UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038447 |
|---|---|
| Receipt number | R000043809 |
| Scientific Title | Comparison between the classical and a new method for episiotomy repair |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2022/05/04 20:00:59 |
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Basic information
Public title
Comparison between the classical and a new method for episiotomy repair
Acronym
Clinical trial
Scientific Title
Comparison between the classical and a new method for episiotomy repair
Scientific Title:Acronym
Comparison between the classical and a new method for episiotomy repair: A clinical trial
Region
| Africa |
Condition
Condition
Clinical trial
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and benefits of the new episiotomy repair method over the classical method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Hemotoma formation
Fistula formation
Repair time
Blood loss
Key secondary outcomes
Infection rate
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 not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Repair of episiotomy by the new method starting by deep muscles then superficial muscles then vaginal mucosa then skin
Interventions/Control_2
Classical repair technique starts by vaginal mucosa then deep muscles then superficial muscles then skin
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
All patients in normal vagunal delivery in need for episiotomy:
Narrow vagina
Primigravida
Operative delivery
Excessive fibrosis of perineum
Key exclusion criteria
Refusal to participate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta University
Division name
Obstetrics and Gynecology
Zip code
31111
Address
Elgeish st. , Tanta, Egypt
TEL
+0201020972067
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
Obstetrics and gynecology
Zip code
31111
Address
Elgesih st., Tanta, Egypt
TEL
+0201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta Univeristy
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
Adel Elgergawy
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
| 2019 | Year | 11 | Month | 01 | 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
114
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
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 30 | Day |
Last modified on
| 2022 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043809
