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.: PACTR201710002607341 Date of Approval: 11/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between forceps , single blade forceps and manual extraction of fetal head in elective ceaserean section :
Official scientific title Comparison between forceps , single blade forceps and manual extraction of fetal head in elective ceaserean section : a randomizied control trial
Brief summary describing the background and objectives of the trial Cesarean section is defined as the surgical termination of pregnancy or delivery by operative opening of uterus (Lurie, 2005). The cesarean section was first described in Roman times(Lurie, 2005). But only at the start of 20th century did it begin to offer acceptable morbidity and mortality for both mother and baby(ICHS, 2008). This procedure has different techniques to minimize morbidity and to reduce complications(Rodriguez, 1994). In the United States most primary cesarean deliveries are performed for the indication of dystocia in labor. In these cases the fetal head is well engaged and the lower uterine segment has been thinned by the forces of labor. If the fetal head is not deeply engaged in the maternal pelvis, it is usually a simple maneuver to make a transverse lower uterine segment incision and lift the fetal head to the level of the incision and effect delivery(Warenski, 1981). There are, however, important clinical differences between an elective cesarean delivery and a primary cesarean performed during active labor. First, with elective cesarean the lower uterine segment has not been effaced and elongated by the forces of labor and it may be more difficult to create an adequate incision for passage of the fetal head. Second, at the time of elective cesarean delivery the fetal head is commonly "floating" above the pelvic brim (unengaged with respect to the maternal pelvis) (Depp, 1996). Most elective cesarean deliveries are performed under regional anesthetic (whether epidural or spinal) for reason of patient safety and satisfaction. The fundal pressure exerted by the surgeon and the assistant in an effort to deliver an unengaged fetal vertex through a thick lower uterine segment is often perceived as uncomfortable, even painful, by the patient(Depp, 1996). Several methods have been described
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Caeseraen section,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 11/09/2017
Actual trial start date 18/09/2017
Anticipated date of last follow up 11/12/2017
Actual Last follow-up date 18/12/2017
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 2 Blades forceps group (F group) ONCE during LSCS 1 minute application of 2 bldes of forceps for extraction of fetal head 50
Experimental Group 1 Blade forceps group (S group) ONCE during LSCS 1 minute application of 1 blade of short forceps and delivery of fetal head 50
Control Group manual extraction of fetal head during CS ONCE during LSCS 1 minute manual extracion of head 50
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) Repeat elective cesarean section. d) 38ws-39ws pregnancy. e) Cephalic presentation. f) No active labor. g) Patient willingness to randomize to delivery technique a) Preterm pregnancy. b) Multiple pregnancies. c) Participation in another intervention-trial with interference of intervention and/or outcome of this study. d) Fetal malpresentation (transverse lie or breech presentation). e) Serious maternal or fetal disease (maternal or fetal coagulopathy, fetal structural malformation, or evidence of nonreassuring fetal status). f) A deeply engaged fetal vertex. g) Maternal unwillingness to undergo randomization 18 Year(s) 40 Year(s) Male
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
No AIR FORCE SPECIALIZED HOSPITAL
Ethics Committee Address
Street address City Postal code Country
EL TESSEEN STREET FIFTH SETTLEMENT NEW CAIRO Egypt
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 10/09/2017 AIR FORCE SPECIALIZED HOSPITAL
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome unintended extension intaopeartive
Primary Outcome uterine vessels injury intraoperative
Secondary Outcome hemoglobin change 24 hours after cesarean section 24 hours after LSCS
Primary Outcome Pain expectation during delivery of fetal head
Primary Outcome pain felt during delivery during delivery of fetal head
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams Materninty hospital Ramsis street - Ain Shams Maternity hospital cairo 11591 Egypt
AIR FORCE SPECIALIZED HOSPITAL EL TESSEEN STREET, FIFTH SETTLEMENT, NEW CAIRO CAIRO
October 6th univeristy October 6th city Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams Maternity hospital Ramsis street - Ain Shams Maternity hospital 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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Sherif Abdel Wahab ahmedgyna@yahoo.com +201227960980 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 sherif wahab ahmedgyna@yahoo.com +201227960980 25 hdayek el oboor building - heliopolis-cairo
City Postal code Country Position/Affiliation
cairo 11375 Egypt lecturer OB/Gyn
Role Name Email Phone Street address
Scientific Enquiries ahmed sherif wahab ahmedgyna@yahoo.com +201227960980 25 hdayek el oboor building - heliopolis-cairo
City Postal code Country Position/Affiliation
cairo 11375 Egypt lecturer OB/Gyn
REPORTING
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