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:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT01131260
Eligibility Criteria:
Inclusion Criteria:
* Singleton, cephalic pregnancy
* Gestational age at least 36 weeks, 1 day
* Cervical dilation of at least 2 cm and no more than 7 cm
* Ruptured membranes
Exclusion Criteria:
* Multifetal gestation
* Planned cesarean delivery
* Need for immediate delivery
* Absent variability or sinusoidal pattern at any time, or a Category II fetal heart rate pattern with absent variability in the last 20 minutes before randomization
* Inability to obtain or maintain an adequate signal within 3 trials of electrode placements
* Occurrence of any ST event during attempt to obtain adequate signal
* Patient pushing in the first stage of labor
* Known major fetal anomaly or fetal demise
* Previous uterine surgery
* Placenta previa on admission
* Maternal fever greater than or equal to 38 C or 100.4 F
* Active HSV infection
* Known HIV or hepatitis infection
* Other maternal and fetal contraindications for using the STAN monitor
* Enrollment in another labor study
* Participation in this trial in a previous pregnancy
* No certified or authorized provider available
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT01131260
Study Brief:
Protocol Section:
NCT01131260