Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH

Postpartum Hemorrhage Clinical Trial

Official title:

Tranexamic Acid and Ethamsylate For Preventing Post Partum Hemorrhage in Patient Undergoing LSCS at High Risk For Post PartumHemorrhage : A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02604719
• Other study ID #: TXA&Ethamsylate-PPH
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: November 12, 2015
• Last updated: November 27, 2015
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2015
• Source: Ain Shams University
• Contact: ahmed Dr alanwar, MD
• Phone: +201111486669
• Email: eladwar[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage

Description:

Research Question:

Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Women undergoing elective caesarean section

2. Patient having one or more risk factor for PPH

• Multiple pregnancy

• Polyhydramnios (AFI >25cm)

• Macrocosmic baby (>4.5 Kg)

• Prolonged , augmented and obstructed labour

• Obese patients(BMI >30)

• Premature rapture of membranes

• Previous history of PPH

3. Age =18 years

4. Gestational Age = 35 Weeks

5. Informed Oral Consent From The Patient

Exclusion Criteria:

1. History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke)

2. History of epilepsy or seizure

3. Any Known Cardiovascular , renal or liver Disease

4. Autoimmune Diseases

5. Sickle Cell Disease

6. Severe hemorrhagic Disease

7. Placenta Previa.

8. Morbidly adherent Placenta

9. Abruptio placenta

10. Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome

11. Administration Of low molecular weight heparin or Anti platelets the week before delivery .

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Tranexamic Acid and Ethamsylate
The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Alanwar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPH defined as blood loss =500 cc	measured by pads placed under women buttocks	the first 24hours	Yes
Secondary	severe PPH (>1000 cc), .		first 24 hours	Yes