UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025315 |
|---|---|
| Receipt number | R000029120 |
| Scientific Title | Comparison of two uterine sparing techniques in the management of placenta accreta spectrum: A multicenter randomized clinical study |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2024/03/18 16:37:54 |
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Basic information
Public title
Comparison of two uterine sparing techniques in the management of placenta accreta spectrum: A multicenter randomized clinical study
Acronym
Comparison of two uterine sparing techniques in PAS. A randomized multicenter study
Scientific Title
Comparison of two uterine sparing techniques in the management of placenta accreta spectrum: A multicenter randomized clinical study
Scientific Title:Acronym
Comparison of two uterine sparing techniques in PAS. A randomized multicenter study
Region
| Africa |
Condition
Condition
completed
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare two uterine sparing techniques in management of placenta accreta
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The primary outcome was the success of the procedure in preserving the uterus.
Key secondary outcomes
need for any other interventions, need for ICU, re-admonitions and re-operation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
group 1 will be operated by Assar's technique that include:
1-Vascular ligation of both Uterine and internal iliac arteries
2-excision of lower segment with placenta enblock
3-cervico-isthmic approximation
Interventions/Control_2
Group 2 operated by shehata's technique which include:
1- double ligation of uterine arteries on both sides before and after placental separation
2- suturing of placenta bed with 2 quadrable sutures
3-insetion of triple way foly's catheter
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 22 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
(a) Preoperative diagnosis of PAS either by ultrasound or magnetic resonance imaging (MRI)
(b) patients wishing future fertility,
(c) patients declined hysterectomy.
Key exclusion criteria
(a) Patients completing their family
(b)Patients accepting hysterectomy
(c) hemodynamic instability
(d) patient with more than 3 prior cesarean sections
Target sample size
145
Research contact person
Name of lead principal investigator
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta University
Division name
Ayman Shehata Dawood
Zip code
31111
Address
Tanta University, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, Egypt
TEL
00201020972067
ayman.dawood@med.tanta.edu.eg
Public contact
Name of contact person
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta University
Division name
Ayman Shehata Dawood
Zip code
31111
Address
Tanta University, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, E
TEL
00201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta University
Institute
Department
Personal name
Funding Source
Organization
Tanta University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tanta university
Address
Elgeish st., Tanta, Egypt
Tel
+201020972067
ayman.dawood@med.tanta.edu.eg
Secondary IDs
Secondary IDs
YES
Study ID_1
Abdelghaffar Said Dawood
Org. issuing International ID_1
Tanta University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
220
Results
will be uploaded
Results date posted
| 2021 | Year | 02 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
will be uploaded
Participant flow
will be uploaded
Adverse events
will be uploaded
Outcome measures
will be uploaded
Plan to share IPD
Accept
IPD sharing Plan description
Accept on reasonable request
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029120
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