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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,333
- 试验地点
- 1
- 主要终点
- Prevalence of severe maternal anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation.
研究概览
简要总结
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.
详细描述
General objective To show that the long-lasting insecticide-treated nets(LLIN)///// plus RDT screening and treatment strategy is not inferior to LLIN plus SP-IPTp in reducing the burden of malaria during pregnancy.
Specific objectives Primary
- To demonstrate that the prevalence of severe anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation in the LLIN plus RDT screening and case management arm is not greater than that in the LLIN plus IPTp arm.
Secondary
- To demonstrate that the prevalence of low birth weight (BW < 2500g) at delivery or within 72 hours after delivery in the LLIN plus RDT screening and case management arm is not greater than that in the LLIN plus IPTp arm.
- To demonstrate that the prevalence of anaemia (Hb < 11g/dl) at 34 to 36 weeks of gestation in the LLIN plus RDT screening and case management arm is not greater than that in the LLIN plus IPTp arm.
- To demonstrate that the prevalence of placental parasitaemia in the LLIN plus RDT screening and case management arm is not greater than that in the LLIN plus IPTp arm.
- To demonstrate that the incidence of spontaneous abortions, intrauterine deaths/stillbirths, neonatal and maternal mortality and developmental delays in the LLIN plus RDT screening and case management arm is not greater than that in the LLIN plus IPTp arm.
- To demonstrate that the cost per case of (1) severe maternal anaemia averted (2) maternal anaemia averted (3) peripheral malaria averted and (4) placenta malaria averted is not higher in the LLIN plus RDT screening and case management arm than in LLIN plus SP-IPTp arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
OptiMAL® antigen screening and treatment with SP plus LLIN
干预措施: Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine (Drug)
2
OptiMAL® antigen screening and treatment with AQ+AS plus LLIN
干预措施: Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine (Drug)
3
SP-IPTp plus LLIN
干预措施: Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine (Drug)
结局指标
主要结局
Prevalence of severe maternal anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation.
时间窗: At 34 to 36 weeks of gestation
次要结局
- Cost per (non-severe) maternal anaemia averted.(Anytime after enrolment and prior to delivery)
- Cost per peripheral malaria case averted.(Anytime after enrolment and prior to delivery)
- Cost per placental malaria averted.(At delivery)
- 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)
- Proportions of spontaneous abortions, intrauterine death, stillbirths, neonatal and maternal mortality and pre-term deliveries.(Anytime after enrolment and prior to delivery)
- Cost per severe maternal anaemia averted.(Anytime after enrolment and prior to delivery)