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 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT03001661
Eligibility Criteria:
Inclusion criteria
Women must meet the following criteria prior to initiation of IoL:
1. ≥ 16 years of age
2. Able to provide informed consent
3. Singleton pregnancy
4. Indication for IoL
5. Pregnancy ≥ 37.0 weeks (assessed as an agreed gestational age by ultrasound dating scan)
6. Living fetus with vertex presentation
7. Intact membranes
Exclusion criteria
1. Women already receiving oxytocin
2. Diagnosis of fulminant preeclampsia / eclampsia
3. Contraindication to DINOPROSTONE or DILAPAN
4. If DINOPROSTONE for IoL is non-compliant with local policy
5. Enrolled in other randomised controlled trials of an IMP or device for cervical ripening or induction of labour
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT03001661
Study Brief:
Protocol Section:
NCT03001661