Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

NCT ID: NCT02372422

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2007-07-31

Brief Summary

The purpose of this study is to determine if the use of routine transvaginal cervical length ultrasound can be used to prevent preterm deliveries in twin gestations.

Detailed Description

This is a randomized controlled trial to determine whether there is a difference in the rate of preterm birth among women with twin pregnancies whose clinicians are aware of transvaginal ultrasound cervical length measurements compared to those managed without this information. The study group had transvaginal cervical length ultrasound monthly from 16-28 weeks and were managed with a standard algorithm for activity restriction and cerclage depending on the cervical length. The control group had digital cervical exams and routine transvaginal cervical length ultrasound was not utilized. The primary outcome was the mean length of gestation. Secondary outcomes included percentage of deliveries < 35 weeks, maternal and neonatal outcomes.

Conditions

Pregnancy

Study Design

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

Study Groups

Transvaginal Cervical Length Group

Clinicians managing the patients were aware of the transvaginal cervical length ultrasound measurements.

Group Type: EXPERIMENTAL

Transvaginal ultrasound determination of cervical length

Intervention Type: OTHER

Transvaginal ultrasound was used to measure the length of the cervix from the internal to external os relying on a standard approach and clinicians caring for the patients were made aware of the results.

Routine Care

Clinicians managing the patients were not aware of any transvaginal cervical length ultrasound measurements.

Group Type: OTHER

Routine care

Intervention Type: OTHER

Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.

Interventions

Transvaginal ultrasound determination of cervical length

Transvaginal ultrasound was used to measure the length of the cervix from the internal to external os relying on a standard approach and clinicians caring for the patients were made aware of the results.

Intervention Type: OTHER

Routine care

Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Twin pregnancy
• Gestational age < 20 weeks

Exclusion Criteria

• History of incompetent cervix with plans to place a cerclage
• History of possible cervical incompetence with preexisting plans to monitor cervical length
• Prior preterm birth at < 28 weeks gestational age
• Plans to leave the area before delivery
• Known major fetal anomaly
• Known diagnosis of twin-twin transfusion syndrome
• Age < 18
• Monoamniotic twins

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Madigan Army Medical Center

FED

Sponsor Role: collaborator

Wright-Patterson Medical Center

UNKNOWN

Sponsor Role: collaborator

William H. Barth, Jr., M.D., Col(ret), USAF, MC

FED

Sponsor Role: lead

Responsible Party

William H. Barth, Jr., M.D., Col(ret), USAF, MC

William H. Barth, Jr., M.D., Col(ret), USAF, MC

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael C Gordon, M.D.

Role: PRINCIPAL_INVESTIGATOR

59th Medical Wing

Other Identifiers

FWH20020099H

Identifier Type: -

Identifier Source: org_study_id