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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

  • General Gynecology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

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.

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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

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Authors and 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

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  1. Ahmed Samy
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  2. Ahmed Mohamed Abdelhakim
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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.

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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.

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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

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