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

Efficacy and safety of carbetocin versus oxytocin in prevention of post partum hemorrhage in high risk women. An Open label randomised controlled trial - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061097

Enrollment

120

Registered

2024-01-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O721- Other immediate postpartum hemorrhage

Interventions

Control Intervention1: CARBETOCIN: SYNTHETIC OXYTOCIN ANALOGUE WITH A LONGER DURATION Control Intervention2: OXYTOCIN: Oxytocin injection is a synthetic hormone

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The total amount of blood loss within 24 hours postpartum measured by V drapes Adverse maternal events like nausea vomiting tachycardia flushing dizziness headache shivering metallic taste dyspnea palpitations itching 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

Measure	Time frame
Need for second line uterotonics and interventions Need of blood and blood products Difference between hemoglobin before and after 24 hours of delivery Difference between hematocrit before and after 24 hours of deliveryTimepoint: 24 hours	—

Countries

India

Contacts

Public ContactMONICA AGRAWAL

KING GEORGE MEDICAL COLLEGE

dr.monikagrawal@gmail.com9628667755

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026