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Prophylaxis of postpartum hemorrhage in high-risk patients: a comparison between Carbetocin and Oxytocin. The PHARCO Study

Study on the prevention of postpartum hemorrhage: Carbetocin vs Oxytocin in high-risk patients - PHARCO Postpartum Hemorrhage in High-Risk Patients: Carbetocin Oxytocin

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-452bhzf
Enrollment
Unknown
Registered
2025-10-01
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

high-risk pregnancy, preeclampsia

Interventions

This is an open, randomized, controlled, two-arm clinical trial among women using magnesium sulfate who undergo vaginal delivery or cesarean section. Participants will be randomized through a draw us

Sponsors

Hospital da Mulher Professor Doutor José Aristodemo Pinotti da Universidade Estadual de Campinas
Lead Sponsor
Universidade Estadual de Campinas
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women; aged 18 years or older; receiving magnesium sulfate at the standard dose (intravenously with a loading dose of 4 g, followed by a maintenance dose of 1 to 2 g/hour); with an indication for delivery by vaginal birth or cesarean section

Exclusion criteria

Exclusion criteria: Women ;under 18 years of age; who decline to participate in the study; with a concurrent diagnosis of sepsis or intra-amniotic infection/chorioamnionitis; whose magnesium sulfate maintenance dose is not between 1–2 grams per hour; who received uterotonic medication more than 5 minutes after delivery

Design outcomes

Primary

MeasureTime frame
Women receiving Carbetocin will present with a lower volume of blood loss compared to those receiving Oxytocin and the incidence of postpartum hemorrhage will be lower among women using Carbetocin compared to those using Oxytocin

Secondary

MeasureTime frame
The frequency of severe maternal outcomes will be lower among women receiving Carbetocin compared to those receiving Oxytocin

Countries

Brazil

Contacts

Public ContactAdriana Luz

Hospital da Mulher Professor Doutor José Aristodemo Pinotti da Universidade Estadual de Campinas

adriluz@unicamp.br+55(19)35219477

Outcome results

None listed

Source: REBEC (via WHO ICTRP)