Malaria Pregnancy and Childbirth
Conditions
Interventions
Sponsors
African Centre for Excellence in Population Health
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Participants who are willing and able to provide informed consent. • Pregnant women with Age =18 years who are at Gestational age of 16 to 26 weeks at enrollment. • Asymptomatic to malaria on presentation, with or without a positive RDT test result. • And are Residence within the study catchment area and no intent to move out of the study catchment area before delivery or to deliver outside of the catchment area. • Participants who are willing to adhere to all study requirements.
Exclusion criteria
Exclusion criteria: • Participants with Infection HIV at enrollment. • Participants with history of IPTp-SP or other antimalarial drug use during the index pregnancy. • Participants with history of intolerance or allergic reaction to any of the study drugs. • Any participant with history of known pregnancy complications or bad obstetric history including pre-existing illness likely to cause complication of pregnancy such as repeated abortions, stillbirths or eclampsia. • Participants with severe anaemia (haemoglobin concentration <7 g/dL). • Participants with any acute illness at the time of enrolment that requires hospitalization, including severe malaria. • Participants with history of treatment with antimicrobials with antimalarial activity within the prior 2 weeks (e.g., clindamycin, azithromycin, tetracycline, clarithromycin, levofloxacin). • Participants with any use of medications with potential for antimalarial drug-drug interaction or potentiation of cardiac arrhythmia. • Participants with history or presence of comorbid conditions like hypertension, diabetes mellitus, asthma, epilepsy, renal disease, liver disease, fistula repair, heart disease, or active tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of Maternal malaria at delivery: The presence of active or recent infection at delivery measured as the composite of peripheral and placental malaria, detected by: a positive peripheral blood smear or RDT or positive placental smear, RDT, or histopathology of placental tissue. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fetal outcome Composite of any of the following: • Preterm birth (birth before 37 weeks gestation) • Low birth weight (birth weight under 2,500 grams) Frequency of fetal congenital malformations Pharmacokinetics- piperaquine level level of biomarkers of placental dysfunction Antibodies to variant surface antigens (VSAs) Frequency of maternal adverse events | — |
Countries
Nigeria
Contacts
Public ContactMurtala Jibril
Senior Lecturer
Outcome results
None listed