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.: PACTR201712002774233 Date of Approval: 16/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Management of placenta accrete - step by step approach
Official scientific title Management of placenta accrete: step by step approach
Brief summary describing the background and objectives of the trial Aim: To evaluate the value of management of palcenta accrete step by step approach Design: randomized controlled study. Methods: Aim: To evaluate the value of management of palcenta accrete step by step apparoach Methods: This study will be conducted on 80 pregnant females , who are selected to suffer from placenta accrete either diagnosed antenatal by MRI or Doppler U/S or both. or diagnosed intraoperative .and the patients will be excluded If the patient had previous four or more cesarean scars. Or If the patient is 40 years old or more The patientsdivided into two groups , the study group will be submitted to the surgical steps from step one to five in order, but they will not proceed from one step to the next step except if the previous step fails to control the condition. The data from each step regarding the duration of the step , amount of bleeding , units of blood used intraoperative , any surgical complication, postpartum sepsis ,need of postpartum ICU will be recorded . The control roup will be submitted to ordinary management of palcenta accrete
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied placenta accrete,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 31/12/2017
Actual trial start date 31/12/2017
Anticipated date of last follow up 30/06/2018
Actual Last follow-up date 30/06/2018
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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 ( odd , even numbers) simple randomization ( alternating one) Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised simple randomization ( odd , even numbers) simple randomization ( alternating one) Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ordinary treatment operative treatent 40 Active-Treatment of Control Group
Experimental Group step by step apprach operative treatment 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients suffer from placenta accrete either diagnosed antenatal by MRI or Doppler U/S or both. or diagnosed intraoperative ¿ If the patient had previous four or more cesarean scars. ¿ If the patient is 40 years old or more As in both conditions no need to expose the female to surgical hazard of conservation and the safe surgical option for those patients is to preform hysterectomy without attempting to remove the placenta. 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 30/11/2017 tanta university ethical committee
Ethics Committee Address
Street address City Postal code Country
elgish street tanta 31529 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome control bleeding observation of amount of blood loss intraoperative and postoperative vital measures observation
Secondary Outcome duration of operation duration of each step and duration of operation
Secondary Outcome amount of blood transfusion no of blood unit and blood products unis given to the patient
Secondary Outcome complications notice need for ICU postoperative sepsis surgical complication other postoperative complications
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university elgish street tanta 31529 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university elgiesh street tanta 31529 Egypt
self funded elrefaee street tanat Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university elgish street tanta 31529 Egypt University
COLLABORATORS
Name Street address City Postal code Country
shereef lotfy elshwekh elrefaee street tanta Egypt
amal abd elsamea elsokary elrefaee street tanta Egypt
ahmed mahmoud elkhyat alexandria square tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator shereef lotfy elshwekh frommetou35@gmail.com 01221561506 elrefaae street
City Postal code Country Position/Affiliation
tanta Egypt lectuerer obestetrics and gynecology/ tanta university
Role Name Email Phone Street address
Public Enquiries amal abdlesamae elsokary abdlesamae elsokary amalelsokary81@gmail.com 01000653879 elrefaae street
City Postal code Country Position/Affiliation
tanta Egypt lectuerer obestetrics and gynecology/ tanta university
Role Name Email Phone Street address
Scientific Enquiries ahmed mahmoud elkhyat elkhyat81@gmail.com 01008179804 alexandria square
City Postal code Country Position/Affiliation
tanta Egypt lectuerer obestetrics and gynecology/ tanta university
REPORTING
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