Clinical Trials Logo
  1. Home
  2. Premature Birth
  3. NCT03251729
  4. Details
NCT03251729 Clinical Trial

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

Premature Birth Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03251729
Other study ID # 17D.164
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 22, 2017
Est. completion date February 20, 2024

Study information
Verified date April 2024
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date February 20, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy University of Naples Federico II Naples
Italy University Cattolica del S. Cuore Rome
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Thomas Jefferson University

Countries where clinical trial is conducted

United States,  Italy, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Preterm birth <35 weeks Incidence of spontaneous preterm birth less than 35 weeks At delivery
Secondary Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks At delivery
Secondary Mean gestational age at delivery At delivery
Secondary Histologically proven clinical chorioamnionitis At delivery
Secondary Neonatal outcomes: birth weight At delivery
Secondary Neonatal outcomes: low birth weight (<2500g), At delivery
Secondary Neonatal outcomes: admission to intensive care nursery At delivery
Secondary Neonatal outcomes: length of neonatal hospital admission at least 30 days after delivery, up to 6 months after delivery
Secondary Neonatal outcomes: respiratory distress syndrome at least 30 days after delivery, up to 6 months after delivery
Secondary Neonatal outcomes: IVH grade 3 or 4 at least 30 days after delivery, up to 6 months after delivery
Secondary Neonatal outcomes: retinopathy of prematurity at least 30 days after delivery, up to 6 months after delivery
Secondary Neonatal outcomes: bronchopulmonary dysplasia at least 30 days after delivery, up to 6 months after delivery
Secondary Neonatal outcomes: neonatal mortality 28 days after delivery
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05048550 - Babies in Glasses; a Feasibility Study. N/A
Active, not recruiting NCT03655639 - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation NCT05542108 - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT03337659 - A Cluster Randomized Controlled Trial of FICare at 18 Months N/A
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Not yet recruiting NCT05039918 - Neonatal Experience of Social Touch N/A
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Completed NCT02952950 - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study N/A
Completed NCT02913495 - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth Phase 4
Not yet recruiting NCT02880696 - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates N/A
Completed NCT02879799 - Family Integrated Care (FICare) in Level II NICUs N/A
Completed NCT02743572 - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants N/A
Completed NCT02661360 - Effects of Swaddling on Infants During Feeding N/A
Completed NCT01352234 - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia Phase 4
Completed NCT01163188 - Social Adjustment and Quality of Life After Very Preterm Birth N/A
Terminated NCT00675753 - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families N/A
Completed NCT00271115 - Kangaroo Holding and Maternal Stress N/A
Terminated NCT00179972 - Evaluation of Pulse Oximetry Sensors in Neonates N/A