UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027946 |
|---|---|
| Receipt number | R000032010 |
| Scientific Title | The impact of mechanical cervical dilatation during elective cesarean section on postpartum infectious morbidity and scar integrity: a randomized double-blind clinical trial |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/11/28 16:31:04 |
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Basic information
Public title
The impact of mechanical cervical dilatation during elective cesarean section on postpartum infectious morbidity and scar integrity: a randomized double-blind clinical trial
Acronym
impact of Mechanical cervical dilatation during cesarean section on postpartum morbidity and scar integrity
Scientific Title
The impact of mechanical cervical dilatation during elective cesarean section on postpartum infectious morbidity and scar integrity: a randomized double-blind clinical trial
Scientific Title:Acronym
impact of Mechanical cervical dilatation during cesarean section on postpartum morbidity and scar integrity
Region
| Africa |
Condition
Condition
completed
Classification by specialty
| Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Ayman Shehata Dawood |
Organization
Tanta university
Division name
Obstetrics and gynecology
Zip code
Address
Tanta university
TEL
+201020972067
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
Obstetrics and gynecology
Zip code
Address
Tanta university
TEL
+201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta university, department of obstetrics and gynecology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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 are finished and we finalize discussion
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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032010
