Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000606684
Ethics application status
Approved
Date submitted
28/05/2014
Date registered
6/06/2014
Date last updated
17/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between the outcomes of adherent placenta encountered during emergencies and adherent placenta managed electively
Scientific title
Comparison between the outcomes of placenta accreta encountered during emergencies and placenta accreta managed electively
Secondary ID [1] 284676 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Placenta accreta 291986 0
Condition category
Condition code
Reproductive Health and Childbirth 292331 292331 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
20 women with placenta accreta presenting to the labour ward in an emergency (Group1) will be compared to 20 women having elective Cesarean section (CS) for placenta accreta (Group2).
Both groups will be compared regarding their base line criteria, their sonographic and Doppler findings, the management, operation time, whether the CS was upper segment or lower segment and if removal of the placenta was attempted.
Each participant is expected to be observed 4 times during the study and the overall duration of observation is expected to be one week.
All women will be subjected to full history taking, abdominal examination, ultrasound examination to confirm fetal number, viability, gestational age, exclusion of congenital anomalies and assessment of the amniotic fluid index and localization of the placenta
All women with Placenta previa and women with previous CS who have anterior placentas covering the CS scar are at increased risk of having placenta accreta.
Placenta accreta will be suspected using a grey scale ultrasound when there is loss of the retroplacental sonolucent zone, irregular retroplacental sonolucent zone, thinning or disruption of the hyperechoic serosa–bladder interface, presence of focal exophytic masses invading the urinary bladder or the presence of abnormal placental lacunae.
In the presence of any of the previous criteria colour Doppler will be applied and the following criteria will support the diagnosis of placenta accreta: diffuse or focal lacunar flow, vascular lakes with turbulent flow (peak systolic velocity over 15 cm/s), hypervascularity of serosa–bladder interface, or markedly dilated vessels over peripheral subplacental zone.
3D ultrasound and MRI facilities are not available in the labour ward, but women presenting electively can have 3D ultrasound, MRI scan or both if necessary for further confirmation of placenta accreta. placenta accreta will be confirmed clinically and histopathologically.
Women presenting to the labour ward will have a CS if they have regular uterine contractions, excessive bleeding indicating delivery or if their gestational age is greater than or equal to 38 weeks.
All women will have CS and placenta accreta will be confirmed clinically and histopathologically.
Intervention code [1] 289460 0
Not applicable
Comparator / control treatment
20 women with placenta accreta presenting to the labour ward in an emergency (Group1) will be compared to 20 women having elective CS for placenta accreta (Group2)
Control group
Active

Outcomes
Primary outcome [1] 292217 0
Eestimated blood loss during surgery.
The amount of blood in the suction container (which represents the amount of blood sucked from the surgical field) will be added to that staining the surgical towels and the sum will represent the estimated blood loss during surgery.
Timepoint [1] 292217 0
5 minutes after the Cesarean section
Secondary outcome [1] 308437 0
Need for hysterectomy
Timepoint [1] 308437 0
5 minutes after surgery
Secondary outcome [2] 308438 0
Need for blood transfusion
Timepoint [2] 308438 0
1 hour after surgery
Secondary outcome [3] 308439 0
surgical complications like injury to the bowel, bladder or ureters
Timepoint [3] 308439 0
5 minutes after completion of surgery
Secondary outcome [4] 308440 0
the need for admission to the intensive care unit
Timepoint [4] 308440 0
24 hours after surgery
Secondary outcome [5] 308441 0
Postoperative hospital stay
Timepoint [5] 308441 0
one week after the surgery

Eligibility
Key inclusion criteria
-Suspected placenta accreta (In the labour ward placenta accrete will be suspected by the grey scale ultrasound and colour Doppler. In women presenting electively, 3D ultrasound or MRI may be used for further confirmation)
-consent to participate in the study
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-Intra uterine fetal death.
-Preeclampsia, Diabetes Mellitus or other medical disorders.
- Boby mass index (BMI)>35
-Known coagulation defects

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a pilot study with no available data on management of suspected placenta accreta during emergencies. We have planned to enrol 40 patients in the study; at the end of the study we may recommend doing further studies with a larger sample size.


Quantitative data will be statistically represented in terms of mean +/- standard deviation (+/- SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using Mann Whitney U test for independent samples while categorical data will be compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/06/2014
Actual
12/06/2014
Date of last participant enrolment
Anticipated
30/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 6074 0
Egypt
State/province [1] 6074 0
Cairo

Funding & Sponsors
Funding source category [1] 289300 0
University
Name [1] 289300 0
Cairo University
Country [1] 289300 0
Egypt
Primary sponsor type
University
Name
Cairo University
Address
Kasr Al-Ainy,
1 Al-Saray Street,
Al-Manial, Cairo
Postal Code 11559
EGYPT
Country
Egypt
Secondary sponsor category [1] 287970 0
Hospital
Name [1] 287970 0
Cairo University hospitals
Address [1] 287970 0
Cairo university hospitals
Kasr Al-Ainy,
1 Al-Saray Street,
Al-Manial, Cairo
Postal Code 11559
EGYPT
Country [1] 287970 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291064 0
Research ethics committee, Department of Gynecology and Obstetrics
Ethics committee address [1] 291064 0
Ethics committee country [1] 291064 0
Egypt
Date submitted for ethics approval [1] 291064 0
Approval date [1] 291064 0
15/05/2014
Ethics approval number [1] 291064 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48670 0
Mr AbdelGany Hassan
Address 48670 0
Work address:
Department of Gynecology and Obstetrics,
Cairo University hospitals
Kasr Al-Ainy,
1 Al-Saray Street,
Al-Manial, Cairo
Postal Code 11559
EGYPT

Country 48670 0
Egypt
Phone 48670 0
+20 010 17801604
Fax 48670 0
Email 48670 0
[email protected]
Contact person for public queries
Name 48671 0
AbdelGany Hassan
Address 48671 0
Work address:
Department of Gynecology and Obstetrics,
Cairo University hospitals
Kasr Al-Ainy,
1 Al-Saray Street,
Al-Manial, Cairo
Postal Code 11559
EGYPT
Country 48671 0
Egypt
Phone 48671 0
+20 010 17801604
Fax 48671 0
Email 48671 0
[email protected]
Contact person for scientific queries
Name 48672 0
AbdelGany Hassan
Address 48672 0
Work address:
Department of Gynecology and Obstetrics,
Cairo University hospitals
Kasr Al-Ainy,
1 Al-Saray Street,
Al-Manial, Cairo
Postal Code 11559
EGYPT
Country 48672 0
Egypt
Phone 48672 0
+20 010 17801604
Fax 48672 0
Email 48672 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

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