PREGNANT Short Cervix Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia Laboratories
ClinicalTrials.gov Identifier:
NCT00615550
First received: January 18, 2008
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Preterm Delivery
Short Cervix
Short Uterine Cervical Length
Drug: progesterone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)]

Resource links provided by NLM:


Further study details as provided by Columbia Laboratories:

Primary Outcome Measures:
  • Number of Participants With Birth <=32 6/7 Weeks Gestation. [ Time Frame: 9 to 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    Each infant is scored based on the 7 morbidity and mortality events above:

    0= no morbidity event

    1. 1 morbidity event
    2. 2 morbidity events
    3. 3 or more morbidity events
    4. mortality

  • 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 ] [ Designated as safety issue: No ]
    Number of participants at <=27 6/7 , <=34 6/7, and <36 6/7.

  • Number of Neonates Who Died. [ Time Frame: Delivery to 28 days ] [ Designated as safety issue: Yes ]
  • Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams [ Time Frame: date of delivery ] [ Designated as safety issue: No ]
    Assessment of birth weight < 1500 grams or < 2500 grams


Enrollment: 465
Study Start Date: March 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo vaginal gel
Drug: placebo
vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation
Active Comparator: Prochieve
Progesterone 8% Vaginal Gel
Drug: progesterone
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
Other Name: Prochieve 8%

Detailed Description:

A Short uterine cervical length in the mid-trimester is the most powerful predictor of preterm birth.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615550

  Show 49 Study Locations
Sponsors and Collaborators
Columbia Laboratories
Investigators
Study Director: George W. Creasy, MD, FACOG Columbia Laboratories, Inc.
Study Director: Roberto Romero, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director: Sonia Hassan, MD Wayne State University
  More Information

Additional Information:
Publications:
Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Fonseca EDa,Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. American Journal of Obstetrics and Gynecology 206 (2): 124-126, 2012.

Responsible Party: Columbia Laboratories
ClinicalTrials.gov Identifier: NCT00615550     History of Changes
Other Study ID Numbers: COL-1620-302, 09-CH-N014
Study First Received: January 18, 2008
Results First Received: February 24, 2012
Last Updated: February 27, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: Ethics Committee
Chile: Instituto de Salud Pública de Chile
Russia: Pharmacological Committee, Ministry of Health
Ukraine: Ministry of Health
Belarus: Ministry of Health
South Africa: Medicines Control Council
Czech Republic: State Institute for Drug Control

Keywords provided by Columbia Laboratories:
Preterm
Cervix

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014