NCT00059683

Brief Summary

Pregnant women who have a shortened cervix and have previously had a premature baby are at increased risk for having another premature baby. This study will determine whether reinforcing the cervix with a surgical stitch can reduce the chance of a premature birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

4.8 years

First QC Date

May 1, 2003

Last Update Submit

September 29, 2014

Conditions

Labor, Premature

Keywords

Preterm BirthPremature BirthCervical cerclageVaginal ultrasoundCervical length

Outcome Measures

Primary Outcomes (1)

  • Incidence of preterm birth less than 35 weeks' gestation

    Birth

Secondary Outcomes (1)

  • Gestational age at birth

    birth

Study Arms (2)

Cervical Cerclage Group

EXPERIMENTAL

Women randomized to receive cerclage should receive cervical cerclage

Procedure: cervical cerclage

Control Group

NO INTERVENTION

Women randomized to not receive cerclage represent the control arm

Interventions

cervical cerclagePROCEDURE

Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix

Cervical Cerclage Group

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant with a singleton gestation
  • History of at least 1 prior spontaneous preterm birth at or before 32 weeks' gestation

You may not qualify if:

  • Cervical cerclage planned for this pregnancy
  • Clinical history of cervical incompetence
  • Untreated C. trachomatis or N. gonorrhoeae infection or symptomatic vaginitis
  • Unable to obtain mid-trimester ultrasound to confirm no major fetal anomaly (i.e., aneuploidy, major organ system defect) or fetal demise prior to enrollment
  • Multiple gestation
  • Prolapsed or ruptured membranes noted on initial speculum examination
  • Cervical os dilation \> 2 cm noted on initial speculum examination
  • Oligohydramnios
  • Complete placenta previa
  • Chronic hypertension or vascular disease requiring therapy
  • Maternal red cell alloimmunization
  • Insulin dependent diabetes
  • Significant renal or cardiopulmonary disease
  • Delivery or prenatal care outside clinical center
  • Enrolled in this study in a previous pregnancy
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

  • Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8. doi: 10.1016/j.ajog.2009.08.015.

    PMID: 19788970RESULT

MeSH Terms

Conditions

Obstetric Labor, PrematurePremature Birth

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • John Owen, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Ob/Gyn-Maternal Fetal medicine

Study Record Dates

First Submitted

May 1, 2003

First Posted

May 5, 2003

Study Start

January 1, 2003

Primary Completion

November 1, 2007

Study Completion

October 1, 2009

Last Updated

September 30, 2014

Record last verified: 2014-09

Locations

US(1)