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Carbetocin for Postpartum Hemorrhage

N/A

Recruiting

Led By Mrinalini Balki, MD

Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with gestational age 37-41 weeks

Non-laboring patients, not exposed to exogenous oxytocin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Awards & highlights

Study Summary

This trial aims to study different drugs that help the uterus contract after childbirth to prevent excessive bleeding. The researchers will test which drug works best to reduce the risk of bleeding after carbetocin has been

Who is the study for?

This trial is for individuals who have recently given birth and are experiencing postpartum hemorrhage, a condition where the uterus does not contract strongly enough to stop bleeding. The study focuses on those who do not respond adequately to initial treatment with carbetocin.Check my eligibility

What is being tested?

The study tests the effectiveness of additional uterotonic drugs (ergonovine, carboprost, oxytocin) after carbetocin has been used. It aims to determine which drug best reduces the risk of continued bleeding in an ex-vivo setting using uterine tissue samples.See study design

What are the potential side effects?

As this is an ex-vivo study involving uterine tissue samples rather than direct patient treatment, participants will not experience side effects from the drugs being tested within this specific trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am pregnant and between 37 to 41 weeks along.

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I have not been given oxytocin for labor induction.

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I am having a cesarean delivery under spinal anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Motility index

Secondary outcome measures

Amplitude of contraction

Frequency of contraction

Integrated area under response curve (AUC)

Trial Design

5Treatment groups

Active Control

Placebo Group

Group I: CarbetocinActive Control2 Interventions

Dose-response testing with increasing concentrations of carbetocin in a pattern of 1 log molar increase every 10 min, from 10-5 M to 10-5 M

Group II: OxytocinActive Control2 Interventions

Dose-response testing with increasing concentrations of oxytocin from 10-10 M to 10-5 M.

Group III: ErgometrineActive Control3 Interventions

Dose-response testing with increasing concentrations of ergometrine from 10-10 M to 10-5 M

Group IV: CarboprostActive Control3 Interventions

Dose-response testing with increasing concentrations of carboprost from 10-10 M to 10-5 M

Group V: ControlPlacebo Group2 Interventions

No drug added to physiological salt solution (PSS).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor

127 Previous Clinical Trials

11,205 Total Patients Enrolled

30 Trials studying Postpartum Hemorrhage

1,693 Patients Enrolled for Postpartum Hemorrhage

Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

29 Previous Clinical Trials

1,947 Total Patients Enrolled

22 Trials studying Postpartum Hemorrhage

1,223 Patients Enrolled for Postpartum Hemorrhage

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for individuals who can participate in this medical research study?

"Candidates eligible for enrollment in this trial must present with postpartum hemorrhage and be aged between 18 and 45 years. The study aims to recruit approximately 32 suitable participants."

Answered by AI

Is the enrollment for this study currently open?

"As per the details on clinicaltrials.gov, recruitment for this research endeavor is currently not underway. The trial was initially disclosed on 2/1/2024 and last revised on 2/22/2024. While this specific study is inactive in terms of participant enrollment, there are a noteworthy 355 alternative trials open to potential participants at present."

Answered by AI

Are participants aged 80 years and older being enrolled in this trial?

"Eligible participants for this study must be between the ages of 18 and 45. Notably, there are 43 ongoing clinical trials tailored for individuals under 18 years old and 293 trials targeting patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium

2024. "Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285409.

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