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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT00646802
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women aged between 18 - 45 years
* Gestational age between 24.0 and before 33.6 gestational weeks
* Singleton pregnancy
* Patients admitted because of preterm labor who have been successfully treated of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)
* Ultrasound cervical length at discharge \< 25 mm
* Signed patient consent form (CI)
Exclusion Criteria:
* Known or suspected infection, premature rupture of membranes or any other pathological gravid maternal or fetal condition coexisting at hospital admission (Pre-eclampsia, RCIU) which may induce iatrogenic labor.
* Present or previous liver disease, present or previous cholestasis gravidarum, abnormal hepatic blood tests.
* With known allergy to progesterone or peanuts (excipient).
* Grade 2 (or upper) renal or liver laboratory abnormalities
* Treated from dependent-hormone malignant cancer (i.e., breast carcinoma...)
* With Diabetes mellitus or insulinized gestational diabetes
* Treated with heparin
* Drug abuse
* Inadequate treatment compliance
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00646802
Study Brief:
Protocol Section:
NCT00646802