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.: PACTR201601001435165 Date of Approval: 23/01/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title intrauterine Washing With Misopristole to improve efficacy of Bakri balloon
Official scientific title Using Of Bakri Ballon Cathter With Intrauterine Washing With Misopristole In Cases Of Atonic Postpartum Hemorrhage
Brief summary describing the background and objectives of the trial this randomized prospective comparative trial will be conducted in maternity hospital Minia University after taking approval of ethical committee of faculty of medicin . target participants will be 150 patient with a tonic PPH not indicated for surgical intervention will be allocated randomly into three groups group (1)will include 50 patients will be treated conservatively group (2) will be managed with Bakri balloon alone group (3) will be managed with Bakri and intrauterine misopristole wash all groups will be compared as regard outcome need for blood transfusion,ICU admission, duration of admission,need for surgical intervention,maternal morbidity and mortality.all cases will be subjected to history taking, assessment for risk factors for PPH,preliminary investigation TVUS to exclude retained product ,pre interventional exclusion of other causes of PPH, postpartum HB%,duration of hospital stay,postpartum endometritis.data will be analysed
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/02/2016
Actual trial start date 01/03/2016
Anticipated date of last follow up 14/06/2016
Actual Last follow-up date 04/09/2016
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 150
Recruitment status Completed
Publication URL not yet
Secondary Ids Issuing authority/Trial register
Minia faculty of medicine Maternity Hospital Minia University
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 randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conservative treatment traditional ecobolic till arrest of bleeding IV infusion of 10 IU oxytocin , IM methargin one ampoul or two if patient not hypertensive , not cardiac 50 Historical
Experimental Group Bakri balloon inflation according to uterine capacity 24 inflation of balloon under US guide according to uterine capacity with follow up of amount of blood loss , if successful removed after 24 h 50
Experimental Group Bakri balloon plus intrauterine wash with misopristole 4 tablets (each one 200microgm) 24 dissolution of 4 tablets misopristole in normal saline and injection through Bakri balloon intrauterine 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age (18-45), All Parities, Delivered inside or outside the hospital, Vaginal or cesarean delivery and Suffered atonic postpartum hemorrhage There is no genital tract laceration, There is no uterine rupture, There is no retention of placenta and Blood coagulation system is intact. 18 Year(s) 45 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
No 01/02/2016 ethical committee faculty of medicine
Ethics Committee Address
Street address City Postal code Country
university street Minia 6111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome need for blood transfusion, need for surgical intervention,postpartum infection first 24 hours after labour till hospital discharge
Secondary Outcome postpartum HB%, ICU admission , duration of ICU admission, duration of hospital stay first 24 h after labour till hospital discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University university street Minia 6111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minia Maternity Hospital university street Minia 6111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minia Maternity Hospital university street Minia 6111 Egypt Hospital
Secondary Sponsor faculty of medicine university street Minia 5161 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Hosni Taha Hussin Minia 5411 Egypt
Mahmoud Hosni Taha Hussin Minia 5411 Egypt
Reham elkateeb Taha Hussin Minia 5111 Egypt
Reham elkateeb Taha Hussin Minia 5111 Egypt
Ahmad Mahran shalabi street Minia 5411 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reham Elkateeb rehamelkhateeb78@yahoo.com 00201011966648 Taha Hussin
City Postal code Country Position/Affiliation
Minia 5111 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries hossam shawki hossam20002003@yahoo.com 0021223475856 Adnan Elmalky
City Postal code Country Position/Affiliation
Minia 5161 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Ahmad Mahran ezzeldin_ahmad@yahoo.com 0021115551073 shalabi street
City Postal code Country Position/Affiliation
minia 51411 Egypt lecturer
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
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information