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.: PACTR201702002020948 Date of Approval: 06/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pain relief during labour
Official scientific title Maternal and fetal outcome with the use of Fentanyl versus Pethidine for pain relief during labour: a randomized clinical trial
Brief summary describing the background and objectives of the trial to assess the safety and acceptability of intravenous fentanyl versus intramuscular pethidine for pain relief during labour.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pain relief during labour,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2017
Actual trial start date 13/02/2017
Anticipated date of last follow up 01/05/2017
Actual Last follow-up date 17/04/2017
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fentanyl group 50 micrograms fentanyl was given after being diluted in 18 ml normal saline once IV 150
Experimental Group Pethidine group 100 mg of pethidine once IMI 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women who were in the active labour (defined as regular uterine contractions of at least two in ten minutes), with a singleton pregnancy, cervical dilatation of at least four cm, with gestation of 37¿41 weeks, and reactive non-stress test. included allergy or previous adverse reaction to opioids or opioid dependency, use of parenteral opioids within the previous 24 hours, presence of severe systemic or mental disease, maternal respiratory rate ¿ 8 or maternal bradycardia (pulse rate less than 60), and women requesting additional dosage of analgesia. The authors excluded women requesting additional analgesia in order to test the specific single dosing for a particular opioid. 18 Year(s) 32 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 02/02/2017 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome changes in pain scores every 60 minutes during the three-hour period after administration of the trial drug
Secondary Outcome Maternal adverse effects fainting, nausea and vomiting, respiratory depression, hypotension
Secondary Outcome Fetal-neonatal outcome Apgar scores at one and five minutes, need for resuscitation, and admission to neonatal intensive care unit
Secondary Outcome maternal acceptability maternal acceptability
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information