Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909623653208 Date of Approval: 30/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Compartive study of the haemodynamic effects of carbetocin and oxytocin in elective caesarean delivery in preeclamptic patients under spinal anesthesia
Official scientific title Compartive study of the haemodynamic effects of carbetocin and oxytocin in elective caesarean delivery in preeclamptic patients under spinal anesthesia
Brief summary describing the background and objectives of the trial Postpartum haemorrhage (PPH) is a potentially life-threatening complication of both vaginal and caesarean delivery. The most frequent cause of PPH is uterine atony .Intravenous injection of 5 IU of oxytocin is recommended as the medication of choice to reduce the incidence and severity of PPH .Currently 100 μg of carbetocin is routinely used for the prevention of PPH.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PE
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/09/2019
Actual trial start date 15/09/2019
Anticipated date of last follow up 15/12/2019
Actual Last follow-up date 01/01/2020
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Recruiting
Publication URL Not yet decided
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group assessment of drugs acting on uterine contraction Oxytocin 5 IU Intraoperative after delivery of the baby Assessment of hemodynamic changes after drug administration 40 Dose Comparison
Experimental Group Assessment of drugs on uterine contraction Carbitocin 100 microgram Intraoperative after delivery of the baby Assessment of hemodynamic changes after drug administration 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study will include pregnant women with preeclampsia criteria undergoing Elective caesarean section at term with regional anaesthesia (spinal anesthesia ) 1-Women refusing regional anesthesia 2-Contraindication of regional anesthesia (e.g. coagulopathy) 3-Women with conditions associated with an increased risk of post partum haemorrhage (PPH) as: placenta praevia, placental abruption, and multiple gestation. 4 -Pregnancy related complications: as gestational diabetes, or pre-existing diseases as insulin-dependent diabetes, cardiovascular or renal diseases, or hypo-/hyperthyroidism as these conditions may interfere with haemodynamic parameters. Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/05/2017 Faculty of Medicine Beni Seuf University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mohamed Hassan st Beni suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Haemodynamic effect (blood pressure, heart rate, oxygen saturation) 1, 5, 10 and 15 minutes
Secondary Outcome Incidence of hypotension following drug administration. 1, 5, 10 and 15 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni sued university hospital Mohamed Hassan st, Beni suef 62521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahmoud Hussein bahr Islam st Beni suef 62511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni suef university hospital Mohamed Hassan st Beni suef 62511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed Andreas ahmed All Jazeera st Beni suef 62511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Hussein Bahr drmahmoudbahr@gmail.com 201004413095 Islam st
City Postal code Country Position/Affiliation
Beni suef 62511 Egypt Lecturer of of anaesthesia surgical ICU and pain management faculty of medicine Beni suef university
Role Name Email Phone Street address
Scientific Enquiries Ahmed abdelaal Ahmed dr.ahmedabdelaalmahmoud@gmail.com 201155563450 Eljazeraa
City Postal code Country Position/Affiliation
Beni suef 62511 Egypt Assistant professor of anaesthesia surgical ICU pain management faculty of medicine Beni suef university
Role Name Email Phone Street address
Public Enquiries Kerollos pioneer Neseem Kmnmk87@yahoo.com 201157679742 Aziz st of safya zaghlol st
City Postal code Country Position/Affiliation
Beni suef 62515 Egypt Assistant lecturer anaesthesia surgical ICU pain management faculty of medicine Beni suef university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results summary Study Protocol Around 10months after finishing the trial Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
mahmoud.mohamed1@med.bsu.edu.eg No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information