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Cervical Cerclage for Preventing Premature Birth (COLORS Trial)

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

N/A

Recruiting

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

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 more

COLORS 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

2015

N/A

~480

Vaginal progesterone

2016

Completed Phase 4

~700

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,508 Total Patients Enrolled

10 Trials studying Premature Birth

13,812 Patients Enrolled for Premature Birth

Media Library

Cervical Cerclage Clinical Trial Eligibility Overview. Trial Name: NCT03251729 — N/A

Premature Birth Research Study Groups: Cerclage, Control

Premature Birth Clinical Trial 2023: Cervical Cerclage Highlights & Side Effects. Trial Name: NCT03251729 — N/A

Cervical Cerclage 2023 Treatment Timeline for Medical Study. Trial Name: NCT03251729 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI