PREGNANT Short Cervix Trial (NCT00615550) | Clinical Trial Compass
CompletedPhase 3
PREGNANT Short Cervix Trial
United States465 participantsStarted 2008-03
Plain-language summary
The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth.
Who can participate
Age range15 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The subject has a short cervical length by transvaginal ultrasound (TVU) defined as 10-20mm. In cases of "dynamic cervix", the shortest observed/documented cervical length by TVU is to be used as the cervical length for inclusion purposes.
✓. Singleton gestation.
✓. The pregnancy has an estimated gestational age between 19 0/7 weeks and 23 6/7 weeks.
✓. Maternal age between 15 (or local age of majority/emancipation) and 45 years of age at the time of screening. An alternative age range can be accepted according to the standards and applicable regulations of the study centers.
✓. The subject speaks either English or a common local language.
✓. The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding.
✓. In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.
Exclusion criteria
✕. The subject has a cervical length \<10 or \>20mm.
✕. The subject has a multifetal gestation.
✕. The subject has or is scheduled to have a cervical cerclage prior to randomization. According to ACOG Practice Bulletin Number 48 (November 2003), cerclage can be considered in a subject with a history of 3 or more unexplained midtrimester pregnancy losses or preterm deliveries.228,229
What they're measuring
1
Number of Participants With Birth <=32 6/7 Weeks Gestation.
✕. Subjects diagnosed to have acute cervical insufficiency with bulging membranes passing the external os.
✕. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.
✕. The subject has been treated with a progestogen within the previous 4 weeks.
✕. The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end-organ dysfunction secondary to vascular disease).
✕. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.