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

NCT00432367 | Completed Phase 3 DMC

• 2 other identifiers: GMP_REG04HKT-GMP
• Study Type: interventional
• Target: 3,333
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Malaria in pregnancy; Case management; Screening; RDT; IPTp; Amodiaquine; Artesunate

Outcome Measures

Primary Outcomes (1)

• Prevalence of severe maternal anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation.

  At 34 to 36 weeks of gestation

Secondary Outcomes (10)

• Prevalence of low birth weight (BW < 2500g) at delivery or within 72 hours of delivery.

  At delivery or within 72 hours of delivery.

• Prevalence of maternal anaemia (Hb < 11g/dl) at 34 to 36 weeks of gestation.

  At 34 to 36 weeks of gestation

• Prevalence of placenta parasitaemia.

  At delivery

• Incidence of post-intervention malaria cases

  Anytime after enrolment and prior to delivery

• Proportions of congenital anomalies in live births among the intervention groups stratified by gestation, gravidity, parity and age.

  At delivery

Study Arms (3)

1

EXPERIMENTAL

OptiMAL® antigen screening and treatment with SP plus LLIN

Drug: Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine

2

EXPERIMENTAL

OptiMAL® antigen screening and treatment with AQ+AS plus LLIN

Drug: Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine

3

ACTIVE COMPARATOR

SP-IPTp plus LLIN

Drug: Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine

Interventions

Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine DRUG

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.

1; 2; 3

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Her pregnancy is confirmed at 16 to 24 weeks at their first booking.
• She is willing to participate and complete the test schedule, and has given informed consent.
• She is willing to have supervised delivered at maternity units in the district.
• She lives within the study district.

You may not qualify if:

• She has a past obstetric and medical history that will adversely affect the interpretation of outcomes such as repeated stillbirths and eclampsia.
• She has a haemoglobin level below 5.0 g/dl.
• She has malaria that is severe enough to require parenteral medication.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Kwame Nkrumah University of Science and Technology: collaborator

Study Sites (1)

Juaben Government Hospital

Juaben, Ashanti Region, Ghana

Location

Related Publications (1)

• Tagbor H, Bruce J, Agbo M, Greenwood B, Chandramohan D. Intermittent screening and treatment versus intermittent preventive treatment of malaria in pregnancy: a randomised controlled non-inferiority trial. PLoS One. 2010 Dec 28;5(12):e14425. doi: 10.1371/journal.pone.0014425.

  PMID: 21203389 DERIVED

MeSH Terms

Conditions

Malaria; Anemia

Interventions

Amodiaquine; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Harry Tagbor, DrPH

  School of Medical Sciences, KNUST, Kumasi, Ghana

  PRINCIPAL INVESTIGATOR

• Brian Greenwood, MD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Daniel Chandramohan, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Jane Bruce, MSc

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Edmund Browne, PhD

  School of Medical Sciences, KNUST, Kumasi, Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 7, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 20, 2016

Record last verified: 2014-02

Locations

GH (1)