Carbetocin vs Oxytocin for prevention of blood loss after normal vaginal delivery

Heat-Stable Carbetocin versus Oxytocin for prevention of postpartum Haemorrhage: A randomised controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053901

Enrollment

220

Registered

2023-06-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: O151- Eclampsia complicating labor Health Condition 2: O80- Encounter for full-term uncomplicated delivery Health Condition 3: O134- Gestational [pregnancy-induced] hypertension without significant proteinuria, complicating childbirth Health Condition 4: O335- Maternal care for disproportion due to unusually large fetus Health Condition 5: O140- Mild to moderate pre-eclampsia Health Condition 6: O403- Polyhydramnios, third trimester Health Condition 7: O630- Prolonged first s

Interventions

Intervention1: Carbetocin: Inj.Carbetocin 100mcg IM after delivery of shoulder and before delivery of the placenta Control Intervention1: Oxytocin: Inj. Oxytocin 10 IU IM after delivery of shoulders a

Eligibility

Inclusion criteria

Inclusion criteria: 1. They are beyond 32 weeks of gestational age 2. They have singleton pregnancy. 3. They present with cephalic presentation. 4. They have at least one risk factor for PPH of the following -Uterine over-distention (Polyhydramnios, suspected macrosomia) -Maternal disorders (Hypertensive disorders, Anaemia) -Prolonged Labour (more than 12 hours of labour in combined 1st and 2nd stage of labour) -Grand multipara -Primipara -Induction of labour

Exclusion criteria

Exclusion criteria: 1. Operative vaginal deliveries 2.Causes of traumatic PPH (Extensive vaginal lacerations,cervical tears) 3. patients with serious medical disorders like cardiovascular disorders, hepatic disorders, renal disorders, epilepsy, and coagulation disorders. 4. Known allergies to carbetocin or oxytocin

Design outcomes

Primary

Measure	Time frame
proportion of cases with blood loss more than 500 ml in first 24 hours postpartum after primary intervention.(Carbetocin or Oxytocin)Timepoint: 24 hours	—

Secondary

Measure	Time frame
Proportion of cases needing additional uterotonicsafter primary intervention in first 24 hours postpartum.Timepoint: 24 hours	—

Countries

India

Contacts

Public ContactDr Purval Vaidya

Maharaja Agrasen Medical College, Agroha,Hisar

director@mamc.edu.in7988405018

Outcome results

None listed

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