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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201701001997177 Date of Registration: 24/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Transverse Versus Cephalad ¿ Caudad Blunt Expansion Techniques for Low Transverse Uterine Incision at Cesarean Delivery
Official scientific title Transverse Versus Cephalad ¿ Caudad Blunt Expansion Techniques for Low Transverse Uterine Incision at Cesarean Delivery: Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Cesarean delivery is the most common and major obstetric operative procedure worldwide Over 90% of cesarean deliveries performed at the lower uterine segment because it is easier to enter the uterine cavity with lesser blood loss comparing with vertical incision Extension of the uterine incision at cesarean delivery usually is performed either sharply by cutting laterally and then slightly upward with bandage scissors or bluntly by tearing the myometrium with the fingers Blunt separation can be either transversely or in cephalad-caudad direction. Scientists have stated that the expansion in the transverse direction could cause sacculation-type defect of uterine wall and increase risk of repeated cesarean section .Alternatively, it was speculated that expansion of uterine incision with a vertical traction might have 2 potential advantages. The first is to avoid greater forward extension of the distal incision because of lack of control of the force magnitude that is applied by the surgeon¿s fingers at the lateral edges of the incision. The second is to minimize tissue trauma by allowing myometrium dissection along natural tissue planes Therefore we will conduct a study to compare 2 methods of expanding the uterine incision (blunt extension by separating the fingers in a transversal vs cephalad-caudad direction) at the time of cesarean delivery as regards unintended extension of the uterine incision primarily and blood loss as a secondary outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied DELIVERY,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2014
Actual trial start date 01/01/2014
Anticipated date of last follow up 31/01/2017
Actual Last follow-up date 31/01/2017
Anticipated target sample size (number of participants) 392
Actual target sample size (number of participants) 392
Recruitment status Closed to recruitment,follow-up continuing
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 Cephalad-caudad traction (Cephalad-caudad Group) (n=196): where uterine incision was widened by sepa ONCE during LSCS 2 minutes procedure uterine incision was widened by separation of the operator¿s forefingers in a cephalad ---caudad direction along the midline 196
Control Group Transversal traction (Transversal Group) (n=196):where the initial uterine incision was extended by ONCE during LSCS 2 minutes procedure Transversal traction (Transversal Group) (n=196):where the initial uterine incision was extended by the operator¿s index fingers pulled apart from medial to lateral and slightly cephalad. 196
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. Age: more than 18 years. b. Singleton pregnancy. c. Primary cesarean section. d. Term pregnancy. a. Preterm pregnancy b. Multiple pregnancies. c. Previous CS. d. Patients with any previous uterine scar of any cause. e. Participation in another intervention-trial with interference of intervention and/or outcome of this study. f. Emergency indications for cesarean delivery that prevent adequate informed consent due to time limitation as abruptio placenta or placenta previa. g. Patients with any bleeding disorder. h. Patients in advanced 1st stage or 2nd stage of labor. 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 30/11/2013 Ain Shams Univeristy Staff
Ethics Committee Address
Street address City Postal code Country
ramsis street cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of uterine vessels injury at time of operation
Secondary Outcome Lateral extension of incision Intraoperative
Secondary Outcome Cervical laceration Intraoperative
Secondary Outcome Need for additional stitches Intraoperative
Secondary Outcome Time in uterine closure intraoperative
Secondary Outcome Haemoglobin drop preoperative and postopertive
Secondary Outcome need of blood transfusion postoperative
Secondary Outcome Need for additional stitches intraoperative
Secondary Outcome Lateral extension of incision intraoperative
Secondary Outcome incidence of uterine vessels injury introperative
Secondary Outcome time of uterine closure intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams Materninty hospital Ramsis street cairo 11591 Egypt
ain shams materinty hospital ramsis street cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams Maternity hospital Ramsis street cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ahmed sherif abdel wahab 25 hdayek el oboor building - heliopolis-cairo cairo 11375 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ahmed sherif abdel wahab 25 hdayek el oboor building - heliopolis-cairo cairo 11375 Egypt
Haithem Torky As El salam international hospital el Maadi cairo 11728 Egypt
Mustafa Mahmoud Asar Ramsis street - Ain Shams Maternity hospital cairo 11591 Egypt
Mohamed Mahmoud El-Sherbeeny ramsis - ain shams maternity hospital cairo 11591 Egypt
esam ammar ramsis street cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed abdel wahab ahmedgyna@yahoo.com 00201227960980 25 hdayek el oboor building - heliopolis-cairo
City Postal code Country Position/Affiliation
cairo 11375 Egypt Lecturer of OB/Gyne
Role Name Email Phone Street address
Public Enquiries ahmed abdel wahab ahmedgyna@yahoo.com 00201227960980 25 hdayek el oboor building - heliopolis-cairo
City Postal code Country Position/Affiliation
cairo 11375 Egypt Lecturer of OB/Gyne
Role Name Email Phone Street address
Scientific Enquiries ahmed abdel wahab ahmedgyna@yahoo.com 00201227960980 25 hdayek el oboor building - heliopolis-cairo
City Postal code Country Position/Affiliation
cairo 11375 Egypt Lecturer of OB/Gyne
REPORTING
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