NCT04201665

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

September 13, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

1.4 years

First QC Date

December 12, 2019

Last Update Submit

June 24, 2022

Conditions

Postpartum Hemorrhage

Keywords

electohysterographypostpartum hemorrhageuterine electromyography

Outcome Measures

Primary Outcomes (1)

  • Power density spectrum peak frequency of uterine EMG bursts

    Change in Power density spectrum (PDS) peak frequency of uterine EMG bursts between EMG at admission and 2-3 hours after treatment

    within 3 hours from starting treatments

Secondary Outcomes (7)

  • Power density spectrum peak amplitude of uterine EMG bursts

    within 3 hours from starting treatments

  • Frequency and duration of uterine EMG bursts

    within 3 hours from starting treatments

  • Propagation velocity of uterine EMG signals

    within 3 hours from starting treatments

  • Power density spectrum integral of uterine EMG bursts

    within 3 hours from starting treatments

  • Change in hematocrit

    within 24 hours after delivery

  • +2 more secondary outcomes

Study Arms (2)

carbetocin

EXPERIMENTAL

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

Drug: Carbetocin

oxytocin

ACTIVE COMPARATOR

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.

Drug: Oxytocin

Interventions

CarbetocinDRUG

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

carbetocin
OxytocinDRUG

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.

oxytocin

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with singleton pregnancies at term ( ≥37 weeks of pregnancy) scheduled for elective cesarean section after one previous cesarean section.

You may not qualify if:

  • Contraindications for any of the study drugs.
  • Anaemia Hb \<100g
  • History of postpartum hemorrhage
  • Uterine fibroids
  • Blood clotting disorder
  • Placental disorder ( Placenta previa, placenta accreta)
  • Preeclampsia
  • Renal, cardiac or hepatic dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana

Ljubljana, Slovenia

Location

Related Publications (1)

  • Paljk Likar I, Becic E, Pezdirc N, Gersak K, Lucovnik M, Trojner Bregar A. Comparison of Oxytocin vs. Carbetocin Uterotonic Activity after Caesarean Delivery Assessed by Electrohysterography: A Randomised Trial. Sensors (Basel). 2022 Nov 21;22(22):8994. doi: 10.3390/s22228994.

    PMID: 36433591DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocinOxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Miha Lucovnik, MD,PhD

    UMCL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 17, 2019

Study Start

September 13, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)