Current partner codePEPTIDESDE
NCT03064568·Phase 4·INTERVENTIONAL

Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Status

Completed

Phase

Phase 4

Enrollment

18

Locations

3

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

Misoprostol 200Mcg Tab

4 tablets will be inserted rectally

DRUG

Placebo

Timeline

From registration to results.

  1. First posted

    Feb 27, 2017

  2. Study start

    Oct 14, 2016

  3. Primary completion

    Jun 18, 2024

  4. Study completion

    Jun 18, 2024

  5. Results posted

    Jul 29, 2025

  6. Registry updated

    Jul 29, 2025

Outcomes

What the study measures.

Primary outcomes

Surgical Blood Loss

Time frame · Intraoperative

Estimated blood loss during surgery

Secondary outcomes

Febrile Morbiditiy

Time frame · 24 hours postop

Number of participants that have evidence of fever or infection postoperatively

Need for Blood Transfusion

Time frame · intraoperative to 24 hours postoperative

Number of participants that had a requirement of blood transfusion

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.

Number of Participants With Medication Side-effects

Time frame · 24 hours postop

Surveillance for any adverse side effects from misoprostol

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
50 Years
Sex
FEMALE
Healthy volunteers
Yes

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

Study locations

3 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

St. Lukes Baptist Hospital

San Antonio, Texas, United States

University Hospital

San Antonio, Texas, United States

University of Texas Health Science Center

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Vasopressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.