Increased-Risk for Preterm Delivery
Conditions
Interventions
Product Name: CRINONE 8%
Pharmaceutical Form: Vaginal gel
INN or Proposed INN: progesterone
Concentration unit: % percent
Concentration type: equal
Concentration number: 8-
Pharmaceutical form of the
Sponsors
Columbia Laboratories, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject has a history of a documented spontaneous singleton preterm delivery (hospital or clinic record, letter from healthcare provider, or birth certificate) from 20 0/7 to 35 0/7 weeks gestational age with the immediate preceding pregnancy or has a cervical length of 2.5 cm or less measured by transvaginal ultrasound with the current pregnancy. “Spontaneous preterm delivery" is a delivery (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel. 2. The subject has been treated with a progestogen within the previous 4 weeks. 3. 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). 4. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders. 5. The subject has liver dysfunction or disease. 6. The subject has known or suspected malignancy of the breast. 7. The subject is currently participating in another investigational study or has participated in an investigational drug study within one month prior to screening for this study. 8. The subject’s current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality. 9. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus) 10. The subject has a multifetal gestation. 11. The subject has a cervical cerclage in place or has plans to have one placed during the current pregnancy. 12. The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures. 13. 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. 14. The subject is HIV positive with a CD4 count of =350 cells/mm3 and is receiving more than 1 medication to prevent the transfer of AIDS to the fetus. 15. The subject has placenta previa or a low-lying placenta. The subject will be considered for the study if she is not at risk for increased bleeding and has not been given any vaginal precautions. 16. The subject’s qualifying preterm delivery was an indicated delivery without preterm labor (i.e. delivery performed for fetal distress, maternal eclampsia/preeclampsia, fetal death, or amnionitis in the absence of contractions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A reduction in the frequency of delivery at =32 0/7 weeks gestational age in subjects who have had a previous preterm delivery.;Primary end point(s): The primary efficacy parameter in this study is the proportion of subjects with a delivery = 32 0/7 weeks gestational age in subjects who have had a previous preterm delivery. A supplemental parameter in this study is the frequency of significant morbidity in infants during the initial hospitalization after birth.;Secondary Objective: 1.Frequency of delivery at =32 0/7 weeks gestational age in subjects who have had a previous preterm delivery or only a short cervix (= 2.5 cm). 2. Frequency of delivery at = 28 0/7 weeks, = 35 0/7 weeks, and = 36 6/7 weeks gestation. 3. Frequency of delivery at = 32 0/7 weeks gestation in both compliant subjects and non-compliant subjects. | — |
Countries
Czech Republic
Outcome results
None listed