NCT05758012

Brief Summary

As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

November 4, 2022

Last Update Submit

March 4, 2023

Conditions

Cesarean Delivery

Outcome Measures

Primary Outcomes (2)

  • Myocardial effects

    Electrocardiograph (QT interval)

    immediately before drug administration

  • Myocardial effects

    Electrocardiograph (QT interval)

    24 hours after drug administration

Secondary Outcomes (3)

  • Cardiac enzyme

    immediately before drug administration

  • Cardiac enzyme

    24 hours after drug administration

  • Uterine contraction

    One hour post delivery

Study Arms (2)

oxytocin group

Oxytocin 5 IU will be administered by a trained anaesthetist as a one-minute IV injection.

Drug: oxytocin

Carbetocin group

Carbetocin 100 μg will be administered by a trained anaesthetist as a one-minute IV injection.

Drug: Carbetocin

Interventions

oxytocinDRUG

Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders

Also known as: Syntocinon
oxytocin group
CarbetocinDRUG

Participants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders

Also known as: Pabal
Carbetocin group

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Women will be recruited from the pregnant women attending antenatal clinics in Sabah Maternity Hospital and planned for Delivery either vaginal or Cesarean section .

You may qualify if:

  • Normal singleton pregnancy at gestational age of 36 weeks or more.
  • Women with common comorbid diagnoses (diabetes, hypothyroidism, hypertension)
  • pregnancy after in vitro fertilization

You may not qualify if:

  • placenta praevia or invasive placenta.
  • pre-eclampsia.
  • Bleeding disorder, such as von Willebrand disease type I.
  • Current treatment with low-molecular-weight heparin or other anticoagulation medication (not including aspirin).
  • Any known intolerance to either of the study drugs.
  • Prolonged QT-time.
  • Other serious cardiac disease.
  • Liver or kidney failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munistery of Health Kuwait

Kuwait City, Kuwait

Location

Related Publications (1)

  • Masuzawa Y, Kataoka Y, Fujii K, Inoue S. Prophylactic management of postpartum haemorrhage in the third stage of labour: an overview of systematic reviews. Syst Rev. 2018 Oct 11;7(1):156. doi: 10.1186/s13643-018-0817-3.

    PMID: 30305154BACKGROUND

MeSH Terms

Interventions

Oxytocincarbetocin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Fatemah Qasem

    Ministry of Health, Kuwait

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatemah Qasem

CONTACT

+98599511550fatemahq82@gmail.com

Mohamed Farghaly

CONTACT

+96551199166mohamedfarghali@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and ICU

Study Record Dates

First Submitted

November 4, 2022

First Posted

March 7, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

KU(1)