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Cervical Cerclage for Preventing Premature Birth (COLORS Trial)
Phase 4
Waitlist Available
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years old or older
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days after delivery
Awards & highlights
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.
Who is the study for?
This trial is for pregnant women over 18 with a single baby and a short cervix (less than or equal to 25mm) measured by ultrasound, who haven't had preterm births or losses in the second trimester before. Women can't join if they already have a cerclage, signs of labor, major fetal issues, dilated cervix over 1cm, infection suspicion, multiple babies, ruptured membranes or certain placenta problems.Check my eligibility
What is being tested?
The study tests whether cervical cerclage—a procedure where the cervix is stitched closed—can prevent early birth in low-risk pregnancies with short cervixes compared to using vaginal progesterone which is a hormone treatment aimed at supporting pregnancy.See study design
What are the potential side effects?
Cervical cerclage might cause discomfort, bleeding or cramping and has risks like breaking water early or causing infection. Vaginal progesterone may include side effects such as headaches, nausea and local irritation.
COLORS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
COLORS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Preterm birth <35 weeks
Secondary outcome measures
Histologically proven clinical chorioamnionitis
Mean gestational age at delivery
Neonatal outcomes: IVH grade 3 or 4
+9 moreCOLORS Trial Design
2Treatment groups
Experimental Treatment
Group I: ControlExperimental Treatment1 Intervention
Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
Group II: CerclageExperimental Treatment2 Interventions
Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cervical cerclage
2017
Completed Phase 4
~570
Vaginal progesterone
2016
Completed Phase 4
~790
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cervical cerclage is a common treatment for preventing premature birth, particularly in patients with a short cervix. The procedure involves placing a stitch around the cervix to prevent it from opening prematurely.
This mechanical support helps maintain the integrity of the cervix and delays labor, allowing the pregnancy to reach a more viable gestational age. This is crucial for premature birth patients as it can significantly improve neonatal outcomes by providing more time for fetal development.
Avoiding endotracheal ventilation to prevent bronchopulmonary dysplasia: a meta-analysis.The effect of facilitated tucking on procedural pain control among premature babies.Inguinal hernia repair in premature infants: more questions than answers.
Avoiding endotracheal ventilation to prevent bronchopulmonary dysplasia: a meta-analysis.The effect of facilitated tucking on procedural pain control among premature babies.Inguinal hernia repair in premature infants: more questions than answers.
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
451 Previous Clinical Trials
148,585 Total Patients Enrolled
10 Trials studying Premature Birth
13,812 Patients Enrolled for Premature Birth
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cerclage
- Group 2: Control
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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