UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031035 |
|---|---|
| Receipt number | R000035443 |
| Scientific Title | Evaluation of postplacental IUD insertion during cesarean section at a tertiary care hospital in Egypt |
| Date of disclosure of the study information | 2018/01/30 |
| Last modified on | 2019/01/29 20:36:32 |
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Basic information
Public title
Evaluation of postplacental IUD insertion during cesarean section at a tertiary care hospital in Egypt
Acronym
Evaluation of postplacenta IUD insertion during CS
Scientific Title
Evaluation of postplacental IUD insertion during cesarean section at a tertiary care hospital in Egypt
Scientific Title:Acronym
Evaluation of postplacenta IUD insertion during CS
Region
| Africa |
Condition
Condition
finished
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of feasibility, acceptability and success rate of IUD insertion during cesarean section
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
duration of surgery, amount of bleeding, postoperative pain, infection,
Key secondary outcomes
Displacement, failure and discontinuation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
IUD insertion CU380 A at cesarean section after placental removal
Interventions/Control_2
IUD insertion at 3 months interval after cesarean section
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
| 19 | years-old | <= |
Age-upper limit
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
elective or emergent cs
patients desiring immediate contraception
Key exclusion criteria
upper segment or classical cesarean scar
previous myomectomy
placenta previa or accreta
evident infections as chorioamnionitis
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayman Shehata Dawood |
Organization
Tanta university
Division name
Ayman shehata dawood
Zip code
Address
Tanta university
TEL
+201020972067
ayman.dawood@med.tanta.edu.eg
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayman shehata dawood |
Organization
Tanta university
Division name
Ayman Shehata Dawood
Zip code
Address
Tanta university
TEL
+201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta University
Obstetrics and Gynecology department
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
Sherif Lotfy Elshoeikh
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
| 2018 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 28 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035443
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| Registered date | File name |
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| Registered date | File name |
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