ISRCTN45944555
Active, not recruiting
Phase 3
Evaluation of point of care digital molecular diagnostic tool in malaria chemoprevention in pregnant women in the context of parasite resistance to sulphadoxine-pyrimethamine in a malaria high transmission area of Nchelenge in Zambia
Tropical Diseases Research Centre0 sites254 target enrollmentApril 11, 2024
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Malaria diagnostic and prevention in pregnant women
- Sponsor
- Tropical Diseases Research Centre
- Enrollment
- 254
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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