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:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT07054359
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 years old, or ≥ the legal age of majority as defined by each country, on the day of inclusion.
2. Pregnancy.
3. Intention to attend antenatal care visits in the Primary Health Center or the Rural Hospital
4. Living in an area covered by the Primary Health Center or the Rural Hospital on the start date of the trial
5. Positive HBsAg identified during the screening phase of the study
6. Free, informed, and written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out as part of the study.
Exclusion Criteria:
1. HIV co-infection.
2. HBV treatment ongoing on the day of inclusion.
3. Having at least one of the following criteria indicatives of the third trimester of pregnancy:
* Gestational Age-Based Exclusion:
The reported gestational age is ≥28 weeks, based on the last menstrual period (LMP) if known.
* Ultrasound-Based Exclusion:
Fetal biometry (e.g., head circumference, femur length) on ultrasound suggests a gestational age of ≥28 weeks.
* Fundal Height-Based Exclusion:
Symphysis-fundal height (SFH) measurement of ≥ 28 cm which corresponds to approximately 28 weeks of gestation.
4. Severe gravid disease at inclusion, which poses a life-threatening risk to the mother and/or child
5. Any concomitant medical condition that, according to the clinical site investigator, would contraindicate participation in the study.
6. Concurrent participation in any other study (unless approved in writing by the Global Principal Investigators).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07054359
Study Brief:
Protocol Section:
NCT07054359