UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of mechanical cervical dilatation during elective cesarean section on postpartum infectious morbidity and scar integrity: a randomized double-blind clinical trial
Title of the study (Brief title)	impact of Mechanical cervical dilatation during cesarean section on postpartum morbidity and scar integrity
Region	Africa

Condition
Condition	completed
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of mechanical dilatation of the cervix during cesarean section on the postpartum infectious morbidity and cesarean scar integrity at 6 months posto-peratively.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Scar evaluation (integrity and defects) after 6 months following cesarean section
Key secondary outcomes	1-Hospital stay 2-Febrile morbidity 3-Wound infection 4-Endometritis. 5-Subinvolution of uterus

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	mechanical dilation of cervical canal from up-down using hegar no. 6
Interventions/Control_2	No mechanical dilation of cervical canal
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	18 years-old <=
Age-upper limit	40 years-old >=
Gender	Female
Key inclusion criteria	patient with closed cervix not allowing passage of blood of peuroerium either previous cesarrean or normal delivery Elective deliveries
Key exclusion criteria	Patients in labour with dilated cervix patient with gestations less than 28 weeks patient refusing to participate in the study
Target sample size	400

Research contact person
Name of lead principal investigator	Ayman Shehata Dawood
Organization	Tanta university
Division name	Obstetrics and gynecology
Address	Tanta university
TEL	+201020972067
Email	ayman.dawood@med.tanta.edu.eg

Public contact
Name of contact person	Ayman shehata dawood
Organization	Tanta university
Division name	Obstetrics and gynecology
Address	Tanta university
TEL	+201020972067
Homepage URL
Email	ayman.dawood@med.tanta.edu.eg

Sponsor
Institute	Tanta university, department of obstetrics and gynecology
Institute
Department

Funding Source
Organization	Tanta university, department of obstetrics and gynecology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
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 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Results are finished and we finalize discussion
Other related information

Management information
Registered date	2017 Year 06 Month 26 Day
Last modified on	2018 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032010