Clinical trial · Interventional
Impact of Misoprostol on Blood Loss In Myomectomy Operations
Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations
NCT02061657CI-TRIAL-00015365completedPhase 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)
The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Misoprostol | Drug | — | UNRESOLVED |
| Placebo( for misoprostol) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Myomectomy, rectal Misoprostol
- description
- 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.
- interventionNames
- Drug: Misoprostol
- type
- ACTIVE_COMPARATOR
- label
- Myomectomy, Placebo
- description
- Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
- interventionNames
- Drug: Placebo( for misoprostol)
Primary outcomes (1)
- measure
- intraoperative blood loss
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 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 (1)
- DERIVEDAbdel-Hafeez M, Elnaggar A, Ali M, Ismail AM, Yacoub M. Rectal misoprostol for myomectomy: A randomised placebo-controlled study. Aust N Z J Obstet Gynaecol. 2015 Aug;55(4):363-8. doi: 10.1111/ajo.12359. Epub 2015 Jul 14. PMID 26174128