Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix (COLORS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Premature Birth
• Intervention / Treatment: Procedure: Cervical cerclage; Drug: Vaginal progesterone

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

• Study Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincenzo Berghella, MD; Phone Number: 215-955-9200; Email: vincenzo.berghella@jefferson.edu

Study Locations

• Italy
  • Naples, Italy
    • Recruiting
    • University of Naples Federico II
    • Contact: Gabriele Saccone, MD
  • Rome, Italy
    • Recruiting
    • University Cattolica del S. Cuore
    • Contact: Nicoletta Di Simone
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cerclage; Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.	Procedure: Cervical cerclage; Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks; Drug: Vaginal progesterone; Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks
OTHER: Control; Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.	Drug: Vaginal progesterone; Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth <35 weeks	Incidence of spontaneous preterm birth less than 35 weeks	At delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks	At delivery
Mean gestational age at delivery	At delivery
Histologically proven clinical chorioamnionitis	At delivery
Neonatal outcomes: birth weight	At delivery
Neonatal outcomes: low birth weight (<2500g),	At delivery
Neonatal outcomes: admission to intensive care nursery	At delivery
Neonatal outcomes: length of neonatal hospital admission	at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: respiratory distress syndrome	at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: IVH grade 3 or 4	at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: retinopathy of prematurity	at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: bronchopulmonary dysplasia	at least 30 days after delivery, up to 6 months after delivery
Neonatal outcomes: neonatal mortality	28 days after delivery

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 22, 2017
• Primary Completion (ANTICIPATED): June 1, 2025
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (ACTUAL): August 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: cerclage, preterm birth, short cervix
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 17D.164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No