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Cervical Cerclage for Preventing Premature Birth (COLORS Trial)
COLORS Trial Summary
This trial will test whether a medical procedure called cervical cerclage can help prevent spontaneous preterm birth in pregnant women with a short cervix.
COLORS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOLORS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COLORS Trial Design
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Who is running the clinical trial?
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- I am experiencing painful contractions or signs of early labor.I am 18 years old or older.I am 18 years old or older.I am currently experiencing vaginal bleeding.My cervix is dilated more than 1 cm or the membranes are visible.You have not had a premature birth or a miscarriage between 23 and 28 weeks of pregnancy.
- Group 1: Cerclage
- Group 2: Control
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is participation in this research project open to volunteers?
"This clinical trial is searching for 206 volunteers who were born prematurely and are between 18 to 50 years old."
Are opportunities currently available for participants to join this trial?
"Data from clinicaltrials.gov confirms that this medical study is presently looking for participants to enrol in the trial. The posting of this research was originally on September 22nd 2017, and it has been modified most recently on February 4th 2022."
Are there any precedents for employing Vaginal progesterone in clinical research?
"Currently, there are 8 Phase 3 Vaginal progesterone studies and 42 ongoing trials for this medication. The majority of these occur in Barcelona, Catalunya; however, 268 other clinical trial sites across the world offer access to it."
Do potential participants have to meet a minimum age criterion for this research?
"This research study is open to any individual who has surpassed 18 years of age and remains below 50."
What medical difficulties has Vaginal progesterone been popularly administered for?
"Vaginal progesterone is an effective prophylactic measure to prevent recurrent spontaneous preterm birth as well as mitigate uterine hemorrhage and hormonal instability."
How many participants are being observed in this clinical research?
"Affirmative. According to records hosted on clinicaltrials.gov, this medical trial is actively seeking participants and was first published on September 22nd 2017 with a most recent update made in February 4th 2022. The study requires 206 patients from 1 site."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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