UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043809