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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038447
Receipt No. 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 2019/10/30

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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
Obsterics 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
Email 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
Email ayman.dawood@med.tanta.edu.eg

Sponsor
Institute Tanta Univeristy
Institute
Department

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
Email 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
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 Preinitiation
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
2020 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
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043809

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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