Ignite Creation Date:
2024-05-06 @ 9:10 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02913495
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2016-09-22
Brief Title:
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Status:
COMPLETED
Status Verified Date:
2021-10
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:
VIP
Brief Summary:
The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth PTB in women with a prior spontaneous preterm birth vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth
Detailed Description:
Preterm birth is one of the leading causes of neonatal morbidity and mortality One of the greatest predictors of preterm birth is a history of prior spontaneous preterm birth Presently 17 hydroxyprogesterone caproate intramuscular is the only FDA approved product for the prevention of recurrent preterm birth however recent studies suggest that vaginal progesterone may be used for this purpose and may even be superior The American College of Obstetrics and Gynecology does not specify the optimal route of progesterone administration for the prevention of recurrent preterm birth It is our intention to compare vaginal and intramuscular progesterone to see if one is superior
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