NCT03251729

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_4

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

6.4 years

First QC Date

June 22, 2017

Last Update Submit

April 17, 2024

Conditions

Premature Birth

Keywords

cerclage, preterm birth, short cervix

Outcome Measures

Primary Outcomes (1)

  • Preterm birth <35 weeks

    Incidence of spontaneous preterm birth less than 35 weeks

    At delivery

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

Cerclage

EXPERIMENTAL

Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.

Procedure: Cervical cerclageDrug: Vaginal progesterone

Control

OTHER

Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.

Drug: Vaginal progesterone

Interventions

Cervical cerclagePROCEDURE

Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks

Cerclage
Vaginal progesteroneDRUG

Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks

CerclageControl

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients must be pregnant to be enrolled. Self-represented gender identity is NOT a basis of eligibility
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Naples Federico II

Naples, Italy

Location

University Cattolica del S. Cuore

Rome, Italy

Location

Related Publications (2)

  • 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.

    PMID: 28295722BACKGROUND

  • Boelig RC, Tersigni C, Di Simone N, Saccone G, Facchinetti F, Scambia G, Berghella V. Cerclage in singleton pregnancies with no prior spontaneous preterm birth and short cervix: a randomized controlled trial. Am J Obstet Gynecol MFM. 2025 Apr;7(4):101602. doi: 10.1016/j.ajogmf.2025.101602. Epub 2025 Jan 27.

    PMID: 39880123DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

August 16, 2017

Study Start

September 22, 2017

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

IPD will be shared upon completion of appropriate data sharing agreements

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
1yr after study completion
Access Criteria
IPD will be shared upon completion of appropriate data sharing agreements

Locations

IT(2)US(1)