Ultrasound-indicated Cerclage to Prevent Premature Birth in High-risk Women

NCT ID: NCT00059683

Last Updated: 2014-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2009-10-31

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.

Detailed Description

Women with a prior early spontaneous preterm birth and a shortened mid-trimester cervical length (less than 25 mm) are at very high risk for having another premature baby. The Vaginal Ultrasound Cerclage Trial is a multicenter, randomized clinical trial designed to determine the efficacy of cerclage (a purse-string suture placed around the uterine cervix) for the prevention of spontaneous preterm birth prior to 35 weeks' gestation. The study will evaluate women at significant risk for recurrent spontaneous preterm birth (those with a prior spontaneous birth at 17 to 32 weeks' gestation) and who have an increased risk based on mid-trimester ultrasound findings of a cervical length less than 25 mm.

The trial will have an observational portion and an interventional portion. In the observational portion, 1,000 women with a history of a spontaneous preterm birth at 17 to 32 weeks' gestation will undergo biweekly vaginal ultrasounds beginning at 16 to 18 weeks' gestation and ending by 22 weeks. Prior research indicates that one third of these women will either have or develop a cervix less than 25 mm long. Women will be seen at a frequency determined by the cervical length (as determined by ultrasound examination starting at 16 weeks' gestation). If cervical length remains greater than 30 mm, the next visits will occur in 2 week intervals until 22.6 weeks' gestation. If the cervical length is 25 mm to 29 mm, the visits will be scheduled weekly. If the cervical length shortens to less than 25 mm, the woman is eligible for randomization, and will undergo one more study visit.

In the interventional portion of the trial, women will be randomized to either cerclage or no cerclage (control group). Randomized women will have weekly contact with a nurse either by phone or in person, whichever is convenient for the woman, until delivery occurs. The woman is followed during the course of her pregnancy and delivery of her infant. Her infant is followed until discharge from the hospital.

Conditions

Labor, Premature

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cervical Cerclage Group

Women randomized to receive cerclage should receive cervical cerclage

Group Type: EXPERIMENTAL

cervical cerclage

Intervention Type: PROCEDURE

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

Control Group

Women randomized to not receive cerclage represent the control arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cervical cerclage

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• Participation in a randomized trial with interventions or endpoints in conflict with the cerclage randomized trial

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Responsible Party

John Owen

Professor Ob/Gyn-Maternal Fetal medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Owen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19788970 (View on PubMed)

Other Identifiers

U01HD039939-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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