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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00701350
Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 years of age or older
* Subject has singleton gestation
* Subject has fetus with getstational age of at least 23 0/7 days and no greater than 33 6/7 days
* Subject has diagnosis of preterm premature rupture of amniotic membranes as determined by at least two of the following:
1. Postive pooling,
2. Presence of ferning from cervical vaginal fluid swab on an air dried slide,
3. Postivie nitrizine pH test, or, in lieu of the criteria listed above
4. Positive Amnisure test result
5. Positive indigo carmine egress vaginally following instillation at amniocentesis
* Subject is enrolled and has an amniocentesis within 24 hours of membrane rupture
* Subject is a candidate for expectant management as evidenced by the following:
1. Absence of labor (defined by absence of painful uterine contractions)
2. No clinical signs of infection (maternal fever of 37.9 C or greater, fetal heart rate greater than 160 bpm, uterine tenderness, purulent aminorrhea)
3. presence of non-reassuring heart tracing
* Subject is a candidate for amniocentesis as evidenced by the following:
1. Ultrasound reveals pocket of fluid likely to result in successful amniocentesis
2. Physician believes that the subject shoudl undergo amniocentesis as part of their routine evaluation of their current problem of PPROM to rule out infection and/or to test for lung maturity
Exclusion Criteria:
* Subject has a fetus with major fetal anomaly (life threatening or requires surgical intervention) or chromosomal aneuploidy
* Subject has pre-existing medical indication for preterm delivery (e.g., pre-eclampsia, refractory hypertension, diabetes with significant complications, active lupus)
* Subject is unable to provide informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00701350
Study Brief:
Protocol Section:
NCT00701350