Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422526
Status:
COMPLETED
Last Update Posted:
2007-01-17
First Post:
2007-01-15
Brief Title:
Progesterone for Prevention of Preterm Birth in Women With Short Cervix Randomized Controlled Trial
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery
Status:
COMPLETED
Status Verified Date:
2007-01
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:
The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery defined as delivery before 336 weeks in women with a short cervical length of 15mm
Detailed Description:
BACKGROUND The results of randomized studies have shown that the prophylactic use of progesterone in women who previously delivered prematurely reduces the risk of recurrence Asymptomatic women found to have a short cervix 15 mm at mid-gestation are at greatly increased risk for spontaneous early preterm delivery and it is uncertain whether in such women the risk is reduced by progesterone
METHODS Cervical length was measured by transvaginal sonography at 22 range 20-25 weeks in 24620 pregnant women attending for routine antenatal care The cervix was 15 mm or less in 413 17 and 250 605 of these women participated in a randomized study of vaginal progesterone 200 mg per night vs identical-looking placebo between 24 and 34 weeks Primary outcome was the frequency of spontaneous delivery before 34 weeks 238 days of pregnancy Analysis was performed according to the intention-to-treat principle
METHODS Cervical length was measured by transvaginal sonography at 22 range 20-25 weeks in 24620 pregnant women attending for routine antenatal care The cervix was 15 mm or less in 413 17 and 250 605 of these women participated in a randomized study of vaginal progesterone 200 mg per night vs identical-looking placebo between 24 and 34 weeks Primary outcome was the frequency of spontaneous delivery before 34 weeks 238 days of pregnancy Analysis was performed according to the intention-to-treat principle
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