Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01063686
Status:
WITHDRAWN
Last Update Posted:
2015-10-28
First Post:
2010-02-04
Brief Title:
The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester
Status:
WITHDRAWN
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Early preterm premature rupture of membranes PPROM complicates 07 of pregnancies When PPROM occurs before the 24th weekthe risk of fetal and neonatal death is 70 There is also a high risk of neonatal and maternal morbidity When the diagnosis of PPROM is uncertain by physical examination additional tests are needed These tests have false positive and false negative rates The gold standard for diagnosing PPROM is amniocentesis and dye test This procedure has a risk of infection and abortionOur hypothesis is that by using a cervical cap for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which are uncertain Our study group will be pregnant women gestational age 14-23 suspected of having PPROM
Detailed Description:
None
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