Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT05426434
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women between 12-26 weeks' gestation
* 16 years of age or older
* Viable singleton intrauterine pregnancy
* Permanent resident of the study area
* Willing to adhere to scheduled and unscheduled study visit procedures
* Willing to birth in a study clinic or hospital
* Able to provide written informed consent
Exclusion Criteria:
* Multiple pregnancy (i.e. twins/triplets)
* Known heart ailment or other chronic medical condition requiring frequent hospital care
* Active medical problem requiring inpatient evaluation at the time of screening
* Severe malformations or non-viable pregnancy if observed by ultrasound
* Antimalarial therapy in the prior two weeks
* Unable to provide written informed consent
* Known allergy or contraindication to any of the study drugs
* Early or active labour
* Known HIV-positive status
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT05426434
Study Brief:
Protocol Section:
NCT05426434