Collaborators:
Name |
Country |
Institution
|
Vivi Maketa |
The Democratic Republic of The Congo |
University of Kinshasa |
Objectives:
Main objective
The main objective is to assess that the proportion of maternal malaria, maternal anemia, spontaneous abortions or intrauterine death during pregnancy, fetal morbidity and neonatal mortality at childbirth is non inferior when using ISTp-US-Py compared to IPTp-SP.
Secondary objective
The secondary objectives are to assess that:
During pregnancy:
- The proportion of asymptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP
- The proportion of parasitic densities is not higher when using ISTp-US-Py compared to IPTp-SP
- The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP
- The incidence of spontaneous abortions or intrauterine deaths is not higher when using ISTp-US-Py compared to IPTp-SP
After the birth:
In women:
- The proportion symptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP
- The parasitic densities are not higher when using ISTp-US-Py compared to IPTp-SP
- The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP
In the offspring:
- Intrauterine death
- The fetal morbidities (Preterm birth, Low-birth-weight) are not higher when using C compared to IPTp-SP
During the 28 days period following the birth:
- The neonatal and early neonatal mortality of the offspring are not higher when using ISTp-US-Py compared to IPTp-SP
Sites:
Maternité Esengo, Kinshasa, DRC
Study Design:
s a 2 arms 1.1 ratio randomized non-inferiority trial. An unique registration number will be associated with a randomization list number, generated before the start of the study and which will determine the assignment of the study participant to one of the study groups.
- The ISTp-US-Py group will comprise pregnant women who will be screened monthly from the beginning of the 2nd trimester with us-RDT and who will be treated with Pyramax® if the test is positive.
- The IPTp-SP group will be pregnant women who will receive the standard regimen recommended by the Malaria National Control Program (MNCP) at week 16, 28, 32 and 36 of their pregnancy.
Outcomes:
Primary outcome
The primary outcome will be the assessment of asymptomatic/symptomatic malaria during pregnancy and of the malaria related morbidities in the offspring
Secondary outcomes
During pregnancy, the following outcomes will be assessed in the study participants:
- The asymptomatic/symptomatic malaria
- The parasitic density of women who will have malaria
- The presence of anemia
- The incidence of spontaneous abortions or intrauterine deaths
After the birth, the outcomes will be assessed as following:
In the mother
- The asymptomatic/symptomatic malaria
- The PD
- The presence of anemia
In the offspring
- Fetal morbidity
- Intra uterine death
Within the 28 days of post-partum, the following outcomes will be assessed in the infant
- The early neonatal mortality (death within 7 days of life)
- The neonatal mortality (death within 28 days of life)