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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: www.pactr.org

Trial no.: PACTR201203000370221 Date registered: 2012/03/22
TRIAL DESCRIPTION
Public title Vaginal versus cesarean delivery for fetal macrosomia
Official scientific title Vaginal versus cesarean delivery for fetal macrosomia
Brief summary describing the background
and objectives of the trial
Fetal macrosomia is defined as birthweight above 4000 or 4500, irrespective of gestational age. Although debate concerning how best to manage suspected macrosomia continues, the question still remains largely unanswered. The study was planned to test this null hypothesis "there is no difference between Cesarean delivery and vaginal delivery of suspected macrosomia in preventing maternal and neonatal adverse outcomes"
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MODEM
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2010-03-27
Actual trial start date 2010-07-01
Anticipated date of last follow up 2012-03-31
Actual date of last follow up
Anticipated target sample size (number of participants) 240   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
U1111-1129-3721

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 with a ratio of 1:1sequence generation computer-generated random sequence central telephone allocation after verification of indications and inclusions Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Vaginal delivery 120 Active
Experimental group Elective cesarean delivery 120

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Women with EFW ¿ 4kgs. Women in reproductive age. Gestational age ¿ 37 weeks estimated from mother's L.M.P. Singleton pregnancy and cephalic presentation. Women with previous uterine scar. Antepartum hemorrhage. Cephalopelvic disproportion. History of previous shoulder dystocia. 18 Years 40 Years 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 2010/03/23 Department of Obstetrics and Gynecology, ERC
Ethics Committee Address
Street address City Postal code Country
Abbassia Cairo 11341 Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postpartum hemorrhage 24 hours
Secondary Outcome Blood transfusion 24 hours
Secondary Outcome Neonatal birth injuries 24 hours

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Maternity Hospital Abbassia Cairo 11341 Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University Cairo Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Cairo 11341 Egypt University

COLLABORATORS
Name Street address City Postal code Country
Ashraf Nabhan Ali Fahmi Kamel Cairo 11351 Egypt
Ahmed Awadalla Egypt
Mahmoud Megahed Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Ashraf Nabhan anabhan@med.asu.edu.eg 0020122337347
Street address City Postal code Country Position / Affiliation
Cairo 11351 Egypt Professor, Ain Shams University
Role Name Email Phone Fax
Scientific Enquiries Prof Ashraf Nabhan ashraf.nabhan@gmail.com 0020226447500
Street address City Postal code Country Position / Affiliation
Egypt
Role Name Email Phone Fax
Public Enquiries Prof Ashraf Nabhan ashraf.nabhan@gmail.com 0020226447500
Street address City Postal code Country Position / Affiliation
Cairo 11351 Egypt