Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women

Alison Edelman, Elizabeth Schaefer, Amanda Olson, Laura Van Houten, Paula Bednarek, Catherine Leclair, Jeffrey Jensen

Research output: Contribution to journalArticle

63 Citations (Scopus)

Abstract

Background: This study was conducted to examine the effects of prophylactic misoprostol prior to intrauterine device (IUD) placement in nulliparous women. Study Design: Nulliparous, reproductive-aged women desiring an IUD for contraception were randomized to receive 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. Subjects completed a series of 100-mm visual analogue scales (VAS, anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain at several times points (anticipated pain, leg positioning, speculum placement, tenaculum placement, IUD insertion, equipment removal and 5 min postinsertion). Secondary outcomes included provider "ease of placement" (100-mm VAS, anchors: 0=easy, 100 mm=extremely difficult), side effects and retention of the IUD after 1 month (self-report or clinic visit). The study had 80% power (α=0.05, one-sided) to detect a reduction with treatment of 20 mm in VAS scores with a combined sample size of 34. Results: A total of 40 subjects were randomized to receive either misoprostol or placebo, and 35 completed the study. Five subjects withdrew (four prior to receiving study medication and one declined IUD). Baseline characteristics were similar between groups. There were no significant differences in patient-reported pain with IUD placement [misoprostol 65 mm (SD 21), placebo 55 mm (SD 21), p=.83] or at any other time point. Moreover, the misoprostol group reported significantly more preinsertion nausea (29% vs. 5%, p=.05) and cramping (47% vs. 16%, p=.04) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported. Conclusion: Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects.

Original languageEnglish (US)
Pages (from-to)234-239
Number of pages6
JournalContraception
Volume84
Issue number3
DOIs
StatePublished - Sep 2011

Fingerprint

Misoprostol
Intrauterine Devices
Placebos
Pain
Cheek
Ambulatory Care
Visual Analog Scale
Contraception
Surgical Instruments
Sample Size
Self Report
Nausea
Dilatation
Leg
Equipment and Supplies

Keywords

  • Cervical priming
  • Intrauterine device
  • Nulliparous
  • Prophylactic misoprostol
  • Prostaglandins

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. / Edelman, Alison; Schaefer, Elizabeth; Olson, Amanda; Van Houten, Laura; Bednarek, Paula; Leclair, Catherine; Jensen, Jeffrey.

In: Contraception, Vol. 84, No. 3, 09.2011, p. 234-239.

Research output: Contribution to journalArticle

@article{50880314792544578259d495a339bd66,
title = "Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women",
abstract = "Background: This study was conducted to examine the effects of prophylactic misoprostol prior to intrauterine device (IUD) placement in nulliparous women. Study Design: Nulliparous, reproductive-aged women desiring an IUD for contraception were randomized to receive 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. Subjects completed a series of 100-mm visual analogue scales (VAS, anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain at several times points (anticipated pain, leg positioning, speculum placement, tenaculum placement, IUD insertion, equipment removal and 5 min postinsertion). Secondary outcomes included provider {"}ease of placement{"} (100-mm VAS, anchors: 0=easy, 100 mm=extremely difficult), side effects and retention of the IUD after 1 month (self-report or clinic visit). The study had 80{\%} power (α=0.05, one-sided) to detect a reduction with treatment of 20 mm in VAS scores with a combined sample size of 34. Results: A total of 40 subjects were randomized to receive either misoprostol or placebo, and 35 completed the study. Five subjects withdrew (four prior to receiving study medication and one declined IUD). Baseline characteristics were similar between groups. There were no significant differences in patient-reported pain with IUD placement [misoprostol 65 mm (SD 21), placebo 55 mm (SD 21), p=.83] or at any other time point. Moreover, the misoprostol group reported significantly more preinsertion nausea (29{\%} vs. 5{\%}, p=.05) and cramping (47{\%} vs. 16{\%}, p=.04) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported. Conclusion: Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects.",
keywords = "Cervical priming, Intrauterine device, Nulliparous, Prophylactic misoprostol, Prostaglandins",
author = "Alison Edelman and Elizabeth Schaefer and Amanda Olson and {Van Houten}, Laura and Paula Bednarek and Catherine Leclair and Jeffrey Jensen",
year = "2011",
month = "9",
doi = "10.1016/j.contraception.2011.01.016",
language = "English (US)",
volume = "84",
pages = "234--239",
journal = "Contraception",
issn = "0010-7824",
publisher = "Elsevier USA",
number = "3",

}

TY - JOUR

T1 - Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women

AU - Edelman, Alison

AU - Schaefer, Elizabeth

AU - Olson, Amanda

AU - Van Houten, Laura

AU - Bednarek, Paula

AU - Leclair, Catherine

AU - Jensen, Jeffrey

PY - 2011/9

Y1 - 2011/9

N2 - Background: This study was conducted to examine the effects of prophylactic misoprostol prior to intrauterine device (IUD) placement in nulliparous women. Study Design: Nulliparous, reproductive-aged women desiring an IUD for contraception were randomized to receive 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. Subjects completed a series of 100-mm visual analogue scales (VAS, anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain at several times points (anticipated pain, leg positioning, speculum placement, tenaculum placement, IUD insertion, equipment removal and 5 min postinsertion). Secondary outcomes included provider "ease of placement" (100-mm VAS, anchors: 0=easy, 100 mm=extremely difficult), side effects and retention of the IUD after 1 month (self-report or clinic visit). The study had 80% power (α=0.05, one-sided) to detect a reduction with treatment of 20 mm in VAS scores with a combined sample size of 34. Results: A total of 40 subjects were randomized to receive either misoprostol or placebo, and 35 completed the study. Five subjects withdrew (four prior to receiving study medication and one declined IUD). Baseline characteristics were similar between groups. There were no significant differences in patient-reported pain with IUD placement [misoprostol 65 mm (SD 21), placebo 55 mm (SD 21), p=.83] or at any other time point. Moreover, the misoprostol group reported significantly more preinsertion nausea (29% vs. 5%, p=.05) and cramping (47% vs. 16%, p=.04) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported. Conclusion: Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects.

AB - Background: This study was conducted to examine the effects of prophylactic misoprostol prior to intrauterine device (IUD) placement in nulliparous women. Study Design: Nulliparous, reproductive-aged women desiring an IUD for contraception were randomized to receive 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. Subjects completed a series of 100-mm visual analogue scales (VAS, anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain at several times points (anticipated pain, leg positioning, speculum placement, tenaculum placement, IUD insertion, equipment removal and 5 min postinsertion). Secondary outcomes included provider "ease of placement" (100-mm VAS, anchors: 0=easy, 100 mm=extremely difficult), side effects and retention of the IUD after 1 month (self-report or clinic visit). The study had 80% power (α=0.05, one-sided) to detect a reduction with treatment of 20 mm in VAS scores with a combined sample size of 34. Results: A total of 40 subjects were randomized to receive either misoprostol or placebo, and 35 completed the study. Five subjects withdrew (four prior to receiving study medication and one declined IUD). Baseline characteristics were similar between groups. There were no significant differences in patient-reported pain with IUD placement [misoprostol 65 mm (SD 21), placebo 55 mm (SD 21), p=.83] or at any other time point. Moreover, the misoprostol group reported significantly more preinsertion nausea (29% vs. 5%, p=.05) and cramping (47% vs. 16%, p=.04) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported. Conclusion: Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects.

KW - Cervical priming

KW - Intrauterine device

KW - Nulliparous

KW - Prophylactic misoprostol

KW - Prostaglandins

UR - http://www.scopus.com/inward/record.url?scp=80051912744&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80051912744&partnerID=8YFLogxK

U2 - 10.1016/j.contraception.2011.01.016

DO - 10.1016/j.contraception.2011.01.016

M3 - Article

C2 - 21843686

AN - SCOPUS:80051912744

VL - 84

SP - 234

EP - 239

JO - Contraception

JF - Contraception

SN - 0010-7824

IS - 3

ER -