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Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Undergoing Caesarean Sections for Placenta Previa: A Randomised Controlled Trial

Primary Purpose

Post Partum Haemorrhage

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Carbetocin
Oxytocin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Haemorrhage focused on measuring Obstetrics

Eligibility Criteria

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

Inclusion Criteria:

  • Women undergoing CS for placenta previa

Exclusion Criteria:

  • Gestational age <37 weeks
  • Hypertension
  • Preeclampsia
  • Cardiac, renal or liver diseases
  • Need for general anaesthesia
  • Known hypersensitivity to carbetocin
  • Suspected placenta accreta

Sites / Locations

  • BeniSuef University hospitalsRecruiting
  • Cairo university hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Carbetocin

Oxytocin

Arm Description

100 µgm of Carbetocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug.

5 mg of oxytocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug.

Outcomes

Primary Outcome Measures

Need for other uterotonic drugs
If the uterus is not contracted 2 minutes after giving the drug, further uterotonic drugs will be given.

Secondary Outcome Measures

Development of PPH
PPH will be diagnosed when bleeding exceeds 500ml

Full Information

First Posted
November 25, 2014
Last Updated
January 20, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02303418
Brief Title
Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Undergoing Caesarean Sections for Placenta Previa: A Randomised Controlled Trial
Official Title
Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Undergoing Caesarean Sections for Placenta Previa: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aims at comparing the roles of carbetocin and oxytocin in the prevention of atonic PPH in women undergoing CS for placenta previa. 200 women will be randomly divided into 2 equal groups using computer generated random numbers, Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).
Detailed Description
Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries. Postpartum haemorrhage (PPH) is defined as a blood loss >500 ml more of blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor (500-1000 ml) or major (more than 1000 ml) . The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases. Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) >30, prolonged labour, fetal macrosomia>4kg and primipara> 40 years. Placenta praevia exists when the placenta is inserted wholly or in part into the lower segment of the uterus. It is classified by ultrasound imaging according to what is relevant clinically: if the placenta lies over the internal cervical os, it is considered a major praevia; if the leading edge of the placenta is in the lower uterine segment but not covering the cervical os, minor or partial praevia exists. Oxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections. Carbetocin is a long-acting oxytocin analogue indicated for the prevention of uterine atony after child birth by cesarean section (CS) under epidural or spinal anaesthesia. Carbetocin has a rapid onset of action (within 1-2 min) and a prolonged duration of action (approximately 1 h) because of sustained uterine response with contractions of higher amplitude and frequency. Its safety profile is comparable to that of oxytocin. The study will be conducted in Cairo university hospitals and BeniSuef university hospitals. All patients with placenta previa covering, or less than 2cm from the internal cervical os will be approached in the antenatal clinic. Women will be invited to participate in the study, the invitation will include a clear full explanation of the study. Only patients signing informed written consents will participate in the study. The exclusion criteria will be gestational age <37 weeks, hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy, need for general anaesthesia, known hypersensitivity to carbetocin and suspected placenta accreta. 200 women will be randomly divided into 2 equal groups using computer generated random numbers, Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml saline and will be given by the anaesthetist slowly intravenously after delivery of the baby. The investigators will not include a control group for ethical reasons. The CS will be done in the presence of a consultant Obstetrician and a consultant anaesthetist, cross-matched blood will be ready and a level 2 critical care bed will be available. CS will be done through the lower uterine segment, if the placenta is encountered, it will be pushed aside and the baby will be delivered. The allocated drug will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug. Blood loss will be estimated through weighing the swabs, using pictorial charts and estimating the amount of blood in the suction containers. Blood haemoglobin will be assessed 24 hours after the CS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Haemorrhage
Keywords
Obstetrics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carbetocin
Arm Type
Active Comparator
Arm Description
100 µgm of Carbetocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug.
Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Description
5 mg of oxytocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug.
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Intervention Description
Carbetocin will be given slowly iv after delivery of the baby
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Oxytocin will be given slowly iv after delivery of the baby
Primary Outcome Measure Information:
Title
Need for other uterotonic drugs
Description
If the uterus is not contracted 2 minutes after giving the drug, further uterotonic drugs will be given.
Time Frame
2 minutes after giving the drug
Secondary Outcome Measure Information:
Title
Development of PPH
Description
PPH will be diagnosed when bleeding exceeds 500ml
Time Frame
2 minutes after giving the drug.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women undergoing CS for placenta previa Exclusion Criteria: Gestational age <37 weeks Hypertension Preeclampsia Cardiac, renal or liver diseases Need for general anaesthesia Known hypersensitivity to carbetocin Suspected placenta accreta
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AbdelGany MA Hassan, MRCOG, MD
Phone
+201017801604
Email
abdelgany2@gmail.com
Facility Information:
Facility Name
BeniSuef University hospitals
City
BeniSuef
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesreen AA Shehata, MD
Phone
+2001227866337
Email
nesoomar@yahoo.com
Facility Name
Cairo university hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AbdelGany Hassan, MRCOG, MD
Phone
002 01017801604
Email
abdelgany2@gmail.com
First Name & Middle Initial & Last Name & Degree
AbdelGany MA Hassan, MRCOG, MD
First Name & Middle Initial & Last Name & Degree
Mohamed MM Kotb, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21668768
Citation
Moertl MG, Friedrich S, Kraschl J, Wadsack C, Lang U, Schlembach D. Haemodynamic effects of carbetocin and oxytocin given as intravenous bolus on women undergoing caesarean delivery: a randomised trial. BJOG. 2011 Oct;118(11):1349-56. doi: 10.1111/j.1471-0528.2011.03022.x. Epub 2011 Jun 14. Erratum In: BJOG. 2011 Nov;118(12):1549.
Results Reference
background
PubMed Identifier
17567419
Citation
Winter C, Macfarlane A, Deneux-Tharaux C, Zhang WH, Alexander S, Brocklehurst P, Bouvier-Colle MH, Prendiville W, Cararach V, van Roosmalen J, Berbik I, Klein M, Ayres-de-Campos D, Erkkola R, Chiechi LM, Langhoff-Roos J, Stray-Pedersen B, Troeger C. Variations in policies for management of the third stage of labour and the immediate management of postpartum haemorrhage in Europe. BJOG. 2007 Jul;114(7):845-54. doi: 10.1111/j.1471-0528.2007.01377.x.
Results Reference
result

Learn more about this trial

Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Undergoing Caesarean Sections for Placenta Previa: A Randomised Controlled Trial

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