| CTRI Number |
CTRI/2025/07/091976 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vaginal misoprostol vs Dinoprostone gel: which is better for induction of labour among females with first delivery. |
|
Scientific Title of Study
|
Comparison of Safety, Efficacy and Fetomaternal Outcome following Induction of Labour With Vaginal Misoprostol v/s Dinoprostone Gel in Primigravida: A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R K Deora |
| Designation |
Professor |
| Affiliation |
DR SN MEDICAL COLLEGE |
| Address |
Department of Obstetrics & Gynecology, JANANA WING, MCH Building, MDM HOSPITAL, JODHPUR
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414285202 |
| Fax |
|
| Email |
drramkanwar613@gmail.com@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrROHITASH KUMAR JAT |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR SN MEDICAL COLLEGE |
| Address |
JANANA WING MDM HOSPITAL JODHPUR
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414285202 |
| Fax |
|
| Email |
rohit26.rc29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrROHITASH KUMAR JAT |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR SN MEDICAL COLLEGE |
| Address |
Department of Obstetrics and Gynecology, JANANA WING, MCH Building, MDM HOSPITAL JODHPUR
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414285202 |
| Fax |
|
| Email |
rohit26.rc29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.S.N.Medical College, Residency ROad, Jodhpur, Rajasthan, India - 342003
342003 |
|
|
Primary Sponsor
|
| Name |
Academic Clinical Trial |
| Address |
Department of Obstetrics and Gynecology, MDM Hospital, Jodhpur |
| 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 ROHITASH KUMAR JAT |
MDM Hospital |
Room 4, Department of Obstetrics and Gynecology, MDM Hospital, Shastri Nagar, Jodhpur
Jodhpur
RAJASTHAN |
09414285202
rohit26.rc29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Dr S.N.Medical College, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dinoprostone gel |
0.5mg, 2 dose 12 hours apart |
| Intervention |
Tab Misoprostol |
25 mcg, 2 dose 12 hours apart |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
primigravida, term pregnancy, live fetus, bishop score less than equal to 5 |
|
| ExclusionCriteria |
| Details |
multifetal pregnancy, malpresentation, abnormal fetal heart rate pattern, CPD, previous uterine surgery, placenta previa |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| induction to delivey interval, change in Bishop score |
Hourly till delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| requirement of oxycotcin augmentation |
6 hours |
|
|
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 |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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="0"
Months="3"
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 randomized controlled study aims to compare the safety, efficacy, and fetomaternal outcomes of two pharmacological agents namely vaginal misoprostol and intracervical dinoprostone gel, for the induction of labor in primigravida women. Conducted at Mathura Das Mathur Hospital, Jodhpur, under the Department of Obstetrics and Gynaecology, the study includes 50 term primigravida patients divided equally into two groups. Group A will receive 25 µg misoprostol intravaginally every 4 hours (maximum 2 doses), while Group B will receive 0.5 mg dinoprostone gel intracervically every 6 hours (maximum 2 doses). The study evaluates key parameters such as induction-to-delivery interval, Bishop score changes, requirement for oxytocin, mode of delivery, maternal and neonatal complications, Apgar score, and overall success or failure of labor induction. Data will be analyzed using SPSS software, with a p-value of <0.05 considered statistically significant. Ethical approval and informed consent procedures are in place to ensure patient safety and confidentiality. Previous literature supports misoprostol as a cost-effective, stable alternative with faster labor outcomes, although with higher risks of uterine hyperstimulation. This study seeks to provide localized, evidence-based recommendations for labor induction practices in resource-limited settings. |