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.: PACTR201606001694689 Date of Approval: 24/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Uterine Salvage Using "Modified Lynch Suture"
Official scientific title Uterine Salvage Management For Atonic Postpartum Hemorrhage Using "Modified Lynch Suture"
Brief summary describing the background and objectives of the trial Uterine Salvage Management For Atonic Postpartum Hemorrhage Using a new technique which is the "Modified Lynch Suture"
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery,Uterine Salvage
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2011
Actual trial start date 29/01/2013
Anticipated date of last follow up 05/01/2015
Actual Last follow-up date 15/09/2015
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 160
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
karimwahbaobgyn@yahoo.com Ain Shams Maternity hospital
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 computer selection closed envelop Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group original b lynch suture brace suture on the uterus 80 Active-Treatment of Control Group
Experimental Group modified sutures n/a n/a brace sutures on the uterus with tying the uterine artery as well 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients under general anesthesia with atonic postpartum hemorrhage refractory to uterine massage, ecbolics (oxytocin 30 units IM, methergine 0.25 mg, misoprostol 1000 µg rectal) and bimanual compression. If these measures failed, the modified or classic technique was done randomly. 5 minutes later, the patient is observed abdominally and vaginally for bleeding. If bleeding had stopped, closure of the abdomen with intraperitoneal drain is done, but if bleeding still continued, this represents a failure of the compression sutures thus, internal iliac artery ligation or hysterectomy will be done. Exclusion criteria Patients with traumatic PPH, DIC, bleeding diathesis, retained parts of the placenta or cases with uterine anomalies 20 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 01/01/2013 Ain Shams University ethical committe
Ethics Committee Address
Street address City Postal code Country
ramses street cairo 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome uterine salvage one day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ainshams university maternity hospital abbaseya cairo 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
n/a n/a n/a n/a Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams university ramses cairo 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ain shams university ramses cairo 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohammed elsokkary mohammedelsokkary1@yahoo.com 0201001574386 abbasya
City Postal code Country Position/Affiliation
cairo 12345 Egypt ainshams
Role Name Email Phone Street address
Public Enquiries karim wahba karimwahbaobgyn@yahoo.com 0201001436033 abbasya
City Postal code Country Position/Affiliation
cairo 12345 Egypt abbaseya
Role Name Email Phone Street address
Scientific Enquiries mohammed elsokkary mohammedelsokkary1@yahoo.com 0201001574386 abbasya
City Postal code Country Position/Affiliation
cairo 12345 Egypt abbaseya
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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