Clinical trial NCT01147497: Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Official title: A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in Intrauterine Device Insertion for Nulliparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: IUD insertion
nulliparous women
contraception
family planning
IUD insertion in nulliparous women
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.

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 criteria: Inclusion Criteria:

* 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 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

Primary outcomes:
measure: Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale
timeFrame: assessed immediately post IUD insertion
Secondary outcomes:
measure: Patient Perceived Pain on a 100 Point Visual Analogue Scale
timeFrame: immediately after insertion
measure: The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD
timeFrame: assessed immediately after IUD insertion
measure: Time for Insertion Procedure
timeFrame: assessed immediately after IUD insertion
measure: Acceptability of Discomfort Associated With Insertion
timeFrame: assessed at one week after insertion and at one month after insertion
measure: Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women
timeFrame: assessed immediately following insertion
measure: Need for Additional Pain Medications After Insertion of the IUD
timeFrame: assessed one week after insertion
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University School of Medicine, Department of Gynecology and Obstetrics
name: Eva Lathrop, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lathrop E, Haddad L, McWhorter CP, Goedken P. Self-administration of misoprostol prior to intrauterine device insertion among nulliparous women: a randomized controlled trial. Contraception. 2013 Dec;88(6):725-9. doi: 10.1016/j.contraception.2013.07.011. Epub 2013 Aug 6.
citation: Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104.