Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery

NCT ID: NCT00342550

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 648 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1998-03-11
• Study Completion Date: 2008-05-01

Brief Summary

Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.

Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.

Detailed Description

Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.

Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with maternal and fetal biological markers, placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.

Conditions

Pregnancy; Preterm Birth; Cervical Length Measurement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant Women

Pregnant women aged 15 and older between 20 and 35 weeks with singleton gestation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Singleton gestation;

2. Estimated gestational age between 20 and 35 weeks gestation;

3 Intact membranes;

4. Signed informed consent for voluntary participation and serial endovaginal scans.

1. Estimated gestational age between 16 and < 24 weeks gestation;

2. Planned cerclage placement due to increased preterm labor risk (i.e., short cervix or dilated cervix);

3. Intact membranes;

4. Signed informed consent for voluntary participation and serial endovaginal scans.

1. Term gestation (greater than 37 weeks);

2. Intact membranes;

3. Cervical dilatation less than 2 cm;

4. Signed informed consent for voluntary participation and serial endovaginal scans.

1. Term gestation (greater than 37 weeks);

2. Intact membranes;

3. Signed informed consent for voluntary participation and serial endovaginal scans.

Exclusion Criteria

1. Absent fetal cardiac activity;

2. Desire not to have vaginal ultrasound scans.

1. Absent fetal cardiac activity;

2. Desire not to have vaginal ultrasound scans.

1. Absent fetal cardiac activity;

2. Desire not to have vaginal ultrasound scans.

1. Absent fetal cardiac activity;

2. Desire not to have vaginal ultrasound scans.

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Romero, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hutzel Women's Hospital

Detroit, Michigan, United States

Countries

United States

References

Ayers JW, DeGrood RM, Compton AA, Barclay M, Ansbacher R. Sonographic evaluation of cervical length in pregnancy: diagnosis and management of preterm cervical effacement in patients at risk for premature delivery. Obstet Gynecol. 1988 Jun;71(6 Pt 1):939-44.

Reference Type: BACKGROUND

PMID: 3285274 (View on PubMed)

Other Identifiers

OH98-CH-N016

Identifier Type: -

Identifier Source: secondary_id

999998016

Identifier Type: -

Identifier Source: org_study_id