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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT04169035
Eligibility Criteria:
Inclusion Criteria:
* The woman is ≥18 years of age
* The woman has a singleton pregnancy
* The pregnancy is ≥28+0 weeks' gestation
* There is a negative antenatal screen for HIV and Hepatitis B
Exclusion Criteria:
* The woman does not fulfil all of the inclusion criteria listed
* There is a diagnosis of a fetal skull abnormality precluding AVB (i.e. macrocephaly)
* There is a known osteogenesis imperfecta affected pregnancy
* There is suspicion of a fetal bleeding disorder (von Willebrand's disease, AITP, haemophilia)
* There is an intrauterine fetal death in the current pregnancy
* The woman is sensitive to latex
* The woman is currently serving a prison sentence
* The woman lacks capacity to consent
* The woman has a lack of ability to read or understand French as this would preclude successful completion of questionnaires
* The woman has received intramuscular or intravenous opiates (i.e. pethidine or morphine) within the past 6 hours
* The woman is in established labour (≥ 4cm cervical dilatation) without regional analgesia in place
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04169035
Study Brief:
Protocol Section:
NCT04169035