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A study comparing Carbetocin and oxytocin for prevention of post partum hemorrhage following vaginal delivery

Carbetocin versus oxytocin in the prevention of atonic postpartum hemorrhage following normal vaginal delivery - An interventional study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065975
Enrollment
60
Registered
2024-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery Health Condition 2: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Carbetocin: Injection Carbetocin 100 mcg in 9 ml of Normal Saline slow I.V Control Intervention1: Oxytocin: Injection Oxytocin 10 IU in Ringer lactate I.V Infusion

Sponsors

Dr.Saranya,Postgraduate in Obstetrics and gynaecology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women in age group 18-35 years 1. Singleton pregnancy 2. Term (37-42 weeks of gestation) 3. Women who undergo vaginal delivery 4. Patients willing to give informed consent

Exclusion criteria

Exclusion criteria: High risk pregnant women including: antepartum hemorrhage- placenta previa, abruptio placentae, preeclampsia, eclampsia, GDM A2, multiple pregnancies, post cesarean pregnancy, polyhydramnios, macrosomia, patients with gynecological disorders such as myomas ? Medical disorders: coagulation disorders, thrombocytopenia (platelets disorders, hepatic disorders, heart disease, asthma, epilepsy, women with HIV ? Intellectual challenged women ? Known allergy to carbetocin ? Patients not willing to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Uterine tone and vaginal bleeding immediately and at 1, 2, 3 hours post delivery in both the groups 1.Estimated blood loss (ml) and PPH (blood loss 500 ml) in both study groups 2. Need for use of additional uterotonic drugs and/or blood transfusion in both the groupsTimepoint: 1-3 Days after Randomization

Secondary

MeasureTime frame
Change in value of hemoglobin, Hematocrit and Packed cell volume (PCV)Pre and 24 -hour post-delivery in both the groups ? Drug related adverse effects such as nausea, vomiting, shivering, headache, anaphylaxis in both the groupsTimepoint: 1-3 Days after Randomization

Countries

India

Contacts

Public ContactDr Sharmila V

AIIMS Mangalagiri

Kondamudisaru72@gmail.com9493550788

Outcome results

None listed

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