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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT03899961
Eligibility Criteria:
Inclusion Criteria:
1. Healthy pregnant women age 18 to 50
2. Singleton pregnancy at gestational age 36 weeks or more
3. Able to read and understand Norwegian.
4. Patients will be recruited from the general population at the birth clinic at Oslo University Hospital or the birth clinic of Akershus University Hospital. Signed informed consent form (ICF) and expected cooperation of the patients for the treatment and follow up will be obtained and documented according to ICH GCP, and national/local regulations.
Exclusion Criteria:
1. Patients with placenta pathology such as praevia, accreta, pre-eclampsia
2. Patients with bleeding disorders including vonWillebrand disease type I.
3. Known intolerance to one of the two drugs.
4. Patients with prolonged QT-time or other serious cardiac diseases.
5. Liver or kidney failure.
6. Epilepsy.
7. Any medical reason why, in the opinion of the investigator, the patient should not participate.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03899961
Study Brief:
Protocol Section:
NCT03899961