Clinical trial NCT04300452: Carbetocin Versus Ergometrin in the Prevention of Postpartum Hemorrhage
Official title: Carbetocin Versus Ergometrin in the Prevention of Postpartum Hemorrhage in Parturients Undergoing Caesarian Section Under Regional Anaesthesia. A Single Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Keywords: carbetocin
ergometrin
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: In the particular study the investigators will compare the effect of Carbetocin and ergometrin in the prevention of postpartum haemorrhage. It is a prospective comparative single blind randomized study which will be carried out in the G.N.M.A. "Elena Venizelou". The protocol will be filed in an international database before the initiation of the study (eg. ClinicalTrials.gov). The sample will be constituted by parturients that will undergo Caesarean section. 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 reliability in the results some exclusion criteria will be set.

A consent form will be given to the parturients that will have to sign after it is explained to them the purpose of the study and that there is a rescue treatment in case of failure of the medication is administered to them. Subsequently a complete medical background will be obtained and it will be performed the standard laboratory control which includes: a blood count, coagulation parameters, biochemical parameters and an assessment by a cardiologist.

Regional anaesthesia will then be performed (spinal, epidural or combined spinal-epidural). After the embryo exit and placental detachment in the ergometrine group will be administered intravenously 0.2 mg of the substance slowly in a bolus administration, while 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.

The efficacy of the uterotonic drugs will be assessed with a new hemoglobin and hematocrit count 24 hours after the end of the cesarean section, as well as by intraoperative blood loss which will be calculated by weighing gauzes and compresses after the end of the operation, by the amount of blood present in the suction unit and by the blood present in the surroundings of the operating table (9). It is obvious that if necessary rescue therapy will be administered which will consist of 15 iu of oxytocin in intravenous infusion in the ergometrin group and 0.2 mg of ergometrin in slow bolus administration in the carbetocin group, as well as 3 tb of misoprostol in both groups administered per rectum.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Exclusion Criteria

  * 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

Primary outcomes:
measure: The efficacy of the uterotonic drugs wil be assessed with a new hemoglobin in gr/dl 24 hours after completion of caesarian section
timeFrame: 2 years
measure: The efficacy of the uterotonic drugs will be assessed with a new hematocrit count measured in % percentage 24 hours after completion of caesarian section.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hospital "Elena Venizelou"
state: Attiki
Study officials:
affiliation: Professor of Pediatrics NKUAthens
name: Nikoleta Iakovidou
role: STUDY_DIRECTOR
References: