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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT00514618
Eligibility Criteria:
Inclusion Criteria:
1. Singleton gestation
2. Intact membranes
3. Bishop score \<= 4
4. Uterine contractions \<=12/hour
5. Cephalic presentation
6. Estimated gestational age of at least 38 weeks by ACOG dates
7. An amniotic fluid index (AFI) \>5 cm
8. Reactive Non Stress Test
9. Class A1, A2 diabetes
10. Good compliance with clinic visits and home glucose monitoring
Exclusion Criteria:
I. Fetal Factors
1. Multiple Gestation
2. Presence of fetal distress/non-reassuring FHR pattern
3. Malpresentation, including breech
4. EFW \> 4500 gm or other evidence of cephalo-pelvic disproportion
5. EFW \< 2000 gm
II. Maternal Factors
1. Frequent uterine contractions \>= 12/hour
2. Ruptured membranes
3. Placenta previa or unexplained vaginal bleeding
4. Vasa previa
5. Active herpes simplex
6. Glaucoma or elevated intraocular pressure
7. Renal or hepatic dysfunction
8. Previous Cesarean delivery or history of uterine surgery
9. Evidence of chorioamnionitis or maternal fetal \>= 100.4 degrees F
10. Significant cardiac lesion or cardiovascular disease
11. Severe asthma
12. Parity \>=6
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00514618
Study Brief:
Protocol Section:
NCT00514618