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 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT05073718
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women up to 32 weeks of gestational age
* Aged 18 years or older\*
* Willing to deliver at the recruitment health facilities
* In Mozambique, in case of age below 18 years, the participant will be asked for the assent and the informed consent will be given by the legal tutor in accordance with the national regulations.
Exclusion Criteria:
* On regular ASA treatment for pre-eclampsia prevention
* On long-term non-steroidal anti-inflammatory medication
* Bleeding disorders, mainly haemophilia, hypoprothrombinaemia orVon Willebrand's disease
* History of hypersensitivity to ASA or to any of the excipients of the investigational product.
* History of peptic ulceration, including active, chronic or recurrent gastroduodenal ulcer; recurrent gastric discomfort History of gastric bleeding or perforation after treatment with aspirin or other non-steroidal anti-inflammatory drugs
* Inability to cooperate with the requirements of the study
* Severe COVID-19 disease (with any of the following: respiratory rate \> 30 breaths/min; severe respiratory distress; SpO2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction).
* Treatment resistant hyperemesis gravidarum
* Hypersensitivity to nonsteroidal anti-inflammatory drugs or to tartrazine (cross-reaction) or to any of the excipients used in its composition.
* Asthma.
* Severe renal or hepatic insufficiency.
* Nasal polyps associated with asthma that are induced or exacerbated by aspirin.
* Severe COVID-19 disease (with any of the following: respiratory rate \> 30 breaths/min; severe respiratory distress; SpO2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction).
* Treatment resistant hyperemesis gravidarum
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT05073718
Study Brief:
Protocol Section:
NCT05073718