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

Phase 1

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Tranexamic Acid and Ethamsylate

• Registration Number: NCT02604719
• Lead Sponsor: Ahmed Alanwar

Brief 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

Detailed 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 ?

Study Timeline

• Status Verified: 2015-11
• Study Start: 2015-11
• Study First Submitted: 2015-11-12
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-13
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30
• Primary Completion: 2016-05
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tanexamic acid and Ethamsylate	Tranexamic Acid and Ethamsylate	10 ml of the study drugs (1 gm Tranexamic acid and 1 gm Ethamsylate ) slowly (over 30-60 sec ) in the 2 minutes after birth
placebo	Tranexamic Acid and Ethamsylate	10 ml normal saline will be administered intravenously just after birth

Primary Outcome Measures

Name	Time	Method
PPH defined as blood loss ≥500 cc	the first 24hours	measured by pads placed under women buttocks

Secondary Outcome Measures

Name	Time	Method
severe PPH (>1000 cc), .	first 24 hours