Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women

University of Arizona61 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Contraception

Interventions

MisoprostolDRUG

400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

PlaceboDRUG

400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

UPH-Kino multispecialty clinic

Tucson, Arizona, United States

University Medical Center Ob/Gyn clinic 8OPC

Tucson, Arizona, United States

Outcomes

Primary Outcomes

The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale

Time frame: after IUD insertion

Secondary Outcomes

Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia

Time frame: during IUD insertion

Side effects of medications

Time frame: prior to IUD insertion

Provider perceived ease of insertion on a 100 mm visual analogue scale

Time frame: after IUD insertion

Acceptability of wait time prior to IUD placement

Time frame: 1 week after IUD insertion

Procedure complications

Time frame: Up to 1 month after IUD placement

Acceptability of total IUD placement process, would you recommend this to a friend?

Time frame: 1 week and 1 month after IUD insertion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.