Intra Uterine Device Insertion in Nulliparous Women

December 8, 2016 updated by: University of Colorado, Denver

IUD Insertion in Nulliparous Women: A Randomized, Placebo-Controlled Trial of Misoprostol for Cervical Priming

Over the last several years, more and more women are choosing intrauterine contraception (IUDs) to meet their birth control needs. The effectiveness of IUDs is very similar to tubal sterilization, with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. Intrauterine contraception has many attributes besides its effectiveness; it is easily reversible, has a low side-effect profile, and provides a long-term solution for contraception (10 years for the copper T380 and 5 years for the levonorgestrel IUD). In addition, using an IUD for birth control requires little on-going effort by the woman to be effective and offers immediate return to fertility with its removal.

The biggest increase in users is among nulliparous women (women who have not had children), due to increased awareness of the safety of modern IUDs in this population, and the many benefits of the method. In fact, The copper IUD (Paragard) is now FDA approved for use in nulliparous women, and the American College of Obstetricians and Gynecologists supports the use of both copper and levonorgestrel IUDs in nulliparous women. The cervix of a nulliparous woman has a smaller diameter which can lead to more difficult and uncomfortable IUD insertions. Many providers avoid offering IUDs to nulliparas because of fears that the procedure will be more difficult, and may require cervical dilation, placement of a paracervical nerve block, or placement under ultrasound guidance, none of which are standard for parous women. The medication misoprostol is a prostaglandin E1 analog. Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their nulliparous patients a dose of this drug prior to IUD insertion. Misoprostol is commonly used to dilate the cervix for similar procedures as in first trimester abortions, hysteroscopy and endometrial biopsies. Its efficacy in cervical priming for IUD insertion is unknown, and some concern exists that uterine contractions caused by the drug may lead to device expulsion or displacement.

In this study, the investigators propose to ask nulliparous women who have undergone contraceptive counseling and decided to use an IUD for birth control to be randomized to the use of misoprostol or placebo prior to their scheduled IUD placement.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Hypothesis: The prostaglandin E1 analog misoprostol will ease insertion of intrauterine contraceptive devices in nulliparous women.

Specific Aim 1: To evaluate the ability to place an IUD in the standard fashion, without ancillary measures, in nulliparous women who have received misoprostol versus placebo Specific Aim 2: To evaluate in nulliparous women who have chosen to receive an IUD whether pre-procedure misoprostol eases pain, compared to placebo Specific Aim 3: To evaluate whether misoprostol reduces the rate of complications of IUD placement, compared to placebo Study drug (misoprostol) is being obtained from the University of Utah Health Sciences Center, which is the main study site. The University of Utah Health Sciences Center has obtained an Investigational New Drug (IND) exemption from the FDA in order to use misoprostol for this use in this study. This study is part of a prospective meta-analysis. Deidentified data will be provided to the other sites in a password protected spreadsheet and sent via encrypted, secure email. No identifiable data will be shared with other sites or via the internet. We did not complete attachment G, use of the internet, because this research is not being done via the internet, and no identifiable data will be accessible via the internet or shared with other sites involved in the study. Only deidentified data will be made available to the other sites involved in the prospective meta-analysis.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hopspital, The Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Desires IUD placement
  • 18 years old or older
  • negative pregnancy test
  • no prior pregnancies beyond 14 6/7 weeks
  • no pelvic inflammatory disease (PID) in last 3 months
  • no current cervicitis
  • no contraindications to IUD insertion (see exclusion criteria below)
  • willing to follow-up in 6-8 weeks for a standard IUD follow-up visit
  • Determined by her clinician to be an appropriate candidate for an IUD.

Exclusion Criteria:

  • Active cervical infection
  • current pregnancy
  • prior pregnancy beyond 15 weeks' gestation
  • uterine anomaly
  • fibroid uterus
  • copper allergy/Wilson's disease (for Paragard)
  • undiagnosed abnormal uterine bleeding
  • cervical or uterine cancer
  • allergy to misoprostol (study drug)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental active comparator

Drug: Misoprostol

Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
Drug: Misoprostol
Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
Other Names:
  • synthetic prostaglandin E1 (PGE1) analog
Placebo Comparator: Placebo comparator

Other: Placebo

Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
Other: Placebo
Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of IUD Insertion (Use of Ancillary Measures)
Time Frame: During the IUD insertion procedure, up to 2 hours
The primary outcome is the proportion in each group able to have the IUD inserted in a standard fashion without the ancillary measures of mechanical dilation of the cervix, placement of paracervical nerve block, or using abdominal ultrasound for guidance. The null hypothesis for the primary outcome is that misoprostol does not influence difficulty of insertion.
During the IUD insertion procedure, up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Stephanie Teal, MD, MPH, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 22, 2011

First Posted (Estimate)

August 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Clinical Trials on Misoprostol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe