UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	brahul2371@gmail.com

Sponsor
Institute	JNMC
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044719