Carbetocin Versus Ergometrin in the Prevention of Postpartum Hemorrhage
Açar sözlər
Mücərrəd
Təsvir
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.
Tarixlər
| Son Doğrulandı: | 02/29/2020 |
| İlk təqdim: | 04/29/2018 |
| Təxmini qeydiyyat təqdim edildi: | 03/05/2020 |
| İlk Göndərmə: | 03/08/2020 |
| Son Yeniləmə Göndərildi: | 03/05/2020 |
| Son Yeniləmə Göndərildi: | 03/08/2020 |
| Həqiqi Təhsilin Başlama Tarixi: | 04/04/2018 |
| Təxmini İlkin Tamamlanma Tarixi: | 06/09/2020 |
| Təxmini İşin Tamamlanma Tarixi: | 09/29/2020 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Drug: Carbetocin group
Drug: Ergometrin group
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Active Comparator: Carbetocin group 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 group Administration of Carbetocin after placental detachment |
| Active Comparator: Ergometrin group In the ergometrine maleate group will be administered intravenously 0.2 mg of the substance slowly in a bolus administration. | Drug: Ergometrin group Administration of ergometrin after placental detachment |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | Female |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | 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 |
Nəticə
İlkin nəticə tədbirləri
1. The efficacy of the uterotonic drugs wil be assessed with a new hemoglobin in gr/dl 24 hours after completion of caesarian section [2 years]
2. The efficacy of the uterotonic drugs will be assessed with a new hematocrit count measured in % percentage 24 hours after completion of caesarian section. [2 years]
