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IUD Insertion in Nulliparous Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01422226
First received: August 22, 2011
Last updated: January 29, 2013
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Nulliparous Women
Contraception
IUD Insertion
 Drug: Misoprostol
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IUD Insertion in Nulliparous Women: A Randomized, Placebo-Controlled Trial of Misoprostol for Cervical Priming

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Ease of IUD Insertion (use of ancillary measures) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 158
Study Start Date: July 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental active comparator Drug: Misoprostol
Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
Placebo Comparator: Placebo comparator Other: Placebo
Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422226

Locations
United States, Colorado
University of Colorado Hopspital, The Children's Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Stephanie Teal, MD, MPH University of Colorado Hospital
  More Information

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01422226     History of Changes
Other Study ID Numbers: 10-1060
Study First Received: August 22, 2011
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
IUD
contraception
nulliparous
women

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on June 18, 2013