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Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

StatusUnknown
PhasePhase 3
Started
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Record status
This record was last updated September 5, 2024 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Start date: Jun 1, 2024 to Oct 1, 2024
    • Study site revised
    • Collaborators shortened, about 3 words
    v4
  3. Enrollment target: 100 to 150v3 Show 7 more changesShow less
    • Primary completion date: Mar 1, 2024 to Dec 1, 2025
    • Start date: Sep 1, 2023 to Jun 1, 2024
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Apr 1, 2024 to Jan 1, 2026
    • Study site revised
    • Study description shortened, about 4 words
    • Collaborators expanded, about 3 words
  4. Eligibility criteria revisedv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cairo University
1,562 trials monitored
See 18 trials at risk
Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent research has shown Egypt to be the third-largest country globally, with an estimated 52% cesarean sections (3). However, the cesarean section has many serious complications, including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter of blood following a vaginal birth and losing over one thousand milliliter after the cesarean section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in poor countries, and the estimated mortality number due to postpartum bleeding is one hundred thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to diminish maternal mortality and morbidity (7). The most successful technique for decreasing PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).
Trial Details
NCT Number NCT06010368
Lead Sponsor Cairo University
Conditions
(from sponsor)		 Cesarean Section Complications, Tranexamic Acid, Oxytocin, Post Partum Hemorrhage
Related terms Postpartum Hemorrhage
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov