UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039212 |
|---|---|
| Receipt number | R000044719 |
| Scientific Title | Oral versus vaginal administration of misoprostol for induction of labor in women with pre labour rupture of membranes. Results of a randomized controlled trial |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2020/01/21 14:57:04 |
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Basic information
Public title
Oral versus vaginal administration of misoprostol for induction of labor in women with pre labour rupture of membranes. Results of a randomized controlled trial
Acronym
Misoprostol for PROM
Scientific Title
Oral versus vaginal administration of misoprostol for induction of labor in women with pre labour rupture of membranes. Results of a randomized controlled trial
Scientific Title:Acronym
Oral versus vaginal misoprostol for PROM
Region
| Asia(except Japan) |
Condition
Condition
Premature rupture of membranes at term
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary outcome measure was to compare the effectiveness of orally administered misoprostol, with vaginally administered misoprostol for induction of labor in PROM cases.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Primary outcome measure was to compare the effectiveness of orally administered misoprostol, with vaginally administered misoprostol for induction of labor in PROM cases.
Key secondary outcomes
Secondary outcomes were evaluation of mean interval between induction and active labor and the Induction to delivery interval.
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 considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
25 mcg of misoprostol 2- hourly, orally
Interventions/Control_2
25mcg misoprostol vaginally, 3-hourly
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
RROM
Key exclusion criteria
CD 4
BS 6
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Vartika |
| Middle name | |
| Last name | Mohan |
Organization
JN Medical College
Division name
Belagavi
Zip code
590010
Address
Department of OBG, JN Medical College, Belagavi, Karnataka
TEL
9643148625
anitamgan@gmail.com
Public contact
Name of contact person
| 1st name | Rahul |
| Middle name | |
| Last name | Bhargava |
Organization
Rama Medical College
Division name
Hapur
Zip code
201301
Address
b2-004, Ananda Apartments
TEL
9999055223
Homepage URL
brahul2371@gmail.com
Sponsor or person
Institute
JNMC
Institute
Department
Personal name
Funding Source
Organization
JN medical college
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JNMC
Address
Nehru Nagar, Belagavi
Tel
08312471350
principal@jnmc.edu
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
Medical College Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
bhargavaeyecare.in
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 21 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044719
