UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pre-operative or post-operative misoprostol in ceasrean delivery:Dose it differ?
Title of the study (Brief title)	Pre-operative or post-operative misoprostol in cesarean delivery: Doseit differ?
Region	Africa

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

Objectives
Narrative objectives1	comparison of preoperative versus postoperative administration of misoprostol rectally in minimizing intraoperative blood loss and prevention of postpartum hemorrhage
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	amount of blood loss intraoperative and postoperative
Key secondary outcomes	Drop in hematocrite level 24 hours after cesarean section and any drug related complications

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	Preoperative misoprostol received 400 microgram misoprostol after anesthesia at time catheter fixation
Interventions/Control_2	postoperative misoprostol received 400microgram misoprostol after the end of 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	18 years-old <=
Age-upper limit	37 years-old >=
Gender	Female
Key inclusion criteria	full term pregnancy 37-40 weeks planned elective cesarean delivery regional spinal anesthesia
Key exclusion criteria	conditions prolonging surgical time or causing atony as: general anesthesia , antepartum hemorrahge coagulation disorders Previous 2 or more cesarean sections previous rupture uterus muliple pregnancies, polyhydramios or macrosomia
Target sample size	180

Research contact person
Name of lead principal investigator	Ayman Shehata Dawood
Organization	Tanta University
Division name	Ayman Shehata Dawood
Address	Tanta University, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, Egypt
TEL	00201020972067
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, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, E
TEL	00201020972067
Homepage URL
Email	ayman.dawood@med.tanta.edu.eg

Sponsor
Institute	Tanta University
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	Hesham M Borg
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	2017 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date	2017 Year 01 Month 01 Day
Date of closure to data entry	2017 Year 01 Month 01 Day
Date trial data considered complete	2017 Year 01 Month 01 Day
Date analysis concluded	2017 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 21 Day
Last modified on	2016 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029196