Recruiting NA Post Partum Hemorrhage

Tests treatment safety and results for Post Partum Hemorrhage

Official title Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery

ClinicalTrials.gov ID: NCT06333340

What this study is testing

What is Oxytocin?

Oxytocin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for post partum hemorrhage.

Also referred to as Pitocin.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 50, women only. Healthy volunteers may be eligible.

You may be able to join if

  • Any one or more of the risk factors for uterine atony:
  • Overdistended uterus due to:
  • Polyhydramnios (amniotic fluid index \>24 cm)
  • Fetal macrosomia reported on prenatal ultrasound \>90th centile or \> 4000 gm
  • Multiple gestation

You likely can't join if

  • Valvular heart disease, arrhythmias, or heart failure
  • Placenta accreta spectrum
  • Bleeding disorder
  • Anemia (\<100 g/dl)
  • Allergy or sensitivity to oxytocin or carbetocin
See the full eligibility criteria
Who can join
  • Any one or more of the risk factors for uterine atony:
  • Overdistended uterus due to:
  • Polyhydramnios (amniotic fluid index \>24 cm)
  • Fetal macrosomia reported on prenatal ultrasound \>90th centile or \> 4000 gm
  • Multiple gestation
  • History of uterine atony/PPH (documented with blood loss of \>1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)
  • Obesity with body mass index (BMI) \>40 kg/m2
  • Diabetes mellitus on treatment
  • Preeclampsia on treatment
  • Placenta previa
What rules you out
  • Valvular heart disease, arrhythmias, or heart failure
  • Placenta accreta spectrum
  • Bleeding disorder
  • Anemia (\<100 g/dl)
  • Allergy or sensitivity to oxytocin or carbetocin

The study team makes the final eligibility decision.

Where it's taking place

  • Toronto, Ontario, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.