Intra Uterine Device Insertion in Nulliparous Women

• ClinicalTrials.gov Identifier: NCT01422226
• Recruitment Status: Terminated
• First Posted: August 23, 2011
• Results First Posted: February 26, 2015
• Last Update Posted: February 2, 2017
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Tracking Information

• First Submitted Date: August 22, 2011
• First Posted Date: August 23, 2011
• Results First Submitted Date: February 11, 2015
• Results First Posted Date: February 26, 2015
• Last Update Posted Date: February 2, 2017
• Study Start Date: July 2011
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 8, 2016)

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.

Original Primary Outcome Measures (submitted: August 22, 2011)

Ease of IUD Insertion (use of ancillary measures) [ Time Frame: 12 months ]

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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intra Uterine Device Insertion in Nulliparous Women
• Official Title: IUD Insertion in Nulliparous Women: A Randomized, Placebo-Controlled Trial of Misoprostol for Cervical Priming

Brief Summary

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Contraception

Intervention

• Drug: Misoprostol
  Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
  Other Name: synthetic prostaglandin E1 (PGE1) analog
• Other: Placebo
  Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion

Study Arms

• Experimental: Experimental active comparator

  Drug: Misoprostol

  Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion

  Intervention: Drug: Misoprostol
• Placebo Comparator: Placebo comparator

  Other: Placebo

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

  Intervention: Other: Placebo

Publications *

• Ghersi D. Prospective Meta-Analysis Methods Group. The Cochrane Collaboration 2002 [cited July 2, 2008]; Available from: http://www.cochrane.org/docs/pma.htm
• Saav I, Aronsson A, Marions L, Stephansson O, Gemzell-Danielsson K. Cervical priming with sublingual misoprostol prior to insertion of an intrauterine device in nulliparous women: a randomized controlled trial. Hum Reprod. 2007 Oct;22(10):2647-52. doi: 10.1093/humrep/dem244. Epub 2007 Jul 25.
• Crane JM, Healey S. Use of misoprostol before hysteroscopy: a systematic review. J Obstet Gynaecol Can. 2006 May;28(5):373-9. doi: 10.1016/s1701-2163(16)32150-8.
• Carbonell JL, Velazco A, Rodriguez Y, Tanda R, Sanchez C, Barambio S, Valera L, Chami S, Valero F, Aragon S, Mari J. Oral versus vaginal misoprostol for cervical priming in first-trimester abortion: a randomized trial. Eur J Contracept Reprod Health Care. 2001 Sep;6(3):134-40.
• Tang OS, Ho PC. The pharmacokinetics and different regimens of misoprostol in early first-trimester medical abortion. Contraception. 2006 Jul;74(1):26-30. doi: 10.1016/j.contraception.2006.03.005. Epub 2006 Apr 27.
• Allen RH, Goldberg AB; Board of Society of Family Planning. Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation). SFP Guideline 20071. Contraception. 2007 Aug;76(2):139-56. doi: 10.1016/j.contraception.2007.05.001. Epub 2007 Jul 10.
• American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 392, December 2007. Intrauterine device and adolescents. Obstet Gynecol. 2007 Dec;110(6):1493-5. doi: 10.1097/01.AOG.0000291575.93944.1a.
• ACOG Committee on Practice Bulletins-Gynecology. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 59, January 2005. Intrauterine device. Obstet Gynecol. 2005 Jan;105(1):223-32. doi: 10.1097/00006250-200501000-00060. No abstract available.
• Trussell J. Contraceptive failure in the United States. Contraception. 2004 Aug;70(2):89-96. doi: 10.1016/j.contraception.2004.03.009.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 11, 2015): 3
• Original Estimated Enrollment (submitted: August 22, 2011): 158
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01422226
• Other Study ID Numbers: 10-1060
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Colorado, Denver
• Original Responsible Party: Stephanie Teal, MD, MPH/Associate Professor, University of Colorado Hospital Anschutz Medical Campus
• Current Study Sponsor: University of Colorado, Denver
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Colorado, Denver
• Verification Date: December 2016