Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Recruitment status was Recruiting
The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women|
- Provider perceived ease of insertion on a 100-point visual analogue scale. [ Time Frame: Immediately post IUD insertion ] [ Designated as safety issue: No ]
- Patient perceived pain on a 100-point visual analogue scale. [ Time Frame: Prior to insertion, immediately after insertion, and prior to clinic discharge. ] [ Designated as safety issue: No ]
- Ability to insert the IUD without the use of adjunctive measures including ultrasound guidance or cervical dilation. [ Time Frame: During IUD insertion and immediately after. ] [ Designated as safety issue: No ]
- Time for IUD insertion procedure. [ Time Frame: Assessed immediately after IUD insertion. ] [ Designated as safety issue: No ]
- Presence of medication side effects. [ Time Frame: Assessed prior to IUD insertion, prior to leaving clinic, and at 1 week follow-up. ] [ Designated as safety issue: No ]
- Procedure complications. [ Time Frame: Assessed up to 1 month from time of IUD insertion. ] [ Designated as safety issue: Yes ]
- Need for additional pain medications the week following the procedure. [ Time Frame: 1 week after IUD insertion. ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.
400 micrograms inserted buccally or vaginally, per the participants desire.
Placebo Comparator: Placebo
Pills which are identical to the study drug in appearance, taste, and smell.
400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307111
|Contact: Eve Espey, MD/MPHfirstname.lastname@example.org|
|United States, New Mexico|
|University of New Mexico Center for Reproductive Health||Recruiting|
|Albuquerque, New Mexico, United States, 87112|
|Principal Investigator: Eve Espey, MD/MPH|
|Principal Investigator:||Eve Espey, MD/MPH||University of New Mexico Department of Obstetrics and Gynecology|