UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of postplacental IUD insertion during cesarean section at a tertiary care hospital in Egypt
Title of the study (Brief title)	Evaluation of postplacenta IUD insertion during CS
Region	Africa

Condition
Condition	finished
Classification by specialty	Obsterics 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	Ayman Shehata Dawood
Organization	Tanta university
Division name	Ayman shehata dawood
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	Ayman Shehata Dawood
Address	Tanta university
TEL	+201020972067
Homepage URL
Email	ayman.dawood@med.tanta.edu.eg

Sponsor
Institute	Tanta University Obstetrics and Gynecology department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035443