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 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT03623061
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the clinical investigation.
* Female, aged 18 years or above.
* Able (in the Investigators opinion) and willing to comply with all clinical investigation requirements.
* Presenting for Group 1: Elective Caesarean section Group 2: Elective gynaecological procedure
* Group 3 will consist of anonymous patient samples
Exclusion Criteria:
* Patients on any antiplatelet or anticoagulant medications
o Patients prescribed subcutaneous low molecular weight heparin medications are permitted to enrol, provided the timing of sampling is outside of 24 hours after the last dose of the medication.
* Any patient with a known thrombophilia or a known haemophilia.
* Any patient with a known dysfibrinogenaemia except in the anonymous low fibrinogen group
* Patients with a known malignancy or autoimmune condition affecting blood clotting
* A personal history of easy bruising strongly suggestive of a blood clotting disorder
* Any reason, in the opinion of the investigator that would make the subject unsuitable for participation
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03623061
Study Brief:
Protocol Section:
NCT03623061