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

This study has been completed.
Sponsor:
Collaborator:
Kwame Nkrumah University of Science and Technology
Information provided by (Responsible Party):
Dr Harry Tagbor, Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00432367
First received: February 5, 2007
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Malaria
Anaemia
Pregnancy
Drug: Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness, Cost and Cost Effectiveness of Intermittent Preventive Treatment or Screening and Treatment of Malaria in Pregnancy Among Women Using Long Lasting Insecticide Treated Bed Net: a Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Prevalence of severe maternal anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation. [ Time Frame: At 34 to 36 weeks of gestation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prevalence of low birth weight (BW < 2500g) at delivery or within 72 hours of delivery. [ Time Frame: At delivery or within 72 hours of delivery. ] [ Designated as safety issue: Yes ]
  • Prevalence of maternal anaemia (Hb < 11g/dl) at 34 to 36 weeks of gestation. [ Time Frame: At 34 to 36 weeks of gestation ] [ Designated as safety issue: Yes ]
  • Prevalence of placenta parasitaemia. [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]
  • Incidence of post-intervention malaria cases [ Time Frame: Anytime after enrolment and prior to delivery ] [ Designated as safety issue: Yes ]
  • Proportions of congenital anomalies in live births among the intervention groups stratified by gestation, gravidity, parity and age. [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]
  • Proportions of spontaneous abortions, intrauterine death, stillbirths, neonatal and maternal mortality and pre-term deliveries. [ Time Frame: Anytime after enrolment and prior to delivery ] [ Designated as safety issue: Yes ]
  • Cost per severe maternal anaemia averted. [ Time Frame: Anytime after enrolment and prior to delivery ] [ Designated as safety issue: No ]
  • Cost per (non-severe) maternal anaemia averted. [ Time Frame: Anytime after enrolment and prior to delivery ] [ Designated as safety issue: No ]
  • Cost per peripheral malaria case averted. [ Time Frame: Anytime after enrolment and prior to delivery ] [ Designated as safety issue: No ]
  • Cost per placental malaria averted. [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Enrollment: 3333
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OptiMAL® antigen screening and treatment with SP plus LLIN
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.

Experimental: 2
OptiMAL® antigen screening and treatment with AQ+AS plus LLIN
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.

Active Comparator: 3
SP-IPTp plus LLIN
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.


  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432367

Locations
Ghana
Juaben Government Hospital
Juaben, Ashanti, Ghana
Sponsors and Collaborators
Gates Malaria Partnership
Kwame Nkrumah University of Science and Technology
Investigators
Principal Investigator: 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
  More Information

Additional Information:
No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Harry Tagbor, Dr, Gates Malaria Partnership
ClinicalTrials.gov Identifier: NCT00432367     History of Changes
Other Study ID Numbers: GMP_REG04, HKT-GMP
Study First Received: February 5, 2007
Last Updated: February 21, 2014
Health Authority: Ghana: Committee on Human Research

Keywords provided by Gates Malaria Partnership:
Malaria in pregnancy
Case management
Screening
RDT
IPTp
Amodiaquine
Artesunate

Additional relevant MeSH terms:
Anemia
Malaria
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Amodiaquine
Pyrimethamine
Sulfadoxine
Artesunate
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on August 28, 2014