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EMG for Uterotonic Efficiency Estimation

NCT04201665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-06-27

No results posted yet for this study

Summary

Studies found conflicting results on efficacy of uterotonic agents used to prevent and treat uterine atony, the most common cause of postpartum hemorrhage. Uterine EMG can be used to objectively assess myometrial contractility and, consequently, efficacy of different uterotonics.

The investigators are planning a single-center, randomized, open-label trial to compare uterine EMG parameters in women receiving oxytocin vs. those receiving carbetocin after cesarean delivery.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Carbetocin

Patients will receive a single dose of carbetocin 100 mcg (Pabal ®) at admission to high dependency obstetric unit after cesarean section.

DRUG

Oxytocin

Patients will receive 5 units of oxytocin ( Syntocinon ®) as a 250 ml 0.9% NaCl infusion at admission to high dependency obstetric unit after cesarean section.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Miha Lucovnik, MD,PhD · UMCL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-13
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04201665 on ClinicalTrials.gov