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OpenTrials
Completed

NCT Number: NCT03064568

Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss when compared to vasopressin alone, which is our current practice at this time. The study will be double-blinded with neither the patient nor the researcher knowing whether the placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and hematocrit, need for transfusion, and operative time among other measures of perioperative morbidity to see if the addition of misoprostol makes a significant difference. We will also observe patients to see if there are any side effects of misoprostol that make its use undesirable.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

St. Lukes Baptist Hospital, San Antonio, Texas, United States

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About this study

All women with planned myomectomy receive Depo Leupron prior to surgery per standard care and undergo routine pre-operative laboratory testing including hemoglobin and hematocrit. If enrolled in the study, patients will be consented at their pre-op appointment for the study and be asked to complete a visual analog scale to assess pre-operative pain. Patients will be randomized to receive misoprostol 800mcg per rectum or an identical inert tablet(s) per rectum 30 minutes preoperatively. Randomization will be performed by a third party so that neither the surgeon nor patient will know which intervention was performed, and interventions will be placed in sealed, sequentially numbered, opaque envelopes. Researcher team will have all needed data corresponding with randomized code which will be broken at conclusion of study and will be able to match code with patient's initials and medical record number after study completion to analyze data. Myomectomy will then be performed per standard care with the use of local vasopressin to aid in decreasing blood loss per our normal standard of care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic myomatous uterus

Exclusion criteria

  • Patient with contraindication to misoprostol or vasopressin, personal history or cardiac or pulmonary disease, history of prior myomectomy

Treatment and study plan

Misoprostol 200Mcg Tab

Drug

4 tablets will be inserted rectally

Other names: Cytotec

Placebo

Drug

Other names: Placebo tablet

Primary outcomes

  1. Surgical Blood Loss

    Time frame: Intraoperative

    Estimated blood loss during surgery

Secondary outcomes

  1. Febrile Morbiditiy

    Time frame: 24 hours postop

    Number of participants that have evidence of fever or infection postoperatively

  2. Need for Blood Transfusion

    Time frame: intraoperative to 24 hours postoperative

    Number of participants that had a requirement of blood transfusion

  3. Pain Score

    Time frame: 24 hours postop

    Assessment of patient subjective pain with the visual analog scale prior to discharge from hospital. The scale used is a a likert pain scale where the participant selects their pain level between 0- 10, where 10 is the highest level of pain experienced.

  4. Number of Participants With Medication Side-effects

    Time frame: 24 hours postop

    Surveillance for any adverse side effects from misoprostol

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2017
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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