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NCT06325501
Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy
Phase 3 trial testing Misoprostol 200mcg Tab in Myoma;Uterus in 56 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Cairo University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 56 |
| Start date | 1 March 2024 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Misoprostol 200mcg Tab — full drug profile →
- Oxytocin (OXYTOCIN) — full drug profile →
Conditions studied
- Myoma;Uterus — all drugs for Myoma;Uterus →
Sponsor
Cairo University
Who can join
Adults 20 to 48, female only, with Myoma;Uterus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion. Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps. Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia. Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06325501
- Europe PMC full search
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Related trials
Other trials of Misoprostol 200mcg Tab
Trials testing the same drug.
- NCT07271056 — Sublingual Misoprostol Versus No Cervical Priming Before Hysteroscopic Resection of Symptomatic Uterine Niches · NA · completed
- NCT06249815 — Sequential Use of Foley's Catheter and Misoprostol Versus Misoprostol Alone for Induction of Labour: a Multicentre Rando · Phase 4 · completed
- NCT06970483 — Comparison of the Efficacy of Misoprostol and Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery · completed
- NCT06056141 — Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter · Phase 4 · completed
- NCT06324279 — Cervical Sliding Sign to Predict Outcome of Induction of Labor · unknown
Other recruiting trials for Myoma;Uterus
Currently open trials in the same condition.
- NCT07526311 — Reducing Blood Loss During Myomectomy:Uterine Artery Ligation Vs Pericervical Tourniquet · NA · recruiting
- NCT07390864 — Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy · NA · recruiting
- NCT06882824 — Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol. · NA · recruiting
- NCT04990076 — Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology · recruiting
- NCT03880435 — HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outc · NA · active not recruiting
Other Cairo University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06325501 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cairo University
- Last refreshed: 22 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06325501.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing