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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT02546193
Eligibility Criteria:
Inclusion Criteria
1. Pregnant women at ≥37 weeks gestation by reliable dating criteria as determined by the American College of Obstetricians and Gynecologists (i.e. gestational age supported by one of the following: ultrasound prior to 20 weeks of gestation, fetal heart tones auscultated by Doppler for 30+ weeks, or documented serum or urine pregnancy test 36+ weeks ago)
2. Scheduled induction of labor with indication and timing supported by the Family Birth Center induction of labor guideline entitled "Induction of labor: Indications and Timing"
3. Singleton gestation
4. Cephalic presentation
5. Amniotic fluid index greater than or equal to 5 centimeters
6. Formal prenatal ultrasound documenting the absence of placenta previa
7. Bishop score \<6 and cervical dilation \<3cm
8. The woman is able to give appropriate consent and has undergone an informed consent process.
9. Maternal age ≥ 18 years old at the time of consent.
Exclusion Criteria
1. New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy)
2. Vaginal bleeding
3. Active labor
4. Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault.
5. Uterine tachysystole (\>5 contractions in 10 minutes)
6. Nonreassuring fetal heart tracing before or after Foley placement
7. Chorioamnionitis or maternal fever
8. Intrauterine fetal demise
9. Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery)
10. Abnormal placentation including a low lying placenta
11. Prior cesarean delivery
12. Intrauterine growth restriction (growth \<10th percentile by formal ultrasound)
13. Known fetal anomaly
14. Human immunodeficiency virus, Hepatitis C, or active herpes infection
15. Maternal cardiopulmonary disease requiring cardiac monitoring during labor
16. Pregestational diabetes
17. Rh isoimmunization
18. Non-English speaking
19. Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02546193
Study Brief:
Protocol Section:
NCT02546193