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

NCT ID: NCT01084213

Last Updated: 2014-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-10-31

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.

Conditions

Malaria; Pregnancy; Anaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

SP-IPTp

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Intermittent screening and treatment of malaria in pregnancy (IST)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Coartem; SP

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical Research and Training Centre, Mali

UNKNOWN

Sponsor Role: collaborator

University of Ouagadougou, Burkina Faso

OTHER

Sponsor Role: collaborator

Medical Research Council Unit, The Gambia

OTHER

Sponsor Role: collaborator

Navrongo Health Research Centre, Ghana

OTHER

Sponsor Role: collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Greenwood, MD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Daniel Chandramohan, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Paul Milligan, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Feiko T Kuile, PhD

Role: PRINCIPAL_INVESTIGATOR

Liverpool School of Tropical Medicine, UK

Harry Tagbor, DrPH

Role: PRINCIPAL_INVESTIGATOR

Kwame Nkrumah University of Science & Technology, School of Medical Sciences, Ghana

Locations

Université de Ouagadougou

Ouagadougou, , Burkina Faso

Navrongo Health Research Centre

Navrongo, , Ghana

Medical Research and Training Centre

Bamako, , Mali

Medical Research Council Laboratories

Basse Santa Su, , The Gambia

Countries

Burkina Faso; Ghana; Mali; The Gambia

References

Berry I, Walker P, Tagbor H, Bojang K, Coulibaly SO, Kayentao K, Williams J, Oduro A, Milligan P, Chandramohan D, Greenwood B, Cairns M. Seasonal Dynamics of Malaria in Pregnancy in West Africa: Evidence for Carriage of Infections Acquired Before Pregnancy Until First Contact with Antenatal Care. Am J Trop Med Hyg. 2018 Feb;98(2):534-542. doi: 10.4269/ajtmh.17-0620. Epub 2017 Nov 30.

Reference Type: DERIVED

PMID: 29210351 (View on PubMed)

Tagbor H, Cairns M, Bojang K, Coulibaly SO, Kayentao K, Williams J, Abubakar I, Akor F, Mohammed K, Bationo R, Dabira E, Soulama A, Djimde M, Guirou E, Awine T, Quaye S, Njie F, Ordi J, Doumbo O, Hodgson A, Oduro A, Meshnick S, Taylor S, Magnussen P, ter Kuile F, Woukeu A, Milligan P, Chandramohan D, Greenwood B. A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy. PLoS One. 2015 Aug 10;10(8):e0132247. doi: 10.1371/journal.pone.0132247. eCollection 2015.

Reference Type: DERIVED

PMID: 26258474 (View on PubMed)

Other Identifiers

MiPcMA05

Identifier Type: -

Identifier Source: org_study_id