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

Ahmed Alanwar

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Postpartum Hemorrhage

Treatments: Drug: Tranexamic Acid and Ethamsylate

Study type: Interventional

Funder types: Other

Identifiers

NCT02604719

TXA&Ethamsylate-PPH

Details and patient eligibility

About

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

Full 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 ?

Enrollment: 64 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

tanexamic acid and Ethamsylate

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid and Ethamsylate

placebo

Placebo Comparator group

Description:

10 ml normal saline will be administered intravenously just after birth

Treatment:

Drug: Tranexamic Acid and Ethamsylate