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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT02713568
Eligibility Criteria:
Inclusion Criteria:
* Subjects is ≥ 18 years of age and able to provide a written informed consent.
* Subject is a pregnant woman carrying a live singleton fetus at the 36+0-36+6 weeks scan, with no major abnormalities appearing during prenatal imaging with no major abnormalities appearing during prenatal imaging potentially affecting the correct use of the Hadlock formula for US-EFW. Conditions such as congenital diaphragmatic hernia with decreased abdominal circumference could be underestimated by the Hadlock USEFW. Another example is a massive sacro-coccygial teratomas.
* Subject is planning a delivery at our maternity at the University Hospital Brugmann, in Brussels, Belgium.
* Subject is known not to have any contra-indication to undergo an MR imaging examination.
Exclusion Criteria:
* Subject is known to have a contra-indication to undergo an MR imaging examination such as: Carrying a pacemaker or a metallic cardiac valve, having metallic material inside the head, having metallic fragments inside the eye following an accident, having any type of implant including ear implant, having a hip prosthesis
* Subject presenting with painful regular uterine contractions or history of ruptured membranes.
* Subjects who are unconscious, severely ill, mentally handicapped or under the age of 18 years.
* If birth occurs before MR and US evaluation.
* If patients delivers outside our local maternity unit.
* If the neonate's weigh is not measured within 6 hours after birth for any reason, including the need for emergency care immediately after delivery
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02713568
Study Brief:
Protocol Section:
NCT02713568