Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy

Summary

The goal of this double blinded randomized control trial is to evaluate the impact of misoprostol on fluid deficit during hysteroscopic myomectomies. The main questions it aims to answer are: Is there is difference in fluid deficit in patients who receive misoprostol vs placebo pre operatively for hysteroscopic myomectomies? Participants will be randomized to received 800 mcg of either rectal misoprostol prior to their hysteroscopic myomectomy or 4 tablets of placebo (ZEEBO) prior to their hysteroscopic myomectomy.

Timeline

Start

2025-12-16

Primary completion

2026-12

Completion

2026-12

Publications

• Background Inacio QAS, Troncon JK, Valerio FP, Herren H, Nogueira AA, Neto OBP, Silva JCRE. Misoprostol Administration Before Hysteroscopy Procedures - A Retrospective Analysis. Rev Bras Ginecol Obstet. 2022 Dec;44(12):1102-1109. doi: 10.1055/s-0042-1755462. Epub 2022 Aug 29.
• Background Guven CM, Avul Z. Evaluation of the effect of preoperative rectal misoprostol use on the postoperative outcomes of hysteroscopic myomectomy. J Obstet Gynaecol Res. 2023 Aug;49(8):2086-2092. doi: 10.1111/jog.15681. Epub 2023 May 19.
• Background Desilets J, Zakhari A, Chagnon M, Ekmekjian T, Nguyen DB, Smith JP, Mansour FW, Krishnamurthy S. Pharmacologic Interventions to Minimize Fluid Absorption at the Time of Hysteroscopy: A Systematic Review and Meta-analysis. Obstet Gynecol. 2023 Feb 1;141(2):285-298. doi: 10.1097/AOG.0000000000005051. Epub 2023 Jan 4.
• Background Welch K, Ek R, Stromme M. Comparative drug release measurements in limited amounts of liquid: a suppository formulation study. Curr Drug Deliv. 2006 Jul;3(3):299-306. doi: 10.2174/156720106777731109.
• Background Bianchi M, Capurso L. Effects of guar gum, ispaghula and microcrystalline cellulose on abdominal symptoms, gastric emptying, orocaecal transit time and gas production in healthy volunteers. Dig Liver Dis. 2002 Sep;34 Suppl 2:S129-33. doi: 10.1016/s1590-8658(02)80180-3.
• Background Vilos GA, Vilos AG, Abu-Rafea B, Ternamian A, Laberge P, Munro MG. Good practice with fluid management in operative hysteroscopy. Int J Gynaecol Obstet. 2025 Jan;168(1):118-125. doi: 10.1002/ijgo.15860. Epub 2024 Aug 22.

Drugs

Indications