Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059683
Status:
COMPLETED
Last Update Posted:
2014-09-30
First Post:
2003-05-01
Brief Title:
Ultrasound-indicated Cerclage to Prevent Premature Birth in High-risk Women
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Vaginal Ultrasound Cerclage Trial
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pregnant women who have a shortened cervix and have previously had a premature baby are at increased risk for having another premature baby This study will determine whether reinforcing the cervix with a surgical stitch can reduce the chance of a premature birth
Detailed Description:
Women with a prior early spontaneous preterm birth and a shortened mid-trimester cervical length less than 25 mm are at very high risk for having another premature baby The Vaginal Ultrasound Cerclage Trial is a multicenter randomized clinical trial designed to determine the efficacy of cerclage a purse-string suture placed around the uterine cervix for the prevention of spontaneous preterm birth prior to 35 weeks gestation The study will evaluate women at significant risk for recurrent spontaneous preterm birth those with a prior spontaneous birth at 17 to 32 weeks gestation and who have an increased risk based on mid-trimester ultrasound findings of a cervical length less than 25 mm
The trial will have an observational portion and an interventional portion In the observational portion 1000 women with a history of a spontaneous preterm birth at 17 to 32 weeks gestation will undergo biweekly vaginal ultrasounds beginning at 16 to 18 weeks gestation and ending by 22 weeks Prior research indicates that one third of these women will either have or develop a cervix less than 25 mm long Women will be seen at a frequency determined by the cervical length as determined by ultrasound examination starting at 16 weeks gestation If cervical length remains greater than 30 mm the next visits will occur in 2 week intervals until 226 weeks gestation If the cervical length is 25 mm to 29 mm the visits will be scheduled weekly If the cervical length shortens to less than 25 mm the woman is eligible for randomization and will undergo one more study visit
In the interventional portion of the trial women will be randomized to either cerclage or no cerclage control group Randomized women will have weekly contact with a nurse either by phone or in person whichever is convenient for the woman until delivery occurs The woman is followed during the course of her pregnancy and delivery of her infant Her infant is followed until discharge from the hospital
The trial will have an observational portion and an interventional portion In the observational portion 1000 women with a history of a spontaneous preterm birth at 17 to 32 weeks gestation will undergo biweekly vaginal ultrasounds beginning at 16 to 18 weeks gestation and ending by 22 weeks Prior research indicates that one third of these women will either have or develop a cervix less than 25 mm long Women will be seen at a frequency determined by the cervical length as determined by ultrasound examination starting at 16 weeks gestation If cervical length remains greater than 30 mm the next visits will occur in 2 week intervals until 226 weeks gestation If the cervical length is 25 mm to 29 mm the visits will be scheduled weekly If the cervical length shortens to less than 25 mm the woman is eligible for randomization and will undergo one more study visit
In the interventional portion of the trial women will be randomized to either cerclage or no cerclage control group Randomized women will have weekly contact with a nurse either by phone or in person whichever is convenient for the woman until delivery occurs The woman is followed during the course of her pregnancy and delivery of her infant Her infant is followed until discharge from the hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None