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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04463966
Other study ID # Tranexamic
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 30, 2020
Est. completion date May 2021

Study information

Verified date July 2020
Source Benha University
Contact Aboubakr Elnashar, MD
Phone 00201066934749
Email elnashar53@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial


Description:

This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage & reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. & reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women at high risk for postpartum hemorrhage after cesarean section

Exclusion Criteria:

- women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tranexamic acid injection
1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .

Locations

Country Name City State
Egypt Police Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary blood loss Estimation of blood loss immediately after deliver
Secondary blood pressure blood pressure immediately after delivery
Secondary pulse pulse immediately after delivery
Secondary temperature temperature immeditely after delivery
See also
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Completed NCT03707132 - Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
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Completed NCT01866241 - Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage Phase 3
Not yet recruiting NCT01236482 - Oxytocin in Cesarean Delivery Phase 4
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Completed NCT01863706 - Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage Phase 1
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Completed NCT04723979 - NovoSeven® in Severe Postpartum Haemorrhage - Experiences From UK, DK, FR, NL
Terminated NCT04277962 - Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial N/A
Completed NCT03570723 - Glove-loaded Foley's Catheter Tamponade for Cesarean Section for Placenta Previa N/A
Completed NCT03117647 - Mansoura-VV Uterine Compression Suture for Primary Atonic Postpartum Hemorrhage N/A
Active, not recruiting NCT03069859 - Use of TXA to Prevent Postpartum Hemorrhage Phase 2
Not yet recruiting NCT03891082 - A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section N/A
Not yet recruiting NCT03463070 - Misoprostol Before and After Cesarean Section Phase 3
Recruiting NCT05532215 - Sublingual Misoprostol in Reduction of Caesarean Blood Loss N/A
Not yet recruiting NCT06255496 - QStat Cartridge in Obstetric Patients