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.: PACTR201603001534220 Date of Approval: 13/03/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Addition of Methyl Ergometrine to Oxytocin is beneficial in reducing blood loss and incidence of post spinal headache after cesarean section
Official scientific title Addition of Methyl Ergometrine to Oxytocin is beneficial in reducing blood loss and incidence of post spinal headache after cesarean section a randomized prospective study
Brief summary describing the background and objectives of the trial This is prospective randomized case controlled study will be conducted in Maternity Hospital during the period of April 2016 to August 2016 Randomization will use randomized consecutive numbered chart. Informed consent will be obtained from all patients .The study populations will be divided into 2groups :for both groups A fluid preload of crystalloid 1000 ml will be administered via an 18gauge intravenous cannula over a period of 10¿15 minutes before spinal anesthesia and expert anesthetist perform spinal anesthesia with the patient in sitting position a 25G needle will be inserted through the L3-4 interspace . Patients will then positioned supine with the wedge under the right hip. group I (n=100) :- received oxytocin and 1ml saline IM before the end of operation Oxytocin will be given as follow: 10 units by intravenous (IV) drip after delivery of neonate while group II ( n=100) recieved oxytocin andmethyl ergometrin was given as 200 mcg(1ml) IM at the end of operation. both groups will be monitored intraoperative for hemodynamic status and will be compared postoperative for incidence of PSH and amount of blood loss between both groups
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MERPSh
Disease(s) or condition(s) being studied ,Anaesthesia,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/04/2016
Actual trial start date 02/04/2016
Anticipated date of last follow up 06/08/2016
Actual Last follow-up date 06/08/2016
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Maternity Hospital Minia University
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 Randomization will use randomized consecutive numbered chart. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group methyl ergometrin 200mcg IM once oxytocin andmethyl ergometrin was given as 200 mcg(1ml) IM at the end of operation. 100
Control Group oxytocin drip 10 IU once received oxytocin and 1ml saline IM before the end of operation Oxytocin will be given as follow: 10 units by intravenous (IV) drip after delivery of neonate 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ age between 20 to 45 years old, ¿ elective caesarian delivery, ¿ non medically diseased women, ¿ no bleeding tendency, ¿ full term alive baby and ¿ non scarred uterus. ¿ patient refusal, ¿ back infection, ¿ haemodynamic, haemostatic or neurological abnormalities, ¿ severe pre-eclampsia ¿ peripartum heamorrhage The 20 Year(s) 45 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
No 02/04/2016 faculty of medicine ethical commitee
Ethics Committee Address
Street address City Postal code Country
Minia University street Minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PSH(post spinal headache) postoperative and for 1 week
Secondary Outcome postpartum blood loss after delivery of placenta and for two hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Maternity hospital Minia University Minia University street Minia 61519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maternity Hospital Minia University Minia University street Minia 61111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Maternity Hospital Minia University Minia University street Minia 61111 Egypt Hospital
Secondary Sponsor Minia University Minia University street Minia 61519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reham elkateeb Taha Hussin Minia 61111 Egypt
Hani Hassan shalabi street Minia 61111 Egypt
Ahmad Hassanin Salah Eldin street Minia 61111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmad hassanin ahmadhassanein10@yahoo.com 00201006946879 Salah Eldin street
City Postal code Country Position/Affiliation
Minia 61111 Egypt lecturer of Anesthesia
Role Name Email Phone Street address
Public Enquiries Hani Hassan hanyhassan1973@yahoo.com 00201001204427 Shalabi
City Postal code Country Position/Affiliation
Minia 61111 Egypt assistant professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Reham Elkateeb rehamelkhateeb78@yahoo.com 00201011966648 Taha Hussin
City Postal code Country Position/Affiliation
Minia 61111 Egypt lecturer of Obstetrics and Gynecology
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information