Laminaria Japonicum Followed by Misoprostol Versus Misoprostol Alone for Mid-Trimester Abortion Induction in Scarred Uterus

Summary

The goal of this clinical trial is to compare the induction-to-abortion time interval between women receiving Laminaria tent followed by misoprostol and those receiving misoprostol alone for mid-trimester abortion induction in women with a scarred uterus. The main question it aims to answer is: • Is the usage of laminaria japonicum as a mechanical dilator for the cervix followed by Prostaglandin E1 more effective and time saving than using prostaglandin E1 alone in induction of mid-trimester abortion in a previously scarred uterus? Researchers will compare induction-to-abortion time interval between women receiving Laminaria tent followed by misoprostol and those receiving misoprostol alone for mid-trimester abortion induction in women with a scarred uterus. Participants in Group A: induction of abortion will be started with insertion of Laminaria japonicum for 12 hours to be followed by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation. Participants in Group B: induction of abortion will be carried out by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.

Timeline

Start

2023-01-10

Primary completion

2025-01-10

Completion

2025-01-25

Publications

• Background Sagiv R, Mizrachi Y, Glickman H, Kerner R, Keidar R, Bar J, Golan A. Laminaria vs. vaginal misoprostol for cervical preparation before second-trimester surgical abortion: a randomized clinical trial. Contraception. 2015 May;91(5):406-11. doi: 10.1016/j.contraception.2015.01.018. Epub 2015 Jan 31.
• Background El Maradny E, Kanayama N, Halim A, Maehara K, Kobayashi T, Terao T. Biochemical changes in the cervical mucus after application of laminaria tent. Acta Obstet Gynecol Scand. 1996 Mar;75(3):203-7. doi: 10.3109/00016349609047087.
• Background Lerma K, Blumenthal PD. Current and potential methods for second trimester abortion. Best Pract Res Clin Obstet Gynaecol. 2020 Feb;63:24-36. doi: 10.1016/j.bpobgyn.2019.05.006. Epub 2019 May 25.
• Background Joob B and Wiwanitkti V (2016): Laminaria species and usefulness in obstetrics and gynaecology. Journal of Coastal Life Medicine, 2016; 4(3):244-5.
• Background Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11.
• Background Clouqueur E, Coulon C, Vaast P, Chauvet A, Deruelle P, Subtil D, Houfflin-Debarge V. [Use of misoprostol for induction of labor in case of fetal death or termination of pregnancy during second or third trimester of pregnancy: Efficiency, dosage, route of administration, side effects, use in case of uterine scar]. J Gynecol Obstet Biol Reprod (Paris). 2014 Feb;43(2):146-61. doi: 10.1016/j.jgyn.2013.11.008. Epub 2014 Jan 22. French.
• Background Chodankar R, Gupta J, Gdovinova D, Bovo MJ, Hanacek J, Kan N, Roizin J, Tyutyunnik V. Synthetic osmotic dilators for cervical preparation prior to abortion-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:249-254. doi: 10.1016/j.ejogrb.2018.07.013. Epub 2018 Jul 11.
• Background Cetin C, Buyukkurt S, Seydaoglu G, Kahveci B, Soysal C, Ozgunen FT. Comparison of two misoprostol regimens for mid-trimester pregnancy terminations after FIGO's misoprostol dosage recommendation in 2012. J Matern Fetal Neonatal Med. 2016;29(8):1314-7. doi: 10.3109/14767058.2015.1046831. Epub 2015 Jun 11.
• Background Bertholdt C, David MG, Gabriel P, Morel O, Perdriolle-Galet E. Effect of the addition of osmotic dilators to medical induction of labor abortion: A before-and-after study. Eur J Obstet Gynecol Reprod Biol. 2020 Jan;244:185-189. doi: 10.1016/j.ejogrb.2019.10.013. Epub 2019 Oct 21.
• Background Barinov SV, Tirskaya YI, Shamina IV, Medyannikova IV, Kadcyna TV, Shkabarnya LL, Lazareva OV. The use of an osmotic dilator for induction of miscarriage in patients with the second trimester missed miscarriage. J Matern Fetal Neonatal Med. 2021 Sep;34(17):2778-2782. doi: 10.1080/14767058.2019.1671331. Epub 2019 Oct 1.
• Background Achenbach AE, Singh S, Jackson B, Caveglia SJ, Berghella V, Seligman NS. Cervical ripening with laminaria tents prior to second trimester induction of labor. J Matern Fetal Neonatal Med. 2022 Dec;35(25):5807-5812. doi: 10.1080/14767058.2021.1893297. Epub 2021 May 24.
• Background Abdallah M, Moheb A, Mousa AB, Saleh AM (2022): Comparison between Mechanical induced Cervical Dilatation in Previous Scar Woman in 2nd Trimester Abortion: Non-Randomized Controlled Study. Minia Journal of Medical Research, 2022; 33(1):44-9.

Drugs

Indications