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.: PACTR201811710982025 Date of Approval: 30/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title lidocaine spray, pomade and infiltrative form in episiotomy repair
Official scientific title The comparison of efficiency of lidocaine spray, pomade and infiltrative form in episiotomy repair
Brief summary describing the background and objectives of the trial Lidocaine spray, pomade and infiltrative form may be useful in episiotomy repair. There are similar studies supporting this issue but not enough. Infiltrative form is mostly used in episiotomy repair. However, with the use of spray and pomade forms, we think we can increase patient comfort.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied The pain of the episiotomy
Purpose of the trial Treatment: Drugs
Anticipated trial start date 29/11/2018
Actual trial start date 13/11/2018
Anticipated date of last follow up 31/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Experimental pomade group We will use first time about 5 g lidocaine pomade (redakain ® 5% pomade 30 g) approximately 9 cm dilatation of cervix and one hour before the birth of the baby. And second time we will use ten minutes before episiotomy repair. Latent and active phase duration first stage of labor, duration of second stage of labor and duration of 3rd stage, episiotomy repair time, additional analgesic requirement during procedure and after, duration of discharge, maternal and fetal complications will be recorded. Pain levels will be recorded by applying VAS (visual analog scoring system) at 0. 4. 8. 12. 24. hours of episiotomy repair. 100
Experimental Group Experimental spray group We will use first time about 5 times puff lidocaine spray (vemcaine ® 10% spray 50 g) approximately 9 cm dilatation of cervix and one hour before the birth of the baby. And second time we will use ten minutes before episiotomy repair. Latent and active phase duration first stage of labor, duration of second stage of labor and duration of 3rd stage, episiotomy repair time, additional analgesic requirement during procedure and after, duration of discharge, maternal and fetal complications will be recorded. Pain levels will be recorded by applying VAS (visual analog scoring system) at 0. 4. 8. 12. 24. hours of episiotomy repair. 100
Control Group Control infiltrative group We will twice use 1 ampul infiltrative form of lidocaine on the perineum (aritmal ® 2% 5ml) will be applied to nulliparous patients before episiotomy is opened and repaired. Latent and active phase duration first stage of labor, duration of second stage of labor and duration of 3rd stage, episiotomy repair time, additional analgesic requirement during procedure and after, duration of discharge, maternal and fetal complications will be recorded. Pain levels will be recorded by applying VAS (visual analog scoring system) at 0. 4. 8. 12. 24. hours of episiotomy repair. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women aged 18-40. 2. Women who have 37-42 weeks of pregnancy. 3. Women with nulliparous pregnancy. 4. Pregnant women with BMI <35. 5. Pregnant women who agree to participate in the study. 6. Pregnant women with postpartum obstetric episiotomy. 1. Multiparity. 2. Women with BMI> 35. 3. Women who have had vaginal surgery before. 4. Women who do not want to participate in the study. 5. Preterm births. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 13/11/2018 MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
RECEP TAYYIP ERDOGANSTREET MOGADISHU 12345 Somalia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain levels will be recorded by applying VAS (visual analog scoring system) at 0. 4. 8. 12. 24. hours of episiotomy repair. 24 hours
Secondary Outcome Latent and active phase duration first stage of labor, duration of second stage of labor and duration of 3rd stage, episiotomy repair time, additional analgesic requirement during procedure and after, duration of discharge, maternal and fetal complications will be recorded. 45 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL RECEP TAYYIP ERDOGAN STREET MOGADISHU Somalia
FUNDING SOURCES
Name of source Street address City Postal code Country
MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL RECEP TAYYIP ERDOGAN STREET MOGADISHU Somalia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL RECEP TAYYIP ERDOGAN STREET MOGADISHU Somalia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator RECEP ERIN erinrecep@gmail.com +905335629874 RECEP TAYYIP ERDOGAN STREET
City Postal code Country Position/Affiliation
MOGADISHU Somalia ASS. PROF. DR.
Role Name Email Phone Street address
Principal Investigator Seyfi Kartal drseyfikartal@gmail.com +905052700508 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass. Prof. Dr.
Role Name Email Phone Street address
Principal Investigator Abdirahman Omar Moallim abdirahmanomar040@gmail.com +252615146245 Recep Tayyip Erdogan
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass.Dr.
Role Name Email Phone Street address
Public Enquiries Samaara Hassan samaara010@gmail.com +252615937497 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Miss.
Role Name Email Phone Street address
Scientific Enquiries Recep Erin erinrecep@gmail.com +905335629874 Recep Tayyip Erdogan
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass. Prof. Dr.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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