Clinical trial · Interventional
the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
NCT03483142CI-TRIAL-00032993unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
assess the effect of using misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications. Research question Does pre-operative misoprostol affect on intra-operative blood loss during and after myomectomy operation ?. Research hypothesis Pre-operative misoprostol may reduce intra-operative blood loss during and after myomectomy operation .
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Loss | — | UNRESOLVED | — |
| Myoma;Uterus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Misoprostol | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- misoprostol group
- description
- misoprostol group ( study group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
- interventionNames
- Drug: Misoprostol
- type
- PLACEBO_COMPARATOR
- label
- placebo group
- description
- ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.
- interventionNames
- Drug: Placebos
Primary outcomes (1)
- measure
- blood loss
- timeFrame
- time of operation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal patients aged between 35 to 50 years old. * Five or less symptomatic uterine myomas . * Maximum diameter of the largest myoma is 6 cm . * All myomas are subserous or intramural. * Uterine size less than 24 weeks pregnancy Exclusion Criteria: * History of previous surgery. * Allergy to Misoprostol. * Hypertension. * Cardiac and Pulmonary diseases. * Patients who have bleeding disorders. * Anemia (Hb \< 10g %). * Chronic endocrine or metabolic diseases such as Diabetes. * Obesity (body mass index \> 30 kg/m2). * Cases that will require intraoperative conversion of myomectomy to hysterectomy.
References
Publications (0)
Data not yet available
No reference posted for this study.