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Enquiry Reference 13

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					                          Faculty of Sexual and Reproductive Healthcare
                          Clinical Effectiveness Unit

                          A unit funded by the FSRH and supported by Sandyford




                                      MEMBER’S ENQUIRY RESPONSE

Enquiry Reference: 2600                                                          Sent: 3.3.09
                                                                                 Prepared: 3.3.09

A: Question
How useful is misoprostol prior to fitting an intrauterine device, in facilitating fitting and reducing
complications?

B: Response
Evidence is suggestive that misoprostol is useful for IUD insertions, where it softens the cervix and
reduces the chance of complications such as perforation, pain and bleeding. In addition, randomised
trials have shown that misoprostol improves the ease with which the cervix can be dilated and reduces
complication in premenopausal women, postmenopausal women and nulliparous women undergoing
operative hysteroscopy. However, it is not yet known what the optimal regimen would be.




C: Evidence-Based Medicine Question (which guided our literature search strategy)
Population:      Women requiring an IUD

Intervention:    Misoprostol

Outcome:         Reduced complications

Keywords: IUD, Intrauterine Device, Misoprostol, Cervical Priming, insertion, cervical
dilation, 2600


D: Information Sources
The CEU searched the following sources in developing this Member’s Enquiry Response
                               Source Searched                                                Information Identified
Existing FSRH and RCOG guidance                                                           See below
The National Guidelines Clearing House                                                    No information
The United Kingdom Medical Eligibility Criteria for Contraceptive Use (2005/2006)
The United Kingdom Selected Practice Recommendations for Contraceptive Use (2002)
The World Health Organization Medical Eligibility Criteria for Contraceptive Use (2004)   No information
The World Health Organization Selected Practice Recommendations for Contraceptive
Use (2005)
The Cochrane Library                                                                      No information
MEDLINE and EMBASE from 1996 to 2008                                                      See below




 Tel: 0141 232 8459                         Fax: 0141 232 8448                       email: ceu.members@ggc.scot.nhs.uk
E: Evidence Reviewed
Existing FSRHC guidance
In FSRHC guidance ‘The Copper Intrauterine Device as Long-term Contraception’ 1 it states that case
reports, but no randomised trials, have described the use of prostaglandins for cervical priming pre-
intrauterine device (IUD insertion). 2 Randomised trials have shown that misoprostol improves the
ease with which the cervix can be dilated and reduces complication in premenopausal women 3,
postmenopausal women 4 and nulliparous 5 women undergoing operative hysteroscopy.

MEDLINE and EMBASE from 1996-2006
A similar study, by Atay et al 6 found that application of misoprostol provided a safe, painless and
effective means of cervical dilation by chemical, rather than mechanical forces, and reduces
complications such as cervical bleeding, laceration and uterine perforation in women attending for
hysteroscopy (n = 22).

Li et al 7 investigated cervical softening with vaginal misoprostol before intrauterine insertion. In the 8
women given misoprostol (400µg), IUDs were successfully inserted without any complications.
Previously, these women had had failed IUD insertions. Misoprostol was found to soften the cervix. 7
women had a medical history of caesarean section and no vaginal delivery and one woman had a
small cervix.

Evidence is suggestive that misoprostol is useful for IUD insertions, where it softens the cervix and
reduces the chance of complications such as perforation, pain and bleeding. In the Li et al study no
expulsions were found after insertions using misoprostol.

A randomised controlled trial similarly suggests that misoprostol is useful in facilitating IUD insertions,
with insertions significantly easier when compared with controls, although the confidence interval was
wide. (p=0.039, CI -0.013-39.99).8

This evidence is from small studies, with small numbers of women and a large randomised control trial
would be needed in order to assess its overall efficacy and the optimal regimen.

It should be noted that misoprostol is not available as a gel or pessary designed for vaginal use. It is
available only as tablets designed for oral administration. However, these tablets are widely used by
the vaginal route in the context of medical abortion. This use is outside the product licence.


F: References
   1. Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. The
      Copper Intrauterine Device as Long-Term Contraception. Journal of Family Planning and
      Reproductive Health Care 2004;30:29-42.

   2. Lauersen NH, Kurkulos M, Graves ZR, Leeds L. A new IUD insertion technique utilizing
      cervical priming with prostagladin. Contraception 1982;26:59-63.

   3. Thomas JA, Leyland N, Durand N, Windrim RC. The use of oral misoprostol as a cervical
      ripening agent in operative hysteroscopy: a double-blind, placebo-controlled trial. American
      Journal of Obstetrics and Gynaecology 2002;186:876-9.

   4. Fung TM, Lam MH, Wong SF, Ho.L C. A randomised placebo-controlled trial of vaginal
      misoprostol for cervical priming before hysteroscopy in postmenopausal women. British
      Journal of Obstetrics and Gynaecology 2002;109:561-5.

   5. Preutthipan S,.Herabutya Y. Vaginal misoprostol for cervical priming before operative
      hysteroscopy: a randomized controlled trial. Obstetrics & Gynaecology 2000;96:8890-894.

   6. Atay V, Duru N.K, Pabuccu R, Ergun A, Tokac G, Aydin B.A. Vaginal misoprostol for cervical
      dilatation before operative office hysteroscopy. Gynaecological Endoscopy 2005;6:47-9.


 Tel: 0141 232 8459                   Fax: 0141 232 8448                 email: ceu.members@ggc.scot.nhs.uk
    7. Li Y.T, Kuo T.C, Kuan L.C, Chu Y.C. Cervical softening with vaginal misoprostol before
       intrauterine device insertion. International Journal of Obstetrics & Gynaecology 2005;89:67-8.

    8. 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. Human Reproduction. 22(10)(pp 2647-2652), 2007.


The advice given in this Member's Enquiry Response has been prepared by the FSRH Clinical Effectiveness
Unit team. It is based on a structured search and review of published evidence available at the date of
preparation. The advice given here should be considered as guidance only. Adherence to it will not ensure a
successful outcome in every case and it may not include all acceptable methods of care aimed at the same
results. This response has been prepared as a service to FSRH members, but is not an official Faculty guidance
product; Faculty guidance is produced by a different and lengthier process. It is not intended to be construed or
to serve as a standard of medical care. Such standards are determined on the basis of all clinical data available
for an individual case and are subject to change as scientific knowledge advances. Members are welcome to
reproduce this response by photocopying or other means, in order to share the information with colleagues.

Enquiry response by JC (updated from LA)
Checked by




 Tel: 0141 232 8459                     Fax: 0141 232 8448                    email: ceu.members@ggc.scot.nhs.uk

				
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