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

NCT00342550 | Completed

• 2 other identifiers: 999998016OH98-CH-N016
• Study Type: observational
• Target: 648
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Preterm Birth; Cervical Length Measurement

Keywords

Pregnancy; Preterm Birth; Pregnancy Complications; Natural History

Outcome Measures

Primary Outcomes (1)

• Document cervical volume and funneling changes in women with preterm labor. Determine the relationship between cervical volume and funneling changes to the risk of preterm delivery.

  Data analysis is ongoing

  Ongoing

Study Arms (1)

Pregnant Women

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

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending Hutzel Women's clinic at Detroit Medical Center

You may qualify if:

• Singleton gestation;
• Estimated gestational age between 20 and 35 weeks gestation;
• Intact membranes;
• \. Signed informed consent for voluntary participation and serial endovaginal scans.

You may not qualify if:

• Absent fetal cardiac activity;
• Desire not to have vaginal ultrasound scans.
• Estimated gestational age between 16 and \< 24 weeks gestation;
• Planned cerclage placement due to increased preterm labor risk (i.e., short cervix or dilated cervix);
• Intact membranes;
• Signed informed consent for voluntary participation and serial endovaginal scans.
• Absent fetal cardiac activity;
• Desire not to have vaginal ultrasound scans.
• Term gestation (greater than 37 weeks);
• Intact membranes;
• Cervical dilatation less than 2 cm;
• Signed informed consent for voluntary participation and serial endovaginal scans.
• Absent fetal cardiac activity;
• Desire not to have vaginal ultrasound scans.
• Term gestation (greater than 37 weeks);

Sponsors & Collaborators

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

Study Sites (1)

Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• 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.

  PMID: 3285274 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pregnancy Complications

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Roberto Romero, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: March 11, 1998
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1)