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.: PACTR201710002424167 Date of Approval: 13/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pain free normal vaginal delivery
Official scientific title Maternal and fetal outcomes in three regimens for intrathecal analgesia in multipara women undergoing normal vaginal delivery
Brief summary describing the background and objectives of the trial Effective intrapartum analgesia attenuates pain, stress, and anxiety which cause release of stress hormones as well as beta-endorphins. Aim. The purpose of this study is to determine the effect of adding fentany, morphine or dexmedetomidine to hyperbaric bupivacaine/ demaethasone for intrathecal analgesia for labor
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied pan free normal vaginal delivery,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 15/08/2017
Actual trial start date 20/08/2017
Anticipated date of last follow up 15/01/2018
Actual Last follow-up date 20/01/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group F 2.5 mg bupivacaine 0.5% (0.5 ml) + Dexamethasone 4 mg (1 ml) + Fentanyl 50 ¿g (0.5 ml). once intrathecal injection 25
Experimental Group group M 2.5 mg bupivacaine 0.5% (0.5 ml) + Dexamethasone 4 mg (1 ml) + preservative free morphine 100 ¿g (0.5 ml). once intrathecal injection 25
Experimental Group group D 2.5mg bupivacaine 0.5% (0.5 ml) + Dexamethasone 4 mg (1 ml) + Dexmedetomidine 5 ¿g (0.5 ml). once intrathecal injection 25
Control Group group C 2.5mg bupivacaine 0.5% (0.5 ml) + Dexamethasone 4 mg (1 ml)+ normal saline 0.5 ml once intrathecal injection 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Multipara woman, ASA physical status I or II, in active labor with engaged fetal head, term pregnancy of singleton fetus not in distress (Normal cardiotocography [baseline fetal heart rate between 110 and 160 beats/minute, baseline variability >5 beats/minute, presence of accelerations, and absence of decelerations], minimal cervical dilatation of at least 3 cm with intact membranes, those requiring oxytocin augmentation, cephalic presentation, and uncomplicated pregnancies. Patients who refuse to participate, preexisting or pregnancy-induced hypertension, obesity, endocrine diseases, diagnosed fetal abnormalities, contra-indications to neuraxial anesthesia, occurrence of wet tap during epidural placement, fade of spinal analgesia & hence need for epidural activation, previous systemic opioid administrations, allergy to study agents, unconscious parturients, patients who are unable to communicate. 18 Year(s) 35 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 27/06/2017 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 maternal VAS score Before intrathecal injection, 2.5, 5, 10, 15, 20, 30, 60,75, 90, 105, 120 min after block 120 min after block
Primary Outcome Time for the beginning of analgesia in each group (onset time). The time from intrathecal injection till first reduction in pain intensity by at least 1 in VAS will be the time to onset of analgesia
Primary Outcome The level of sensory block will be assessed using alcohol swabs on both sides of the body and the maximum level of sensory block once
Primary Outcome The time from intrathecal injection to two dermatome sensory regression, sensory regression to S1 dermatome, and motor block regression to Bromage 1 once
Primary Outcome Pain at the peak of a contraction every 5 min for 30 min then every 15 min until request for further analgesic
Primary Outcome pain score during the last contraction once
Primary Outcome Duration of pain relief defined as the time from spinal injection to the first request for rescue analgesics or when the VAS is >3.and Time to first administration of supplemental analgesics (clinical duration) once
Primary Outcome Highest sensory block to pin prick in the midline 5 min after block 15 min after block 30 min after block
Primary Outcome Motor block as assessed by the modified bromage scale 5 min after block 15 min after block 30 min after block
Primary Outcome Fetal heart rate 5, 10, 15, 30, 60, 120, min after performing the block
Primary Outcome Apgar score at birth 1, 5 min after birth
Primary Outcome Umbilical arterial blood gases immediately after delivery
Primary Outcome neonatal heart rate 5, 15 and 30 minutes after delivery.
Secondary Outcome maternal adverse effects: respiratory depression ¿ Hypotension (and the need of ephedrine supplementation). . Nausea and vomiting, Shivering, Pruritus, respiratory depression, urine retention before delivery :in the first and second stages;
Secondary Outcome Hemodynamic changes (pulse & blood pressure) 5, 10, 15, 20, 30, 60 and 120 minutes after block. Hemodynamic changes (pulse & blood pressure) 5, 10, 15, 20, 30, 60 and 120 minutes after block.
Secondary Outcome fetal heart rate Before intrathecal injection, 5,10,15,30,60 and120 minutes after intrathecal injection
Secondary Outcome maternal sedation state by modified Ramsay sedation score Before intrathecal, 15,30,45,60,75,90,105,120 minutes after intrathecal injection
Secondary Outcome maternal adverse to effects:nausea, vomiting, pruritis, respiratory depression, Shivering, urine retention, pistdural puncture headache, back pain, neurological damage Continuously checked looking for it's incidence
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
khaled gaballah 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 00201016009073 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Public Enquiries sabry abdallah sabryabdallah222@yahoo.com 00201012378888 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Scientific Enquiries sabry abdallah sabryabdallah222@yahoo.com 00201012378888 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
REPORTING
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