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.: PACTR201310000597400 Date of Approval: 20/07/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Repair technique of the uterine incision of cesarean section.
Official scientific title Extra abdominal versus insitu repair of the uterine incision of cesarean section in a low resource setting.
Brief summary describing the background and objectives of the trial One of the most contentious issues regarding cesarean technique is the manner by which uterine repair is conducted after delivery of the newborn and placenta. Two techniques are well described; insitu repair of uterine incision within the peritoneal cavity or extra abdominal repair of uterine incision after temporary uterine exteriorization outside the mother's abdomen.This study aims to compare both techniques in a low resoure setting via a randomized trial design.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Repair techniques of uterine incision during cesarean section.,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 17/06/2013
Actual trial start date 08/07/2013
Anticipated date of last follow up 24/02/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Recruiting
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 randomisation table from a statistical book. Sealed opaque envelopes. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A Surgical repair of uterine incison after exteriorization of the uterus during cesarean section. During cesarean section after delivery of the newborn and the placenta, the uterus is exteriorized out of the skin incision then the uterine incision is repaired into two layers. 49 Active-Treatment of Control Group
Experimental Group Group B Surgical repair of uterine incison inside the peritoneal cavity (without exteriorization of the uterus) during cesarean section. During cesarean section after delivery of the newborn and the placenta, the uterine incision is repaired into two layers inside the peritoneal cavity (without exteriorization of the uterus). 51
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Term primigravid women with an indication for an elective cesarean section. Women with previous cesarean delivery. Chorioamnionitis. Previous gynecologic or abdominal surgery. Antepartum hemorrhage. Prolonged obstructed labor. Prolonged rupture of membranes. Pregnant women with fibroid uterus or ovarian masses. 19 Year(s) 39 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 13/05/2013 Menoufiya Faculty of Medicine Ethical Committee.
Ethics Committee Address
Street address City Postal code Country
University Street Shebin Al-Kom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraoperative blood loss. Postoperative pain. Postoperative infection Intraoperative blood loss will be measured during cesarean section. Postoperative pain will be measured within the first 24 hours post cesarean section. Postoperative infection will be measured after the 48 hours following cesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynecology at Menoufiya University Hospitals. University Street Shebin Al-Kom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufiya University Hospitals. University Street Shebin Al-Kom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetrics and Gynecology University Street Shebin Al-Kom Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Ahmed Samy Kandil Madenat Al-Dobat Street Cairo Egypt
Tarek Mohammad Sayyed Mostafa Al-Nahas Street Cairo Egypt
Alaa Masoud Abd El-Gayed Adly Street Shebin Al-Kom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Kandil kandeelcando@yahoo.com 002 01005784043 Madenat Al-Dobat Street
City Postal code Country Position/Affiliation
Egypt Professor of Obstetrics and Gynecology at Menoufiya University.
Role Name Email Phone Street address
Principal Investigator Tarek Sayyed tareksayed70@yahoo.com 002 01222739097 Mostafa Al-Nahas Street
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer in Obstetrics and Gynecology at Menoufiya University.
Role Name Email Phone Street address
Principal Investigator Alaa El-Gayed Alaa_masoud75@hotmail.com 002 01001545759 Adly Street
City Postal code Country Position/Affiliation
Shebin Al-Kom Egypt Lecturer in Obstetrics and Gynecology at Menoufiya University
Role Name Email Phone Street address
Public Enquiries Zakaria Sanad zakariasanad@yahoo.com 002 01067677065 Shabana Street
City Postal code Country Position/Affiliation
Tanta Egypt Assistant professor of Obstetrics and Gynecology at Menoufiya University
Role Name Email Phone Street address
Scientific Enquiries Alaa Abd El-Gayed Alaa_masoud75@hotmail.com 002 01001545759 Adly Street
City Postal code Country Position/Affiliation
Shebin Al-Kom Egypt Lecturer in Obstetrics and Gynecology at Menoufiya University
REPORTING
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