Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT00886834
Status:
COMPLETED
Last Update Posted:
2014-12-22
First Post:
2009-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women
Status:
COMPLETED
Status Verified Date:
2014-12
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:
MPIIN
Brief Summary:
The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.
Detailed Description:
Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.
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?: