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Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section

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ClinicalTrials.gov Identifier: NCT02101567
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

Brief Summary:
The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin & ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.

Condition or disease Intervention/treatment Phase
Bleeding Anemia Drug: Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head Drug: Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv Phase 4

Detailed Description:
  • Postpartum hemorrhage (PPH) accounts for nearly one quarter of all maternal deaths worldwide 1 and was the second most frequent cause of maternal death in the UK for the 2000-2002 triennium.
  • Caesarean section is a recognized risk factor for PPH and the worldwide caesarean delivery rate is increasing .2
  • A combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension.
  • A recent guideline on PPH prevention developed by the World Health Organization recommended the use of oxytocin for prevention of PPH in settings in which active management of labor is not practiced.
  • Ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia.
  • Carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. It is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects .
  • A prospective double blinded randomized study . The study population will include 200 patients. The study will take place in Beni_suef University Hospitals.
  • Inclusion criteria:

    • Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation.

  • Exclusion criteria

    • Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
    • women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
    • Hypertension with pregnancy.
    • Cardiac and coronary diseases with pregnancy
  • Women included in the study were divided into 2 groups:

.Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of the fetal head.

.Group (B): including 100 patients who will receive a combination of intraoperative oxytocin 5 I.U & ergometrine 0.2 mg.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison Between Carbetocin, Oxytocin and Ergometrine in Prevention of Postpartum Haemorrhage Following Caesarean Section
Study Start Date : May 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: Pabal ( carbetocin)
Pabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head.
Drug: Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head
In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.
Other Name: Carbetocin

Active Comparator: Oxytocin and Methergine (methyl ergometrine)
The second group of patients included in the study will be given Oxytocin 5 IU ampoule by intravenous infusion and Methergine 0.2 mg IV after delivery of fetal head.
Drug: Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv
In the second group of patients oxytocin 5 IU will be given iv infusion and Methergine 0.2 mg iv
Other Name: Oxytocin and Methyl ergometrine




Primary Outcome Measures :
  1. Uterine tone and size [ Time Frame: One hour after the cesarean section ]
    The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.


Secondary Outcome Measures :
  1. Blood loss [ Time Frame: One hour after cesarean section ]
    Blood loss will be estimated postoperatively by giving each woman of each group standard 2 dressings (standard weight of dressing is 25 gm) for one hour postoperative and recording weight of blood soaked dressings and volume of lost blood.


Other Outcome Measures:
  1. Hemoglobin concentration [ Time Frame: Before and 24 hours after the operation ]
    Changes in hemoglobin concentrations before and 24 hours postoperative. Using a 10% fall in hematocrit value to define post-partum hemorrhage.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.

Exclusion Criteria:

  • Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
  • women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
  • Hypertension with pregnancy.
  • Cardiac and coronary diseases with pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101567


Locations
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Egypt
Nesreen Abdel Fattah Abdullah Shehata
Cairo, Egypt
Sponsors and Collaborators
Beni-Suef University
Investigators
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Principal Investigator: Nesreen A Shehata, MD Beni-Suef University

Additional Information:
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Responsible Party: Nesreen Abdel Fattah Abdullah Shehata, Lecturer of Obstetrics and Gynecology, Beni-Suef University
ClinicalTrials.gov Identifier: NCT02101567     History of Changes
Other Study ID Numbers: Beni-Suef 3
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University:
Postpartum hemorrhage, Cesarean section, Uterotonics

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Oxytocin
Carbetocin
Ergonovine
Methylergonovine
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs