What side effects are associated with this type of intervention?

Cervical cerclage, a procedure where a stitch is placed around the cervix to prevent premature opening, is generally considered safe but can have some side effects. These may include mild cramping, vaginal bleeding, and discharge. In rare cases, more serious complications such as infection, cervical damage, or preterm premature rupture of membranes (PPROM) can occur. Other treatments for preventing premature birth, such as progesterone supplementation, may cause side effects like headaches, nausea, and breast tenderness. It is important to discuss these potential risks with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for the prevention of premature birth. One notable mechanical intervention similar to cervical cerclage is the use of pessaries, which are devices inserted into the vagina to support the cervix. Additionally, progesterone treatments, such as hydroxyprogesterone caproate injections, have been approved to reduce the risk of preterm birth in women with a history of spontaneous preterm birth. These treatments aim to prolong pregnancy and improve neonatal outcomes.

What other types of research exist?

Promising novel alternatives to cervical cerclage for preventing premature birth include the use of vaginal progesterone and pessary devices. Vaginal progesterone has been shown to reduce the risk of preterm birth in women with a short cervix by promoting cervical stability. Pessary devices, which are silicone rings placed around the cervix, provide mechanical support to prevent premature cervical dilation. Both methods are less invasive compared to cerclage and have demonstrated effectiveness in clinical trials.

← Back to Search

Cervical Cerclage for Preventing Premature Birth (COLORS Trial)

Q: What is the mechanism of action of this treatment?

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.

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

Must not have

Painful regular uterine contraction and/or preterm labor

Active vaginal bleeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at delivery

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying if stitching the cervix closed can prevent early births in pregnant women with a short cervix who haven't had a previous preterm birth. The procedure aims to provide support to the cervix and reduce the risk of early delivery.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am experiencing painful contractions or signs of early labor.

Select...

I am currently experiencing vaginal bleeding.

Select...

My cervix is dilated more than 1 cm or the membranes are visible.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Preterm birth <35 weeks

Awards & Highlights

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 4Eligibility criteria met

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.