National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

Mid-Trimester Endovaginal Sonography in Women at
at High Risk for Spontaneous Preterm Delivery

Related Publications & Presentations

Objective

To test the hypothesis that mid-trimester endovaginal sonography can identify a group of high risk women whose cervical cervical characteristics define them as candidates for a future clinical trial of cerclage or other intervention strategies.

Conclusion

Cervical length at 16-18 weeks of gestation predicts spontaneous preterm delivery < 35 weeks in women with a prior early spontaneous delivery. Information derived from serial scans is associated with higher relative risk and sensitivity. These data will be useful in designing future intervention trials.

Clinical Centers

Tennessee, Alabama, Wayne State, Cincinnati, Bowman Gray, Chicago, Ohio State, Miami, Utah, Thomas Jefferson

Sample Size

• Goal = 235

Major Eligibility Criteria

Women who have been screened for the BV/TV study at less than 19 weeks and who also have had a spontaneous preterm birth between 16⁰ and 31⁶ weeks.

Scheduled Evaluations/Data Collection

• Enrollment between 16⁰ and 18⁶ weeks:
• Baseline data
• First cervical ultrasound
• Follow-up:
• Biweekly endovaginal exams to end at 22-23 weeks for a total of three to four exams per patient
• Post-Delivery:
• Labor and delivery
• Post-partum prior to discharge
• Neonatal

Outcome Measures

• Primary:
• Spontaneous preterm delivery ( < 35 weeks gestation)

Timetable

• Recruitment: 03/97-09/98
• Data Collection: 09/98-03/99
• Closeout/Final Analysis: 03/99-09/99