| CTRI Number |
CTRI/2026/04/109072 [Registered on: 22/04/2026] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two methods of inducing labour in women with term pregnancy |
|
Scientific Title of Study
|
Comparative study of safety and efficacy of dinoprostone vaginal insert versus dinoprostone gel for cervical ripening and induction of labour |
| Trial Acronym |
DINO-IOL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalpana Mehta |
| Designation |
Senior Professor |
| Affiliation |
DR SN MEDICAL COLLEGE,JODHPUR |
| Address |
DR SN MEDICAL COLLEGE
Department of obstetrics and Gynaecology
Sector D shastri Nagar, Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9468813459 |
| Fax |
|
| Email |
hod.obstgyne@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Mehta |
| Designation |
Senior Professor |
| Affiliation |
DR SN MEDICAL COLLEGE,JODHPUR |
| Address |
DR SN MEDICAL COLLEGE
Department of obstetrics and Gynaecology
Sector D shastri Nagar, Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9468813459 |
| Fax |
|
| Email |
hod.obstgyne@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Gupta |
| Designation |
Junior Resident |
| Affiliation |
DR SN MEDICAL COLLEGE ,JODHPUR |
| Address |
DR. SN MEDICAL COLLEGE
Department of obstetrics and Gynaecology
Sector D Shastri Nagar,Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342003
India |
| Phone |
08239218076 |
| Fax |
|
| Email |
shwetadoctor444@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SN MEDICAL COLLEGE Department of obstetrics and Gynaecology
Shastri Nagar ,Jodhpur, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
Dr SN Medical college Jodhpur Rajasthan |
| Address |
Residency Road Sector-D Shastri Nagar Jodhpur Rajasthan India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Gupta |
Dr S N Medical College, Jodhpur |
Department of Obstetrics and Gynaecology umaid hospital labour room
Jodhpur
RAJASTHAN |
8239218076
shwetadoctor444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dinoprostone vaginal gel |
0.5mg intracervical gel for total duration of 6 months |
| Intervention |
Dinoprostone vaginal insert |
10mg controlled release for a total duration of 6months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
In this study we will include pregnant women with Term singleton pregnancy with indications for Induction of labour like gestation Hypertension,gestational diabetes and Oligohydrominos having bishop score less than 6 |
|
| ExclusionCriteria |
| Details |
It include pregnant women in active phase of labour with ruptured membranes or having previous history of c section or myomectomy or allergic to prostaglandins |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Induction to delivery interval |
start point:time when dinoprostone is administered either gel or vaginal
End point: time when baby is delivered(vaginal or C section) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in bishop score |
Baseline(before drug) at 0.0 mins & every 6 hours until active labour that is 6hrs, 12hrs etc |
| Need for oxytocin augmentation |
During labour until delivery that is 0,2,4,6hrs |
| Maternal complications |
During labour and within 24 hours postpartum |
| Neonatal outcomes |
Apgar at Birth, 5 min & until discharge from nursery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
05/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized open label parallel group trial Comparing dinoprostone vaginal gel and dinoprostone vaginal insert for induction of labour in term pregnant women with unfavourable cervix. The primary outcome is induction to delivery interval. Secondary outcome include Bishop score change need for oxytocin mode of delivery and maternal and neonatal safety |