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Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy

ConditionsFibroids, UterineFluid DeficitHysteroscopy / Methods
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients presenting for hysteroscopic myomectomy for uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months

Age ≥ 18 years and ≤ 50 years.

Fibroids between 1-3cm in size

Myomectomy using myosure or resectoscope devices

Disqualifiers

Pregnancy. All patients will be required to have a negative urine pregnancy test prior to surgery.

Post-menopausal women.

Patients with a history of gynecologic malignancy.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Misoprostol Tabets

    Drug

    800 mcg of misoprostol will be administered per rectum to intervention group prior to their scheduled hysteroscopic myomectomy.

  • Placebo

    Drug

    4 tablets of Zeebo (Microcsrystalline cellulose) placebo tablets will be placed per rectum to prior to undergoing a hysteroscopic myomectomy, for patients assigned to the placebo arm.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Misoprostol (treatment aem)Experimental treatment 1 intervention
Group B: Zeebo (Placebo arm)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fluid Deficit

Primary outcome is difference in fluid deficit at the conclusion of the hysteroscopic myomectomy

Time frame
Immediately at the conclusion of the procedure.

Secondary outcomes

1

Total fluid volume

Difference in total fluid volume used (in milliliters) between groups.

Time frame
intraoperative
2

Time

Difference in total procedure time (in minutes) between groups.

Time frame
Intraop
3

Reoperation

Frequency of repeat hysteroscopic myomectomy due to incomplete fibroid resection caused by early termination of the initial procedure

Time frame
within 3 month post op
4

Specimen weight

Total specimen weight

Time frame
Immediately post op

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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