Comparing two drugs efficacy and safety in prevention of PPH in a computer generated randomisation technique

Phase 3

Conditions: Health Condition 1: O721- Other immediate postpartum hemorrhage

Registration Number: CTRI/2024/01/061097

Lead Sponsor: DR SMRITI BAG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Women of age between 18-35 years of Gestational age of 37-42 weeks

Patients who have given written informed consent Women at risk of PPH including

Factors resulting in overdistention of the uterus

Multiple gestation (eg, twins)

Fetal macrosomia

Polyhydramnios

Nature of labor and delivery

Induced labor

Precipitous labor (lasting less than 3 hours)

Prolonged labor

Forceps or vacuum-assisted delivery

Cesarean delivery

Factors relating to the placenta

Abruptio placentae

Placenta previa

Abnormal implantation

High multiparity

Preeclampsia

Chorioamnionitis

Amniotic fluid embolism

May precipitate disseminated intravascular coagulation, resulting in consumptive coagulopathy and uncontrolled blood loss

Under general Anesthesia

Medications

Prolonged oxytocin use

Magnesium sulfate

Anticoagulants

Exclusion Criteria

Gestational age less than 37 or more than 42 weeks

History of thromboembolic disorders,

Cases suffering from chronic medical diseases (cardiac, hepatic, renal),

Not giving consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total amount of blood loss within 24 hours postpartum measured by V drapes <br/ ><br>Adverse maternal events like nausea vomiting tachycardia flushing dizziness headache shivering metallic taste dyspnea palpitations itching <br/ ><br>Hemodynamic status will be measured at 0 min 30 min 60min 120 minTimepoint: The total amount of blood loss within 24 hours postpartum measured by V drapes

Secondary Outcome Measures

Name	Time	Method
eed for second line uterotonics and interventions <br/ ><br>Need of blood and blood products <br/ ><br>Difference between hemoglobin before and after 24 hours of delivery <br/ ><br>Difference between hematocrit before and after 24 hours of deliveryTimepoint: 24 hours