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

Primary Purpose

Postpartum Hemorrhage

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Carbetocin
Misoprostol
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring PPH

Eligibility Criteria

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

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.

Sites / Locations

  • Beni-Suef UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pabal ( carbetocin)

Misoprostol

Arm Description

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.

Misoprostol ( Misotac, Sigma, Egypt) is a stable, synthetic form of prostaglandin E1 analogue. Patients wil be given 600 microgram of misotac immediately postoperative.

Outcomes

Primary Outcome Measures

Uterine tone and size
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

Blood loss
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.

Full Information

First Posted
October 26, 2014
Last Updated
January 30, 2021
Sponsor
Beni-Suef University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02277067
Brief Title
Carbetocin Versus Misoprostol in High Risk Patients for Postpartum Hemorrhage After C.S.
Acronym
PPH
Official Title
Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Pregnant Women at High Risk Following C.S.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
Collaborators
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
PPH

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pabal ( carbetocin)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Misoprostol
Arm Type
Active Comparator
Arm Description
Misoprostol ( Misotac, Sigma, Egypt) is a stable, synthetic form of prostaglandin E1 analogue. Patients wil be given 600 microgram of misotac immediately postoperative.
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Pabal
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Misotac
Intervention Description
600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.
Primary Outcome Measure Information:
Title
Uterine tone and size
Description
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.
Time Frame
One hour after the cesarean section
Secondary Outcome Measure Information:
Title
Blood loss
Description
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.
Time Frame
One hour after cesarean section
Other Pre-specified Outcome Measures:
Title
Hemoglobin concentration
Description
Changes in hemoglobin concentrations before and 24 hours postoperative. Using a 10% fall in hematocrit value to define post-partum hemorrhage.
Time Frame
Before and 24 hours after the operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nesreen A Shehata, MD
Phone
00201227866337
Email
nesoomar@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelgany M Hassan, MD
Phone
00201017801604
Email
abdelgany2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesreen A Shehata, MD
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-Suef University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesreen A Shehata, Lecturer
First Name & Middle Initial & Last Name & Degree
Abdelgany M Hassan, Lecturer

12. IPD Sharing Statement

Links:
URL
http://www.google.com.eg/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=%E2%80%A2%20Almog%20B%2CMalabarey
Description
• Almog B,Malabarey O, Brown R, Abenhaim HA, Shrim A. (2011), Postpartum hemorrhage in low risk population. J Perinat Med. 2011 Sep; 39(5):495-8. Epub 2011 Jun 30. Department of Obstetrics and Gynecology, McGill University Health Center, Montreal, QC,
URL
http://www.google.com.eg/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=Oladapo%20et%20al.%2C%202012)
Description
Advance misoprostol distribution for preventing and treating postpartum haemorrhage. Cochrane Database Syst Rev. 2012 Feb 15; 2:CD009336. Maternal and Fetal Health Research Unit, Department of Obstetrics and Gynaecology, Obafemi Awolowo College of Health
URL
http://www.google.com.eg/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=Hofmeyr+et+al%2C+2009
Description
Maternal consequences of caesarean section. A retrospective study of intra-operative and postoperative maternal complications of caesarean section during a 10- year period. Eur J Obstet Gynecol Reprod Biol. 2009;74(1):1-6.
URL
http://www.google.com.eg/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=Dansereau+et+al.%3B+1999
Description
• Dansereau J, Joshi AK, Helewa ME, Doran TA, Lange IR, Luther ER, et al. Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section. Am J Obstet Gynecol 1999; 180:670-6.

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

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