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.: PACTR201203000370221 Date of Approval: 22/03/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Childbirth,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 27/03/2010
Actual trial start date 01/07/2010
Anticipated date of last follow up 31/03/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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-Treatment of Control Group
Experimental Group Elective cesarean delivery 120
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 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 23/03/2010 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 Street address
Principal Investigator Ashraf Nabhan anabhan@med.asu.edu.eg 0020122337347
City Postal code Country Position/Affiliation
Cairo 11351 Egypt Professor, Ain Shams University
Role Name Email Phone Street address
Public Enquiries Ashraf Nabhan ashraf.nabhan@gmail.com 0020226447500
City Postal code Country Position/Affiliation
Cairo 11351 Egypt
Role Name Email Phone Street address
Scientific Enquiries Ashraf Nabhan ashraf.nabhan@gmail.com 0020226447500
City Postal code Country Position/Affiliation
Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information