PREGNANT Short Cervix Trial
Condition: Preterm Delivery; Short Cervix; Short Uterine Cervical Length
MeSH terms: Premature Birth
Intervention: progesterone; placebo
Intervention description: 8% vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation; vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 465.0
Sex: Female
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Preterm; Cervix

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Singleton gestation.

          3. The pregnancy has an estimated gestational age between 19 0/7 weeks and 23 6/7 weeks.

          4. 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.

          5. The subject speaks either English or a common local language.

          6. 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.

          7. 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:

          1. The subject has a cervical length <10 or >20mm.

          2. The subject has a multifetal gestation.

          3. 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

          4. Subjects diagnosed to have acute cervical insufficiency with bulging membranes passing
             the external os.

          5. The subject has a previous history of an adverse reaction to progesterone or any
             component present in Prochieve® 8% vaginal gel.

          6. The subject has been treated with a progestogen within the previous 4 weeks.

          7. 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).

          8. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of
             hormone-associated thrombophlebitis or thromboembolic disorders.

          9. The subject has active liver dysfunction or disease.

         10. The subject has known or suspected malignancy of the breast or genital organs.

         11. The subject is currently participating in another interventional study or has
             participated in an interventional drug study within one month prior to screening for
             this study.

         12. The subject's current pregnancy is complicated by a major fetal anomaly or known
             chromosomal abnormality.

         13. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus)

         14. The subject, in the judgment of the investigator, will be unable or unwilling to
             comply with study-related assessments and procedures.

         15. The subject currently has preterm rupture of membranes, vaginal bleeding, known or
             suspected amnionitis, or signs or symptoms of preterm labor at the time of enrollment.

         16. The subject is HIV positive with a CD4 count of <350 cells/mm3 and is receiving more
             than one (1) medication to prevent the transfer of AIDS to the fetus.

         17. Complete placenta previa.