 - 12 months	No
Primary	Prevalence of placenta malaria		6 - 18 months	No
Secondary	Prevalence of anaemia at the time of delivery or shortly afterwards.		6 - 18 months	No
Secondary	Prevalence of peripheral blood parasitaemia		6 - 18 months	No
Secondary	Episodes of clinical malaria during the course of the pregnancy.		1 year	No
Secondary	Serious adverse events in the mother.		6 - 18 months	Yes
Secondary	Adverse outcome of pregnancy - abortions, still births and neonatal deaths.		6 - 18 months	Yes
Secondary	Occurrence of congenital abnormalities.		6 - 18 months	No
Secondary	Feasibility and costs of each approach to the control of malaria in pregnancy.		1 year	No
Secondary	Cost per cases of maternal anaemia (severe and non-severe) and peripheral malaria averted.		1 year	No
Secondary	Acceptability of each approach by pregnant women and antenatal clinic staff.		1 year	No