Clinical trial NCT01001897: Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women
Official title: A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: IUD insertion
nulliparous women
contraception
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.

Detailed description: IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.

Eligibility criteria: Inclusion Criteria:

* Nulliparous, no prior pregnancy beyond 14 week
* Over 18 years of age
* Negative pregnancy test

Exclusion Criteria:

* current pregnancy or pregnancy within 6 weeks
* current cervicitis or PID (active or within 3 months)
* undiagnosed abnormal uterine bleeding
* allergy to copper/ Wilson's disease (for Paragard)
* cervical or uterine cancer
* uterine anomaly altering uterine cavity

Primary outcomes:
measure: The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale
timeFrame: after IUD insertion
Secondary outcomes:
measure: Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia
timeFrame: during IUD insertion
measure: Side effects of medications
timeFrame: prior to IUD insertion
measure: Provider perceived ease of insertion on a 100 mm visual analogue scale
timeFrame: after IUD insertion
measure: Acceptability of wait time prior to IUD placement
timeFrame: 1 week after IUD insertion
measure: Procedure complications
timeFrame: Up to 1 month after IUD placement
measure: Acceptability of total IUD placement process, would you recommend this to a friend?
timeFrame: 1 week and 1 month after IUD insertion
Other outcomes:
Locations:
city: Tucson
country: United States
facility: UPH-Kino multispecialty clinic
state: Arizona
city: Tucson
country: United States
facility: University Medical Center Ob/Gyn clinic 8OPC
state: Arizona
Study officials:
References:
citation: Espey E, Singh RH, Leeman L, Ogburn T, Fowler K, Greene H. Misoprostol for intrauterine device insertion in nulliparous women: a randomized controlled trial. Am J Obstet Gynecol. 2014 Mar;210(3):208.e1-5. doi: 10.1016/j.ajog.2013.11.018. Epub 2013 Nov 8.
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.