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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT00201656
Eligibility Criteria:
Inclusion Criteria:
1. A previously placed prophylactic cerclage defined as any cerclage done \< 23 6/7 weeks including those done for previous history of cervical incompetence, asymptomatic cervical shortening (regardless of effacement) and asymptomatic cervical dilation \< 3 cm
2. Spontaneous rupture of membranes 22-32 weeks
3. Singleton or twin gestation
4. Shirodkar or McDonald cerclage in place \> 1 week
Exclusion Criteria:
1. Active labor (\> 8 uterine contractions \[UCs\] per hour)
2. Chorioamnionitis as defined by temperature \> 38 plus fetal tachycardia or uterine tenderness
3. Placenta previa or undiagnosed vaginal bleeding
4. Nonreassuring fetal status by nonstress test (NST) or biophysical profile (BPP)
5. Mature pulmonary studies
6. Positive gram stain, culture, white blood cells (WBC) \> 30, or glucose \< 14 on amniocentesis
7. Major fetal anomaly
8. Presentation \> 48 hours after rupture of membranes
9. abdominal cerclage
10. Cerclage done for symptomatic cervical dilation (cervix dilated \> 3 cm)
11. Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00201656
Study Brief:
Protocol Section:
NCT00201656