Malaria in Pregnancy Clinical Trial
— ULTRAPYRAPREGOfficial title:
Comparison of IST Using Ultra-sensitive Malaria Rapid Diagnostic Test and Pyronaridine - Artesunate - PYRAMAX®) to Standard IPT Sulfadoxine-pyrimethamine to Prevent Malaria in Pregnant Women Living in Endemic Areas
Verified date | November 2022 |
Source | University of Kinshasa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In endemic settings Plasmodium falciparum (Pf) can sequester in the placenta resulting in low peripheral parasitemia and false negative malaria diagnosis in pregnant women. Intermittent Preventive Treatment in pregnant women with Sulphadoxine-Pyrimethamine (IPTp-SP) is one of the World Health Organization's recommended malaria control strategies in sub-Saharan African countries. The strategy overcomes the risk of misdiagnosis of malaria in pregnant women by treating them all with SP according to predetermined schedules, but the strategy is now threatened by the spread of Plasmodium parasite resistant strains. As a necessary alternative, Intermittent Screening and Treatment in pregnancy (ISTp), aims on the monthly screening of pregnant women with a malaria rapid diagnostic test (RDT) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. The ISTp depends on the performance of the diagnostic tests, and the use of ultrasensitive RDTs (us-RDTs), which have a higher analytical sensitivity than conventional RDTs, should improve the efficacy of the strategy. Unlike IPTp-SP, ISTp prevents overuse of antimalarials and thus limits drug pressure on malaria parasites. This advantage could be potentiated by using, for pregnant women, an ACT that is not yet used or should not be used in the field for other strata of the population. The recently approved new ACT combination, Pyronaridine - Artesunate (Pyramax®) is the ideal candidate for this purpose. This study will compare the effects of the ISTp using an us-RDT and Pyramax® (ISTp-US-Py) with the standard IPTp-SP on maternal malaria indicators (malaria infection, parasite density), maternal anemia, spontaneous abortions or intrauterine deaths during pregnancy, fetal morbidity (preterm birth, low birth weight, small for gestational age) and neonatal mortality at delivery in both study groups through conducting a randomized clinical trial enrolling second trimester pregnant women in Maternité Esengo Health Center, located in Kisenso, Kinshasa, the Democratic Republic of the Congo (DRC), a malaria perennial transmission area. The results generated from this study will be essential for the National Malaria Control Program in the selection and implementation of new malaria control policies and addresses the effectiveness of IPTp-SP decline among pregnant women in the DRC.
Status | Completed |
Enrollment | 250 |
Est. completion date | June 22, 2022 |
Est. primary completion date | June 22, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Gestation =16 weeks; 2. Age: =18 years; 3. Residence within the health facility catchment area; 4. Willing to adhere to study requirements and to deliver at the health facility. 5. Willing to provide written informed consent; if the woman is illiterate, she can choose an impartial witness, not related to the study, to accompany her during the informant consent process and they will both sign the informed consent form Exclusion Criteria: 1. Known history of allergy to SP or to an ACT 2. An ongoing antibioprophylaxis with cotrimoxazole, 3. Current issue requiring hospital admission (including severe malaria as defined by WHO) 4. Pregnancy at high risk |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | Maternité Esengo | Kinshasa |
Lead Sponsor | Collaborator |
---|---|
University of Kinshasa | European and Developing Countries Clinical Trials Partnership (EDCTP), Novartis |
Congo, The Democratic Republic of the,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of asymptomatic malaria in the 2 study arms | Asymptomatic malaria is defined as the presence of Pf diagnosed by an us-RDT in the peripheral blood and a T°=38°C | 6 months | |
Primary | The proportion symptomatic malaria in the 2 study arms | Symptomatic malaria is be defined as the presence of Pf diagnosed by an us-RDT in the peripheral blood and a T°=38°C | 6 months | |
Primary | The proportion of parasitic densities in the 2 study arms | Parasite density is assessed by the quantification of Pf parasites in the peripheral blood of asymptomatic/symptomatic women by a thin blood smear examined by standard malaria microscopy | 6 months | |
Primary | The proportion of anemia in the 2 study arms | Anemia is defined as a level of hemoglobin (Hb) <10g/dl | 6 months | |
Primary | The incidence of spontaneous abortions or intrauterine deaths in the 2 study arms | Intrauterine death is defined to describe the death of the offspring in the uterus | 6 months | |
Primary | The proportion of fetal morbidities in the 2 study arms | Fetal morbidity is defined as any of the following: Preterm birth (birth before 37 weeks gestation) and low-birth-weight (birth weight under 2,500 grams) | 6 months | |
Primary | The proportion of the neonatal and early neonatal mortality of the offspring in the 2 study arms | The early neonatal mortality is defined as infant death at birth or within 7 days of life; And the neonatal mortality is defined as infant death within the first 28 days of life | 28 days |
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