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

NCT ID: NCT01307111

Last Updated: 2016-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-03-31

Brief 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.

Detailed 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.

Conditions

Pain

Study Design

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

Study Groups

Misoprostol

Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pills which are identical to the study drug in appearance, taste, and smell.

Interventions

Misoprostol

400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.

Intervention Type: DRUG

Placebo

Pills which are identical to the study drug in appearance, taste, and smell.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Eve Espey

Professor, OB-GYN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eve Espey, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Department of Obstetrics and Gynecology

References

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

HRRC #09-426

Identifier Type: -

Identifier Source: org_study_id