Status:
COMPLETED
Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy
Preterm Birth
Eligibility:
FEMALE
15+ years
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-dime...
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-dime...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:
- Singleton gestation;
- Estimated gestational age between 20 and 35 weeks gestation;
- 3 Intact membranes;
- 4\. Signed informed consent for voluntary participation and serial endovaginal scans.
- EXCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
- INCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:
- 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.
- EXCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
- INCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:
- Term gestation (greater than 37 weeks);
- Intact membranes;
- Cervical dilatation less than 2 cm;
- Signed informed consent for voluntary participation and serial endovaginal scans.
- EXCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
- INCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:
- Term gestation (greater than 37 weeks);
- Intact membranes;
- Signed informed consent for voluntary participation and serial endovaginal scans.
- EXCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
Exclusion
Key Trial Info
Start Date :
March 11 1998
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT00342550
Start Date
March 11 1998
End Date
May 1 2008
Last Update
February 24 2023
Active Locations (1)
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1
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201