Intra Uterine Device Insertion in Nulliparous Women
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Misoprostol (Drug); Placebo (Other)
Phase: N/A
Status: Terminated
Sponsored by: University of Colorado, Denver Official(s) and/or principal investigator(s): Stephanie Teal, MD, MPH, Principal Investigator, Affiliation: University of Colorado, Denver
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.
Clinical Details
Official title: IUD Insertion in Nulliparous Women: A Randomized, Placebo-Controlled Trial of Misoprostol for Cervical Priming
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Ease of IUD Insertion (Use of Ancillary Measures)
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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)
Locations and Contacts
University of Colorado Hopspital, The Children's Hospital, Aurora, Colorado 80045, United States
Additional Information
Related 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 Sääv 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. 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. Review. Carbonell JL, Velazco A, Rodriguez Y, Tanda R, Sánchez C, Barambio S, Valera L, Chami S, Valero F, Aragón S, Marí 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. Epub 2006 Apr 27. Review. 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. 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. 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. Trussell J. Contraceptive failure in the United States. Contraception. 2004 Aug;70(2):89-96. Review.
Starting date: July 2011
Last updated: February 11, 2015
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