Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

Pain Clinical Trial

Official title:

A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307111
• Other study ID #: HRRC #09-426
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: May 27, 2015
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2015
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

• 14 years old or older

• Negative pregnancy test

• No prior pregnancies lasting beyond 19 6/7 weeks

• Minimum 2 weeks after spontaneous or medical abortion

• Minimum 4 weeks post 2nd trimester or surgical abortion

• No previous IUD insertions

• No PID in last 3 months

• No current cervicitis

• Willing to follow-up in 1-2 months for an IUD string check

Exclusion Criteria:

• Active cervical infection

• Current pregnancy

• Prior pregnancy beyond 19 6/7 weeks gestation

• Known uterine anomaly

• Fibroid uterus distorting uterine cavity

• Copper allergy/Wilson's Disease (for Paragard)

• Undiagnosed abnormal uterine bleeding

• Cervical or uterine cancer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Misoprostol
400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
• Placebo
Pills which are identical to the study drug in appearance, taste, and smell.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Provider perceived ease of insertion on a 100-point visual analogue scale.		Immediately post IUD insertion	No
Secondary	Patient perceived pain on a 100-point visual analogue scale.		Prior to insertion, immediately after insertion, and prior to clinic discharge.	No
Secondary	Ability to insert the IUD without the use of adjunctive measures including ultrasound guidance or cervical dilation.		During IUD insertion and immediately after.	No
Secondary	Time for IUD insertion procedure.		Assessed immediately after IUD insertion.	No
Secondary	Presence of medication side effects.		Assessed prior to IUD insertion, prior to leaving clinic, and at 1 week follow-up.	No
Secondary	Procedure complications.		Assessed up to 1 month from time of IUD insertion.	Yes
Secondary	Need for additional pain medications the week following the procedure.		1 week after IUD insertion.	No