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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00615550 |
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Date of registration:
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18/01/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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PREGNANT Short Cervix Trial
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Scientific title:
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The Effect of Vaginal Progesterone Administration in the Prevention of Preterm Birth in Women With a Short Cervix [Vaginal Progesterone Bioadhesive Gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)] |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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465 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00615550 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Belarus
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Chile
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Czech Republic
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India
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Israel
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Italy
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Russian Federation
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South Africa
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Ukraine
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United States
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Contacts
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Name:
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Roberto Romero, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Name:
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George W. Creasy, MD, FACOG |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia Laboratories, Inc. |
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Name:
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Sonia Hassan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wayne State University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
15 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Preterm Delivery
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Short Uterine Cervical Length
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Short Cervix
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Intervention(s)
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Drug: placebo
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Drug: progesterone
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Primary Outcome(s)
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Number of Participants With Birth <=32 6/7 Weeks Gestation.
[Time Frame: 9 to 13 weeks]
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Secondary Outcome(s)
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Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)
[Time Frame: Delivery Hospitalization (1-212 days)]
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Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams
[Time Frame: date of delivery]
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Number of Neonates Who Died.
[Time Frame: Delivery to 28 days]
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Number of Subjects With Preterm Birth at =27 6/7, =34 6/7, and <36 6/7 Weeks Gestation.
[Time Frame: Gestational Age at Delivery]
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Secondary ID(s)
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COL-1620-302
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09-CH-N014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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