Pregnancy Complications Parasitic
Conditions
Keywords
malaria, pregnancy, prevention, treatment, molecular markers
Brief summary
The study has two components: component A is a cohort study to determine the in vivo efficacy of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and component B is a cross sectional study of women delivering at the study hospitals to assess the effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context of increasing SP resistance. Results of component A and B studies will be used to model the relationship between the prevalence of molecular markers of SP resistance, in vivo efficacy to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for routine monitoring effectiveness of SP-IPTp as part of ANC surveillance.
Detailed description
Study sites will include different levels of transmission and social factors affecting ANC attendance Damboa hospital in Borno state has a catchment area with pop of 231,573 with a semi arid climate and where malaria is mesoendemic. The expected number of patients is 15-25 per week for new bookings Park Lane hospital serves a semiurban population. Malaria transmission is holoendemic and stable. 1400 women attend ANC services per month Women will receive SP-IPTp according to National guidelines and will be followed for 42 days to assess the therapeutic efficacy in parasitaemic women and to assess the ability to remain parasite free. PCR will be used to determine reinfection from recrudescence
Interventions
DRUGEfficacy of suphladoxine/pyrimethamine as IPTp
3 tablets (single dose)given twice during pregnancy one month apart after quickening
Sponsors
Department for International Development, United Kingdom
London School of Hygiene and Tropical Medicine
University of Nigeria, Enugu Campus
Malaria Consortium, UK
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* gestational age 16-30 weeks * Axillary temperature ,37.5 Degrees * informed consent
Exclusion criteria
* gravida \> 2 * previous inclusion in this study * history of hypersensitivity to SP or components of SP * Use of IPTp with SP during this pregnancy * history of taking other antimalarials in the past month * Known HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women | 15 months | PCR corrected Adequate parasitological clearance by day 42 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women | 15 months | PCR uncorrected parasitological clearance by day 42 |
| To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women | 15 months | Prevalence of molecular markers of SP resistance at enrolment |
Countries
Nigeria
Contacts
Primary ContactDr Ebenezer Baba
Backup ContactDr Elvis Shu
Outcome results
None listed