Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000793415
Ethics application status
Approved
Date submitted
12/04/2016
Date registered
17/06/2016
Date last updated
17/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Conservative treatment of adherent placenta in women experiencing uterine bleeding after childbirth
Scientific title
Cervical isthmic opposition suture with bilateral internal iliac artery ligation as a conservative treatment for postpartum hemorrhage in patients with placenta previa accrete
Secondary ID [1] 288980 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postpartum hemorrhage 298375 0
Condition category
Condition code
Surgery 298478 298478 0 0
Surgical techniques
Reproductive Health and Childbirth 298690 298690 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The protocol consists of transverse compression suture of lower uterine segment with bilateral iliac artery ligation . Isthmic-cervical apposition suture will be applied . A qualified obstetrician with minimum 5 years of surgical experience will perform this procedure, A No.1 vicryl on curved needle will be passed through the uterus from cevix down up to the uterine incision including the lower uterine segment . The needle will be passed from the anterior to the posterior aspect of the uterus and then brought back from the posterior through the anterior wall and tied anteriorly. This will be applied on the oozing side of the lower uterine segment avoiding the cervical canal keeping a tract for a continuous flow. This will be followed with bilateral internal iliac artery ligation .
Intervention code [1] 294466 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297964 0
Proportion of participants in which uterus is conserved through surgical procedure through review of medical records,
Timepoint [1] 297964 0
During surgery
Secondary outcome [1] 322779 0
duration of surgery in hours by review of medical records
Timepoint [1] 322779 0
during surgery
Secondary outcome [2] 323383 0
iatrogenic complications as bladder tears and ureter ligation by intraoperative observation or postoperative complains and ultrasound with in one week of surgery
Timepoint [2] 323383 0
intraoperative
Secondary outcome [3] 323384 0
number of blood products transfused through of review of medical records
Timepoint [3] 323384 0
during surgery and till discharge from hospital

Eligibility
Key inclusion criteria
women not desiring future fertility,
placenta previa centralis and accrete on ultrasound
women who experience postpartum hemorrhage on removal of the placenta with placental invasion suspicious of placenta accreta
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
hemodynamically unstable patients , poor availability of blood products for transfusion

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/04/2015
Date of last participant enrolment
Anticipated
15/07/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 7807 0
Egypt
State/province [1] 7807 0

Funding & Sponsors
Funding source category [1] 293335 0
Hospital
Name [1] 293335 0
Shatby Hospital
Country [1] 293335 0
Egypt
Primary sponsor type
Hospital
Name
Shatby Hospital
Address
Department of Obstetrics and Gynaecology , El-Shatby Maternity University Hospital beside Bibliotheca Alexandrina , El-Shatby , Alexandria , Egypt , 21526
Country
Egypt
Secondary sponsor category [1] 292154 0
None
Name [1] 292154 0
Address [1] 292154 0
Country [1] 292154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294804 0
ALEXANDRIA UNIVERSITY
Ethics committee address [1] 294804 0
Department of Obstetrics and Gynaecology , El-Shatby Maternity University Hospital beside Bibliotheca Alexandrina , El-Shatby , Alexandria , Egypt , 21526
Ethics committee country [1] 294804 0
Egypt
Date submitted for ethics approval [1] 294804 0
12/03/2015
Approval date [1] 294804 0
30/03/2015
Ethics approval number [1] 294804 0
N/A

Summary
Brief summary

OBJECTIVE:
To report our experience with a new conservative management approach to treat postpartum hemorrhage (PPH) due to placenta previa accreta. We evaluated the control of postpartum hemorrhage by isthmic-cervical apposition suture and iliac artery ligation.
METHODS:
A prospective interventional study that will include 20 patients with placenta previa accreta who undergo a conservative management protocol . Inclusion: not desiring future fertility, placenta previa centralis and accrete .Exclusion : unstable , poor availability of blood . The protocol consists of transverse compression suture of lower uterine segment with bilateral iliac artery ligation . Isthmic-cervical apposition suture was applied . A No.1 vicryl on curved needle was passed through the uterus from cevix down up to the uterine incision including the lower uterine segment . This will be followed or preceded with bilateral internal iliac artery ligation .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65114 0
Dr AHMED ELAGWANY
Address 65114 0
Department of Obstetrics and Gynaecology , El-Shatby Maternity University Hospital beside Bibliotheca Alexandrina , El-Shatby , Alexandria , Egypt , 21526
Country 65114 0
Egypt
Phone 65114 0
+201228254247
Fax 65114 0
Email 65114 0
[email protected]
Contact person for public queries
Name 65115 0
Dr AHMED ELAGWANY
Address 65115 0
Department of Obstetrics and Gynaecology , El-Shatby Maternity University Hospital beside Bibliotheca Alexandrina , El-Shatby , Alexandria , Egypt , 21526
Country 65115 0
Egypt
Phone 65115 0
+201228254247
Fax 65115 0
Email 65115 0
[email protected]
Contact person for scientific queries
Name 65116 0
Dr AHMED ELAGWANY
Address 65116 0
Department of Obstetrics and Gynaecology , El-Shatby Maternity University Hospital beside Bibliotheca Alexandrina , El-Shatby , Alexandria , Egypt , 21526
Country 65116 0
Egypt
Phone 65116 0
+201228254247
Fax 65116 0
Email 65116 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.