Carbetocin Versus Ergometrin in the Prevention of Postpartum Hemorrhage

NCT04300452 | Unknown Phase 4 DMC

• 1 other identifier: carbetocin-ergometrin
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study will be compared Carbetocin with ergometrin in the prevention of postpartum haemorrhage (PPH) in parturients that are undergoing caesarean section and are not presenting risk factors for PPH. As indicators will be used intraoperative blood loss, as well as the value of hemoglobin and hematocrit 24 hours after the caesarian section.

Conditions

Postpartum Hemorrhage

Keywords

carbetocin; ergometrin

Outcome Measures

Primary Outcomes (2)

• The efficacy of the uterotonic drugs wil be assessed with a new hemoglobin in gr/dl 24 hours after completion of caesarian section

  The efficacy of the uterotonic drugs will be assessed with a new hemoglobin in g/dl 24 hours after the end of the cesarean section, as well as by intraoperative blood loss in ml which will be calculated by weighing gauzes and compresses after the end of the operation, by the amount of blood in ml present in the suction unit and by the blood present in the surroundings of the operating table.

  2 years

• The efficacy of the uterotonic drugs will be assessed with a new hematocrit count measured in % percentage 24 hours after completion of caesarian section.

  The efficace of the uterotonic drugs will be assessed with a new hematocrit count measured in % percentage 24 hours after completion of caesarian section.

  2 years

Study Arms (2)

Carbetocin group

ACTIVE COMPARATOR

In the carbetocin group will be administered 100 mcg of carbetocin diluted in 100 cc of N/S 0.9% in a continuous rapid-flow intravenous infusion.

Drug: Carbetocin

Ergometrin group

ACTIVE COMPARATOR

In the ergometrine maleate group will be administered intravenously 0.2 mg of the substance slowly in a bolus administration.

Drug: Ergometrine Maleate

Interventions

Carbetocin DRUG

Administration of Carbetocin after placental detachment

Also known as: Pabal

Carbetocin group

Ergometrine Maleate DRUG

Administration of ergometrin after placental detachment

Also known as: Mitrotan

Ergometrin group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female of reproductive age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female gender Gestating Between 18-40 years No co-morbidity

You may not qualify if:

• Under age parturients
• Parturients \>40 years of age
• Multiple pregnancies
• Parturients with abnormal placental adhesion
• Parturients with two or more caesarian sections in the past
• Parturients with haematological diseases
• Parturients that receive anticoagulation therapy for a concomitant disease
• Parturients with severe co-morbidity
• Refusal to sign the consent form
• Caesarian section under general anaesthesia

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Hospital "Elena Venizelou"

Athens, Attica, 11525, Greece

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin; Ergonovine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nikoleta Iakovidou

  Professor of Pediatrics NKUAthens

  STUDY DIRECTOR

Central Study Contacts

Christos KOLIAFAS

CONTACT

6972787798; ckoliafas@yahoo.gr

Ilektra Iordanidou

CONTACT

2132051214

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants will be unaware of the treatment they will receive as well as the care provider responsible for its administration
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant anaesthesiologist at "Elena Venizelou Hospital"

Model Details: The parturients will be divided in two groups: the group to which carbetocin will be administered and the group to which ergometrin will be used as the main uterotonic drug. Randomization will be achieved with the help of a computer and the method ¨sealed envelope¨. In this method the investigator receives a sealed envelope either by mail or by computer, in which a random number will be placed. This number will correspond to one of the treatments. For greater relialibility in the results some exclusion criteria will be set.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: March 9, 2020
• Study Start: April 5, 2018
• Primary Completion: June 10, 2020
• Study Completion: September 30, 2020
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)