Preterm birth (less than or equal to 32 6/7 weeks gestation)
Conditions
Interventions
Trade Name: Crinone 8%
Product Name: Prochieve/Crinone
Pharmaceutical Form: Vaginal gel
INN or Proposed INN: PROGESTERONE
CAS Number: 57830
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Columbia Laboratories, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject has a short cervical lenght by transvaginal ultrasound (TCVU) defined as 10-20 mm. In cases of "dynamic cervix", the shortest observed/documented cervical lenght by TVU is to be used as the cervical lenght for inclusion purposis. 2. Singleton gestation. 3. The pregnancy has a 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 od 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has a cervical length 20 mm. 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 of an adverse reaction to progesterone or any component present in Prochieve®/Crinone 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 a thromboembolic disorder. 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 judgement of the investigator, will be unable or unwilling to comply with study-related assesments and procedures. 15. The subject currently has preterm rupture or membranes, vaginal bleeding. known o suspected amnionitis, or signs or symptoms or 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction in the frequency of preterm birth (less than or equal to 32 6/7 weeks gestation);Secondary Objective: Reduction in the frequency of neonatal morbidities such as respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), proven sepsis, and necrotizing enterocolitis (NEC);2) Reduction in the frequency of preterm birth at =27 6/7, =34 6/7, and <36 6/7 weeks gestation; 3)Reduction in the frequency of neonatal mortality;4) Reduction in the frequency of admission for preterm labor;5) Assessment of the admission-to-delivery interval in subjects receiving tocolytic therapy for preterm labor;6) Assessment if Apgar scores, length, weight, and head circumference at birth and incidence of congenital anomalies;7) Assessment of other indicators of neonatal morbidity such as admission to the NICU, the duration of stay in the NICU, and the total hospital stay. ;Primary end point(s): Proportion of subjects with a delivery of less than or equal to 32 6/7 weeks gestational age | — |
Countries
Czech Republic
Outcome results
None listed