UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025363 |
|---|---|
| Receipt number | R000029196 |
| Scientific Title | Pre-operative or post-operative misoprostol in ceasrean delivery:Dose it differ? |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2016/12/21 21:33:09 |
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Basic information
Public title
Pre-operative or post-operative misoprostol in ceasrean delivery:Dose it differ?
Acronym
Pre-operative or post-operative misoprostol in cesarean delivery: Doseit differ?
Scientific Title
Pre-operative or post-operative misoprostol in ceasrean delivery:Dose it differ?
Scientific Title:Acronym
Pre-operative or post-operative misoprostol in cesarean delivery: Doseit differ?
Region
| Africa |
Condition
Condition
Finished
Classification by specialty
| Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Ayman Shehata Dawood |
Organization
Tanta University
Division name
Ayman Shehata Dawood
Zip code
Address
Tanta University, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, Egypt
TEL
00201020972067
ayman.dawood@med.tanta.edu.eg
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayman Shehata Dawood |
Organization
Tanta University
Division name
Ayman Shehata Dawood
Zip code
Address
Tanta University, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, E
TEL
00201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta University
Institute
Department
Personal name
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
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029196
