Malaria diagnostic and prevention in pregnant women Infections and Infestations
Conditions
Interventions
This study has both interventional and observational elements as follows:
Interventional:
The study is a phase IIIb open-label randomized controlled superiority trial of standard intermittent Presumpt
Sponsors
Tropical Diseases Research Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Gestational age of 16 to 26 weeks at enrolment 2. Asymptomatic* on presentation 3. Hb = 7 g/dL 4. HIV negative at enrolment 5. No history of IPTp-SP or antimalarial drug use during the current pregnancy 6. At least 15 years old 7. Residence within the health facility catchment area 8. Willing to deliver at the health facility 9. Willing to adhere to the study requirements (HIV voluntary counseling and testing (VCT included) 10. Ability to provide written informed consent; if the woman is a minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law (* Asymptomatic defined as the absence of fever (temperature <37.5 °C) at baseline; less than three of the following symptoms: fever in the past 24 h, weakness/fatigue; muscle and/or joint aches, headache. An assent will also be obtained from the participant).
Exclusion criteria
Exclusion criteria: 1. HIV positive or unknown at enrolment 2. Hb<7 g/dl 3. History of allergic reactions to the study drugs 4. 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 5. History or presence of major illnesses likely to influence pregnancy outcome including hypertension, diabetes mellitus, asthma, epilepsy, renal disease, liver disease, fistula repair, heart disease, or active tuberculosis 6. Current cotrimoxazole prophylaxis or ARV treatment 7. Any significant illness at the time of screening that requires hospitalization, including severe malaria 8. Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment area 9. Prior enrolment in the study or concurrent enrolment in another study 10. Unable to take oral medication 11. Clear evidence of recent (2 weeks) treatment with antimicrobials with antimalarial activity (clindamycin, azithromycin, clarithromycin, levofloxacin etc.) 12. On at least one of the following drugs: Pentamidine, Antiarrhythmic agents (e.g., amiodarone, sotalol), Antihistamines (e.g., promethazine), Antifungals (systemic): ketoconazole, fluconazole, itraconazole, Diuretics (e.g., hydrochlorothiazide, furosemide), Antipsychotics (neuroleptics): haloperidol, thioridazine, Antidepressants: imipramine, citalopram, escitalopram, Antiemetics: domperidone, chlorpromazine, ondansetron
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean birth weight and prevalence of low birth weight (LBW) newborns measured using data collected in patient records at the end of the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medication-related adverse events and serious adverse measured using data collected in patient records at the end of the study period 2. Sensitivity and Specificity including the proportion of SP resistance mutation as determined by Lacewing measured by comparing it against PCR at the end of the study period 3. Proportions of preterm delivery measured using data collected in patient records at the end of the study period 4. The proportion of stillbirths measured using data collected in patient records at the end of the study period 5. The proportion of congenital malaria cases measured using data collected in patient records at the end of the study period 6. The proportion of maternal anemia measured using data collected in patient records at the end of the study period 7. The incidences of neonatal deaths measured using data collected in patient records at the end of the study period 8. The proportions of malaria at delivery measured using data collected in patient records at the end of the study period 9. The positive and negative predictive values measured using data collected in patient records at the end of the study period | — |
Countries
Zambia
Contacts
Public ContactJean-Bertin Bukasa Kabuya
Outcome results
None listed