Back to resultsCerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix (COLORS)
Primary Purpose
Premature Birth
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cervical cerclage
Vaginal progesterone
Sponsored by
About this trial
This is an interventional treatment trial for Premature Birth focused on measuring cerclage, preterm birth, short cervix
Eligibility Criteria
Inclusion Criteria:
- 18 year old or older
- Singleton pregnancy
- No prior SPTB or second trimester losses between 160 and 366 weeks
- TVU CL ≤25mm between 180 and 236 weeks
Exclusion Criteria:
- Multiple pregnancy
- Prior SPTB or second trimester losses between 160 and 366 weeks
- Cerclage in situ
- Painful regular uterine contraction and/or preterm labor
- Rupture membranes
- Major fetal anomaly or aneuploidy
- Active vaginal bleeding
- Placenta previa and/or accreta
- Cervical dilation >1.0 cm and/or visible membranes by pelvic exam
- Suspicion of chorioamnionitis
Sites / Locations
- Thomas Jefferson University HospitalRecruiting
- University of Naples Federico IIRecruiting
- University Cattolica del S. CuoreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cerclage
Control
Arm Description
Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
Outcomes
Primary Outcome Measures
Preterm birth <35 weeks
Incidence of spontaneous preterm birth less than 35 weeks
Secondary Outcome Measures
Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks
Mean gestational age at delivery
Histologically proven clinical chorioamnionitis
Neonatal outcomes: birth weight
Neonatal outcomes: low birth weight (<2500g),
Neonatal outcomes: admission to intensive care nursery
Neonatal outcomes: length of neonatal hospital admission
Neonatal outcomes: respiratory distress syndrome
Neonatal outcomes: IVH grade 3 or 4
Neonatal outcomes: retinopathy of prematurity
Neonatal outcomes: bronchopulmonary dysplasia
Neonatal outcomes: neonatal mortality
Full Information
NCT ID
NCT03251729
First Posted
June 22, 2017
Last Updated
February 4, 2022
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT03251729
Brief Title
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
Acronym
COLORS
Official Title
Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (<=25mm) and without prior spontaneous preterm birth
Detailed Description
Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth <35 weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
cerclage, preterm birth, short cervix
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cerclage
Arm Type
Experimental
Arm Description
Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
Arm Title
Control
Arm Type
Other
Arm Description
Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
Intervention Type
Procedure
Intervention Name(s)
Cervical cerclage
Intervention Description
Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks
Intervention Type
Drug
Intervention Name(s)
Vaginal progesterone
Intervention Description
Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks
Primary Outcome Measure Information:
Title
Preterm birth <35 weeks
Description
Incidence of spontaneous preterm birth less than 35 weeks
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks
Time Frame
At delivery
Title
Mean gestational age at delivery
Time Frame
At delivery
Title
Histologically proven clinical chorioamnionitis
Time Frame
At delivery
Title
Neonatal outcomes: birth weight
Time Frame
At delivery
Title
Neonatal outcomes: low birth weight (<2500g),
Time Frame
At delivery
Title
Neonatal outcomes: admission to intensive care nursery
Time Frame
At delivery
Title
Neonatal outcomes: length of neonatal hospital admission
Time Frame
at least 30 days after delivery, up to 6 months after delivery
Title
Neonatal outcomes: respiratory distress syndrome
Time Frame
at least 30 days after delivery, up to 6 months after delivery
Title
Neonatal outcomes: IVH grade 3 or 4
Time Frame
at least 30 days after delivery, up to 6 months after delivery
Title
Neonatal outcomes: retinopathy of prematurity
Time Frame
at least 30 days after delivery, up to 6 months after delivery
Title
Neonatal outcomes: bronchopulmonary dysplasia
Time Frame
at least 30 days after delivery, up to 6 months after delivery
Title
Neonatal outcomes: neonatal mortality
Time Frame
28 days after delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients must be pregnant to be enrolled. Self-represented gender identity is NOT a basis of eligibility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 year old or older
Singleton pregnancy
No prior SPTB or second trimester losses between 160 and 366 weeks
TVU CL ≤25mm between 180 and 236 weeks
Exclusion Criteria:
Multiple pregnancy
Prior SPTB or second trimester losses between 160 and 366 weeks
Cerclage in situ
Painful regular uterine contraction and/or preterm labor
Rupture membranes
Major fetal anomaly or aneuploidy
Active vaginal bleeding
Placenta previa and/or accreta
Cervical dilation >1.0 cm and/or visible membranes by pelvic exam
Suspicion of chorioamnionitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo Berghella, MD
Phone
215-955-9200
Email
vincenzo.berghella@jefferson.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rupsa C Boelig, MD
Phone
215-955-9196
Email
rupsa.boelig@jefferson.edu
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupsa C Boelig, MD
Email
rupsa.boelig@jefferson.edu
Facility Name
University of Naples Federico II
City
Naples
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Saccone, MD
Facility Name
University Cattolica del S. Cuore
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicoletta Di Simone
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28295722
Citation
Berghella V, Ciardulli A, Rust OA, To M, Otsuki K, Althuisius S, Nicolaides KH, Roman A, Saccone G. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Nov;50(5):569-577. doi: 10.1002/uog.17457. Epub 2017 Oct 5.
Results Reference
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Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
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