PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Fri, 24 Sep 2021 15:06:09 GMT)

CTRI Number CTRI/2019/06/019614 [Registered on: 11/06/2019] - Trial Registered Prospectively Last Modified On 05/12/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study Clinical trial to study different methods of induction agents to induce labour Scientific Title of Comparison of efficacy of different modes of induction in predicting the outcome of labour- A Study Randomized controlled trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Vasanthi V Trial Coordinator (multi-center study) Designation Senior Resident Affiliation Joseph nursing home Address Dept of OBGYN, Joseph nursing home, No 10A, Doctor Guruswamy road,,-600031 Dept of OBGYN, Joseph nursing home, No 10A, Doctor Guruswamy road,Chetpet,Chennai-600031 Chennai 600082 Phone 9994197741 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Kurian Joseph Query) Designation Managing Director Affiliation Joseph nursing home Address Flat 2,Rosellyn palace, Doctor Guruswamy road, Chetpet, Chennai Dept of OBGYN, Joseph nursing home, No 10A, Doctor Guruswamy road,Chetpet,Chennai-600031 Chennai TAMIL NADU 600031 India Phone 9840599969 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Kurian Joseph Designation Managing Director Affiliation Joseph nursing home Address Dept of OBGYN, Joseph nursing home, No 10A, Doctor Guruswamy road,Chetpet,Chennai-600031 Dept of OBGYN, Joseph nursing home, No 10A, Doctor Guruswamy road,Chetpet,Chennai-600031 Chennai TAMIL NADU 600082

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India Phone 9840599969 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Dept of OBGYN, Joseph nursing home, No 10A, Doctor Guruswamy road,Chetpet,Chennai-600031 Primary Sponsor Primary Sponsor Details Name Joseph nursing home Address Dept of OBGYN, No 10A,Doctor Guruswamy road, Chetpet,Chennai-31 Type of Sponsor Private hospital/clinic Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Kurian Joseph Joseph nursing home Dept of OBGYN, No 9840599969 10A, Doctor Guruswamy road,Chetp [email protected] et,Chennai-600031 Chennai TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethical Approved 20/05/2019 No Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Pregnant women Intervention / Type Name Details Comparator Agent Intervention Active Control group Prostaglandin E2 gel 0.5mg Prostaglandin E2 gel vaginally maximum 3doses 6hrs apart Comparator Agent Active Control group Oral Misoprostol 25mcg Oral Misoprostol maximum 4 doses 2hours apart Comparator Agent Active Control group Foleys Foleys bulb vaginally and Oral bulb vaginally and Oral Misoprostol 25mcg maximum 4 Misoprostol doses 2hours apart Inclusion Criteria Inclusion Criteria Age From 20.00 Year(s) Age To 40.00 Year(s) Gender Female Details GA more than 37weeks,irrespective of parity
Singleton,cephalic
Intact membranes
Unfavourable cervix
Reassuring Cardiotocography Exclusion Criteria Exclusion Criteria

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Details Fetal malpresentation Rupture of membranes Multifetal gestation Non reassuring FHR changes Fetal growth restriction Fetal demise Prev LSCS or any uterine surgery Anomalous fetus Method of Generating Computer generated randomization Random Sequence Method of On-site computer system Concealment Blinding/Masking Participant Blinded Primary Outcome Outcome Timepoints 1.Time interval between induction and active Time of induction to 72hours maximum phase of labour, 2.Time interval between induction and delivery 3.Patients who had vaginal delivery within 24hours from induction Secondary Outcome Outcome Timepoints 1.Mode of delivery, Intrapartum to 48hrs from delivery 2.Maternal complications, 3.Fetal outcomes Target Sample Size Total Sample Size=300 Sample Size from India=300 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 3 Date of First 16/06/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=8 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details nil Brief Summary This study is a randomised,single blind,parallel group,multiarm trial comparing the efficacy of PGE2 gel,Oral Misoprostol and combination of Foleys and Oral Misoprostol in induction of Lbaour.The primary outcomes were time interval between induction to entry into active phase of labour, time interval between induction to delivery, number of patients who had vaginal delivery within 24hrs of induction. Secondary outcomes include maternal and neonatal complications.

6months update:

The study is on the process, undergoing recruitement. As of now 250 patients have been enrolled in the study for the past 6months.

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