MedDataX Logo

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

NCT ID: NCT00886834

Last Updated: 2014-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. 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 use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

IUD insertion Nulliparous women Contraception Family Planning IUD insertion in nulliparous women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Misoprostol

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

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

400 micrograms inserted vaginally or buccally, 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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Misoprostol

400 micrograms inserted vaginally or buccally, 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

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cytotec

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years old or older
* negative pregnancy test
* no prior pregnancies beyond 14 6/7 weeks
* no PID in last 3 months
* no current cervicitis
* be willing to follow-up in 1-2 months for an IUD string check.

Exclusion Criteria

* active cervical infection
* current pregnancy
* prior pregnancy beyond 14 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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Utah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Turok

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Turok, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah Department of Obstetrics and Gynecology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Planned Parenthood Association of Utah

Salt Lake City, Utah, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Swenson C, Turok DK, Ward K, Jacobson JC, Dermish A. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):341-7. doi: 10.1097/AOG.0b013e31825d9ec9.

Reference Type DERIVED
PMID: 22825094 (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

Review additional registry numbers or institutional identifiers associated with this trial.

24403

Identifier Type: -

Identifier Source: org_study_id