Intermittent Preventive Treatment (IPTp) Versus Rapid Diagnostic Testing (RDT) and Treatment of Malaria in Pregnancy
Recruitment status was Recruiting
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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. |
- 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 ]
- 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 ]
| Estimated Enrollment: | 3330 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | December 2008 (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 |
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| Contact: Harry Tagbor, MBChB; DrPH | 00233 244 417701 | Harry.Tagbor@lshtm.ac.uk |
| Ghana | |
| Juaben Government Hospital | Recruiting |
| Juaben, Ashanti, Ghana | |
| Contact: Harry Tagbor, DrPH 00233 244 417701 Harry.Tagbor@lshtm.ac.uk | |
| Principal Investigator: Harry Tagbor, MBChB; DrPH | |
| 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, Juaben government Hospital, Juaben, Ashanti, Ghana |
| ClinicalTrials.gov Identifier: | NCT00432367 History of Changes |
| Other Study ID Numbers: | GMP_REG04, HKT-GMP |
| Study First Received: | February 5, 2007 |
| Last Updated: | February 7, 2008 |
| 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 Sulfadoxine-pyrimethamine 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 May 19, 2013