Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-14 @ 8:39 AM
Study NCT ID:
NCT02121067
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LNG-IUS at 2 Weeks Postpartum
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes
Status:
COMPLETED
Status Verified Date:
2017-07
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:
LNG-IUS
Brief Summary:
This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides contraception for 5 years with excellent effectiveness. Women enrolled in this study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months postpartum, and participants will be able to keep their LNG-IUS following study completion.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: