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Carbetocin Versus Misoprostol in High Risk Patients for Postpartum Hemorrhage After C.S. (PPH)

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ClinicalTrials.gov Identifier: NCT02277067
Recruitment Status : Recruiting
First Posted : October 28, 2014
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

Brief Summary:
We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients after C.S.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Carbetocin Drug: Misoprostol Phase 4

Detailed Description:
  • Postpartum hemorrhage was traditionally defined as blood loss in excess of 500 mL from a vaginal delivery or 1000 mL at cesarean section. It can result from uterine atony, retained placental tissue including that from abnormal placentation, maternal genital tract trauma and coagulopathies. (Almog et al, 2011)
  • Uterotonic agents (e.g. ergometrine, misoprostol) should be easily accessible. Many units of an oxytocin infusion and/or rectal misoprostol during and after cesarean deliveries used to reduce the incidence of atony. -Misoprostol has been widely recommended for the prevention of post-partum hemorrhage when other methods are not available. The most common regimen reported for the treatment of post-partum hemorrhage is rectally. (Oladapo et al., 2012)
  • Misoprostol is a prostaglandin E1 analogue. It has been investigated in the prevention of postpartum hemorrhage, using either the oral or rectal route of administration. (Hofmeyr et al, 2009)
  • Carbetocin is a long-acting oxytocin studied by Dansereau et al.; 1999.They found that the carbetocin group of patients had a decreased incidence of PPH and of the need for therapeutic oxytocics. The recommended dose of carbetocin is 100 mg given either IM or slowly (over 1 minute).
  • Risk factors may present antenatally or intrapartum; care plans must be modified when risk factors present. Clinicians must be aware of risk factors for PPH and should take these into account for the wellbeing and safety of both the mother and the baby.RCOG GUIDLIN Table 1: Risk factors for PPH

    • Suspected or proven placental abruption
    • Known placenta praevia
    • Multiple pregnancy
    • Pre-eclampsia/gestational hypertension
    • Previous PPH .
    • Obesity (BMI >35)
    • Anaemia (<9 g/dl)
    • Delivery by elective caesarean section
    • Induction of labour
    • Retained placenta Tissue
    • Prolonged labour (> 12 hours) .
    • Big baby (> 4 kg) Royal College of Obstetrics and Gynecology.Green-top Guideline No. 52 May 2009 Minor revisions November 2009 and April 2011. Prevention and Management of Postpartum Hemorrhage. Thus our aim is to compare the effeciency and cost effectiveness of Carbitocin and Misoprostol in patients at high risk of PPH after C.S. in prevention of PPH.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Pregnant Women at High Risk Following C.S.
Study Start Date : October 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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: Carbetocin
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: Pabal

Active Comparator: Misoprostol
Misoprostol ( Misotac, Sigma, Egypt) is a stable, synthetic form of prostaglandin E1 analogue. Patients wil be given 600 microgram of misotac immediately postoperative.
Drug: Misoprostol
600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.
Other Name: Misotac




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.



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Any medical disorder with pregnancy that carries a risk factor for PPH.

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.

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): NCT02277067


Contacts
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Contact: Nesreen A Shehata, MD 00201227866337 nesoomar@yahoo.com
Contact: Abdelgany M Hassan, MD 00201017801604 abdelgany2@gmail.com

Locations
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Egypt
Beni-Suef University Recruiting
Cairo, Egypt
Principal Investigator: Nesreen A Shehata, Lecturer         
Sub-Investigator: Abdelgany M Hassan, Lecturer         
Sponsors and Collaborators
Beni-Suef University
Cairo 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: NCT02277067     History of Changes
Other Study ID Numbers: Beni-Suef 7
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Keywords provided by Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University:
PPH

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Misoprostol
Carbetocin
Oxytocin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics