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

NCT ID: NCT01147497

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-09-30

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

misoprostol

Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit

placebo

Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit

Interventions

Misoprostol

400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit

Intervention Type: DRUG

Placebo

Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Eva Lathrop, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Lathrop, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University School of Medicine, Department of Gynecology and Obstetrics

Locations

The Emory Clinic

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24034580 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21527040 (View on PubMed)

Other Identifiers

MISO Emory

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00021303

Identifier Type: -

Identifier Source: org_study_id