Intermittent Preventive Treatment (IPTp) Versus Rapid Diagnostic Testing (RDT) and Treatment of Malaria in Pregnancy

Summary

Among the best practices recommended for malaria control during pregnancy is ensuring effective case management of malaria illness. However, this is often not practiced because (1) malaria infection in pregnancy is often asymptomatic, (2) peripheral parasitaemia may be absent even when the placenta is heavily parasitized, (3) implementing diagnosis and treatment of malaria within a routine antenatal service may be difficult and (4) antimalarial treatment options available to pregnant women are limited due to resistance to chloroquine(CQ) and sulfadoxine-pyrimethamine(SP0 and paucity of safety and efficacy data on other antimalarial drugs in pregnancy, particularly artemisinin combination treatments (ACT). Therefore the commonest recommended practice in pregnancy is the administration of SP as intermittent preventive treatment (SP-IPTp). However, the effectiveness of SP-IPTp has been questioned because parasite resistance to SP is spreading rapidly across sub-Saharan Africa.

This is a three-arm open label randomised control non-inferiority trial of insecticide-treated nets(ITN) plus rapid diagnostic test(RDT) screening, and treatment with SP or amodiaquine plus artimisinin(AQ+AS) versus ITN plus IPTp using SP. It is to be carried out in pregnant women of all parities presenting at enrolling antenatal clinics with a gestation of 16 to 20 weeks at their first booking. The key objectives are to demonstrate that (1) the prevalence of severe anaemia (Hb \< 8g/dl) at 34 to 36 weeks of gestation (2) the prevalence of low birth weight (BW \< 2500g) at delivery or within 72 hours after delivery (3) the prevalence of placenta parasitaemia and (4) the incidence of serious and non-serious adverse events in the ITN plus RDT screening and treatment arm are not greater than those in the ITN plus IPTp arm. Alongside the clinical assessments, health care cost assessments will be done to determine the cost-effectiveness of the two delivery strategies measured as cases of severe maternal anaemia averted.

Conditions

• Malaria
• Anaemia
• Pregnancy

Interventions

DRUG

Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine

Eligible women will be allocated randomly to one of three groups and treated as follows: Arm 1 (OptiMAL® antigen screening and treatment with SP plus LLIN group) - a woman in this will receive 1500mg/75mg (S/P) administered at the ANC as single dose on enrollment if her screening test is positive. Arm 2 (OptiMAL® antigen screening and treatment with AQ+AS plus LLIN) - a woman in this will receive 300mg of AQ and 100mg co-administered two times a day for 3 days if her screening test is positive. The first dose is observed on enrolment day at the ANC. Arm 3 (SP-IPTp plus LLIN group) - a woman in this will receive 1500mg/75mg (S/P) administered at the ANC as single dose on enrollment as recommended by national policy. All enrolled women will be given one long lasting insecticide treated bed net each for use.

Sponsors & Collaborators

• Kwame Nkrumah University of Science and Technology

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Harry Tagbor, DrPH · School of Medical Sciences, KNUST, Kumasi, Ghana

• Brian Greenwood, MD · London School of Hygiene and Tropical Medicine

• Daniel Chandramohan, PhD · London School of Hygiene and Tropical Medicine

• Jane Bruce, MSc · London School of Hygiene and Tropical Medicine

• Edmund Browne, PhD · School of Medical Sciences, KNUST, Kumasi, Ghana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-02-28

Primary Completion

2009-02-28

Completion

2009-09-30

Countries

• Ghana

Study Locations