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Carbetocin Versus Oxytocin for the Prevention of Postpartum Hemorrhage in Emergency Caesarean Delivery

Primary Purpose

Postpartum Hemorrhage (Primary)

Status
Completed
Phase
Phase 4
Locations
Iraq
Study Type
Interventional
Intervention
Carbetocin
Oxytocin
Sponsored by
Al-Kindy College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage (Primary) focused on measuring Oxytocin, Carbetocin, Emergency Caesarean Section

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients age ≥18 years
  • Singleton pregnancy
  • Full term gestation
  • Emergency cesarean section during labor

Exclusion Criteria:

  • Cases of coagulopathy
  • Drug hypersensitivity
  • Medical diseases as; cardiac, hypertension, liver, renal or endocrine diseases
  • Uterine fibroids
  • Suspected placental pathology (accreta, previa or abruptio)
  • General anesthesia
  • Longitudinal uterine incision

Sites / Locations

  • Al Kindy College of Medicine/ University of Baghdad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbetocin

Oxytocin

Arm Description

One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection after labor of the baby at once.

One ml of Oxytocin (10 IU), was given as a bolus intravenous injection after labor of the baby at once.

Outcomes

Primary Outcome Measures

Blood loss equal or more than 1000 ml
Proportion of women with blood loss equal or more than 1000 ml in both study groups
Use of additional uterotonics
Proportion of the women whom they need additional uterotonic agents

Secondary Outcome Measures

Blood pressure changes in carbetocin versus oxytocin group
Systolic and diastolic blood pressure changes that may occur in both groups
Pulse rate changes in carbetocin versus oxytocin group
Detection of pulse rate changes that may occur in both groups
Blood transfusion need
Proportion of the women whom they need blood transfusion

Full Information

First Posted
November 24, 2018
Last Updated
November 27, 2018
Sponsor
Al-Kindy College of Medicine
Collaborators
Elweyia Maternity Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03755531
Brief Title
Carbetocin Versus Oxytocin for the Prevention of Postpartum Hemorrhage in Emergency Caesarean Delivery
Official Title
Heat Stable Carbetocin Versus Oxytocin for the Prevention of Primary Postpartum Hemorrhage in Emergency Caesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
June 10, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Kindy College of Medicine
Collaborators
Elweyia Maternity Teaching 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
Postpartum haemorrhage keeps to be the leading cause of maternal mortality in middle and low-income countries, including Iraq. Much advancement had been made in the field of treatment for postpartum haemorrhage but no much progress had been made in the field of prevention, where one of its main component is the administration of uterotonic, preferably oxytocin, immediately after birth of the baby. In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding the other uterotonics; ergometrine degrades when exposed to heat or light. Misoprostol degrades rapidly when exposed to Moisture. Innovation in the manufacture of carbetocin had meet the stability requirements for hot and humid climates. This study had been accomplished to evaluate the uterotonic effect of carbetocin compared with oxytocin for the prevention of postpartum haemorrhage in emergency caesarean delivery. Looking if carbetocin is superior to oxytocin in term of reduction in the need for additional uterotonic agents or the occurrence of PPH.
Detailed Description
Setting and design: It is a double blinded randomized parallel clinical trial. That had been conducted at Al Elweyia Maternity Teaching Hospital in Baghdad during the period from Jan., 4th, 2018 to August, 1st, 2018. Written consent was insured for all the participants. Data collection: Three hundred and twenty pregnant women who were underwent emergency caesarean sections under regional anesthesia were enrolled in the study (due to limitation of carbetocin ampoules that were available). Those women were randomized to oxytocin or carbetocin in a rate of 2:1 (for prophylaxis of PPH in the active management of third stage of labour). Twenty cases were omitted since they were not fulfilled the eligibility criteria and only three hundred women were completed the study. They were divided into two groups: Group1 (case group): 100 pregnant women, whom they received carbetocin for the prevention of PPH. Group 2 (control group): 200 pregnant women, whom they received oxytocin for the prevention of PPH. Additional information including age, parity, past medical history, and body mass index (BMI) were taken. Intervention: The following steps were followed: Hemoglobin and hematocrit were assessed before caesarean section. One ml of either carbitocin (100 mcg) or oxytocin (10 IU) was given as a bolus intravenous injection by the anesthesiologist after labor of the baby at once. The placentae were delivered by controlled cord traction. It was the operating obstetrician decision to evaluated the uterine tone, bleeding intra-operatively and the need for an additional uterotonic and method of its administration, dose and duration. Our center usual regimen for uterine atony is an oxytocin (40 IU in 500 ml isotonic crystalloid solution) intravenous infusion over 4-5 hours. Follow up: For 24 hours was done, that is include: Evaluation of blood loss by the obstetrician and the anesthesiologist after skin closure, that is include the entire amount that had been suctioned, taken by the surgical gauzes or spilled in the surgical field, using visual estimation chart for assessment of blood loss. The need of any additional uterotonic drugs after the operation was recorded. The need of blood transfusion post delivery. The blood pressure and pulse rate of the women involved in the study were documented at 0, 5, 10, 20, 30 and 60 minutes after the injection of the drug. The period of operation (skin cut into the final closure of the skin) was recorded. Intravenous fluid infusion was administered regularly and as it had been stated by the obstetricians and maintained after the operation until oral intake was started. Hemoglobin and hematocrit was assessed the day after the caesarean section. Statistical analysis: Statistical Package for Social Sciences (SPSS) version 21 was used. Descriptive statistics presented as (mean ± standard deviation) and frequencies as percentages. The database was examined for errors using range and logical data cleaning methods, and inconsistencies were remedied. Chi square test was used to compare between categorical variables (Fishers exact test used when expected variable was less than 20% of total) and t-test was used to compare between two means. Cohen's d, a standardized measure of effect size for difference between 2 means, which can be compared across different variables and studies, since it has no unit of measurement was used. Significance level was set at P < 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage (Primary)
Keywords
Oxytocin, Carbetocin, Emergency Caesarean Section

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The anesthetist was the person in charge for giving the allocated drug after labor of the baby at once. Otherwise the operating obstetricians, the care givers, investigators and the ouctcomes assessor were all blinded to the type of the injection.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbetocin
Arm Type
Experimental
Arm Description
One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection after labor of the baby at once.
Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Description
One ml of Oxytocin (10 IU), was given as a bolus intravenous injection after labor of the baby at once.
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
BABAL
Intervention Description
Heat stable Carbetocin, a clear colourless solution. Oxytocic activity: approximately 50 IU of oxytocin/vial. One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection, slowly over 1 minute after labor of the baby at once. It was used once and no further doses were given. Drug was kept in cold storage (2 to 8°C).
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
Oxytocin, a clear colourless solution. One ml of oxytocin (10 IU), was given as a bolus intravenous injection over 1 minute, after labor of the baby at once. Further doses can be given accordingly. Drug was kept in cold storage (2 to 8°C).
Primary Outcome Measure Information:
Title
Blood loss equal or more than 1000 ml
Description
Proportion of women with blood loss equal or more than 1000 ml in both study groups
Time Frame
During the first 24 hours
Title
Use of additional uterotonics
Description
Proportion of the women whom they need additional uterotonic agents
Time Frame
During the first 24 hours
Secondary Outcome Measure Information:
Title
Blood pressure changes in carbetocin versus oxytocin group
Description
Systolic and diastolic blood pressure changes that may occur in both groups
Time Frame
Within one hour after administration of the drugs
Title
Pulse rate changes in carbetocin versus oxytocin group
Description
Detection of pulse rate changes that may occur in both groups
Time Frame
Within one hour after administration of the drugs
Title
Blood transfusion need
Description
Proportion of the women whom they need blood transfusion
Time Frame
During the first 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients age ≥18 years Singleton pregnancy Full term gestation Emergency cesarean section during labor Exclusion Criteria: Cases of coagulopathy Drug hypersensitivity Medical diseases as; cardiac, hypertension, liver, renal or endocrine diseases Uterine fibroids Suspected placental pathology (accreta, previa or abruptio) General anesthesia Longitudinal uterine incision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taghreed K Alhaidari, CABOG
Organizational Affiliation
Al Kindy College of Medicine, University of Baghdad
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shayma S Al-Zubaidy, FICOG, MD
Organizational Affiliation
Al- Elweyia Maternity Teaching Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alaa A Hussein, FICOG, MD
Organizational Affiliation
Al- Elweyia Maternity Teaching Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulfat M Alnakkash, CABOG
Organizational Affiliation
Al- Elweyia Maternity Teaching Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed S Alnuaimi, PhD
Organizational Affiliation
Baghdad College of Medicine/ University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Kindy College of Medicine/ University of Baghdad
City
Baghdad
ZIP/Postal Code
10096
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the main outcomes' result reported in this article will be shared.
IPD Sharing Time Frame
Beginning 6 months and ending 24 months following article publication, unless otherwise stated by the publisher
IPD Sharing Access Criteria
The data will be available up to 24 months following article publication for anyone who wishes to access the data or for meta-analysis.

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Carbetocin Versus Oxytocin for the Prevention of Postpartum Hemorrhage in Emergency Caesarean Delivery

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