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.: PACTR201909807831604 Date of Approval: 02/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Carbetocin versus Oxytocin for the Prevention of Postpartum Hemorrhage in Hypertensive Pregnant Women
Official scientific title Carbetocin versus Oxytocin for the Prevention of Postpartum Hemorrhage in Hypertensive Pregnant Women
Brief summary describing the background and objectives of the trial In patient with hypertension during pregnancy there is an increased risk of PPH, but the hemodynamic changes associated with hypertension during pregnancy make the management of any kind of bleeding particularly troublesome. There are many pharmacological options for the management of PPH ,oxytocin being the first line of treatment, there is yet no evidence about safety and efficacy of using carbetocin, an oxytocin agonist, in these patient. The aim of this work is to assess the effectiveness and safety of carbetocin ,an oxytocin agonist, versus oxytocin in the prevention of PPH in hypertensive pregnant women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2014
Actual trial start date
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group oxytocin group one ampoule 10 IU oxytocin (Syntocinon; Alliance, Chippenham, UK) in 1000 ringer lactate as IV drip at a rate of 125 ml/h during the cs active treatment 80 Active-Treatment of Control Group
Experimental Group carbetocin group 100 μg carbetocin diluted in 10 ml of Ringer’s lactate solution injected directly into the vein over 2 min (Pabal; Ferring, Langley, UK). during the cs treatment 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women aged 18-35 years with term singleton pregnancy prepared for elective lower segment CS at gestational age of ≥ 37 weeks wit h diagnosed hypertensive disorders in pregnancy. risk factors for excessive blood loss during the surgery (placenta previa, twin pregnancy or presence of uterine fibroid), a history of thromboembolic disorders cases suffering from chronic medical diseases (cardiac, hepatic, renal). 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 18/09/2013 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Estimated amount of blood loss. • Incidence and amount of blood transfusion. • Hemoglobin and hematocrit changes pre-and post delivery. • Use of further ecobolics. 48 hours after cs
Secondary Outcome • Vital signs during and after delivery. • Time of discharge from hospital. • Complications post-delivery (fever, Disseminated Intravascular Coagulation (DIC), maternal infection, ICU admission and cesarean hysterectomy). • Uterine tone and adverse effects. • Neonatal weight. • Neonatal Apgar score. • Neonatal admission to neonatal intensive care. 48 hours after cs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
omima tharwat taha ring road kilo 4.5 ismailia Egypt
zakia mahdy abolill ring road kilo 4.5 ismailia Egypt
Mohamed Ahmed ElBaihy ring road kilo 4.5 ismailia Egypt
Waleed Ali Sayed Ahmed ring road kilo 4.5 ismailia Egypt
Eman Mostafa Abd ElHamid ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator zakia abolill zakiamahdyabolill@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data sharing will be through the published results and after approval of our research ethics committee Study Protocol within 6 months data access will be after approval of the research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Both drugs were associated with a statistically significant decrease in blood pressure. Hemoglobin decreased significantly among the oxytocin group (pre-operative hemoglobin 12.1 ± 3.8 versus post-operative 10.4 ± 1.1). Blood loss was significantly more among the oxytocin group (424.75 ± 182.59 in carbetocin group versus 679.5 ± 200.25 in the oxytocin group, p- value <0.001). Nausea, vomiting, and sweating were reported more significantly in oxytocin group patients. 23/08/2019 23/08/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.dropbox.com/scl/fi/sejhjuonqgcxpvxr6n02p/Protocol.doc?dl=0&rlkey=w6o14ouea6rza5u4ff6x4spor
Changes to trial information