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Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Hemorrhage

Primary Purpose

Cesarean Section Complications

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Carbetocin
oxytocin
ergometrine
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications focused on measuring cesarean section, post-partum hemorrhage, multiple pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women with a multiple term pregnancy undergoing elective cesarean section

Exclusion Criteria:

  • single gestation
  • placenta praevia and placental abruption
  • undergoing cesarean section with general anesthesia
  • women undergoing cesarean section at less than 37 weeks of gestation
  • with a severe medical disorder

Sites / Locations

  • AswanUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

carbetocin arm

oxytocin and ergometrine arm

Arm Description

carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby

oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist plus intramuscular ergometrine 0.2 mg after the birth of the baby

Outcomes

Primary Outcome Measures

estimation of intraoperative blood loss (ml).
Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and vaginal bleeding

Secondary Outcome Measures

need for blood transfusion
need for blood transfusion
Hemoglobin concentration
pre and postoperative hemoglobin estimation

Full Information

First Posted
May 14, 2018
Last Updated
August 3, 2020
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03578263
Brief Title
Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Hemorrhage
Official Title
Carbetocin Versus Oxytocin and Ergometrine for Prevention of Postpartum Hemorrhage Following a Cesarean Section in Women With Multiple Gestation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The cesarean section is a bloody operation, about 750 to 1000 ml are lost at most operations and over 1000 ml of blood have lost to bring them into the definition of a postpartum hemorrhage (PPH). In developing countries, PPH is the main cause of maternal deaths. Uterine atony is the most common cause of immediate heavy PPH.Multiple pregnancy ones of a common factor for uterine atony. The administration of oxytocic's after the delivery of the neonate reduces the likelihood of PPH and 5 IU oxytocin by slow intravenous injection is currently recommended for all cesarean sections. However, the use of additional oxytocic medication is common, to arrest bleeding, or prophylactically if there are risk factors for PPH . Carbetocin is a synthetic analog of human oxytocin with structural modifications that increase its half-life, thereby prolonging its pharmacological effects. Carbetocin has been approved in 23 countries for prevention of uterine atony and excessive bleeding following cesarean delivery in spinal or epidural anesthesia. Oxytocin is a peptide of nine amino acids (Nona peptide). The structure of oxytocin is very similar to that of arginine vasopressin, whose sequence differs from oxytocin by 2 amino acids. The best-known mechanism for oxytocin to exert its stimulatory effect on myometrial contractility is by increasing the intracellular concentration of calcium. Owing to its short plasma half-life (mean 3 min), a continuous intravenous infusion is required to maintain the uterus in a contracted state. The usual dose is 20 IU in 500 ml of crystalloid solution, with the dosage rate adjusted according to response. Ergometrine is a selective and moderately potent tryptaminergic receptor antagonist in various smooth muscles, being only a partially agonistic or antagonistic at tryptaminergic receptors in the central nervous system. In blood vessels, the alkaloid is only weakly antagonistic of dopaminergic receptors and partially agonistic of α-adrenergic receptors. oxytocin (19%). Blood loss>500 ml was only observed in women who received oxytocin. The aim of the investigator's study was to compare the effect of carbetocin vs. oxytocin and ergometrine for prevention of PPH during cesarean section in women with multiple pregnancies.
Detailed Description
Women included in the study were divided into 2 groups: Group (A): included patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby. Group (B): included patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and intramuscular ergometrine 0.2 mg. The slow administration has been shown to reduce the potentially harmful hemodynamic effects of oxytocin (and presumably carbetocin). Also, intramuscular injection of ergometrine did the same. All women were subjected to full history taking, general and obstetric examination and investigations in the form of preoperative routine labs and obstetric ultrasound, and postoperative serum hemoglobin %.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
cesarean section, post-partum hemorrhage, multiple pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The current study was a single-blinded randomized controlled trial conducted at a tertiary University Hospital Women included in the study were divided into 2 groups: Group (A): included 100 patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after birth of the baby. Group (B): included 100 patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and intramuscular ergometrine 0.2 mg.
Masking
Participant
Masking Description
the participants blinded the arms of the study
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carbetocin arm
Arm Type
Experimental
Arm Description
carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby
Arm Title
oxytocin and ergometrine arm
Arm Type
Active Comparator
Arm Description
oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist plus intramuscular ergometrine 0.2 mg after the birth of the baby
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Pabal
Intervention Description
Group (A): included 100 patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby.
Intervention Type
Drug
Intervention Name(s)
oxytocin
Other Intervention Name(s)
Active Comparator
Intervention Description
Group (B): included 100 patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and
Intervention Type
Drug
Intervention Name(s)
ergometrine
Other Intervention Name(s)
Active Comparator
Intervention Description
intramuscular ergometrine 0.2 mg.
Primary Outcome Measure Information:
Title
estimation of intraoperative blood loss (ml).
Description
Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and vaginal bleeding
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
need for blood transfusion
Description
need for blood transfusion
Time Frame
24 hours postoperative
Title
Hemoglobin concentration
Description
pre and postoperative hemoglobin estimation
Time Frame
ist 24 hours postoperative]

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with a multiple term pregnancy undergoing elective cesarean section Exclusion Criteria: single gestation placenta praevia and placental abruption undergoing cesarean section with general anesthesia women undergoing cesarean section at less than 37 weeks of gestation with a severe medical disorder
Facility Information:
Facility Name
AswanUH
City
Aswan
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

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Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Hemorrhage

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