Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women (miso)
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Purpose
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 whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.
| Condition | Intervention |
|---|---|
|
Contraception |
Drug: Misoprostol Drug: Placebo |
| Study Type: | Interventional |
| 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 Intrauterine Device Insertion for Nulliparous Women |
- Provider perceived ease of insertion on a 100 point visual analogue scale [ Time Frame: assessed immediately post IUD insertion ] [ Designated as safety issue: No ]
- Patient perceived pain on a 100 point visual analogue scale [ Time Frame: assessed immediately 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: assessed immediately after IUD insertion ] [ Designated as safety issue: No ]
- Time for insertion procedure [ Time Frame: assessed immediately after IUD insertion ] [ Designated as safety issue: No ]
- Acceptability of discomfort associated with insertion [ Time Frame: assessed at one week after insertion and at one month after insertion ] [ Designated as safety issue: No ]
- ease of insertion and presence of pain in nulliparous women versus nulligravid women [ Time Frame: assessed immediately following insertion ] [ Designated as safety issue: No ]
- Need for additional pain medications after insertion of the IUD [ Time Frame: assessed one week after insertion ] [ Designated as safety issue: No ]
| Enrollment: | 78 |
| Study Start Date: | June 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: misoprostol
Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
|
Drug: Misoprostol
400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit
|
|
Placebo Comparator: placebo
Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
|
Drug: Placebo
Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit
|
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], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. 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 give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 18 years
- negative pregnancy test
- no prior pregnancy beyond 19 6/7 weeks
- no PID in last 3 months
- no current cervicitis
- willing to follow up in 1-2 months
Exclusion Criteria:
- 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
Contacts and Locations| United States, Georgia | |
| The Emory Clinic | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Eva Lathrop, MD, MPH | Emory University School of Medicine, Department of Gynecology and Obstetrics |
More Information
No publications provided by Emory University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eva Lathrop, MD, Assistant Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT01147497 History of Changes |
| Other Study ID Numbers: | MISO Emory |
| Study First Received: | June 15, 2010 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
IUD insertion nulliparous women contraception family planning IUD insertion in nulliparous women |
Additional relevant MeSH terms:
|
Misoprostol Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
Oxytocics Reproductive Control Agents Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 23, 2013