Intra Uterine Device Insertion in Nulliparous Women

NCT01422226 | Terminated Results

• 1 other identifier: 10-1060
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

IUD; contraception; nulliparous; women

Outcome Measures

Primary Outcomes (1)

• Ease of IUD Insertion (Use of Ancillary Measures)

  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

Study Arms (2)

Experimental active comparator

EXPERIMENTAL

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

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

Other: Placebo

Interventions

Misoprostol DRUG

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

Also known as: synthetic prostaglandin E1 (PGE1) analog

Experimental active comparator

Placebo OTHER

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

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Desires IUD placement
• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hopspital, The Children's Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (9)

• Ghersi D. Prospective Meta-Analysis Methods Group. The Cochrane Collaboration 2002 [cited July 2, 2008]; Available from: http://www.cochrane.org/docs/pma.htm

  BACKGROUND

• 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.

  PMID: 17652452 BACKGROUND

• 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.

  PMID: 16768880 BACKGROUND

• 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.

  PMID: 11763976 BACKGROUND

• 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.

  PMID: 16781256 BACKGROUND

• 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.

  PMID: 17656184 BACKGROUND

• 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.

  PMID: 18055754 BACKGROUND

• 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.

  PMID: 15625179 BACKGROUND

• Trussell J. Contraceptive failure in the United States. Contraception. 2004 Aug;70(2):89-96. doi: 10.1016/j.contraception.2004.03.009.

  PMID: 15288211 BACKGROUND

MeSH Terms

Interventions

Misoprostol; Alprostadil

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E; Fatty Acids, Monounsaturated

Results Point of Contact

• Title: Christina Gavito
• Organization: University of Colorado Denver

christina.gavito@ucdenver.edu

303-724-5559

Study Officials

• Stephanie Teal, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 23, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 2, 2017
• Results First Posted: February 26, 2015

Record last verified: 2016-12

Locations

US (1)