NCT03251729 (COLORS) is a Phase 4 clinical trial of Cervical cerclage in Premature Birth, sponsored by Thomas Jefferson University.

Who is sponsoring NCT03251729?

NCT03251729 is sponsored by Thomas Jefferson University.

What drugs are being tested in NCT03251729?

Interventions in NCT03251729: Cervical cerclage, Vaginal progesterone.

What condition does NCT03251729 study?

NCT03251729 studies Premature Birth.

Is NCT03251729 still recruiting?

NCT03251729 is currently completed. Last updated 19 April 2024.

Last reviewed 2024-04-19 · How we verify

NCT03251729: COLORS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 19 April 2024

What this trial tests

Phase 4 trial testing Cervical cerclage in Premature Birth in 93 participants. Completed in 20 February 2024.

Timeline

22 September 2017

Primary endpoint
20 February 2024

20 February 2024

Quick facts

Lead sponsor	Thomas Jefferson University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	93
Start date	22 September 2017
Primary completion	20 February 2024
Estimated completion	20 February 2024
Sites	3 locations across Italy, United States

Drugs / interventions tested

Cervical cerclage
Vaginal progesterone — full drug profile →

Conditions studied

Premature Birth — all drugs for Premature Birth →

Sponsor

Thomas Jefferson University

Who can join

Adults 18 to 50, female only, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Utility of follow-up cervical length screening in low-risk women with a cervical length of 26 to 29 mm.
Boelig RC, Kripalu V, Chen SL, Cruz Y, et al · · 2021 · cited 9× · PMID 33652056 · DOI 10.1016/j.ajog.2021.02.027
Cerclage in singleton pregnancies with no prior spontaneous preterm birth and short cervix: a randomized controlled trial.
Boelig RC, Tersigni C, Di Simone N, Saccone G, et al · · 2025 · cited 7× · PMID 39880123 · DOI 10.1016/j.ajogmf.2025.101602

Verify or expand the search:

Other trials of Cervical cerclage

Trials testing the same drug.

NCT07372495 — Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix · NA · not yet recruiting
NCT05334264 — Prophylactic Cervical Cerclage in Twin Pregnancies With Non-shortened Cervix · NA · unknown
NCT04151303 — The Optimal Timing for Cerclage Removal · unknown
NCT03863613 — Pessary Versus Cerclage With or Without Progesterone in Twins · NA · terminated
NCT03781466 — Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix · NA · unknown

Other recruiting trials for Premature Birth

Currently open trials in the same condition.

NCT07490912 — Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/o · recruiting
NCT07183462 — Azithromycin and Ampicillin for Late PPROM · Phase 4 · recruiting
NCT07306793 — The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body We · NA · recruiting
NCT06554522 — Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa · Phase 4 · recruiting
NCT06340971 — Air Pollution and Pregnancy · recruiting

Other Thomas Jefferson University trials

Trials by the same sponsor.

NCT07526480 — Improving Dementia Care in Primary Practice · NA · not yet recruiting
NCT07414550 — Radiotherapy for Refractory Hidradenitis Suppurativa · NA · not yet recruiting
NCT07402018 — Intra-aortic Balloon Counterpulsation (IABC) Compliance · recruiting
NCT07217197 — Respiratory Monitoring System That Detects & Predicts OIRD · NA · enrolling by invitation
NCT07145099 — The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03251729 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Thomas Jefferson University
Last refreshed: 19 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03251729.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing