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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07430358
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years at the time of consent
* Able and willing to provide written informed consent
* Nulliparous (no prior birth ≥ 24 weeks' gestation)
* Singleton live pregnancy
* Cephalic (vertex) fetal presentation
* Gestational age ≥ 37+0 weeks
* Admitted to the labor ward in labor (cervical dilation ≥ 3 cm with regular contractions) or undergoing induction or augmentation of labor with intent to proceed to vaginal delivery
* Planned trial of labor (no scheduled or elective cesarean delivery)
* Receiving intrapartum care at Hadassah-Hebrew University Medical Center, Mount Scopus campus
Exclusion Criteria:
* Planned or elective cesarean delivery prior to labor admission
* Multifetal gestation
* Non-cephalic fetal presentation
* Gestational age \< 37+0 weeks
* Major fetal anomaly expected to affect labor or neonatal management
* Contraindication to vaginal delivery (e.g., placenta previa, invasive placentation, prior uterine surgery precluding labor)
* Category III fetal heart rate tracing on admission requiring immediate delivery
* Maternal hemodynamic instability or other life-threatening condition necessitating urgent surgical or critical-care intervention
* Inability to provide informed consent due to cognitive impairment, intoxication, or other incapacity
* Concurrent participation in another interventional obstetric study that could confound outcomes or increase risk
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07430358
Study Brief:
Protocol Section:
NCT07430358