Skip to main content

Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial

Archives of Gynecology and Obstetrics volume 301, pages 1463–1471 (2020)Cite this article

Abstract

Purpose

This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD).

Methods

We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects.

Results

Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3; p < 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1; p < 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups.

Conclusion

Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.

This is a preview of subscription content, access via your institution.

Access options

Buy single article

Instant access to the full article PDF.

43,34 €

Price includes VAT (Finland)
Tax calculation will be finalised during checkout.

Fig. 1

References

  1. Buhling KJ, Zite NB, Lotke P et al (2014) Worldwide use of intrauterine contraception: a review. Contraception 89:162–173

    Article  Google Scholar 

  2. Rose S, Chaudhari A, Peterson CM (2009) Mirena (levonorgestrel intrauterine system): a successful novel drug delivery option in contraception. Adv Drug Deliv Rev 61:808–812

    CAS  Article  Google Scholar 

  3. Chor J, Bregand-White J, Golobof A et al (2012) Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial. Contraception 85:558–562

    CAS  Article  Google Scholar 

  4. Ireland LD, Allen RH (2016) Pain management for gynecologic procedures in the office. Obstet Gynecol Surv 71:89–98

    Article  Google Scholar 

  5. Kass-Wolff JH, Fisher JE (2014) Evidence-based pain management for endometrial biopsies and IUD insertions. Nurse Pract 39:43–50

    Article  Google Scholar 

  6. Kaislasuo J, Heikinheimo O, Lähteenmäki P, Suhonen S (2014) Predicting painful or difficult intrauterine device insertion in nulligravid women. Obstet Gynecol 124(2):345–353

    Article  Google Scholar 

  7. Santos ARG, Bahamondes MV, Hidalgo MM et al (2013) Pain at insertion of the levonorgestrel-releasing intrauterine system in nulligravida and parous women with and without cesarean section. Contraception 88:164–168

    Article  Google Scholar 

  8. Hubacher D, Reyes V, Lillo S et al (2006) Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol 195:1272–1277

    CAS  Article  Google Scholar 

  9. Akers AY, Steinway C, Sonalkar S et al (2017) Reducing pain during intrauterine device insertion: a randomized controlled trial in adolescents and young women. Obstet Gynecol 130:795–802

    Article  Google Scholar 

  10. Lopez LM, Bernholc A, Zeng Y et al (2015) Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev 7:CD007373

    Google Scholar 

  11. Matthews LR, OʼDwyer L, OʼNeill E (2016) Intrauterine device insertion failure after misoprostol administration: a systematic review. Obstet Gynecol 128:1084–1091

    CAS  Article  Google Scholar 

  12. Liu A, Lv J, Hu Y et al (2014) Efficacy and safety of intravaginal misoprostol versus intracervical dinoprostone for labor induction at term: a systematic review and meta-analysis. J Obstet Gynaecol Res 40:897–906

    CAS  Article  Google Scholar 

  13. Abulnour AAE-R, Mohamed ME-M, Khalaf WM (2018) Dinoprostone versus misoprostol for cervical ripening before diagnostic hysteroscopy in nulliparous women: a randomized controlled trial. Egypt J Hosp Med 71:2287–2293

    Article  Google Scholar 

  14. Inal HA, Ozturk Inal ZH, Tonguc E, Var T (2015) Comparison of vaginal misoprostol and dinoprostone for cervical ripening before diagnostic hysteroscopy in nulliparous women. Fertil Steril 103:1326–1331

    CAS  Article  Google Scholar 

  15. Bakker R, Pierce S, Myers D (2017) The role of prostaglandins E1 and E2, dinoprostone, and misoprostol in cervical ripening and the induction of labor: a mechanistic approach. Arch Gynecol Obstet 296:167–179

    CAS  Article  Google Scholar 

  16. Rowbotham M (2001) What is a ‘clinically meaningful’ reduction in pain? Pain 94:131–132

    CAS  Article  Google Scholar 

  17. Dakhly DMR, Bassiouny YA, Bayoumi YA et al (2018) Current contraceptive trends among married Egyptian women: a cross-sectional survey. Eur J Contracept Reprod Health Care 23:351–356

    Article  Google Scholar 

  18. Al Rifai RH (2017) Trend of caesarean deliveries in Egypt and its associated factors: evidence from national surveys, 2005–2014. BMC Pregnancy Childbirth 17:417

    Article  Google Scholar 

  19. Akdemir Y, Karadeniz M (2019) The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care 24:240–245

    Article  Google Scholar 

  20. Shirley M (2018) Dinoprostone vaginal insert: a review in cervical ripening. Drugs 78:1615–1624

    CAS  Article  Google Scholar 

  21. Anthoulakis C, Iordanidou E, Vatopoulou A (2018) Pain perception during levonorgestrel-releasing intrauterine device insertion in nulliparous women: a systematic review. J Pediatr Adolesc Gynecol 31:549–556.e4

    Article  Google Scholar 

  22. Perez-Lopez FR, Martinez-Dominguez SJ, Perez-Roncero GR, Hernandez AV (2018) Uterine or paracervical lidocaine application for pain control during intrauterine contraceptive device insertion: a meta-analysis of randomised controlled trials. Eur J Contracept Reprod Health Care 23:207–217

    CAS  Article  Google Scholar 

  23. Miles SM, Shvartsman K, Dunlow S (2019) Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial. Contracept Reprod Med 4:13

    Article  Google Scholar 

  24. Samy A, Abbas AM, Mahmoud M et al (2019) Evaluating different pain lowering medications during intrauterine device insertion: a systematic review and network meta-analysis. Fertil Steril 111:553–561.e4

    CAS  Article  Google Scholar 

  25. Abdellah MS, Abbas AM, Hegazy AM, El-Nashar IM (2017) Vaginal misoprostol prior to intrauterine device insertion in women delivered only by elective cesarean section: a randomized double-blind clinical trial. Contraception 95:538–543

    CAS  Article  Google Scholar 

  26. Maged AM, Youssef G, Eldaly A et al (2018) Benefits of vaginal misoprostol prior to IUD insertion in women with previous caesarean delivery: a randomised controlled trial. Eur J Contracept Reprod Health Care 23:32–37

    CAS  Article  Google Scholar 

  27. Swenson C, Turok DK, Ward K et al (2012) Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol 120:341–347

    CAS  Article  Google Scholar 

  28. Ibrahim ZM, Sayed Ahmed WA (2013) Sublingual misoprostol prior to insertion of a T380A intrauterine device in women with no previous vaginal delivery. Eur J Contracept Reprod Health Care 18:300–308

    CAS  Article  Google Scholar 

  29. Zapata LB, Jatlaoui TC, Marchbanks PA, Curtis KM (2016) Medications to ease intrauterine device insertion: a systematic review. Contraception 94:739–759

    CAS  Article  Google Scholar 

  30. Preutthipan S, Herabutya Y (2006) A randomized comparison of vaginal misoprostol and dinoprostone for cervical priming in nulliparous women before operative hysteroscopy. Fertil Steril 86:990–994

    Article  Google Scholar 

  31. Samy A, Abbas AM, Rashwan ASSA et al (2019) Vaginal dinoprostone in reducing pain perception during diagnostic office hysteroscopy in postmenopausal women: a randomized, double-blind placebo-controlled trial. J Minim Invasive Gynecol

  32. Brown WM, Trouton K (2014) Intrauterine device insertions: which variables matter? J Fam Plann Reprod Health Care 40:117–121

    Article  Google Scholar 

  33. Maguire K, Davis A, Rosario Tejeda L, Westhoff C (2012) Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception 86:214–219

    CAS  Article  Google Scholar 

  34. Dina B, Peipert LJ, Zhao Q, Peipert JF (2018) Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol 218:236.e1–236.e9

    Article  Google Scholar 

  35. Van der Griendt MC, Goldstuck ND (1990) Dilatation of the cervix with dinoprostone (‘Prepidil Gel’) prior to insertion of an intrauterine device: report of two cases. Adv Contracept 6:53–56

    Article  Google Scholar 

  36. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice, Long-Acting Reversible Contraception Working Group (2009) ACOG Committee Opinion no. 450: Increasing use of contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol 114:1434–1438

    Article  Google Scholar 

  37. Biggs MA, Arons A, Turner R, Brindis CD (2013) Same-day LARC insertion attitudes and practices. Contraception 88:629–635

    Article  Google Scholar 

Download references

Acknowledgements

We thank Mrs. Yasmin Negm (Teacher at Om El Momineen Primary School, Helwan, Egypt) for her invaluable efforts in recording and organizing study data and computer work.

Funding

None.

Author information

Affiliations

  1. Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt

    Ahmed Samy, Dina Latif, Mohamed Hamza, Omneya M. Osman & Ahmed A. Metwally

  2. Department of Histology, Faculty of Medicine, Kasr-Alainy, Cairo University, Cairo, Egypt

    Ahmed Mohamed Abdelhakim

Authors
  1. Ahmed Samy
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ahmed Mohamed Abdelhakim
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Dina Latif
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Mohamed Hamza
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Omneya M. Osman
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Ahmed A. Metwally
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

AS, AMA, DL, and MH collected and analyzed the data; all authors revised and drafted the article. All authors approved the definitive version of the article to be published. AS: Project development, data collection, data analysis, and manuscript writing. AMA: Manuscript writing, data collection. DL: data collection and analysis, MH: Manuscript writing, data collection. OMO: Manuscript writing, data collection. AAM: Manuscript writing.

Corresponding author

Correspondence to Ahmed Mohamed Abdelhakim.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical standards

Institutional review boards approved the study and informed consent forms had been obtained from all participants included in the study. All procedures performed in this study were in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Samy, A., Abdelhakim, A.M., Latif, D. et al. Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial. Arch Gynecol Obstet 301, 1463–1471 (2020). https://doi.org/10.1007/s00404-020-05543-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00404-020-05543-0

Keywords

  • Dinoprostone
  • Pain
  • Mirena
  • Satisfaction