Status:
COMPLETED
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Lead Sponsor:
Emory University
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whet...
Detailed Description
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization\[1...
Eligibility Criteria
Inclusion
- 18 years
- negative pregnancy test
- no prior pregnancy beyond 19 6/7 weeks
- no pelvic inflammatory disease in last 3 months
- no current cervicitis
- willing to follow up in 1-2 months
Exclusion
- active cervical infection
- current pregnancy
- prior pregnancy beyond 19 6/7 weeks
- uterine anomaly
- fibroid uterus distorting uterine cavity
- copper allergy or wilson's disease for ParaGard
- undiagnosed abnormal uterine bleeding
- cervical or uterine cancer
- sepsis associated with the most recent pregnancy
- current breast cancer for levonogestrel IUD
- inflammatory bowel disease
- allergy to misoprostol
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01147497
Start Date
June 1 2010
End Date
September 1 2011
Last Update
January 12 2018
Active Locations (1)
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1
The Emory Clinic
Atlanta, Georgia, United States, 30322