Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439374
Status:
TERMINATED
Last Update Posted:
2019-07-15
First Post:
2007-02-21
Brief Title:
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
Sponsor:
The George Washington University Biostatistics Center
Organization:
The George Washington University Biostatistics Center
Study Overview
Official Title:
A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Halted by NICHD after recommendation by DSMC to stop for futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCAN
Brief Summary:
The purpose of this study is to see if giving progesterone medication to pregnant women who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix lowers the risk of early delivery and improves the health of their baby
Detailed Description:
Preterm births defined as the delivery of a baby less than 37 weeks of gestation are responsible for the majority of neonatal mortality and morbidities Studies have shown that a number of risk factors including never having a baby before and having a short cervix are associated with early delivery Recently the NICHD did a study in women who were pregnant again after having delivered preterm It showed that giving 17 alpha-hydroxyprogesterone caproate 17P medication during pregnancy decreased the chance of delivering another preterm baby by 34 This placebo-controlled randomized clinical trial will address the primary research question does treatment with 17P initiated before 23 weeks of gestation prevent delivery prior to 37 weeks in nulliparous women with a singleton gestation who have a short cervix
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10HD053118 | NIH | None | httpsreporternihgovquickSearchU10HD053118 |
| U10HD021410 | NIH | None | None |
| U10HD027869 | NIH | None | None |
| U10HD027917 | NIH | None | None |
| U10HD053097 | NIH | None | None |
| U10HD027915 | NIH | None | None |
| U10HD034116 | NIH | None | None |
| U10HD034208 | NIH | None | None |
| U10HD034136 | NIH | None | None |
| U10HD040500 | NIH | None | None |
| U10HD040485 | NIH | None | None |
| U10HD040544 | NIH | None | None |
| U10HD040545 | NIH | None | None |
| U10HD040560 | NIH | None | None |
| U10HD040512 | NIH | None | None |
| U10HD036801 | NIH | None | None |